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This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

The proposed study compares Tai Chi + Routine Care with Routine Care alone to see if the addition of Tai Chi to Routine Care can improve Knee OA pain. The study will be conducted at Tufts Medical Center, UCLA, Boston Medical Center, and Cleveland Clinic. The study is funded by the National Institutes of Health National Center for Complementary and Integrative Health. We expect to enroll up to 480 subjects across all sites needed to complete the study

The purpose of this study is to learn if asundexian is safe for the participants, how it affects the body, and to look at how well it works to prevent future ischemic strokes in participants who already had had an acute non-cardioembolic ischemic stroke or high-risk TIA.

RGN-259 eye drops compared to placebo eye drops 5 times per day in both eyes for the treatment of Neurotrophic Keratopathy. Percentage of subjects achieving complete healing (defined as 0 mm lesion size) of the Persistent Epithelial Defect (PED) at Visit 5 (Day 29) determined by corneal fluorescein staining captured by corneal photography and analyzed by a central reading center

The study is being conducted to compare whether an optical correction of bifocal spectacle lenses (BFL) or single-vision spectacle lenses (SVL) is more effective for the treatment of children with esotropia greater at near. Children will be randomized to be treated with BFLs or SVLs for 3 years and be evaluated at regular intervals throughout the study to determine whether their condition has worsened.

Persistent corneal epithelial defect (PCED) is a persistent non-healing corneal defect or wound. KPI-012 is a novel, human bone-marrow derived human mesenchymal stem cell (hMSC) secretome composed of biologically active components, which have been shown in preclinical studies and early clinical trials to facilitate corneal healing. This study will investigate the efficacy and safety of KPI-012 eye drops 4 times daily for 8-weeks for healing of PCED.

Patients receiving maintenence hemodialysis will be screened for underlying cognitive impairment using the Montreal Cognitive Assessment (MoCA) Tool, a cognitive screening tool. Routine dialysis data, including biochemical measures and attendance records, will then be subsequently examined. Depending on the MoCA results, patients may be invited to participate in an interview to explore their experience with the MoCA screening tool and other aspects of their dialysis care.

This is a study to determine if a video that utilizes a peer to teach self administration of subcutaneous depot medroxyprogesterone is both effective and well accepted by adolescent patients who are already receiving ongoing treatment with depot medroxyprogesterone by a medical provider via an inter muscular injection.  Self administration can be done at home and therefore offers an alternative to traveling to a medical office.

This study is looking at home cooking patterns in people seen at the Tufts GI clinic with IBD and those without IBD. Participants will be given a questionnaire that will ask about different parts of the participants' home cooking patterns including attitudes, self-efficacy, and knowledge. By taking the responses to the questionnaire, we plan to examine different variables linked to home cooking pattern and how they differ between people seen at the GI clinic here at Tufts with IBD, and people seen at the clinic without IBD.

This is a randomized, phase 2, double-blind, placebo-controlled study of KER-012 in combination with background therapy in participants with PAH of World Health Organization (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 2:2:2:3 ratio to receive KER-012 (Dose A), KER-012 (Dose B), KER-012 (Dose C), or placebo by subcutaneous injection (SC) every 4 weeks for a period of 24 weeks in the placebo-controlled treatment period of the study while on background therapy.

The purpose of this study is to determine whether treatment with OP-1250 as a monotherapy will result in improvement of progression-free survival (PFS) and overall survival (OS) compared to SOC ET and assess the safety of treatment with OP-1250 in participants with ER+, HER2– advanced or MBC with and without estrogen receptor 1 gene (ESR1) activating mutation(-s) whose disease has relapsed or progressed on 1 or 2 prior lines of SOC ET, including a cyclin-dependent kinase (CDK) 4/6 inhibitor.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria.

Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous treatment options are available. The therapies vary in mechanism of action, mode of administration, side- effect (adverse event) profile, and cost. While consensus treatment guidelines are available, identifying an optimal treatment sequence is often based on clinician choice with treatment changes based on tolerability and short- term outcome. The N-of-1 trial will evaluate individual participant and aggregate data. Individual participants will be enrolled and randomized to a sequence of three U.S.

The primary goal of this study is to use the WHOOP fitness band as a way to measure heart rate variability (HRV) in patients with coronary artery disease (CAD) and to establish a change in HRV before coronary artery bypass graft (CABG) surgery and during post-operative stay. The secondary aim of this study would be to associate this change in HRV with the patient’s clinical course. The validation component will test WHOOP’s HRV capabilities compared to the gold-standard Holter monitor. 

This is a phase 2, randomized, double-blind, placebo-controlled, crossover study to evaluate the safety and efficacy of atrasentan vs placebo while on background therapy with SGLT2i in subjects with IgAN. The primary efficacy assessment is the change from baseline in proteinuria (UPCR) at week 12. Eligible subjects who are enrolled in the study will be randomly assigned in a 1 to 1 ratio to either sequence AB or sequence BA.

This is a randomized, sham controlled, double-blinded multi-center global clinical trial to evaluate exhalation synchronized abdominal functional electrical stimulation (FES) in adult patients receiving, or recently disconnected from, invasive mechanical ventilation to prevent or retard disuse atrophy of the abdominal wall muscles and reduce the number of days of ventilator support. Eligible participants will be randomized 1:1 to the VentFree Respiratory Muscle Stimulator or a sham treatment. FES or sham treatment will be applied as an adjunct to standard of care.

Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of programmed cell death 1 (PD-1) inhibitors in advanced lung cancer, such as pembrolizumab, there has been an improvement in  response rates and survival compared to chemotherapy.

However, there is still a need for improvement in response rates in first-line treatments for patients with stage 4 Non Small Cell Lung Cancer (NSCLC) without genetically targetable alterations, especially in those patients with PDL-1 <50%.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in patients with traumatic injury and confirmed or suspected acute major bleeding predicted to receive a large volume blood product transfusion. Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site. Subjects will receive a single IV infusion of either BE1116 or placebo, in addition to the study site's standard resuscitation methods and protocol.

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade E, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

The total duration of this study for each participant is approximately 165 weeks, which includes a screening period of 5 weeks, followed by a 16-week placebo-controlled period which will run concurrently with a 24-week active comparator-controlled period, followed by treatment with JNJ-77242113 200 mg once daily through Week 156 and a 4-week safety follow-up period.