Amphoe Mueang Lampang

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

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.

Atrial fibrillation (AF) is a common heart rhythm disorder that can lead to serious complications like stroke and bleeding. Asian patients with AF tend to have higher rates of major bleeding, including bleeding in the brain, compared to non-Asian patients. This research focuses on understanding the use of blood-thinning medications called anticoagulants, especially newer drugs known as non-vitamin K antagonist oral anticoagulants (NOACs), which are considered safer than warfarin but are less commonly used in Asian countries due to cost concerns. The study aims to track changes in how these medications are used and how they affect health outcomes over time. The study is a large, prospective observational registry conducted across 33 centers in Thailand, enrolling 3680 patients with non-valvular AF over two years. There is no intervention or treatment assigned by the study; instead, researchers observe patients' current treatments and outcomes. Participants will be followed every six months for a total of three years to monitor their use of warfarin and NOACs and record any serious events such as stroke, systemic embolism, major bleeding, heart attacks, heart failure, and overall quality of life. Throughout the study, patients will undergo regular assessments including clinical evaluations and monitoring of their medication use. The main outcomes measured over the three years include rates of using warfarin and NOACs, occurrence of ischemic stroke or transient ischemic attack, systemic embolism, intracranial hemorrhage, and major bleeding events. This long-term follow-up aims to provide valuable information on treatment patterns and safety in Asian patients with atrial fibrillation.

Researchers are evaluating doravirine combined with tenofovir and lamivudine as an alternative to dolutegravir combined with tenofovir and lamivudine or emtricitabine in adults living with HIV-1 who have never received treatment before. This Phase III, open-label, randomized, non-inferiority trial is conducted in multiple countries including Brazil, Cameroon, Côte d'Ivoire, France, Mozambique, and Thailand. The study aims to compare the effectiveness of these regimens by measuring the control of HIV viral load at 48 weeks. Participants will be randomly assigned to receive either doravirine plus tenofovir and lamivudine or dolutegravir plus tenofovir and lamivudine or emtricitabine, all given orally. The study will follow 610 participants for a total of 96 weeks after starting antiretroviral therapy. Primary evaluation focuses on the proportion of participants who achieve a viral load below 50 copies/mL at week 48. Secondary assessments will be performed at weeks 48 and 96. During the trial, participants will undergo regular monitoring including laboratory tests to measure viral load and kidney and liver function. The study will also assess safety and adherence to treatment. Participants must provide informed consent and will be closely followed throughout the study duration to ensure accurate outcome measurements and safety monitoring.

Researchers are evaluating a phase 3 study of pembrolizumab combined with carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT) in adults with metastatic squamous non-small cell lung cancer. The study aims to determine if adding sac-TMT maintenance to pembrolizumab improves overall survival compared to pembrolizumab alone. Participants have confirmed stage IV squamous NSCLC and measurable disease. All participants first receive an induction phase of four cycles lasting 21 days each. During induction, they receive pembrolizumab every 3 weeks plus carboplatin every 3 weeks, along with either paclitaxel every 3 weeks or weekly nab-paclitaxel. After induction, participants are randomly assigned to continue pembrolizumab maintenance alone or pembrolizumab combined with sac-TMT maintenance. Treatments are given by intravenous infusion. Participants undergo scans to measure tumor response and are monitored for side effects and overall health. Researchers assess overall survival up to about 50 months. Organ function, adverse events, and performance status are regularly evaluated before and during the study. The study includes safety monitoring and follows participants through their treatment and maintenance phases.

Researchers are evaluating sacituzumab tirumotecan compared to a combination of pemetrexed and carboplatin for treating advanced nonsquamous non-small cell lung cancer (NSCLC) with a specific EGFR mutation. This trial focuses on participants whose cancer progressed despite prior treatment with EGFR tyrosine kinase inhibitors. The main goal is to determine if sacituzumab tirumotecan improves overall survival compared to standard platinum-based chemotherapy. Participants are randomly assigned to one of two groups: one receiving sacituzumab tirumotecan at 4 mg/kg through an intravenous infusion, and the other receiving pemetrexed at 500 mg/m² plus carboplatin dosed by area under the curve (AUC 5 mg/mL*min) via intravenous infusion. Treatment continues until certain criteria for stopping are met. Rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, or steroid mouthwash may be given as needed according to approved guidelines. During the study, participants will be closely monitored for overall survival for up to approximately 51 months. Researchers will assess health status, side effects, and treatment response throughout the trial. Eligibility includes confirmed advanced nonsquamous NSCLC and stable health conditions, with regular evaluations to ensure safety and effectiveness over the course of participation.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.

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.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-DM1, a drug being studied for people with type 1 myotonic dystrophy (DM1). This phase 1/2a study is double-blinded and placebo-controlled, involving both male and female participants aged 18 to 65 years who have genetically confirmed DM1 with clinical signs of the disease. The study aims to compare single and multiple ascending doses of ARO-DM1 with placebo to assess its effects and safety. Participants will be randomly assigned to receive either ARO-DM1 or a matching placebo through intravenous infusion or subcutaneous injection. The study has two parts: Part 1 involves a single dose with follow-up up to Day 90, and Part 2 involves multiple doses with follow-up up to Day 180. The doses will be increased stepwise to evaluate safety and how the drug behaves in the body at different levels. Throughout the study, participants will be monitored for treatment-emergent adverse events and other safety measures. Researchers will track how the drug is absorbed and processed, as well as its biological effects. Participants will undergo clinical assessments, and their ability to walk independently will be evaluated. Safety labs and other health evaluations will be performed regularly to ensure participant well-being during the study period.