Davie

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the feasibility and effectiveness of an evidence-based breathwork and meditation intervention called Sudarshan Kriya Yoga (SKY) Breath to improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, aged under 75, along with their care partners. Parkinson's Disease is a progressive neurodegenerative disorder with symptoms like tremors and neuropsychiatric issues, and stress can worsen these symptoms. The study aims to assess whether this intervention can reduce stress and improve quality of life for both patients and their care partners. The intervention includes a 4-day active learning phase where participants attend morning sessions lasting around 2.25 hours each day to learn the SKY Breath practice. Afterward, participants practice daily at home for about 25 minutes with support materials like audiotapes and handouts. The program also includes twice-weekly instructor-led group sessions—one online lasting approximately 45 minutes and one in-person lasting about 75 minutes. The program is tailored to accommodate participants' abilities and schedules, with parallel courses for both patients and care partners. Participants will be evaluated before starting the intervention and at 1, 4, and 8 weeks afterward using various surveys and standardized Parkinson's Disease symptom scales to measure stress, psycho-social well-being, motor and non-motor symptoms, and quality of life. Care partners will also be assessed for stress, resilience, and caregiver burden. The study will track adherence through practice logs and includes both online and in-person assessments at multiple sites. Data collected will be analyzed for changes in symptoms and overall well-being related to the breathwork practice.

The HEALEY ALS Platform Trial is an ongoing, multi-center study designed to evaluate the safety and effectiveness of various investigational treatments for Amyotrophic Lateral Sclerosis (ALS). This perpetual platform trial uses a single Master Protocol to test multiple treatments either simultaneously or one after another, allowing efficient study of different therapies under one trial structure. Participants diagnosed with ALS are randomly assigned to receive one of the active investigational drugs or a matching placebo in a controlled setting. The study includes several treatment regimens, each testing a different investigational product. These treatments include subcutaneous injections and oral medications given daily or twice daily, such as Zilucoplan, Verdiperstat, CNM-Au8, Pridopidine, and others. Each regimen is placebo-controlled and has its own specific study details summarized in separate appendices. New investigational products and regimens are continuously added to the trial, allowing enrollment of additional participants over time. Participants will be involved in regular assessments over a minimum 36-week period to monitor disease progression and treatment effects. Evaluations include clinical exams, consent and compliance checks, and respiratory function measurements. Safety is closely monitored throughout the trial. The study aims to gather detailed information on how these investigational products impact ALS progression, with participants having equal chances of being assigned to any active regimen at screening.

Researchers are evaluating the safety and effectiveness of intranasal insulin combined with glutathione as an additional treatment for people with Parkinson's Disease. This Phase II randomized, double-blind, placebo-controlled study compares this combination treatment to a placebo to understand its impact on verbal fluency and other outcomes over 24 weeks. Participants will be randomly assigned to receive either intranasal insulin and glutathione (INS-GSH) or matched placebo sprays, administered twice daily. The study treatment is given over a 24-week period to assess the effects as an add-on to their current medications and lifestyle routines. During the study, participants will have regular assessments including evaluations of verbal fluency and safety monitoring. Researchers will track adherence to the treatment, monitor for side effects, and ensure that participants maintain stable doses of their Parkinson's and related medications. The overall participation duration is about 24 weeks, during which safety, tolerability, and cognitive outcomes will be closely observed.

Researchers are evaluating the effects of non-invasive electrical stimulation on facial pain, jaw movement, and chewing ability in people with Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS). The study also aims to assess how this stimulation influences patient-reported difficulty with oral hygiene tasks. This prospective, cross-sectional study involves individuals diagnosed with ALS or PLS and focuses on improving their facial and oral functions. Participants will receive a single 30-minute session of transcutaneous electrical nerve stimulation (TENS) applied to facial muscles, specifically over the masseter muscle belly and the temporomandibular joint (TMJ) area. Electrode pads will be placed on both sides of the face, and the stimulation current will be adjusted to each participant's comfort level while seated. The session includes pre-intervention assessments, the electrical stimulation treatment, and post-intervention assessments conducted during one in-person clinic visit. During the clinic visit, participants will complete evaluations of jaw and facial pain using a numeric rating scale, jaw range of motion tests, and chewing efficiency tests involving a saltine cracker. Muscle activity will be recorded using surface EMG sensors. Twenty-four hours after the treatment, participants will have a telephone interview to self-rate their facial pain and report any difficulties with oral hygiene tasks. The study will measure pain levels immediately before, immediately after, and 24 hours post-intervention to understand the stimulation's impact.

Researchers are evaluating the effectiveness and safety of His or Left bundle branch pacing compared to standard biventricular pacing in patients with heart failure caused by left ventricular systolic dysfunction and a left ventricular ejection fraction (LVEF) of 50% or less. The study focuses on patients with either a wide QRS duration of 130 milliseconds or more, or those with anticipated or current right ventricular pacing exceeding 40%, all of whom are receiving standard heart failure medications. The goal is to assess patient-centered outcomes like quality of life, physical activity, heart failure hospitalizations, and mortality, while also monitoring device-related complications and re-interventions.

Stress during pregnancy can lead to serious complications such as preterm labor and increased risks for both mother and baby. This research focuses on understanding how pregnant women experience and respond to stress, especially those who face repeated or chronic stress. It aims to explore how social factors like socioeconomic status, education, and access to prenatal care contribute to stress and its biological impacts, including changes in heart rates and cellular aging. Participants will be exposed to video stimuli to observe their biological and physiological reactions to stress and relaxation. They will also engage in independent stress management practices at home to evaluate how these techniques might reduce stress. The study observes pregnant women aged 21 to 37 years who are at least 24 weeks into their pregnancy. Throughout the study, researchers will monitor changes in stress levels over a period of 4 to 8 weeks. They will assess how social and biological factors influence stress and how stress management affects participants. The study also looks at the participants' prenatal care journey and collects data on their emotional and physiological responses to support systems and stress reduction methods.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are studying treatment options for patients with intra-bony periodontal defects, which result from chronic inflammation and bone loss around teeth. This trial evaluates the effectiveness of two regenerative therapies: recombinant human platelet derived growth factor (rh-PDGF, marketed as GEM-21) combined with allogenic bone graft versus enamel matrix derivatives (EMD, marketed as Emdogain) with allograft. The study focuses on one-wall and two-wall intra-bony defects in adults who have persistent deep probing depths after receiving scaling and root planing due to periodontal disease. This research is conducted as a phase 1 and phase 2 clinical trial to compare these treatments for periodontal regeneration. Participants will be randomly assigned to one of two groups receiving the same surgical protocol. One group will be treated with rh-PDGF plus allogenic bone graft, while the other group will receive EMD plus allograft. Both treatments involve regenerative therapy aimed at promoting bone and tissue healing in the affected periodontal sites. The treatments will be monitored over a follow-up period of 6 months and 12 months to assess clinical attachment changes and bone regeneration. During the study, participants will undergo evaluations including clinical attachment level measurements and probing depths to monitor treatment effects. Researchers will assess periodontal health improvements, bone height gain, and pocket depth reduction. Follow-up visits at 6 and 12 months will re-evaluate the effectiveness of the therapies applied. The total participation includes initial screening, treatment, and two follow-up assessments over one year to ensure safety and measure clinical outcomes.

Researchers are conducting the STOP AF First Post Approval Study, a global, multi-center observational trial focused on patients with symptomatic paroxysmal atrial fibrillation (AF). The study aims to collect long-term data on the clinical performance and safety of the Arctic Front12 cardiac cryoablation catheter system. This device is being evaluated as an alternative initial rhythm control strategy to antiarrhythmic drug therapy in treating recurrent symptomatic paroxysmal AF. The study is part of a post-approval condition set by the U.S. Food and Drug Administration. Participants will undergo pulmonary vein isolation using the commercially available Arctic Front12 cardiac cryoablation catheter system. This device delivers cardiac cryoablation therapy to help control heart rhythm. The study observes patients treated with this system, without randomization to other treatments, to monitor long-term outcomes and safety. During the study, researchers will monitor freedom from atrial fibrillation, atrial flutter, or atrial tachycardia over 36 months, as well as freedom from primary safety events up to 12 months. Participants will be followed to collect clinical performance and safety data. The total duration of follow-up and assessments is based on these timelines to better understand the device's long-term effects and safety profile.