Milford

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

This research aims to evaluate the safety and immune response triggered by mRNA-based vaccines targeting the influenza virus in healthy adults aged 18 years or older. It is a Phase 2, randomized, double-blind clinical study assessing both investigational and licensed flu vaccines to better understand their tolerability and ability to stimulate the body's defense against flu infection. Participants will receive a single dose of one of six investigational influenza vaccines or one of two licensed influenza vaccines as a comparison. The vaccine is administered as an injection in the arm. The study involves about 6 months of participation, including at least three visits to the study site where blood samples will be collected each time. A nasal swab will also be collected at the first visit. During the study, researchers will monitor local and systemic reactions within 7 days after vaccination, adverse events within 1 month, and serious adverse events as well as newly diagnosed chronic medical conditions within 6 months. The assessments include physical exams, medical history, and laboratory tests. This comprehensive monitoring aims to gather detailed safety and immune response data from all participants throughout their 6-month involvement.

Researchers are examining how blood flow restriction (BFR) training affects immune cell metabolism and gene expression in people recovering from anterior cruciate ligament reconstruction. This phase 4 crossover study aims to understand the impact of BFR on immunometabolic processes during rehabilitation. The study hypothesizes that BFR will promote anabolic immune responses, enhance energy metabolism in white blood cells, and increase key metabolite concentrations to support tissue repair. Participants will complete two training sessions in random order: one with BFR using an inflated AirBand device and one control session using an uninflated AirBand. The AirBand cuffs will be placed on the thigh and inflated to 60% artery occlusion guided by ultrasound and controlled via Bluetooth. A certified personal therapist will observe participants to ensure safety and proper compliance during training. Throughout the study, blood samples will be taken before and at multiple times after exercise to measure changes in gene expression and concentrations of amino acids, glucose, lactate, fatty acids, insulin, glucagon, and catecholamines. Participants must attend two visits spaced at least one week apart. The study monitors immune and metabolic responses to BFR to better understand its role in rehabilitation after ligament surgery.

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 safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. This post-approval study aims to confirm the safety of these lenses in the intended US patient population. Safety data from a previous MiSight 1 Day study will also be used to supplement this evaluation. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on children interested in wearing contact lenses for about 10 hours per day, 6 days per week. During this time, subjects will be monitored to assess the incidence of microbial keratitis and other safety outcomes. Throughout the study, children will undergo regular eye exams to check visual acuity and eye health, ensuring they remain free from infections or complications. Parent or guardian consent and assent from the child will be obtained, and medical records will be reviewed to track outcomes related to contact lens safety over the three-year period.

Researchers are comparing two treatments for people with treatment-resistant depression (TRD): intravenous racemic ketamine and intranasal Esketamine (Spravato4). This study is a non-inferiority, multi-site, randomized trial involving about 400 adults over 5 years. It aims to evaluate how well each treatment improves depression symptoms, how acceptable they are to patients, and how well patients tolerate any side effects. The study will also explore factors that might predict which treatment works better for certain individuals. Participants are randomly assigned to receive either ketamine or Esketamine. Ketamine is given as a drip into the arm with a maximum dose of 60 mg per day, infused over 40 minutes, and participants can receive up to 8 doses in their lifetime. Esketamine is administered as a nasal spray at doses between 56 and 84 mg, with options to lower the dose to 28 mg if needed for tolerability. Both treatments follow FDA guidelines and are delivered under clinical supervision. During the study, participants will be monitored for treatment effectiveness, side effects, and overall acceptability over 30 days after treatment. Assessments include self-reported measures of symptom improvement and safety. Participants must be available for the full duration of the study and agree to follow all procedures. Safety measures include blood pressure monitoring and ensuring participants have someone to drive them home after treatment sessions. The total study duration can last up to 5 years with ongoing evaluations.

Researchers are evaluating the Portable Rehabilitation Interface (PoRI), a handheld device designed to assist hand movement, for improving hand motor function in patients recovering from stroke. This randomized clinical trial compares the use of the PoRI device against conventional hand therapy to understand its effects on hand rehabilitation after stroke. The study focuses on individuals who have experienced a stroke within the past two months and have sensorimotor problems or paralysis affecting one or both hands. Participants will use the PoRI device, which is designed to move the hand for those with sensorimotor dysfunction, during the rehabilitation period. This intervention will be compared with traditional hand therapy approaches. The device is intended for use by patients who can comfortably fit their hand inside it. The study involves monitoring and treatment within a specific timeframe after stroke onset. During the study, participants will undergo assessments at the start and again between two to three weeks later. These assessments include measures of motor function such as the Fugl-Meyer Assessment and Box-and-Block Tests, evaluation of pain using the Visual Analog Scale and the Short Form McGill Pain Questionnaire, as well as muscle tone assessment with the Modified Ashworth Scale. The trial will track changes in these scores to evaluate the effectiveness and safety of the rehabilitation approaches over the study period.

Researchers are evaluating an online program called "SCI & U" designed to support people with spinal cord injury (SCI) as they transition from hospital to community living. The study aims to find out if this web-based self-management program, delivered through peer health coaches, can improve health management skills, increase self-efficacy, and reduce emotional distress in individuals within three years of their injury. Participants are from British Columbia, Canada, or Connecticut, United States, and the study compares those using the SCI & U program to those receiving usual peer support. Participants will take part in up to 14 online coaching sessions with trained peer health coaches certified in motivational interviewing, goal setting, and brief action planning. Each session lasts about an hour and covers health topics like bladder, bowel, skin care, pain, healthy eating, physical activity, or mental health, along with self-management skills. The number of sessions per topic is tailored to each participant's needs, and coaches provide relevant resources through the online platform. The study includes a comparison group receiving standard peer support from local spinal cord injury organizations. During the study, participants complete surveys at the start, 6 months, and 12 months to assess emotional distress and self-management abilities. Researchers will track progress using the Emotional Distress Subscale of the Health Education Impact Questionnaire over six months. The total study duration involves follow-up assessments to monitor changes in emotional health, self-efficacy, and secondary complications, with ongoing support provided via the web-based platform.

Researchers are conducting a 5-year observational study across six sites, including academic medical centers and community psychiatric practices, to gather long-term data on patients with Major Depression Disorder who are receiving treatment with either Spravato4 or intravenous (IV) ketamine. The study aims to understand patient satisfaction, usage patterns, long-term effectiveness, and safety of these two treatments for moderate to severe treatment-resistant depression without psychotic features. Participants will either have recently started or are scheduled to start treatment with intranasal esketamine (Spravato4) or IV ketamine as prescribed by their clinician. The study will follow 450 patients in total, tracking their treatment over time without altering their prescribed therapy. Data collection includes baseline measures and ongoing monitoring during clinical treatment. Participants will be involved in regular assessments, including patient satisfaction measured by the TSQM-9 questionnaire over six months. Researchers will monitor treatment adherence, effectiveness, and safety throughout the study period. The study requires participants to be adults willing to comply with study procedures and available for long-term follow-up to provide valuable real-world information.