Davie

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Researchers are conducting the ASSESS ALL ALS study to collect a wide range of clinical information, samples, and measurements from people with symptomatic Amyotrophic Lateral Sclerosis ALS, individuals carrying ALS genes, and control participants without these conditions. This observational study is supported by the National Institutes of Health and managed by clinical centers across the country. The goal is to gather data that will be shared with the research community for future studies on ALS and related neurological diseases. Participants include symptomatic ALS patients who either visit clinics or participate remotely, and control participants without ALS or related diagnoses. Over 24 months, participants will provide medical histories, clinical outcomes, and blood samples every four months. They will also complete patient-reported outcomes and speech recordings monthly. Those attending clinics may optionally provide cerebrospinal fluid samples through lumbar puncture. During the study, participants will undergo various assessments including the ALS Functional Rating Scale-Revised at multiple time points, cognitive testing, and digital speech evaluations. Blood samples and other measurements are collected regularly, with some participants assessed remotely via video calls and home phlebotomy. The study tracks physical function, cognitive status, and social and environmental factors over two years to understand ALS progression and characteristics compared to controls.

Researchers are evaluating the feasibility and effectiveness of a breathwork and meditation program called Sudarshan Kriya Yoga SKY Breath for people with Parkinsons Disease iPD in stages 1, 2, and 3, who are under 75 years old, along with their care partners. The study aims to see if SKY Breath can reduce stress, improve mental and physical well-being, and relieve the emotional and physical burden on care partners. The research also explores how tailored the program can be to meet the unique needs of these individuals. The intervention consists of a 10-12 hour active learning phase over four mornings, where participants learn the SKY Breath and Meditation practice. Following this, participants practice daily at home for about 25 minutes, six days a week, supported by weekly instructor-led group sessionsone online and one in person. The program is adapted for each participants disability level, with parallel courses offered to care partners. The study timeline includes recruitment, baseline assessments, intervention phases, booster sessions, and follow-up evaluations up to eight weeks post-intervention. Participants will undergo evaluations before starting the program and at weeks 1, 4, and 8 after the intervention begins. These assessments include measures of stress, anxiety, depression, Parkinsons symptoms, and quality of life for both individuals with Parkinsons and their care partners. Participants will keep logs of their practice time and attend weekly sessions online and in person. The study involves repeated assessments to monitor changes in well-being and symptom management throughout the study period.

Researchers are evaluating the safety and effectiveness of intranasal insulin combined with glutathione as an additional treatment for people with Parkinsons Disease. This phase II, randomized, double-blind, placebo-controlled study aims to compare these treatments against a placebo to better understand their impact on the condition. The study is sponsored by the Gateway Institute for Brain Research and seeks to explore new options for managing Parkinsons symptoms. Participants will be assigned to receive either the active drugsintranasal insulin Novolin R plus glutathioneor matching placebo treatments. These are administered twice daily as add-on therapies alongside participants usual medications. The study design includes a parallel group model where participants are monitored over a 24 to 28 week period to assess outcomes related to verbal fluency, motor function, cognitive function, non-motor symptoms, and patient-reported outcomes. During the study, participants will be closely monitored with evaluations of their verbal fluency at 24 weeks as the primary outcome measure. Secondary assessments include motor and cognitive function tests as well as reports on non-motor symptoms and overall patient well-being. Safety and tolerability of the treatments will also be carefully observed. Participants are expected to maintain consistent diets, exercise, and medication regimens throughout the trial. The total participation period extends up to approximately 28 weeks, with scheduled visits for assessments and monitoring.

Researchers are studying the effects of non-invasive electrical stimulation on facial pain, jaw movement, chewing, and oral hygiene in people with Amyotrophic Lateral Sclerosis ALS and Primary Lateral Sclerosis PLS. The study aims to see if this treatment can reduce jaw pain and improve jaw mobility and chewing ability. It also looks at how the treatment might affect difficulty with oral hygiene tasks, based on patient reports. This is a prospective, cross-sectional study involving individuals diagnosed with ALS or PLS who experience jaw pain.

This research aims to compare two pacing methods, His or Left bundle branch pacing HisLBBP and biventricular pacing BiVP, in patients with heart failure caused by left ventricular systolic dysfunction LVEF 50% who have either a wide QRS duration 130 ms or requireanticipate more than 40% pacing. The study focuses on patient-centered outcomes such as quality of life, physical activity, hospitalizations for heart failure, mortality, and device-related complications like lead dislodgement and infection, while participants continue standard heart failure medication. Participants are randomly assigned to receive either HisLBBP or BiVP devices. For patients with LVEF 35%, the HisLBBP group receives a defibrillator with three implanted leads, including a His-bundle or left bundle branch pacing lead, while those with LVEF 36-50% receive a pacemaker with two leads. The BiVP group receives a defibrillator with three leads for LVEF 35% and a pacemaker with three leads, including an epicardial left ventricular lead, for LVEF 36-50%. The pacing devices aim to synchronize heartbeats through different approaches to improve heart function. Throughout the study, participants are monitored for up to 5.5 years. Researchers will assess combined outcomes of all-cause death and heart failure hospitalizations as the primary measure. Secondary assessments include quality of life changes, psychological adjustment at one year, and heart function measured by left ventricular volume changes. Patient activity and heart failure symptoms will also be tracked using questionnaires, walk tests, and implanted device data. Safety and complications related to the devices will be closely followed during the study period.

This research investigates how stress affects pregnant women, focusing on those experiencing repeated or chronic stress. The study aims to understand the journey pregnant women take to seek prenatal care and to develop models assessing the harmful health and biological impacts of social factors on stress during pregnancy. It also explores ways to reduce stress effects in pregnant women from diverse backgrounds who face high stress levels. Participants will be exposed to a mild 50-second stress stimulus followed by a 50-second relaxation period to record their physiological responses. After this initial assessment, they will independently practice simple stress management techniques at home, such as breathing exercises and listening to music, for one week. The study uses behavioral interventions to examine stress responses and management. During the study, researchers will monitor changes in stress levels over a 4 to 8 week period. Participants physiological responses to stress and relaxation will be recorded during the sessions. The study includes follow-up assessments to evaluate how stress management impacts these measures. Overall participation will span several weeks to capture changes and effects of the interventions on stress.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

This research focuses on treating intra-bony defects caused by periodontal disease, which can lead to changes in bone structure around teeth. The study evaluates and compares two treatments to improve bone regeneration and periodontal health recombinant human platelet derived growth factor rh-PDGF combined with bone allograft versus enamel matrix derivatives EMD combined with bone allograft. The goal is to assess the effectiveness of these therapies in patients with persistent deep probing depths and intra-bony defects. Participants will be randomly assigned to one of two groups. One group will receive rh-PDGF GEM-21 with allogenic bone graft, and the other group will receive EMD with allograft. Both groups will undergo the same surgical procedure. The study includes follow-up visits at 6 and 12 months after treatment to monitor progress and re-evaluate the results. During the study, patients will be assessed for clinical attachment changes and other periodontal health measures. Researchers will perform evaluations including probing depth measurements and radiographic imaging to observe bone gain and attachment improvements. The study aims to monitor treatment outcomes over a 12-month period, with safety and effectiveness assessments at specified intervals.

Researchers are conducting the STOP AF First Post-Approval Study, a prospective, global, multi-center observational trial focusing on patients with recurrent symptomatic paroxysmal atrial fibrillation AF. The study aims to collect long-term clinical performance and safety data on the Arctic Front Cardiac Cryoablation Catheter System as an alternative initial rhythm control strategy to antiarrhythmic drug therapy. This study is part of a post-approval condition required by the U.S. Food and Drug Administration. Participants undergo pulmonary vein isolation PVI using the Arctic Front cardiac cryoablation catheter system. The study observes patients treated with this device rather than assigning specific interventions, as it follows routine clinical care. The trial extends over several years to monitor outcomes and safety of this treatment approach in a real-world setting. During the study, participants are monitored for freedom from atrial fibrillation, atrial flutter, and atrial tachycardia over 36 months, as well as safety events for up to 12 months. Data collection includes tracking clinical outcomes and adverse events related to the cryoablation procedure. Participants will be observed according to standard care and study requirements, with follow-up assessments scheduled to gather these long-term results.