Smithfield

Researchers are evaluating the safety, tolerability, pharmacodynamics, and effectiveness of multiple increasing doses of CNP-103 in people aged 12 to 35 who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b2a first-in-human clinical trial aims to better understand how CNP-103 works in this population and to assess any immune safety concerns. Participants receive three intravenous doses of CNP-103 at varying amounts 100 mg, 300 mg, or 600 mg on Days 1, 8, and 90. The study includes multiple groups, including adolescent and adult cohorts, with dosing for an expansion group determined based on initial results. A placebo containing 0.9% sodium chloride is also used for comparison. The trial follows a parallel design with random assignment and double masking. The study lasts approximately 393 days and consists of a 28-day screening period, a 90-day treatment period, and a 275-day post-dose evaluation phase. Participants will be monitored for safety and immune safety throughout the entire year. Various assessments will be conducted during visits to track the effects and tolerability of the study drug, with regular follow-up to evaluate long-term outcomes.

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 a new digital therapeutic aimed at preventing posttraumatic stress disorder PTSD and cannabis use disorder CUD in women who have recently experienced sexual assault. The study focuses on women presenting for emergency care after assault, as many develop chronic PTSD and face increased risk for CUD. This research also trains investigators in advanced clinical trial methods and biobehavioral mechanisms related to PTSD-CUD prevention. Participants will be randomly assigned to one of two behavioral intervention groups. One group will receive the RISE Guide, a brief cognitive behavioral program delivered via smartphone within three weeks post-assault, teaching stress education, cognitive retraining, and anxiety sensitivity reduction techniques supported by personalized ecological momentary intervention reminders. The other group will use the Breathe2Relax app, which provides diaphragm breathing exercises for stress management, along with reminders to engage with the relaxation exercises. During the study, participants will be monitored for anxiety sensitivity using the Anxiety Sensitivity Index-3 at 6 weeks, as well as various measures of cannabis use, anxiety, depression, and PTSD symptoms over 6 months. The study includes smartphone-based assessments, ecological momentary interventions, and questionnaires to track symptoms and intervention adherence. The total study duration extends to six months, including ongoing evaluation and support.

Researchers are studying a treatment called MANP modified atrial natriuretic peptide for people with difficult to control or resistant hypertension. This Phase 2 study compares the safety and effects of daily MANP injections to a placebo in reducing daytime systolic blood pressure over 42 days. Participants are adults aged 18 to 80 who are already taking three or more blood pressure medications. Participants will be randomly assigned to receive either MANP or a placebo injection once daily for 42 days. The MANP is given as a subcutaneous injection. The study is double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo until the study ends. A subset of participants with slightly reduced kidney function may also be included, but not exceeding 10% of total enrollment. During the study, participants will have their blood pressure monitored closely using 24-hour ambulatory blood pressure devices and clinic measurements. Safety will be assessed through reports of side effects and serious adverse events up to 4 weeks after treatment ends. Blood samples will be taken for pharmacokinetic and antibody testing. The total study duration includes about 42 days of treatment plus 4 weeks of safety follow-up.