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Found 6 Actively Recruiting clinical trials

A

Actively Recruiting

The Abbott Vascular Medical Device Registry (AV-MDR) is a prospective, non-randomized, open-label, multi-center registry designed to collect and evaluate clinical data on various Abbott vascular devices. The study focuses on confirming the safety and performance of these devices throughout their expected lifetime, monitoring risks, detecting new issues based on actual evidence, and ensuring that the benefit-risk balance remains favorable. It also aims to identify any possible misuse or off-label use to verify appropriate device use in patients with conditions such as acute myocardial infarction, coronary artery lesions, restenoses, and embolisms. Participants receive one or more Abbott vascular devices including coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging devices such as fractional flow reserve (FFR) and optical coherence tomography (OCT), peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closure and compression devices, or vascular access introducers. The devices are used during planned or completed vascular procedures, with treatment and device types depending on the participant's medical needs and the study scope. Throughout the study, participants are monitored during the vascular procedure and followed up at multiple time points including during the procedure, at 30 days, and at 12 months. Researchers assess outcomes such as death, myocardial infarction, target lesion revascularization, amputations, device success, complications, and imaging quality. The study involves collecting data on device performance and safety events, ensuring adherence to follow-up schedules, and aims to provide comprehensive information on the long-term use and risks associated with Abbott vascular devices.

Age: 18Years +All Genders
37 locations
A

Actively Recruiting

Researchers are investigating the impact of correcting forward head posture (commonly known as nerd neck) on individuals who have temporomandibular joint dysfunction (TMD), a condition affecting the jaw. The study aims to determine if improving head posture can help reduce jaw pain and improve jaw function. This research addresses gaps in understanding the connection between forward head posture and TMD, particularly focusing on myogenic (muscle-related) TMD and how posture correction might provide additional benefits. Participants will be randomly assigned to one of two treatment groups. One group will receive conservative management including stretching and relaxation exercises combined with daily use of the Denneroll cervical traction device for 3 to 15 minutes. The other group will receive the same conservative management with a placebo traction device instead. Both treatment programs will last for six weeks. Throughout the study, participants will complete assessments of jaw pain and function before treatment, at three weeks, and after seven weeks. These assessments include the Fonseca anamnestic questionnaire and measurements of craniocervical angle (CVA) to monitor posture changes. Researchers will compare results between groups to evaluate if correcting forward head posture adds benefit to jaw function and pain relief. Participants are monitored at baseline, during treatment, and after treatment to understand the treatment effects and safety.

Age: 18Years - 40YearsAll GendersPhase Not Applicable
2 locations
C

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of auricular vagus nerve stimulation (AVNS) on neck pain, heart rate variability (HRV), and balance in healthy collegiate athletes aged 18 to 26 years. The study aims to determine if different AVNS settings differently influence these outcomes. The focus is on how AVNS may reduce pain perception, decrease HRV, and improve balance and neck function in this athletic population. Participants are divided into two groups, each receiving AVNS with different settings applied using a conventional TENS device. One group receives stimulation at 25 Hz frequency on the tragus of the ear, while the other group receives 10 Hz frequency stimulation. Both groups undergo a total of four sessions, two sessions per week over two weeks. Each session lasts 15 minutes, during which participants are seated and relaxed. Heart rate is measured before and after the first and last stimulation sessions to evaluate effects. During the study, participants complete questionnaires including the International Physical Activity Questionnaire and the Neck Pain Disability Index. Balance is assessed using the Biodex Balance System, and heart rate is monitored with a pulse oximeter. Researchers measure neck pain intensity, neck pain disability, balance, and heart rate changes up to six weeks. The study's total duration covers these assessments and four intervention sessions to understand the impact of AVNS parameters on these health factors.

Age: 18Years - 26YearsAll GendersPhase Not Applicable
1 location
D

Actively Recruiting

Researchers are evaluating the DynamX Coronary Bioadaptor System in patients with coronary artery disease caused by new native coronary artery lesions. This registry aims to confirm the safety, effectiveness, and performance of this device in a real-world patient population. The study focuses on patients who require percutaneous coronary intervention (PCI) with stent implantation. All participants will receive at least one DynamX Novolimus-eluting Coronary Bioadaptor implant following the product's Instructions for Use. The treatment is provided in a commercial setting as part of routine clinical care. This registry collects additional data on the device's performance and safety over time in patients undergoing this procedure. Participants will be monitored for at least 12 months to assess device-oriented clinical outcomes. Researchers will collect data on safety and effectiveness during this period. Patient involvement includes providing informed consent and complying with study procedures. The total duration of participation is based on the 12-month follow-up for clinical endpoints.

Age: 18Years +All Genders
17 locations
E

Actively Recruiting

This registry study collects information on the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System used in regular clinical practice across diverse real-world populations. It serves as a Post-Market Clinical Follow-up (PMCF) to monitor the device's use after it has been released to the market. The study is observational and prospective, involving multiple centers internationally to gather data on patient outcomes. The study will involve up to 10,000 patients treated with the BioFreedom Ultra stent, which combines a cobalt chromium stent platform with a polymer and carrier-free coating of the active ingredient BA9. Patients will be enrolled from as many as 150 interventional cardiology centers in up to 15 countries, including Europe, South America, the Middle East, and Asia, over a period of 5 years. Participants will be followed for 12 months after their percutaneous coronary intervention (PCI) procedure, primarily through telephone or clinic visits, to collect data. The main outcome measured is Target Lesion Failure (TLF) at 12 months. This follow-up helps assess the real-world performance and safety of the BioFreedom Ultra stent in everyday clinical use.

Age: 18Years +All Genders
10 locations
I

Actively Recruiting

This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.

Age: 18Years +All Genders
55 locations