Koganei,tokyo, Japan

Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

Low back pain (LBP) is a nearly universal human experience with 80% of adults having at least one episode in the adult's lifetime and 25% of adults reporting LBP lasting at least 1 day in the past 3 months. Not only is LBP exceedingly common, but it can be very burdensome. The tremendous burden imposed by LBP on health and well-being was recently highlighted in the Global Burden of Disease initiative of the World Health Organization, showing that LBP is associated with greater disability and overall burden for affected individuals than depression, Alzheimer's disease, substance abuse disorders, or arthritis. This high ranking of LBP reflects the sheer number of people who experience the condition and the amount of pain, functional loss, and overall diminishment in quality of life that these individuals experience. It is not surprising that LBP imposes a substantial societal burden being the most common condition encountered in healthcare and the 3rd costliest medical condition, behind only diabetes and heart disease. Despite intensive and expensive treatment efforts, the number of individuals impacted by chronic LBP continues to increase. Ineffective LBP management by health care systems is also contributing to the crisis of opioid over-prescribing. Physical therapy (PT) has been found to be effective in reducing pain and disability related to LBP and as such, is recommended as the first line of treatment for LBP in clinical practice guidelines. Studies have shown that providing timely access to PT leads to significant decreases in pain and disability compared to usual care and has been associated with decreased odds of receiving advanced imaging, injection, surgery, or opioids over the next year. Despite the benefits of PT, only 7-13% of patients with LBP receive PT services. This low rate of utilization is likely related to barriers surrounding access (i.e., wait times, cost) and logistics (i.e., missed work time, transportation), which have been reported as reasons for not attending PT in previous studies. While these barriers are not unique to PT, the frequency of PT visits (1-3 times per week) and the length of PT care (6-12 weeks) exacerbate already existing barriers to attending in-person visits. Importantly, these barriers are amplified among minority groups and those living in rural areas of the country - minority individuals are 26% less likely than non-minority individuals to receive PT services for musculoskeletal pain. The COVID-19 pandemic has facilitated the rapid emergence of remotely-delivered PT (i.e., telerehabilitation). Prior to the pandemic, outpatient PT was delivered almost exclusively in-person. However, as the pandemic began, policy changes led to major expansions in the way that PT is delivered. In early 2020, the Center for Medicare and Medicaid Services (CMS) announced temporary authorization for reimbursement of PT services delivered using real-time video visits. Shortly afterwards, the majority of commercial payors followed suit. A non-randomized clinical trial was recently conducted that found that patients with chronic spine pain experienced similar changes in pain, disability and quality of life with multidisciplinary rehabilitation delivered using real-time video visits compared to those that received in-clinic care. A prospective longitudinal study conducted by the study team found that a standardized PT protocol delivered using real-time video visits resulted in significant improvement in disability, pain intensity, pain interference, physical function and sleep disturbance among patients with chronic LBP. The investigators will compare the effectiveness of telerehabilitation and in-clinic PT for patients with chronic LBP to demonstrated that telerehabilitation will provide non-inferior clinical effects to in-clinic PT. The investigators propose to enroll 1,000 patients with chronic LBP who present to primary or specialty care at one of three health systems in Baltimore and Utah. Patients will be randomly assigned to receive an 8-session evidence-based PT treatment delivered via in-person or telehealth visits and will be followed for 12 months. Primary outcomes will be disability. Secondary outcomes will be pain intensity and interference, physical function, and patient engagement with treatment. Exploratory outcomes will be mental health, fatigue, social participation, and opioid and other LBP-related healthcare utilization. Moderating factors will be psychosocial risk for poor outcome and pain self-efficacy. Results will provide important information for patients, clinicians, physical therapists, and payers to make informed decisions about optimizing delivery of evidence-based physical therapy to improve quality of life in patients with chronic LBP.

Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

The proposed CONTEMP-ICD trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with HFrEF, on stable and optimal guideline-directed medical therapy (GDMT), who are eligible for a primary prevention ICD, but have a low predicted arrhythmic risk. Enrolled participants will be randomized in a 1:1 ratio to non-ICD vs. ICD treatment arms. The investigators hypothesize that, in participants with HFrEF who have a low predicted arrhythmic risk, non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (CV) events. This study will recruit adults 18 years of age and older with heart failure. Participants will be asked to complete questionnaires. Information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. Visits will be at initial, three, six months, and every six months beyond six months. For those who get an ICD device an interrogation will be collected at the visits.

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery

EFS of the DUO System for Tricuspid Regurgitation

Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.

HEAL-IST IDE Trial

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

A total of 300 subjects will be randomized at up to 75 investigational sites in the United States, Canada, and Europe. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio. Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant. If the subject meets the anatomic requirements for device placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control). Subjects randomized to the Intervention group will undergo the Carillon implant procedure. Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure. After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status. After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact and echocardiogram for an additional three (3) years, for a total of five (5) years.

Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

In this observational study, blood samples will be collected from adult and pediatric patients with CGD. The level of circulating adenovirus antibodies and inflammatory cytokines will be measured to characterize the prevalence of these markers in this population.

MiSight 1 Day Safety Post-Approval Study

This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

Evolut™ EXPAND TAVR II Pivotal Trial

Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.