Cranston

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors TCRs to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohns disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are conducting a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-14 esreboxetine in managing fibromyalgia. The study aims to understand how well AXS-14 works for people with fibromyalgia by comparing continued treatment to placebo after an initial response. This multi-center trial is sponsored by Axsome Therapeutics, Inc. The study includes a 12-week open-label period where all participants receive AXS-14 tablets once daily. Those who respond to treatment will then enter a 12-week double-blind, placebo-controlled randomized withdrawal period. During this phase, participants are randomly assigned to either continue AXS-14 or switch to placebo until a loss of therapeutic response occurs or the period ends. Participants will be closely monitored throughout both study periods. Researchers will assess the time from randomization to loss of therapeutic response over 12 weeks. The study involves regular evaluations to track safety and treatment effects. Total participation spans up to 24 weeks, including both treatment phases.

Researchers are evaluating a simplified, low-barrier hepatitis C virus HCV treatment program designed for adults with active HCV who are incarcerated and awaiting trial at the Rhode Island Department of Corrections. This study aims to determine whether this approach is feasible, acceptable, and effective in a jail setting, especially for people who inject drugs. It is a pilot study assessing if the treatment can be completed and if participants are cured of HCV using this method, potentially informing future expansion of HCV treatment in correctional facilities. Participants will receive a 12-week course of the medication sofosbuvirvelpatasvir Epclusa without the need for lab monitoring during treatment. If released before completing treatment, participants will take remaining doses with them and receive support from Community Health Workers CHWs. These CHWs will assist with medication adherence, community re-entry, and coordination of follow-up lab work. The study includes one experimental arm where all participants receive the full treatment and CHW support. During the study, participants will be tracked for cure rates of HCV between 12 and 24 weeks after treatment completion. Researchers will also assess how easy the program is to deliver, how well participants follow the treatment plan, and how acceptable the program is to both participants and staff. Additional data collected includes participant demographics, adherence to medication inside and outside jail, program costs, and qualitative feedback from participants and staff. The study will help determine if this treatment model can be maintained and scaled in other jail settings.

This research aims to compare two extended-release buprenorphine medications, Sublocade and Brixadi, for people with opioid use disorder OUD who are leaving prison and reentering the community. The study is a pilot hybrid trial evaluating both how well these treatments work and how feasible and acceptable they are in a correctional setting. It also explores whether allowing participants to choose their medication affects how long they stay in treatment. Participants will receive monthly injections of either Sublocade or Brixadi before and after their release from prison. Some participants will choose which medication they prefer, while others will be randomly assigned to one of the two treatments. The study includes ongoing monthly treatment with flexibility for dosing based on clinical decisions. Participants can switch treatments or stop at any time. During the study, participants will complete surveys and clinical assessments about their treatment experience and satisfaction. Researchers will monitor treatment retention, opioid use through self-report and urine tests, cravings, adverse events, emergency visits, and hospitalizations for six months after release. The study will use these measures to compare the two medications and assess implementation outcomes such as acceptability and feasibility.