Woodbury

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the safety and effectiveness of different doses of IMG-007 compared to placebo in adults with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well IMG-007 works and its safety profile over a period of up to 48 weeks. Participants will receive subcutaneous injections of IMG-007 or placebo according to the study protocol. The study includes multiple dose regimens of IMG-007 and placebo groups, with some placebo participants crossing over to receive IMG-007 later. Treatments follow a parallel group design where different groups receive different doses or placebo. During the study, participants will undergo assessments including Eczema Area and Severity Index EASI scoring and Investigator Global Assessment for Atopic Dermatitis vIGA-AD at baseline and Week 24. Researchers will monitor treatment-emergent adverse events throughout the study. Participants will be followed for up to 48 weeks to evaluate changes in skin condition and safety outcomes during and after treatment.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years who have nonsegmental vitiligo. The study focuses on pediatric participants with depigmented areas of skin caused by this condition and seeks to better understand how the cream may impact these areas. Participants will be randomly assigned to receive either ruxolitinib 1.5% cream or a matching vehicle cream. Both creams are applied topically as a thin film twice daily to the affected skin areas according to the study protocol. The trial includes a 24-week treatment period during which improvements in skin pigmentation and safety outcomes are monitored. During the study, children will have regular assessments including evaluations of the affected skin areas using the Facial Vitiligo Area Scoring Index and Total Body Vitiligo Area Scoring Index. Safety is monitored through reports of any side effects and laboratory tests at various timepoints up to 52 weeks. Participants are followed closely for adherence to treatment and overall health throughout the study duration.

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 bioactive leg sleeve called the Reparel Sleeve, comparing it to a placebo sleeve that looks and feels similar. This study aims to see if the Reparel Sleeve can reduce pain and improve patient-reported outcomes after partial arthroscopic meniscectomy or meniscus repair. The study will include about 100 patients and will assess pain, satisfaction, physical therapy time, and motor function over time. Participants will be randomly assigned to wear either the Reparel Sleeve, made from fabric embedded with a special nano-sized material designed to reflect energy and promote healing, or a generic black placebo sleeve without this technology. Both sleeves come in various sizes and have similar compression and feel. The study is blinded, meaning neither participants nor researchers know who is receiving which sleeve. Participants will complete questionnaires before surgery and at several time points afterward, including 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Researchers will track pain using a visual scale, patient satisfaction, range of motion, and other outcome measures. The study will monitor progress and safety throughout the two-year follow-up period to evaluate the sleeves effects on healing and pain control.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.

Researchers are evaluating the use of BrainsWay Deep Transcranial Magnetic Stimulation Deep TMS to treat individuals diagnosed with moderate to severe Alcohol Use Disorder AUD. The trial is a prospective, double-blind, randomized, controlled, multi-center study involving outpatients aged 18 to 86 years. It aims to compare alcohol use outcomes between a group receiving active Deep TMS treatment and a group receiving sham inactive treatment. This study includes subjects seeking treatment to reduce or stop heavy drinking. Participants are randomly assigned to either the Deep TMS group or the sham group in a 11 ratio. The acute treatment phase involves 15 visits over 3 to 5 weeks, with each visit including two treatment sessions spaced 30 minutes apart, each lasting about 20 minutes. Following this, the maintenance and follow-up phase includes one treatment session per week until the six-month follow-up visit. Before each treatment session, participants are exposed to alcohol-related cues, then receive either active or sham Deep TMS stimulation. Throughout the study, participants will have their alcohol use monitored using the percent of heavy drinking days during months 2 to 4 based on self-reported timelines and supportive lab results. Researchers will also use several assessment scales to evaluate alcohol use and craving. Safety is closely monitored by tracking adverse events, vital signs, and physical and neurological examinations. The entire study participation lasts up to six months, including treatment and follow-up phases.

Researchers are evaluating the safety, how the body absorbs and processes, and the treatment effects of CABTREO lotion when applied to the skin in children aged 9 to 11 years, 11 months who have moderate to severe acne vulgaris. The study is open-label and phase 4, focusing on pediatric participants with specific acne severity and lesion counts on the face and at least one trunk area. The purpose is to understand how well CABTREO works and how safe it is in this age group. Participants will apply CABTREO, a combination gel containing clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15%, to affected areas once each morning for 12 weeks. On study visit days, participants will apply the gel at the study center after assessments. The study includes a main group and a smaller pharmacokinetics PK sub-study group to examine drug levels in the blood. The treatment is a topical gel gently rubbed into the skin. Participants will first complete a screening period of up to 5 weeks to confirm eligibility. During the 12-week treatment, they will attend visits at baseline and Days 14, 15 PK sub-study only, 28, 29 PK sub-study only, 56, and 84. Researchers will monitor safety by tracking any adverse events and measure changes in inflammatory and non-inflammatory acne lesions, as well as global acne severity scores. Participants must follow study instructions and attend visits with their parent or guardian if under age of consent.

This research aims to assess the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment phase followed by an open-label extension. The goal is to better understand how well deuruxolitinib works and how safe it is for this age group with significant hair loss. Participants will be randomly assigned to receive either deuruxolitinib tablets or matching placebo tablets taken orally twice daily for 24 weeks during the initial treatment period. Following this, all participants will have the opportunity to receive deuruxolitinib for an additional 52 weeks in an open-label extension phase. This design allows comparison of the drug to placebo and longer-term evaluation of the drugs effects. Throughout the study, participants will have regular assessments of their hair loss using the Severity of Alopecia Tool SALT at multiple time points up to week 24 and beyond. Safety will be closely monitored by tracking side effects, vital signs, heart tests, lab results, and physical exams. Additional measurements include patient and clinician impressions of improvement, quality of life, and mental health assessments. The total study duration can extend up to 76 weeks of treatment plus safety follow-up to fully evaluate outcomes and tolerability.