Orem

Researchers are conducting a Phase 3 clinical trial to evaluate the drug DT120 compared to placebo in adults aged 18 to 74 years diagnosed with Major Depressive Disorder MDD. Participants must have a confirmed diagnosis according to the DSM-5, be experiencing a major depressive episode lasting between 8 weeks and 24 months, and have certain minimum scores on depression severity scales. The study aims to assess the efficacy and safety of DT120 in treating MDD symptoms. The study includes a 12-week randomized, double-blind period where participants receive a single dose of either DT120 or placebo. After this, eligible participants can enter a 40-week open-label extension phase where all receive DT120 and are monitored for safety and symptom changes, with the possibility of retreatment based on specific criteria. The study drug works mainly through serotonin 2A receptor activity. Participants will undergo various assessments throughout the study, including regular evaluations of depression severity using the Montgomery-sberg Depression Rating Scale MADRS, Clinical Global Impression scales, anxiety rating, quality of life questionnaires, and sexual functioning assessments. The primary outcome is the change in MADRS score at Week 6. Safety and treatment needs will also be monitored during the extension phase. Total participation may last up to 52 weeks, with ongoing monitoring of mood and symptom changes.

Researchers are studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

Researchers are evaluating the adaptation and implementation of an innovative clinical decision support CDS tool called ePNa, originally validated in emergency departments, for use in urgent care clinics to improve pneumonia diagnosis and treatment. This study aims to combine ePNa with Stanfords CheXED artificial intelligence model to classify chest images quickly and accurately. The goal is to enhance pneumonia care in ambulatory settings where high patient volumes may benefit from updated and efficient diagnostic tools, especially as COVID-19 evolves. The study involves adapting ePNa for use in urgent care clinics by modifying it to work with the more limited patient data available in these settings and incorporating a chest imaging prompt. The combined ePNa-CheXED tool will be piloted among super user clinicians during clinic shifts. One of two clusters of urgent care clinics will receive the adapted tool, while the other will serve as usual care control. Additionally, a physician survey will assess clinicians experiences with ePNa-CheXED six months after implementation. Participants will be patients aged 12 and older diagnosed with pneumonia, confirmed by radiographic imaging. Physicians and advanced practice clinicians in selected urgent care clinics will also participate by completing surveys. The study will monitor outcomes including the accuracy of pneumonia diagnosis, changes in transfer rates to emergency departments, unplanned subsequent ED visits or hospitalizations, and overall healthcare resource use. The study will continue for up to three years, with ongoing evaluation of ePNa use and impact in the urgent care clinical environment.

Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder PTSD who have had symptoms for at least six months. The study involves participants who have previously tried at least one medication or trauma-focused psychotherapy for PTSD. This phase 3 randomized, double-blind, placebo-controlled trial aims to compare two doses of TSND-201 capsules with a placebo to better understand treatment options for PTSD. Participants will enter a 4-week Treatment Period during which they will be randomly assigned to receive either one of two doses of TSND-201 or a placebo capsule once a week, taken orally. After completing this treatment phase, they will continue into an 8-week Follow-up Period to monitor their progress and any changes in their condition. The study uses a parallel design and masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo assessments including the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 to measure changes in PTSD severity from the start through 12 weeks. Researchers will also monitor safety and efficacy by evaluating participants regularly through interviews and questionnaires. The entire participation duration covers 12 weeks, including treatment and follow-up, with safety and response being closely observed throughout.

This research aims to evaluate a step-wise treatment protocol using collagenase Clostridium histolyticum CCH injections for men with Peyronies Disease who have not responded to initial treatments. The study focuses on a modified injection technique with limited in-office modeling, assessing safety and effectiveness compared to previous data. It also involves sexual partners who will provide feedback on their support during treatment. Participants will receive up to four series of CCH injections administered on back-to-back days, with a total dose of 0.9 mg per series diluted to 0.8 mL. Mild in-office modeling is performed on the second treatment day of each series, along with wrap applications to reduce bruising. Men will take sildenafil 25 mg nightly starting on treatment day 2 and use Restorex daily beginning post-injection day 3, continuing both until six weeks after the final injection. If patients are not satisfied after four series, they may enter a salvage phase 9-12 months later, receiving up to two additional series with more aggressive modeling. During the study, participants and their partners will complete questionnaires at baseline, before each series, six weeks after the fourth series, and one year after the final injection. Researchers will measure penile curvature and length at one year, along with therapy adherence, satisfaction, adverse events, and partner support. The total study duration extends to one year post-treatment, with ongoing safety and efficacy monitoring throughout.

This research aims to evaluate the effectiveness of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy with bilateral nerve preservation and moderate or better baseline erectile function. The study addresses the challenge of erectile dysfunction following prostate cancer surgery, a problem without effective preventative treatments, by comparing erectile function outcomes at 6 months between groups using the device or not. It builds on previous smaller trials that suggested potential benefits of RestoreX in erectile function and penile length preservation. Participants will be randomly assigned to either use the RestoreX device starting one month after surgery for 30-60 minutes daily, 5-7 days per week, continuing until 6 months, or to a control group that does not use the device during this period. After 6 months, all participants may choose to use the device openly for an additional 3 months. Only the straight traction feature of the device will be used during the study. Throughout the study, men will undergo assessments of erectile function and other related measures using questionnaires at 3, 6, and 9 months post-surgery. Researchers will monitor changes in erectile function scores as the primary outcome at 6 months, along with secondary outcomes including additional questionnaire domains and adverse events over 9 months. The study duration is planned for 3 years to allow for enrollment and follow-up, with safety and effectiveness carefully tracked during and after treatment phases.

Researchers are conducting an observational study to create a large national registry that evaluates the safety and effectiveness of treatments for men experiencing ejaculatory andor orgasmic dysfunctions. The study aims to capture important outcomes from men receiving therapy for these conditions to better understand treatment results. This collaboration with the Sexual Medicine Society of North America helps inform sexual medicine providers and encourage patient participation. Participants, including men receiving treatment and their sexual partners, will be invited by their local providers to join the study. They will complete questionnaires about their diagnosis and treatment effectiveness at the start of the study, then every three months for one year, followed by every six months for two additional years. Patient partners may also enroll and follow the same questionnaire schedule. During the study, participants will provide information through regular questionnaires over a three-year period. Researchers will use these responses to assess primary outcomes related to treatment safety and efficacy. This ongoing data collection will help build a comprehensive understanding of therapies for ejaculatory and orgasmic dysfunctions and contribute to future care improvements.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the long-term safety and tolerability of a drug called NBI-1117568 in adults diagnosed with schizophrenia. This phase 3, open-label study aims to monitor participants over an extended period to better understand how the drug affects people with this condition and to gather important safety information. Participants in this study will take NBI-1117568 once daily by mouth for up to 36 months. This single treatment group will allow researchers to observe the effects of the medication over a long duration without comparing to a placebo or other treatments. During the study, researchers will track any treatment-emergent adverse events experienced by participants to assess safety. Participants will be monitored regularly throughout the 36 months for their health and response to the drug. This ongoing observation helps ensure participant well-being and collects valuable data on how the drug performs long-term.

Researchers are evaluating a single injection of RE104 for Injection to see if it reduces anxiety symptoms in adults with Generalized Anxiety Disorder GAD. This Phase 2 trial compares the effects of RE104 against a placebo in a randomized, double-blind, placebo-controlled setting to understand its impact on anxiety levels. Participants receive either a single subcutaneous injection of 30 mg RE104 or a placebo 0.9% sodium chloride during the study. The trial uses a parallel design where each participant is randomly assigned to one of the two groups. The main treatment effect is measured at 4 weeks after dosing, and follow-up assessments continue up to 12 weeks to monitor anxiety symptoms and any adverse events. During the study, participants will undergo evaluations including the Hamilton Anxiety Rating Scale HAM-A and Hospital Anxiety and Depression Scale HADS at multiple time points. Researchers will assess changes in anxiety scores, response rates, remission rates, and safety by monitoring treatment-emergent adverse events. The total follow-up after dosing lasts 12 weeks, with scheduled assessments at weeks 1, 2, 4, 8, and 12 to track progress and safety.