Orem

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are studying sleep patterns in adults with Major Depressive Disorder (MDD) who experience moderate to severe insomnia symptoms (MDDIS) or no to mild insomnia symptoms (non-MDDIS). The goal is to evaluate brain activity during sleep using an at-home sleep Electroencephalogram (EEG) device and to understand how these objective sleep measurements relate to participants' own sleep experiences. Participants will use a sleep EEG device at home to record brain activity during sleep over a specified period. Alongside this, subjective sleep data will be collected using various self-report tools including sleep diaries and standardized questionnaires like the Structured Interview Guide for the Hamilton Depression Rating Scale and Patient-Reported Outcomes Measurement Information System forms. During the study, participants will be assessed both objectively through the EEG recordings and subjectively through questionnaires and interviews about their sleep quality and disturbances. The researchers will analyze these data to characterize sleep features in participants with different levels of insomnia symptoms, monitoring safety and compliance throughout the study period.

Researchers are evaluating a clinical decision support (CDS) tool called ePNa, originally designed for emergency departments, to improve pneumonia diagnosis and treatment in urgent care clinics in Utah. This study focuses on adapting ePNa for use in urgent care centers (UCCs), where pneumonia patients are frequently seen, and combining it with Stanford's CheXED artificial intelligence model to enhance chest image analysis. The goal is to implement and test this adapted tool to support clinicians in making accurate and timely pneumonia care decisions, especially as diagnostic and treatment methods evolve during the COVID-19 pandemic. The study involves adapting ePNa to fit the data limitations and workflow of urgent care clinics, incorporating AI-based chest image classification that provides results in less than one second. The adapted tool will be piloted with selected "super user" clinicians and then deployed to one of two randomly chosen UCC clusters, while the other cluster continues usual care. The implementation process will follow the CFIR framework for best practices in integrating new clinical tools, including identifying barriers and facilitators through focus groups, interviews, and workflow observation. Participants include pneumonia patients aged 12 years and older with specific diagnostic codes, and clinicians working in the selected urgent care clinics. The study will collect data on pneumonia diagnosis accuracy, patient transfers to emergency departments, and safety outcomes like unplanned hospital visits and mortality within 30 days. Physician surveys will assess user experience with ePNa. The study is planned to last up to three years, with ongoing monitoring of how ePNa impacts urgent care clinical environments.

Researchers are evaluating the safety and effectiveness of TSND-201 capsules for adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 trial includes participants who meet the DSM-5 criteria for PTSD with symptoms lasting at least six months and who have previously tried at least one pharmacological or trauma-focused psychotherapy treatment. The study aims to measure changes in PTSD severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Participants will be randomly assigned in equal groups to receive either one of two doses of TSND-201 or a placebo. These treatments are given orally once a week over a four-week Treatment Period. After completing treatment, participants will enter an eight-week Follow-up Period to monitor ongoing effects and safety. During the study, participants will complete interviews and written questionnaires to assess their PTSD symptoms and overall health. Researchers will track changes in PTSD severity up to 12 weeks from the start of treatment. Safety monitoring will include assessments to ensure participants remain free from other significant illnesses and manage any side effects. The total participation time includes the four-week treatment and eight-week follow-up phases.

Researchers are evaluating a step-wise treatment protocol using collagenase Clostridium histolyticum (CCH) injections in men with Peyronie's Disease who have a penile curvature of 30 degrees or more. This Phase 4 study aims to assess the safety and effectiveness of up to four series of CCH injections combined with mild in-office modeling, daily use of Restorex device, and nightly sildenafil medication. The study also includes the participation of sexual partners, who will complete questionnaires about their support for the patient's treatment.

This research aims to evaluate the effectiveness of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted bilateral nerve-sparing prostatectomy who have moderate erectile dysfunction or better before surgery. Erectile dysfunction is a common and challenging side effect after prostate cancer treatment, especially prostatectomy, with no previously proven preventative therapies. Prior studies suggested that RestoreX may improve erectile function and penile length, so this larger, multi-center trial seeks to confirm these findings. Participants will be randomly assigned to use the RestoreX device starting one month after prostatectomy, applying direct penile traction for 30 to 60 minutes, 5 to 7 days per week until six months post-surgery. After the randomized phase, all participants can use the device from six to nine months post-prostatectomy in an open-label phase, using only the straight traction function. The device is a class I orthotic developed with technology licensed from Mayo Clinic, previously shown to be safe and potentially effective in improving erectile function. During the study, participants will have their erectile function assessed using standard questionnaires at 3, 6, and 9 months after surgery. The main measure is the change in erectile function scores at 6 months. Researchers will monitor safety and collect data over a total study duration of up to three years to allow for enrollment and follow-up. The study will also track secondary outcomes based on questionnaire responses throughout the study period.

Researchers are studying men with ejaculatory and/or orgasmic dysfunction to understand the safety and effectiveness of different treatments. The study aims to build a large national registry that collects important health outcomes from men receiving treatment for these sexual dysfunctions. It also includes partners of affected men to gather comprehensive data. Participants will join the registry through their healthcare providers, who refer them via email. Once enrolled, participants will complete questionnaires about their diagnosis and treatment results at the start of the study, then every three months for one year, followed by every six months for two more years. This schedule allows detailed tracking of treatment progress and outcomes over a total of three years. Throughout the study, participants provide information through regular questionnaires to help researchers monitor treatment effects and safety. The main goal is to capture key outcomes related to ejaculatory and orgasmic dysfunction over this three-year period, enabling a better understanding of the conditions and their management.

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 long-term safety and tolerability of the drug NBI-1117568 in adults diagnosed with schizophrenia. This phase 3, global, multicenter, open-label study focuses on adults aged 18 to 65 years with a primary diagnosis of schizophrenia. The study aims to better understand how this medication performs over an extended period in this patient group. Participants will receive NBI-1117568 according to a specified dosing schedule. The treatment is administered openly, meaning both researchers and participants know the medication being given. No comparator or placebo group is mentioned, and the study primarily monitors the safety and side effects related to the drug over time. Throughout the study, participants will be closely monitored for any treatment-emergent adverse events for up to 36 months. Researchers will assess safety through regular evaluations and check participants' adherence to the protocol. The study includes careful screening and ongoing observation to ensure participant well-being and the collection of long-term safety data.

Researchers are studying whether adding ABX-002 to an existing antidepressant can improve depression symptoms in adults aged 18 to 65 with moderate to severe major depressive disorder who have not adequately responded to their current treatment. This Phase 2, double-blind, placebo-controlled study randomly assigns participants to receive either ABX-002 or a placebo alongside their antidepressant medication. Participants must have a current major depressive episode lasting more than 6 weeks and up to 18 months, and meet specific depression and anxiety rating scores to qualify. Participants will take ABX-002 or placebo oral solution once daily on an empty stomach, followed by water. The study includes a screening period of about 35 days, followed by a 42-day treatment period, a 2-week safety follow-up after dosing, and a 6-month targeted safety follow-up. Throughout these phases, participants continue their stable antidepressant treatment without changes. During the study, participants undergo assessments including depression rating scales to measure changes in symptoms. Researchers monitor safety through follow-up visits after treatment ends. The main outcome measured is the change in depression severity from the start to 6 weeks after treatment begins. Total participation spans several months, including screening, treatment, and extended safety monitoring.