Ameph Emuue Ngsmuthrsaakhr

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating whether skipping tracheal suctioning right before removing the breathing tube is as safe as routine suctioning for adult patients aged 18 to 90 undergoing elective surgery with general anesthesia. The study focuses on early postoperative oxygen levels and looks at whether not suctioning increases the risk of oxygen drops or affects cough severity, sore throat, and other airway-related complications after surgery. Participants are randomly assigned to one of two groups: one receiving routine suctioning, which includes suctioning inside the trachea and throat before extubation, and the other receiving only throat suctioning without inserting a suction catheter into the trachea. All patients get standard anesthesia care during surgery, and the treatments are performed immediately before removing the breathing tube. After surgery, participants are monitored in the recovery room for 60 minutes to check their oxygen levels and watch for breathing problems. Researchers also follow up 24 hours later to assess airway symptoms like cough and sore throat and gather patient satisfaction information. The primary outcome is measuring oxygen desaturation within the first hour after extubation.

Researchers are evaluating the safety and effectiveness of palazestrant (OP-1250) compared to standard treatments fulvestrant or an aromatase inhibitor in adults with ER-positive, HER2-negative advanced or metastatic breast cancer. Participants have previously received endocrine therapy combined with a CDK4/6 inhibitor, and their cancer has progressed despite this treatment. This phase 3, international, randomized, open-label trial aims to provide new information on treatment options for this population. Participants will be assigned to receive either palazestrant daily in a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or standard endocrine therapy with fulvestrant or one of three aromatase inhibitors (anastrozole, letrozole, or exemestane), given according to their approved schedules. After selecting the optimal palazestrant dose, more participants will be randomized to receive either that dose or standard care. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for adverse events, dose reductions, or treatment discontinuation for up to 16 weeks after randomization. The main outcome is progression-free survival, measured until disease progression or death, with an estimated follow-up of up to 2 years. Assessments will include physical exams, lab tests, and regular evaluations of cancer status and side effects to ensure safety and track the effectiveness of the treatments.

Researchers are evaluating the efficacy and safety of combining gedatolisib with fulvestrant and CDK4/6 inhibitors for treating patients with locally advanced or metastatic hormone receptor positive, HER2-negative (HR+/HER2-) advanced breast cancer. This Phase 3, open-label, randomized trial focuses on patients whose cancer progressed during or within 12 months of adjuvant endocrine therapy and who have not received prior systemic therapy for advanced breast cancer. The trial separates participants into groups based on PIK3CA mutation status and compares the investigational treatment to standard care. Participants receive either the investigational treatment of intravenous gedatolisib once weekly for three weeks followed by a week off, combined with oral palbociclib or ribociclib taken on days 1-21 of each 28-day cycle plus intramuscular fulvestrant every 2 weeks during the first cycle and then every 4 weeks, or the standard-of-care treatment of oral palbociclib or ribociclib with intramuscular fulvestrant on the same schedules without gedatolisib. The study includes a safety run-in phase to determine dosing of gedatolisib with ribociclib before randomization. Throughout the study, participants will undergo assessments to monitor progression-free survival, which is measured from randomization until death from any cause for up to approximately 48 months. Evaluations include tumor tissue or liquid biopsies for PIK3CA status, imaging to assess measurable disease, and monitoring of bone marrow, liver, kidney, and coagulation functions. Safety and efficacy are closely followed with ongoing clinical evaluations, and participants must have an expected life expectancy greater than six months for enrollment.

Researchers are investigating the safety, effectiveness, and acceptance of a five-day course of Remdesivir (VEKLURY4) in children under two years old who are hospitalized with confirmed respiratory syncytial virus (RSV) infection. This Phase II, open-label, multicenter, randomized controlled trial aims to see if Remdesivir can safely reduce RSV replication and be well accepted in this young patient population. The study involves 120 participants and compares standard care alone to standard care plus Remdesivir treatment. Participants will be randomly assigned to one of two groups: one receiving the standard care alone, and the other receiving Remdesivir alongside standard care. Remdesivir is given by intravenous infusion every 24 hours for five consecutive days. The study monitors children hospitalized with RSV infection, with follow-up visits occurring 7 to 10 days after the fifth day of treatment. During the study, children will be assessed for safety and tolerability of Remdesivir, including monitoring clinical signs and laboratory tests. Researchers will evaluate antiviral activity and acceptability of the treatment. The total participation includes the hospitalization period plus additional follow-up days post-treatment to ensure safety and gather final study data.