Ameph Emuue Ngsmuthrsaakhr

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating elritercept for its ability to reduce the need for red blood cell RBC transfusions and its safety compared to epoetin alfa in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who require regular blood transfusions. The study aims to understand if elritercept improves tiredness, lowers transfusion burden, enhances quality of life, and elicits an immune response. Participants receive either elritercept or epoetin alfa injections. Elritercept is given as a subcutaneous injection starting at 3.75 mgkg every 4 weeks, with possible dose increases to 5.0 mgkg. Epoetin alfa is administered as a subcutaneous injection starting at 450 IUkg once weekly, with possible dose escalation up to 1050 IUkg. The study follows participants for approximately 5 years to monitor treatment effects and safety. During the trial, participants are regularly assessed for transfusion independence, hemoglobin levels, fatigue, quality of life, and hematological improvements. Researchers monitor blood samples for drug concentration and immune response. Safety is evaluated through medical history, lab tests, and adverse event tracking. The main outcome is the proportion of participants achieving RBC transfusion independence for at least 12 weeks during the first 24 weeks. The study uses questionnaires and clinical assessments to measure fatigue and quality of life.

Researchers are evaluating whether skipping tracheal suctioning right before removing a breathing tube is as safe as routine suctioning for adult patients aged 18 to 90 who undergo planned surgery under general anesthesia with endotracheal intubation. The study aims to see if avoiding suctioning affects early oxygen levels after the tube is removed and whether it impacts cough severity, sore throat, and other related side effects. Participants are randomly divided into two groups one receiving routine suctioning inside the trachea and throat just before extubation, and the other receiving suctioning only in the throat without inserting the suction catheter into the trachea. All patients receive standard anesthesia care and are monitored in the post-anesthesia care unit PACU for 60 minutes after extubation. Airway symptoms and satisfaction are checked again 24 hours after surgery. During the study, participants will have their oxygen levels monitored closely for the first hour after extubation, along with assessments of coughing, sore throat severity, nausea, vomiting, and any extubation-related problems. Researchers will also record oxygen therapy needs and patient satisfaction at 24 hours. Safety monitoring continues up to 6 hours post-PACU arrival. Overall participation involves the surgery day and a follow-up at 24 hours post-surgery.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

Researchers are evaluating the efficacy and safety of combining gedatolisib and palbociclib with endocrine therapy compared to endocrine therapy and ribociclib in adults with hormone receptor-positive, HER2-negative advanced breast cancer. This Phase 3, open-label, randomized clinical trial involves patients with locally advanced or metastatic breast cancer who have either endocrine-resistant or endocrine-sensitive disease. The study aims to explore treatment options for this specific breast cancer subtype to improve outcomes for patients. Participants are assigned to one of two studies based on their endocrine sensitivity status. Study 1 includes patients with endocrine-resistant cancer who will receive either intravenous gedatolisib combined with oral palbociclib and intramuscular fulvestrant or oral ribociclib with fulvestrant. Study 2 includes endocrine-sensitive patients who will receive intravenous gedatolisib with oral palbociclib and letrozole or oral ribociclib with letrozole. Treatments are administered in cycles with specific dosing schedules, including weekly intravenous infusions and oral medications over 28-day cycles. During the trial, participants will undergo screening to confirm eligibility before randomization. Researchers will monitor progression-free survival for up to 48 months as the primary outcome, along with secondary outcomes such as overall survival, response rates, duration and time to response, clinical benefit, quality of life, and adverse events. Safety follow-up will occur 30 days after treatment, and ongoing assessments will include imaging, tumor biopsies, laboratory tests, and quality of life questionnaires. The study is expected to last several years with continuous monitoring of patient health and treatment effects.

Researchers are evaluating Remdesivir VEKLURY4 in children under two years old who are hospitalized with confirmed respiratory syncytial virus RSV infection. This Phase II, open-label, randomized controlled trial aims to assess the safety, antiviral activity, and acceptability of a five-day course of Remdesivir compared to standard care. The study focuses on how well the treatment reduces RSV replication and its safety profile in this young patient group. Participants will be randomly assigned to one of two groups one group will receive standard care alone, which may include oxygen therapy, bronchodilators, intravenous fluids, steroids, antibiotics, and treatment for underlying diseases as needed. The other group will receive Remdesivir by intravenous infusion every 24 hours for five consecutive days in addition to the standard care. Treatment doses will be based on the childs weight at the time of randomization. The study will enroll about 120 children and follow them throughout hospitalization plus a final visit 7 to 10 days after Day 6. Throughout the study, researchers will monitor participants for safety and tolerability of Remdesivir, measure RSV viral load, and assess the treatments effectiveness over one week. Assessments will include clinical observations, laboratory tests, and evaluations of respiratory status. The follow-up after hospitalization will help determine the lasting effects and acceptability of the treatment in this population.