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Found 6 Actively Recruiting clinical trials

O

Actively Recruiting

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Age: 18Years +All Genders
91 locations
P

Actively Recruiting

Researchers are comparing two types of radiation therapy, proton beam radiation therapy PBT and intensity modulated photon radiotherapy IMRT, to treat patients with stage I to IVA esophageal cancer. The study aims to find out whether PBT improves overall survival and causes fewer serious heart and lung side effects compared to IMRT. Additional goals include examining symptom burden, quality of life, tumor response, cost-effectiveness, hospitalization length, lymphocyte levels, and rates of treatment failures and complications. Participants are randomly assigned to one of two groups. One group receives PBT over 28 treatment sessions, five days a week for 5.5 weeks, combined with chemotherapy chosen by the patient and their doctor. The other group receives IMRT on the same schedule with similar chemotherapy options. After chemoradiation, patients may have surgery to remove the esophagus tumor if they are eligible. Throughout the study, blood samples and imaging scans PETCT or CT are collected. Participants are closely monitored during treatment and followed for up to eight years. Follow-up visits occur every 3 to 6 months for the first three years and annually thereafter. The study measures overall survival, heart and lung side effects, symptom changes, tumor response, hospitalization time, immune cell counts, and quality-adjusted life years. The study also collects biospecimens for future research on treatment complications and assesses economic factors related to each radiation therapy.

Age: 18Years +All GendersPhase 3
96 locations
H

Actively Recruiting

Healthy Volunteer

This observational study evaluates the measurement of blood p-tau217 levels, a biomarker related to Alzheimers disease, using a home-based Tasso lancet device compared to the standard venipuncture blood collection method. The study includes participants with Alzheimers disease confirmed by amyloid PET or cerebrospinal fluid tests, healthy individuals without cognitive impairment, and people with cognitive impairment not caused by Alzheimers disease who are amyloid-negative. Researchers aim to compare p-tau217 concentrations in these different groups to assess agreement between the two blood collection methods. Participants are divided into three groups those with Alzheimers disease confirmed by amyloid PET or CSF, healthy controls without cognitive impairment, and individuals with non-Alzheimers cognitive impairment confirmed to be amyloid-negative. Blood samples will be collected at home using the Tasso device and also by standard venipuncture for comparison. The study focuses on baseline measurements of p-tau217 concentration agreement between these two collection methods. During the study, participants will provide blood samples through both methods, with assistance and caregiver consent available if needed. The primary outcome measured is the agreement between p-tau217 levels in blood collected by the Tasso device and by venipuncture at baseline. The study plans to enroll adults aged 40 to 90 years and includes safety monitoring related to systemic health conditions and recent medical history. Overall participation involves blood collection and monitoring without therapeutic intervention.

Age: 40Years - 90YearsAll Genders
5 locations
S

Actively Recruiting

Researchers are evaluating the effects of remibrutinib compared to continuous ocrelizumab treatment in people living with relapsing multiple sclerosis RMS. This Phase 3b study aims to provide data on the efficacy, safety, and tolerability of remibrutinib when patients switch from ocrelizumab. The trial is randomized, open-label, and conducted across multiple centers globally, including the USA. Participants in the study are assigned to either switch to remibrutinib tablets taken orally or continue with ocrelizumab administered via infusion or injection at standard doses. The study includes a Core Part lasting up to 24 months, during which these treatments are compared. Those completing the Core Part may enter an Extension Part lasting up to 24 months, where all participants receive remibrutinib in an open-label format. Throughout the study, participants will undergo regular monitoring including MRI scans to measure new or enlarging T2 lesions and assessments for disease activity and adverse events. The main outcome is the annualized rate of new or enlarging T2 lesions during the Core Part, with continued evaluations during the Extension Part. Safety and tolerability are closely monitored, and total participation can last up to 48 months.

Age: 40Years - 70YearsAll GendersPhase 3
128 locations
S

Actively Recruiting

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Age: 18Years +All Genders
2368 locations
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Actively Recruiting

Healthy Volunteer

This research focuses on dementia caregivers who provide in-home care, aiming to reduce their work-related stress and social isolation by creating a virtual reality platform for support. The VR-CARES project engages caregivers through a user-led design process to ensure the technology meets their needs and is accessible. It builds on Rendevers existing VR social engagement platform to enhance caregivers mental health, social connection, and job satisfaction. Participants will first learn and use the basic Rendever VR social engagement platform for about 4 to 8 weeks, engaging with clients and familiarizing themselves with VR activities. Next, they will use the specially developed VR-CARES platform for 8 weeks, which offers a virtual community space for caregivers to connect, share experiences, participate in group activities, and attend weekly support groups led by certified instructors. Caregivers receive training on using the VR systems and the new platform features remotely. Throughout the study, caregivers complete surveys and participate in focus groups at baseline, mid-point 8 weeks, and study end 16 weeks to assess usability, job satisfaction, empowerment, mental health, and social support. The study monitors adherence to the VR-CARES intervention and gathers detailed user experience data. Total participation lasts up to 16 weeks, with ongoing support and feedback guiding platform refinement.

Age: 18Years +All GendersPhase Not Applicable
8 locations