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Found 10 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Age: 18Years - 130YearsAll GendersPhase 3
306 locations
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Actively Recruiting

Researchers are studying zelicapavir, a new oral medication that stops the replication of Respiratory Syncytial Virus RSV. This Phase 2 trial is evaluating zelicapavir as a potential treatment for RSV infection in children aged 28 days to 36 months who have symptoms of RSV. The study compares zelicapavir to a placebo to assess its effects and safety in both hospitalized and non-hospitalized children. Participants are randomly assigned to receive either zelicapavir oral suspension or a matching placebo once daily for 7 days. The study monitors the time it takes for RSV symptoms to completely resolve, along with other outcomes such as the severity of symptoms, viral load changes, and any hospitalizations during the study period. These assessments occur mainly from Day 1 through Day 14, with safety followed until Day 35. During the trial, caregivers and children will be assessed regularly to track symptom resolution and viral levels using specific measurement tools. Safety is carefully monitored by recording any adverse events up to Day 35. The study spans from the initial dosing period through follow-up visits, ensuring comprehensive evaluation of zelicapavirs potential in treating RSV in young children.

Age: 28Days - 36MonthsAll GendersPhase 2
8 locations
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Actively Recruiting

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Age: 18Years +All GendersPhase 3
246 locations
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Actively Recruiting

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Age: 18Years - 99YearsAll GendersPhase 3
284 locations
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Actively Recruiting

Atrial fibrillation AF is a major cause of heart-related illness and death, especially among Asian patients who face higher risks of serious bleeding such as brain hemorrhage compared to non-Asians. This research, called the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation COOL-AF Phase 2, aims to study how antithrombotic medication use changes over time and how these changes affect health outcomes in people with AF. The study is observational and conducted across multiple centers in Thailand. Participants in this study have known or newly diagnosed non-valvular AF and are followed without any intervention or treatment assigned by the study. The study plans to enroll about 3680 patients over two years from 33 centers. Participants will be monitored every 6 months for up to 3 years to observe patterns of medication use, particularly warfarin and non-vitamin K antagonist oral anticoagulants NOACs, and clinical events including stroke, systemic embolism, bleeding, heart attacks, and heart failure. Throughout the study, patients will have regular check-ins every six months to track their medication usage and health status. Researchers will collect data on important outcomes such as rates of stroke, bleeding events, and quality of life. The studys primary focus is on long-term safety and effectiveness of antithrombotic treatments in this population. The total participation duration can be up to 3 years, ensuring thorough observation of clinical outcomes and treatment patterns.

Age: 18Years - 100YearsAll Genders
33 locations
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Actively Recruiting

Researchers are evaluating doravirine as an alternative to dolutegravir in people newly diagnosed with HIV-1 infection who have not yet received treatment. This Phase III, open-label, randomized clinical trial aims to determine if doravirine combined with tenofovir and lamivudine is not less effective than dolutegravir combined with tenofovir and lamivudine or emtricitabine. The study will be conducted across multiple countries including Brazil, Cameroon, Cte dIvoire, France, Mozambique, and Thailand, enrolling 610 participants. Participants will be randomly assigned to one of two groups one receiving doravirine 100 mg plus tenofovir DF 300 mg and lamivudine 300 mg daily, and the other receiving dolutegravir 50 mg plus tenofovir DF 300 mg and either lamivudine or emtricitabine daily. The treatment period will last for 96 weeks after starting antiretroviral therapy ART, with primary assessment at week 48 to measure viral suppression. During the study, participants will undergo evaluations to monitor viral load, drug resistance, metabolic health, body weight changes, liver and kidney function, cardiovascular status, and mental health. Adherence to ART will be tracked, and blood samples will be taken to measure drug levels and immune cell counts. The research team will review virological efficacy and safety outcomes at weeks 48 and 96, supporting a comprehensive understanding of the treatments effects over nearly two years of participation.

Age: 18Years +All GendersPhase 3
19 locations
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Actively Recruiting

Researchers are evaluating pembrolizumab combined with carboplatin and taxane chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC. This phase 3 trial aims to compare overall survival between patients receiving pembrolizumab with maintenance sacituzumab tirumotecan sac-TMT and those receiving pembrolizumab alone during maintenance therapy. The study explores whether the addition of sac-TMT improves outcomes for patients with this type of lung cancer. Participants first undergo an induction phase of four cycles receiving pembrolizumab every 3 weeks along with carboplatin and either paclitaxel or nab-paclitaxel. After induction, they are randomly assigned to one of two maintenance groups pembrolizumab alone every 6 weeks for up to 96 weeks, or pembrolizumab combined with sac-TMT every 2 weeks until discontinuation criteria are met. The chemotherapy drugs are given intravenously during the induction phase, and maintenance treatments continue intravenously according to assigned groups. Throughout the study, participants will be monitored for overall survival as the primary outcome, with secondary outcomes including progression-free survival, adverse events, treatment discontinuations, and quality of life measures such as dyspnea, cough, and chest pain. Assessments include tumor scans to evaluate disease status, performance status checks, and patient-reported questionnaires on symptoms and health-related quality of life. Participants are followed for up to approximately 79 months to gather comprehensive safety and efficacy data, with ongoing monitoring by the research team.

Age: 18Years +All GendersPhase 3
215 locations
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Actively Recruiting

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.

Age: 18Years +All GendersPhase 2Phase 3
261 locations
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Actively Recruiting

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.

Age: 0Days - 2YearsAll GendersPhase 2
8 locations
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Actively Recruiting

Researchers are evaluating SRP-1003 in adults aged 18 to 65 with type 1 myotonic dystrophy DM1 in this phase 12a study. The trial aims to assess the safety, tolerability, how the drug moves through and affects the body pharmacokinetics and pharmacodynamics, comparing different doses of SRP-1003 to a placebo. Participants must have genetically confirmed DM1 with symptoms starting after age 12 and show clinical signs including myotonia. Participants will be randomly assigned to receive either SRP-1003 or a placebo through intravenous IV infusion or subcutaneous SC injection. The study has two parts Part 1 involves single doses, and Part 2 involves multiple doses. The treatment will be given under close monitoring to evaluate how the drug is processed and its effects. During the study, participants will have assessments including monitoring for adverse events up to 90 days for single-dose and 180 days for multiple-dose phases. Researchers will measure drug levels in the blood, changes in motor function tests such as hand opening time, timed walking tests, muscle strength, and quality of life scales specific to DM1. Safety and tolerability will be carefully observed throughout the study period that lasts several months.

Age: 18Years - 65YearsAll GendersPhase 1Phase 2
35 locations