Spring

Researchers are evaluating the safety and effectiveness of a periodontal hydrogel wound dressing called Emanate Perio PODS in people with generalized stage III periodontitis. The study aims to see if this dressing helps the healing process better than no treatment after cleaning plaque and tartar from teeth. Periodontitis is considered a chronic wound where harmful bacteria can invade the gums, and this study focuses on healing after scaling and root planing (SRP). Participants in the treatment group will use the Emanate Perio PODS device twice daily for 30 minutes immediately after toothbrushing and interdental cleaning. This device physically protects the healing periodontal pocket from bacteria during the critical healing phase, which usually lasts 15 to 30 minutes. By four weeks after SRP, the gum tissue is expected to mature enough to stop treatment. The device is only used after oral hygiene when the tissue is vulnerable to mechanical forces, minimizing patient burden and aligning with regular twice-daily toothbrushing. During the study, participants will be assessed for periodontal wound healing by checking for the presence or absence of gum bleeding 60 days after non-surgical therapy. Researchers will monitor safety and wound healing effectiveness while participants follow study procedures and avoid certain oral hygiene products and devices. The study includes thorough periodontal evaluations and digital scans to track healing progress over time.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the effectiveness and safety of KarXT for treating schizophrenia in adolescents aged 13 to 17 years. This Phase 3 study focuses on adolescents who meet diagnostic criteria for schizophrenia and experience symptoms of psychosis. The study aims to better understand how KarXT may impact symptoms as measured by a standard schizophrenia rating scale. Participants will receive either KarXT or a matching placebo at specified doses on specific days. The study is randomized, double-blind, and placebo-controlled, meaning neither the participants nor the researchers know who receives the active drug or placebo during the trial. During the study, researchers will assess changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS) after 5 weeks of treatment. Participants will be monitored for safety and symptom changes throughout the study period. The goal is to gather detailed information about KarXT's impact on schizophrenia symptoms in this adolescent population.

Researchers are assessing the long-term safety and tolerability of two treatments, KarXT and KarX-EC, for adolescents with schizophrenia and children and adolescents with irritability related to autism spectrum disorder. This Phase 3, multicenter, open-label study includes participants aged 5 to 17 years and aims to monitor how these treatments are tolerated over time in these specific populations. Participants receive KarXT or a combination of KarXT and KarX-EC at specified doses on designated days. The study includes adolescents aged 13 to 17 years with schizophrenia and children and adolescents aged 5 to 17 years with autism-related irritability. Treatment is administered openly, meaning both researchers and participants know the treatment being given. Throughout the study, researchers will evaluate participants for any treatment-emergent adverse events, adverse events of special interest, and serious adverse events for up to 54 weeks. Safety assessments include monitoring physical examinations, vital signs, and ECGs. Participants must have completed earlier related studies without safety concerns to join, and their health will be closely monitored during the study to ensure safety and tolerability.

Researchers are evaluating the effectiveness and safety of a single injection of AURN001 compared to a placebo in adults with corneal edema caused by corneal endothelial dysfunction. This Phase 3 study focuses on participants who need surgery for this eye condition and aims to improve visual acuity. The trial targets adults with specific vision levels and pseudophakic eyes with posterior chamber intraocular lenses (PCIOL). Participants will receive either the combination product AURN001 plus Y-27632 or a placebo injected into the front chamber of the eye. The study is randomized, double-masked, and conducted at multiple centers. Treatment involves a single injection, and participants are monitored over time to assess the treatment effects. During the study, participants' vision will be tested to measure improvements in Best Corrected Visual Acuity (BCVA) at six months after injection. Researchers will monitor safety and any eye changes closely throughout the study. The main outcome is the percentage of participants who gain at least 15 letters (3 lines) in visual acuity compared to their baseline at month six.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the Nevro1 Sacroiliac (SI) Transfixing and Fusion System to treat sacroiliac joint dysfunction in adults aged 21 and older. The study aims to find out what percentage of patients experience meaningful pain relief without adverse events, and how many achieve joint fusion at one and two years after treatment. This clinical study is observational and focuses on long-term outcomes following the use of this medical device. The Nevro1 device is a titanium cage implanted from the back of the sacroiliac joint. Anchors are deployed to stabilize the joint, and the device has openings that surgeons fill with the patient's own bone graft to encourage fusion. The study follows patients treated with this system as part of standard care, assessing the results over time without comparison to other treatments. Participants will be monitored through scheduled visits where researchers will assess pain relief and safety outcomes. The main outcome measured is a combination of pain relief and absence of adverse events at six months. The study also tracks fusion of the joint at one and two years. Patients must consent to participate and be able to follow study procedures throughout the observation period.