Bloomington

This research aims to assess the safety and effectiveness of the UrOActive4 Artificial Urinary Sphincter AUS device in men diagnosed with stress urinary incontinence SUI. It is a prospective, multicenter, single-arm clinical study focused on evaluating this device in appropriate surgical candidates. The study is sponsored by UroMems SAS and targets adult men aged 22 years or older who have experienced SUI for at least six months. Participants who meet the eligibility requirements will receive the UroActive AUS implant during the study. The treatment involves surgically implanting the device, which is designed to manage stress urinary incontinence symptoms. There are no comparator groups as this is a single-arm study. The trial focuses on monitoring the safety and effectiveness of the device over time. During the study, participants will be assessed for their response to the implant, with a key measurement being the responder rate at 26 weeks after the device activation. Researchers will evaluate outcomes related to urinary control and any potential safety concerns. The study will continue through 2031, providing long-term observation of participants progress following the implantation.

Researchers are evaluating two approaches to rehabilitation following anterior cruciate ligament ACL reconstruction in young patients aged 15 to 21 years. The study compares Rehabilitation with Exercise and Psychological Support REPS, which integrates exercise with psychological guidance, to standard rehabilitation without specialized psychological support. This pilot randomized controlled trial aims to see if REPS improves psychological readiness and knee function more than standard care during recovery. Participants will be randomly assigned to one of two groups. Both groups will follow standard exercise protocols for ACL reconstruction using bone-patellar tendon-bone or quadriceps tendon autografts, with optional additional therapies like electrical stimulation or manual therapy. The REPS group will receive extra psychological support through trained physical therapists and patient training videos focusing on mental skills and recovery mindset. All participants will watch group-specific videos and receive exercise guidance via an online platform. Participants will attend four study visits over six months one before surgery and three during follow-up after surgery. Assessments include psychological readiness for sport, fear of movement, knee function, pain, range of motion, and strength tests at various time points before and after surgery. Researchers will also monitor the feasibility and acceptance of REPS, collecting questionnaires about empathy and therapeutic alliance. The study follows participants for six months post-surgery to evaluate outcomes.

Researchers are evaluating a new atrioventricular interval modulation AVIM algorithm designed for dual-chamber Medtronic AstraAzure pacemakers. This multinational, randomized, double-blind clinical trial aims to assess the safety and effectiveness of this AVIM therapy in patients with hypertension who either have or are scheduled to receive these pacemakers. The study is led by Orchestra BioMed, Inc and focuses on managing high blood pressure through this innovative device approach. The trial includes three phases a screening phase, a one-year double-blind randomized phase, and a two-year unblinded phase. Participants who meet eligibility criteria will have the investigational AVIM therapy software downloaded into their AstraAzure pacemaker. They will be randomly assigned to either have the AVIM therapy activated along with their stable antihypertensive drug treatment or have the AVIM therapy deactivated while continuing their usual drug therapy. Participants will be monitored over the course of the study, with the main outcomes measured including changes in 24-hour ambulatory systolic blood pressure at three months and the occurrence of any unanticipated serious adverse device effects. Throughout the study, subjects will continue their antihypertensive medications and undergo regular assessments to evaluate blood pressure control and device safety. The total study duration extends up to five years, allowing for long-term follow-up and evaluation.

Researchers are conducting the Helix Research Network study to create a large clinicogenomics dataset by collecting genetic and clinical information from participants. This observational study aims to discover molecular and genetic factors influencing disease risk, progression, treatment response, and other health outcomes. The study also seeks to identify targets for therapies and improve diagnosis and treatment through clinical implementation. Participants will provide samples for exome sequencing, which analyzes the protein-coding regions of genes. The study is open to an unlimited number of individuals recruited from various healthcare systems within the network. Enrollment continues until participants withdraw or the study ends. Participants will receive individual genetic results and annual reports on overall study findings and their impact. Throughout the study, participants will provide data used to identify genetic biomarkers and explore genetic determinants of disease over an average of 10 years. Researchers will collect patient-reported outcomes and may re-contact participants as needed. The study involves ongoing data aggregation and long-term follow-up to support research and improve personalized medical care.

Researchers are evaluating the Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty TKA. This observational study aims to assess the devices performance, clinical benefits, and safety through a retrospective cohort with prospective follow-up. The study involves patients treated with this knee system at up to 20 sites, with a maximum enrollment of 380 participants. The study includes patients implanted with various configurations of the Persona Revision Knee System, including different tibial stems, tibial components, articular surfaces, and femoral components. Participants are identified retrospectively and then invited to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device and any compatible instruments used follow the approved instructions for use. Participants will provide data through scheduled follow-up visits over several years, with assessments including the Knee Society Clinical Rating System objective knee score at 2 years as the primary outcome. Secondary measures include adverse events, pain scores, and knee function scores. The study monitors safety and clinical outcomes over time, with a total participation duration potentially extending up to 10 years postoperatively.

Researchers are evaluating rehabilitation methods following reverse total shoulder arthroplasty RTSA, a surgery used for conditions like rotator cuff arthropathy and shoulder fractures. The study compares immediate active shoulder rehabilitation IASR with the traditional post-operative rehabilitation to understand their effects on pain relief, shoulder function, complications, and cost effectiveness over one year. This trial aims to improve patient health, experience, and reduce healthcare costs following RTSA. Participants are randomly assigned to one of two rehabilitation groups after RTSA surgery. One group starts immediate active shoulder physical therapy from the first day after surgery, including specific stretches and full active shoulder motion. The other group follows a traditional therapy protocol that gradually introduces active shoulder motion starting around week 6, involving about 18 physical therapy visits. Physical therapy sessions take place at a location comfortable for the patient. Throughout the study, participants will be assessed before surgery and at multiple time points up to one year after surgery. Evaluations include shoulder function scores, pain and quality of life questionnaires, and measurements of shoulder range of motion. Researchers will also monitor complications like subscapularis tears. Participants must be willing to complete questionnaires and attend follow-up visits, with results used to determine the overall impact of the rehabilitation methods.

Researchers are studying the safety and effectiveness of TARA-002, a biological preparation containing Streptococcus pyogenes cells, for adults aged 18 and older with high-grade non-muscle invasive bladder cancer NMIBC, including carcinoma in situ CIS with or without TaT1 tumors. This Phase 2 open-label trial further evaluates TARA-002 at a dose established in an earlier Phase 1a study. Participants include those with active disease confirmed within 3 months before enrollment, divided into two groups based on prior treatment with BCG therapy. Participants receive TARA-002 directly into the bladder through instillation. The treatment involves an initial period of six weekly doses, followed by a possible second period of six additional weekly doses or three weekly maintenance doses for those with a complete response. Maintenance doses continue at specified months up to 24 months. After treatment, participants enter a follow-up period lasting from month 27 to month 60 to monitor long-term outcomes. Throughout the study, participants undergo regular assessments including evaluations of tumor response, progression-free survival, overall survival, and quality of life using specific questionnaires. Researchers monitor urinary biomarkers and track adverse events from the first day of treatment through the entire follow-up period. The studys main outcome is the rate of high-grade complete response measured from 3 to 60 months after treatment. Total participation may last up to 5 years.

Researchers are evaluating a care pathway designed to prevent suicide by connecting patients to behavioral health services when they are released from jail. The study aims to assess the impact of this intervention on reducing suicide attempts, increasing behavioral health service use, and understanding how the intervention can be implemented effectively and sustainably in health and jail systems. Participants are randomly assigned to one of two groups one group receives an intervention including outreach contacts, suicide risk screening, safety planning, and connection to healthcare services and virtual support if needed. The other group receives usual healthcare services without knowledge of study involvement. This approach helps compare the effectiveness of the intervention versus standard care at the time of jail release. During the study, participants will be monitored for suicide attempts and deaths over six months following jail release. Researchers will evaluate behavioral health service use and gather data on the interventions cost, acceptability, and practicality for future use. The study runs from June 2024 to July 2027, with regular assessments to measure outcomes and implementation success.

Researchers are evaluating the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instruments in patients undergoing primary or revision shoulder arthroplasty. The study aims to confirm implant survival over 10 years, monitor adverse events, and assess improvements in shoulder function, pain, quality of life, and radiographic outcomes using standard scoring systems and imaging. Participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System, including devices like the Alliance Glenoid and Identity Stem, designed for various types of shoulder replacements. The study will follow patients for 10 years to track implant survival and safety, with a 2-year evaluation focusing on clinical performance and radiographic measures. During the study, patients will undergo assessments of implant survival using the Kaplan Meier method, adverse event monitoring, and evaluations of shoulder function with the American Shoulder and Elbow Surgeons ASES score, quality of life questionnaires, and detailed radiographic imaging. Follow-up visits at 2 years and up to 10 years will help researchers understand the long-term results of the shoulder arthroplasty system.