Milford

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

Researchers are evaluating the safety and immune response of several mRNA-based influenza vaccines in healthy adults aged 18 years and older. This Phase 2, randomized, double-blind study compares six investigational mRNA flu vaccines against licensed influenza vaccines. The goal is to understand how well these vaccines stimulate the bodys defense against the flu virus and to monitor any side effects. Participants will receive one single dose of either one of the six mRNA influenza vaccine candidates or one of the licensed flu vaccines by intramuscular injection on Day 1. The study includes one treatment period where the vaccines are administered, and the participants will be monitored for reactions and immune responses over time. Participants will visit the study site at least three times over approximately six months. At each visit, blood samples will be collected to measure antibody levels, and a nasal swab will be taken at the first visit. Researchers will track local and systemic reactions within 7 days of vaccination, as well as adverse events, serious adverse events, and any new chronic medical conditions for up to six months. The study aims to assess the immune response and safety profile of the vaccines during this period.

Researchers are investigating how blood flow restriction BFR training affects immune cell metabolism and gene expression in people recovering from anterior cruciate ligament ACL reconstruction. This phase 4 study explores the impact of BFR on immunometabolism during rehabilitation to better understand its biological effects. The study uses a single-blind crossover design where participants experience both BFR and control sessions in random order. Participants will attend two training sessions at least one week apart. In one session, an AirBand device will be inflated to restrict blood flow by 60 in the femoral artery while an ultrasound probe monitors the artery. In the other session, participants will wear an uninflated AirBand as a control. A certified Personal Therapist will supervise all sessions to ensure safety and adherence. Throughout each session and at baseline, immediately after, and at 30 and 60 minutes post-exercise, researchers will measure changes in leukocyte metabolic gene expression, substrate preference, and concentrations of amino acids, glucose, lactate, fatty acids, insulin, glucagon, and catecholamines. Secondary measures include creatine kinase levels, patient-reported soreness, and baseline immunometabolic profiles. The total study duration involves two visits with monitoring of biological and self-reported outcomes.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication LSS with NC in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression IPD. The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the studys NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

This research aims to confirm the safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. It is a prospective post-approval study conducted in the US, evaluating how these lenses perform within the intended patient population. Safety data from a related study will also be used to supplement the findings. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on monitoring the incidence of microbial keratitis and other types of infiltrative keratitis, as well as any loss of best-corrected visual acuity. The study does not include a comparison group or masking. Throughout the study, participants will be regularly assessed for eye health and vision changes. Researchers will collect and review data on eye infections and visual acuity loss over the three-year period. Parents or guardians will provide consent and assist with data release related to healthcare encounters. The total participation time is three years with ongoing safety monitoring.

Researchers are evaluating two treatments for adults with treatment-resistant depression TRD to compare their effectiveness, comfort, and side effects. The study focuses on ketamine given through an IV drip, which is not yet FDA approved for this use, and Esketamine Spravato, a nasal spray approved by the FDA for TRD. The trial aims to understand which treatment works better for different patients and how well each is tolerated. Participants will be randomly assigned to receive either intravenous ketamine or intranasal Esketamine. Ketamine doses will be up to 60 mg per day, infused over 40 minutes, with a lifetime limit of eight doses. Esketamine doses range from 56 to 84 mg per session, with adjustments allowed for those who have difficulty tolerating the medication, including a lower dose option of 28 mg if needed. The study will last about five years and enroll around 400 patients across multiple sites. Throughout the study, participants will be monitored for depression symptoms and side effects using self-reports and clinician evaluations over four weeks of treatment. Researchers will assess changes in depression severity, suicidal thoughts and behaviors, quality of life, disability levels, and healthcare use. Safety and tolerability will be carefully tracked during this period. The primary outcome will be self-reported effectiveness at 30 days, with additional assessments continuing until the end of treatment.

Researchers are evaluating the Portable Rehabilitation Interface PoRI device to improve hand motor function in patients recovering from a stroke. This clinical trial compares the use of the PoRI device combined with conventional hand therapy versus conventional therapy alone for post-stroke hand rehabilitation. The study aims to assess the devices impact on hand function and pain in individuals who have experienced a stroke recently. Participants in the experimental group will receive seven 20-minute sessions with the PoRI device over 10 days, alongside one hour of conventional therapy five days a week for two to three weeks. The control group will receive only the conventional therapy for the same duration and frequency. The PoRI device is a handheld tool designed to assist movement in the hand for patients with sensorimotor hand dysfunction. During the study, participants will be assessed using several measures including the Fugl-Meyer Assessment, Box-and-Block Test, Visual Analog Scale for pain, Short Form McGill Pain Questionnaire, and Modified Ashworth Scale at baseline and after two to three weeks. Researchers will also evaluate device usability and accessibility through a survey. The total participation period spans approximately two to three weeks of therapy sessions with ongoing monitoring of hand function and pain levels.

This research aims to evaluate whether the online program and web-based platform called SCI U can support people with spinal cord injury SCI as they transition from hospital to community living. The study focuses on individuals within three years of their SCI who are either planning to be discharged to or currently living in the community in British Columbia, Canada, or Connecticut, United States. The main question is whether this program can reduce emotional distress and improve self-management skills and confidence compared to usual peer support. Participants will be randomly assigned to either the SCI U self-management program or a control group receiving the existing peer support program. Those in the SCI U group will take part in up to 14 online coaching sessions with trained peer health coaches. These sessions, lasting about 45 to 60 minutes each, will cover health topics like bladder, bowel, skin care, pain, healthy eating, and mental health, along with self-management skills such as goal setting and problem solving. The control group will receive standard peer support services. During the study, participants will complete surveys at the start, 6 months, and 12 months to measure emotional distress, self-efficacy, health activities, social support, and other health-related outcomes. Coaches will track progress on the web platform, including goal setting and action plans. The research team will closely monitor these measures to understand the programs impact on health self-management and secondary complications over time.

Researchers are evaluating whether using RECELL4 Autologous Skin Cell Suspension ASCS with de-epithelialized tissue provides better skin color matching than standard grafting techniques in patients undergoing head and neck reconstruction. This study aims to compare color match, healing, and patient satisfaction across three reconstruction methods for cutaneous defects in the head and neck region. Participants will have their wound divided into three sections to receive different treatments split-thickness skin graft, de-epithelialized tissue alone, and de-epithelialized tissue combined with RECELL4 ASCS. The intervention is applied on the day of surgery, with all participants receiving the same combined treatment and serving as their own controls. The study compares these methods to see which provides better color matching. After surgery, participants will return for follow-up visits on Day 14 and at 1, 3, and 6 months. During these visits, researchers will measure skin color matching using a handheld colorimeter, assess wound healing and morbidity, collect patient satisfaction data through questionnaires, and monitor for any adverse events. The study tracks outcomes over six months to evaluate the success of the reconstruction methods.

Researchers are gathering long-term follow-up information on adults with treatment-resistant major depression who are starting or continuing treatment with either intravenous IV ketamine or Spravato, an intranasal form of esketamine. This observational study aims to learn about patient satisfaction, use patterns, long-term effectiveness, and safety of these treatments. The study will take place over five years across six sites including academic medical centers and community psychiatric practices. Participants will be those receiving standard clinical care with either IV ketamine or Spravato as prescribed by their clinicians. The study will observe two groups patients taking IV ketamine and those using Spravato. Treatments are given as part of usual clinical care, and the study does not assign or change treatments. The primary focus is to compare these two treatment approaches over time. During the study, researchers will collect information at baseline and through six months on treatment satisfaction using the TSQM-9 questionnaire, depression severity reported by patients and clinicians, treatment patterns such as number of treatments, reasons for stopping treatment, average dose, and any adverse events. Participants will be followed for up to five years to provide comprehensive data on these measures and their experiences with treatment.