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The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are: - how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface? - how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV...
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This is an Observational Pre-post Study to Observe if the Off Label Use of Anti-IL1 Therapies, Such as Anakinra or Canakinumab, Can Block ACVR1-induced Flare Activity and Heterotopic Ossification in FOP
This is an observational pre-post study to observe if the off label use of anti-IL1 therapies, such as anakinra or canakinumab, can block ACVR1-induced flare activity and heterotopic ossification in FOP. It will also generate key tools and preliminary data that are needed to design a future Phase II study. This study specifically focuses on patients with severe FOP who are being considered by their medical team for rescue therapy with anti-IL1 therapy. Preliminary data suggests patients experience significant decreases in flare frequency when taking anti-IL1 therapy, but other measures of efficacy remain unassessed, such as changes in heterotopic ossification formation, changes...
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Thoracic-Lumbar Arthrodesis- Implanet Jazz
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
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Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.
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To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).
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Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
This study will assess the safety and efficacy of topical ruxolitinib for treating the refractory cutaneous manifestations in patients with dermatomyositis. The investigators' hypothesis is that topical ruxolitinib will be both safe and effective for such patients.
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Topical Treatment for TMJ Arthralgia
The goal of this clinical trial is to evaluate the efficacy of topical 2.5% hydrocortisone in TMJ arthralgia. The main questions it aims to answer are: - How does pain reduction compare? - How does improvement in jaw function limitation compare? - How do side effects compare? Participants will - On day 1 be examined and report their pain level and jaw function limitation - On days 1-21, apply their cream four times a day - On day 21, report their pain level, jaw function limitation, compliance with instructions, and side effects. Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects...
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Total Joint Arthroplasty (TJA) Weight Loss Study
This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA). The study population will include patients with hip or knee joint osteoarthritis and BMI (Body Mass Index) > 40 kg/m2 who are evaluated in the joint arthroplasty clinic at Boston Medical Center. The primary objective of the study is to determine if bariatric surgery or medical weight loss is more effective than the usual standard of care in optimizing a morbidly obese patient with osteoarthritis of the hip or...
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Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called [Zr-89]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.
