Wellesley

Researchers are investigating whether combined treatment using the EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices can improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal and aged 40 years or older without other medical causes. This study is a prospective, multi-center, two-arm, single-blinded interventional trial that compares active treatment versus sham treatment to answer if these devices improve depressive symptoms and urinary incontinence. Participants are randomly assigned in a 3:1 ratio to receive either active or sham treatment. The active group receives six transcranial magnetic stimulation sessions with the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, spaced 3 to 7 days apart, along with six treatments using the HPM-6000UF device on pelvic floor muscles at intensities up to 100%. The sham group receives similar sessions but at 1% intensity for both devices. All treatments and visits occur over approximately five months. Throughout the study, participants complete questionnaires assessing depressive symptoms, urinary incontinence, sexual function, mental wellbeing, therapy comfort, and satisfaction. These include the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, and others, administered at baseline, during treatment, and at follow-ups 1 and 3 months after the last session. Researchers monitor changes in subjective depressive symptoms over 15 months to evaluate safety and efficacy.

The Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST), which will be managed by the American College of Radiology (ACR), Center for Research and Innovation (CRI), seeks to determine if dual-energy contrast-enhanced spectral mammography (CESM) screening provides more accurate cancer detection compared to digital breast tomosynthesis (DBT) in women with dense breasts. Year 0 Visit: All women aged 45 to 74 years of age known mammographically dense breasts, as reported on their most recent prior mammogram who are scheduled for a routine annual screening DBT will be offered CESM in addition to DBT. Baseline imaging (Year 0) will be performed within 30 days after participant registration. Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup. Year 1 Visit (12 Months ±2 Months After Year 0 Imaging): Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup. Year 2 Visit: Follow-Up - Return for Standard Mammography Screening (12 Months ±2 Months After Year 1 Imaging): The 2-year participant follow-up contact (email, text, or phone calls) should be performed 12 months (±2 months) after the Year 1 imaging to confirm the participant has not been diagnosed with an interval breast cancer. If 2-year imaging has not been scheduled, the 2-year participant follow-up contact should be performed prior to 14 months post year 1 visit. Participants diagnosed with breast cancer in the interval between the Year 1 and Year 2 imaging studies will have no subsequent follow-up and will not undergo the Year 2 study imaging in the scope of the study. The participant will be asked for AEs/SAEs with a non-leading question.

Researchers are collecting Optical Coherence Tomography (OCT) data to better understand both healthy eyes and eyes affected by retinal disease, glaucoma, and corneal diseases. The study includes adults aged 22 years or older who meet specific eye health criteria and are able to consent to participate. The purpose is to gather detailed imaging data from various eye conditions to support further research and evaluation. Participants will undergo imaging using the A10900 OCT device, which captures detailed scans of the eyes. The study includes multiple groups: those with retinal disease, glaucoma, corneal diseases, and healthy eyes. Each participant will have their eyes scanned to collect OCT images, with the number of scans tracked over one year. The device imaging will be carefully performed to ensure acceptable image quality for research purposes. Throughout the study, participants will be assessed for their ability to tolerate imaging and comply with study procedures. Researchers will collect and analyze OCT scan data to evaluate eye health and disease characteristics. Safety and image quality will be monitored, and participants will be followed for one year to track the number of OCT scans obtained and any related observations.

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 evaluating an online program designed to help fathers communicate with their high-school aged teens about sex and relationships. This pilot study uses Social Cognitive Theory and an Intervention Mapping approach to test the program's acceptability, feasibility, and early effects on participants' knowledge and confidence. The study involves 50 pairs of fathers and their teens and aims to see if this approach could lead to a larger future study. The intervention includes three weekly online modules delivered via Qualtrics and Zoom, each containing separate lessons for fathers and teens, joint father-teen activities, and father-only support group sessions. Participants complete one module per week, including interactive activities and scheduled online support groups for fathers. The program incorporates feedback questions and reminders to encourage participation and engagement. Participants will complete surveys before and after the intervention to measure changes in sexual knowledge, communication confidence, and comfort discussing sex with family. Researchers will track enrollment, retention, and lesson participation for feasibility, and conduct interviews with a sample of fathers and teens to gather detailed feedback. The total participation spans six weeks, allowing for a thorough assessment of the program's impact and participant experience.

Researchers are evaluating a modified regimen of ublituximab in adults with relapsing multiple sclerosis (RMS) to assess its effectiveness and safety. The study is a phase 3b trial consisting of three parts: Part A is open-label and single-arm, Part B is randomized, double-blind, and placebo-controlled, and Part C is open-label focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The main goal is to measure changes in T1 Gadolinium-enhancing lesions in the brain to see how well the treatment works. Participants receive ublituximab or placebo through intravenous (IV) infusions during different parts of the study. Part A and Part C involve ublituximab infusions, while Part B compares ublituximab to placebo infusions. Part C includes participants who have been treated with an anti-CD20 agent for at least six months but had suboptimal results and meet specific washout requirements before beginning this study. During the study, participants undergo regular assessments, including brain MRI scans to monitor T1 Gd-enhancing lesions over 48 weeks and pharmacokinetic measurements up to 16 weeks. Researchers also evaluate safety and treatment responses throughout the study. The trial includes adults aged 18 to 65 with stable neurological status and a disability score of 5.5 or less. Female participants of childbearing potential must use contraception during and after the study. Total participation time varies based on the study part and treatment schedule.

Researchers are evaluating the performance, safety, and effectiveness of the GORE4 VIABAHN4 FORTEGRA Venous Stent for treating symptomatic iliofemoral venous obstruction. This is a prospective, non-randomized, multicenter, single-arm clinical study involving up to 30 clinical sites across the U.S. The study aims to enroll 165 subjects who will receive the stent to help improve blood flow in affected veins. Participants will be treated with the GORE4 VIAFORT Vascular Stent, targeting unilateral symptomatic iliofemoral venous obstruction. The stent is implanted during a procedure designed to open blocked or narrowed veins. The study includes patients with non-malignant venous obstruction meeting specific clinical and anatomical criteria, and the procedure involves use of imaging to guide stent placement. Only one stent type is used, and treated subjects are limited per site. After treatment, participants will be followed closely starting from hospital discharge, with follow-up visits scheduled at 1, 6, 12, 24, 36, 48, and 60 months to monitor safety and device performance. Researchers will assess safety events such as stent embolization and evaluate effectiveness by measuring vein openness (primary patency) over 12 months. Additional monitoring includes clinical assessments and imaging as needed to track outcomes and ensure participant safety throughout the study duration.