Ninh Kieu

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Tuberculosis (TB) continues to be a major public health and socioeconomic challenge worldwide, especially in low- and middle-income countries like Vietnam. This study evaluates a psycho-socioeconomic support intervention aimed at improving TB treatment outcomes and reducing the financial hardships faced by TB-affected households. The research uses a hybrid type II effectiveness-implementation randomized control trial design across 12 provinces in Vietnam, focusing on areas with lower TB treatment success rates. Participants will be randomly assigned to receive either standard care or an intervention consisting of cash transfers tied to attendance at peer-led TB Club support meetings. These clubs provide education about TB treatment, encourage adherence, offer social support, and help reduce stigma. Participants in the intervention group can receive up to three cash transfers totaling 3,000,000 VND, with payments made after attending specific TB Club sessions. Throughout the study, researchers will collect data on treatment success, health-related quality of life, stigma, anxiety, depression, and household-level financial impacts such as catastrophic costs and changes in livelihoods. The study will also assess implementation factors like participation, satisfaction, and quality. The main outcomes will be measured over periods ranging from six months to one year, with participants followed through the completion of TB treatment and beyond.

This trial investigates the use of the One-Minute Preceptor (OMP) method to improve bedside teaching for medical students. It is a cluster-randomized study where resident physicians serve as preceptors, and outcomes are measured at the student level. Adequate OMP exposure is defined as at least two structured feedback sessions of five minutes or more, delivered across at least two separate weeks during the rotation. The intervention involves a faculty development workshop lasting 90 minutes, supplemented by a pocket card, coaching, and audits using a five-step OMP fidelity checklist. Preceptors in the intervention group receive OMP training and are monitored for adherence, while control group preceptors do not receive this training. The study clusters consist of 15 preceptors in each arm, each supervising about 15 medical students during an 8 to 12-week rotation. Participants will be assessed using the Mini-Clinical Evaluation Exercise (mini-CEX) total score between 8 and 12 weeks. Students provide informed consent and are observed during their rotations to evaluate teaching quality. The study includes continuous monitoring of teaching fidelity and ensures preceptors do not teach across study arms. The total participation duration aligns with the standard rotation length of 8 to 12 weeks.

The HYIMPACT study is a large, observational research project across seven Asian countries designed to understand how Nebilet (nebivolol) works in people with high blood pressure, also called hypertension. It focuses on how Nebilet affects blood pressure control over time, treatment adherence, quality of life, prescription habits, and heart-related outcomes. The study includes about 5,000 adults with newly diagnosed or uncontrolled hypertension, some of whom may have other heart-related conditions. Participants will either start Nebilet treatment or have been on it for no more than two weeks before joining. They will be observed regularly for up to three years, with blood pressure measurements taken at baseline, 12, 24, and 36 months. The study also compares Nebilet used alone versus in combination with other treatments, and examines the relationship between blood pressure readings taken at home and in the clinic. Throughout the study, patients will have their blood pressure monitored, complete questionnaires about medication adherence and quality of life, and provide health information including cardiovascular risk factors and lab test results when available. Researchers will track major heart events like heart attacks and strokes, and record any side effects. Data will be collected electronically to ensure quality and consistency, helping to provide real-world insights about Nebilet's role in managing hypertension over time.

Researchers are evaluating shorter and safer treatment options for latent tuberculosis infection in adults and children aged 5 years and older. This Phase 2 randomized open-label trial aims to identify at least one tuberculosis preventive treatment (TPT) regimen lasting two months or less that matches or exceeds the safety, completion, and tolerability of the standard 4-month rifampin 10 mg/kg regimen. The study will eventually select the best regimen to move forward into a Phase 3 trial for effectiveness and efficacy testing. Participants will be randomly assigned to one of three daily self-administered treatments: the standard 4 months of rifampin at 10 mg/kg, 2 months of rifampin at 20 mg/kg, or 1 month of levofloxacin and rifapentine. A third experimental regimen, such as 1 month of isoniazid plus rifapentine or a novel regimen, may be added later based on ongoing studies. Treatment completion, safety, and tolerability will be monitored closely, with early safety analyses planned after 100 participants complete each new regimen. Enrollment will continue for up to 24 months to assess all regimens. Participants will have scheduled in-person visits and telephone follow-ups during and after treatment to monitor symptoms, adverse events, and adherence. Blood tests and pharmacokinetic sampling will be done at 2 weeks for all. After treatment, participants will be contacted every 3 months for up to 26 months to check for active tuberculosis disease. Safety will be the primary outcome, focusing on severe treatment-related adverse events from the start of treatment until two weeks after completion. The study will also assess regimen completion, tolerability, acceptability, and tuberculosis incidence.