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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating treatments for participants with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) in this Phase III, randomized, open-label, international study. The study aims to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with durvalumab against investigator's choice chemotherapy combined with pembrolizumab, and also evaluates Dato-DXd alone. The main goal is to assess whether Dato-DXd with durvalumab helps participants live longer without their cancer worsening or improves overall survival compared to the standard chemotherapy plus pembrolizumab. Participants are assigned to one of three treatment groups: Dato-DXd combined with durvalumab; investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab; or Dato-DXd alone. All treatments are given by intravenous infusion. The study includes stratification by geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early stage TNBC. Throughout the study, participants will undergo regular assessments including imaging to measure cancer progression, laboratory tests, and evaluations of symptoms and quality of life. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and time to deterioration in symptoms such as pain and physical functioning. Safety and tolerability of the treatments will also be closely observed. Participation may last up to several years with ongoing follow-up to capture long-term outcomes.
Actively Recruiting
Researchers are evaluating the efficacy and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 CPS ≥ 1. A separate study arm will assess rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, sponsor-blinded clinical trial conducted globally at about 200-250 sites in approximately 25 countries. Participants will be assigned to one of three treatment groups: Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine (capecitabine or 5-FU); Arm B receives pembrolizumab, trastuzumab, and chemotherapy (5-FU plus cisplatin or capecitabine plus oxaliplatin); Arm C receives rilvegostomig, trastuzumab, and chemotherapy (5-FU plus cisplatin or capecitabine plus oxaliplatin). Most drugs are administered by intravenous infusion every three weeks, except capecitabine, which is given orally twice daily. The study compares the effects of these combinations as first-line treatments. Participants will be monitored for up to approximately six years to measure outcomes such as progression-free survival and overall survival. Other assessments include response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and impact on feeding and side effect burden. The study includes regular evaluations of tumor status using RECIST criteria, organ function, cardiac function, and collection of tumor tissue samples. Safety and treatment effects will be followed closely throughout the study duration.
Actively Recruiting
Researchers are studying adults who have had an acute ischemic stroke caused by a blood clot blocking a brain blood vessel. This study focuses on people whose stroke started more than 4.5 hours ago or who woke up with stroke symptoms, with imaging showing brain tissue that can still be saved. The goal is to evaluate whether the medicine tenecteplase given after 4.5 hours helps recovery compared to standard care. Participants are randomly assigned to one of two groups. One group receives a single injection of tenecteplase into a vein, while the other group gets the standard medical treatment. The study lasts about three months, starting with about one week of hospital stay. During this time, participants receive seven clinical evaluations, with the last two visits likely done remotely from home. Doctors assess recovery using a scale that measures disability and daily function levels to compare outcomes between groups. They also monitor health and any side effects. The main outcome is the level of disability at 90 days after treatment, measured by the modified Rankin Scale. This comprehensive monitoring helps understand how the treatments affect stroke recovery and safety over the study period.
Actively Recruiting
Researchers are evaluating the use of high-flow nasal oxygen (HFNO) to improve preoxygenation before and during anesthesia induction in adult emergency surgery patients with full stomachs. These patients face a high risk of regurgitation and aspiration under general anesthesia and are vulnerable to low oxygen levels during induction. HFNO, commonly used in intensive care units, offers benefits such as continuous positive airway pressure and better oxygen delivery, which may enhance safety during anesthesia induction. In this randomized controlled trial, adult patients undergoing emergency surgery are assigned to one of two groups. The intervention group receives HFNO preoxygenation with heated, humidified pure oxygen at 60 L/min for 3 minutes using nasal cannulae suited to their nostril size. HFNO continues during intubation to provide continuous or apneic oxygenation. The control group receives preoxygenation with a traditional face mask delivering 100% oxygen at 10 L/min for 3 minutes, removed after induction to allow intubation. Rapid sequence induction uses standard medications with cricoid pressure until intubation is complete. Participants are monitored throughout the perioperative period with measurements including arterial oxygen levels (PaO2), oxygen saturation changes during preoxygenation, and episodes of desaturation during intubation. Additional outcomes assessed include carbon dioxide levels, gastric volume, regurgitation and aspiration events, nasal congestion after extubation, and hemodynamic effects. The study collects data during the anesthesia induction and immediately after, aiming to improve oxygenation strategies for this high-risk group.