Oct 14th, 2022 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

Oct 14th, 2022 - This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Oct 14th, 2022 - CIDP is a heterogeneous disease with variable responses to therapy. Recently, a distinctive subgroup of patients with serum autoantibodies to the paranodal proteins contactin and neurofascin have been identified. Although they present with active and serious disease, multiple clinical reports suggest that these patients can be cured with a treatment that depletes B cells and presumably eliminat...

Oct 14th, 2022 - The GAMEPAD study is a two-arm randomized controlled trial aimed at evaluating whether a home-based walking program with automated coaching augmented with gamification and behavioral economic principles improves functional capacity in patients with PAD. GAMEPAD will be conducted using the Way to Health platform, and patients will enroll and consent for participation online, with available help ...

Oct 14th, 2022 - Magnetic Resonance (MR) Imaging performed on volunteers will be used to develop and optimize techniques useful in the advancement of MRI technology. The results will be used to evaluate the performance of new imaging methods and equipment on human subjects, and to provide essential ground work for research and development for use in future patients. MR imaging is a non invasive technology, thou...

Oct 14th, 2022 - Glucocorticoids are among the most frequently prescribed immunosuppressive and anti-inflammatory medications worldwide. Long-term use, however, is complicated by serious non-immunologic side effects. Ongoing in vitro experiments with human primary cells in our laboratory suggest that there are indeed fundamental differences in the genomic response of immune and non-immune cells to glucocorticoi...

Oct 14th, 2022 - We propose to characterize the etiology and natural history of rare and uncommon diseases, both known and unknown that present with symptoms and signs associated with the risk of overt or potential cardiovascular dysfunction. We will also study rare genetic modifiers and identify novel disease mechanisms contributing to common cardiovascular diseases. In so doing, we will expand our knowledge a...

Oct 14th, 2022 - This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

Oct 14th, 2022 - The drug being tested in this study is called TAK-676. TAK-676 is being tested to treat people who have advanced or metastatic solid tumors. The study will enroll approximately 288 participants. Part 1 consists of an initial Safety Lead-in to Dose Escalation Phase; Part 2 and Part 3 compose the Expansion Phase in 2 specific indications namely, previously untreated metastatic or recurrent, unres...

Oct 14th, 2022 - In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining insid...

Oct 14th, 2022 - Study Description: We hypothesize that supplementation with a ketone ester drink [Ketone Ester (KE)] compared to placebo, in cognitively intact adults >= 55 years old with Metabolic Syndrome (MetS), will (i) increase peripheral and brain ketone levels [primarily beta-hydroxybutyrate (BHB) and secondarily acetoacetate (AcAc)], (ii) improve neuronal/astrocytic insulin resistance (IR) and induce a...

Oct 14th, 2022 - Lung transplantation currently is one way to treat a variety of serious diseases and conditions such as emphysema, pulmonary fibrosis, and cystic fibrosis. Ischemia Reperfusion Injury (IRI) is a known problem that can happen during the first few days after a lung transplant. IRI can cause swelling of the lungs and low levels of oxygen. The most serious type of IRI can cause the transplanted lun...

Oct 14th, 2022 - PRIMARY OBJECTIVES: I. To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU (fluorouracil), leucovorin (leucovorin calcium), oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. SECONDARY OBJECTIVES: I. To compare overall survival between the regimens. II. To further define the toxicity profiles of the ...

Oct 14th, 2022 - This trial is a single arm, non-randomized prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Data through the 30-day time point will be used for a Regulatory Submission to the Notified Body. Additionally, subjects will be followed for one (...

Oct 14th, 2022 - Background Mutations in the Dedicator of Cytokinesis-8 (DOCK8) gene are responsible for an immunodeficiency disease characterized by: severe cutaneous and sinopulmonary infections with bacterial organisms; extensive cutaneous viral infections with Herpes simplex, Herpes zoster, Molluscum contagiosum, and Human Papilloma Virus; a marked elevation in serum IgE levels and eosinophilia; homozygous ...

Oct 14th, 2022 - OBJECTIVE: The objective of this study is to investigate whether there is a correlation between genetic mutations, beginning with an analysis of ABCA4, and Plaquenil -induced retinal toxicity and to describe the phenotype of Plaquenil -induced retinal toxicity. STUDY POPULATION: The study will enroll 100 patients, 18 years of age or older, found to have Plaquenil -induced retinal toxicity. 200 ...

Oct 14th, 2022 - Sepsis is a common syndrome responsible for multiple organ failure. Septic shock, defined as sepsis with hyperlactatemia and cardiovascular failure requiring vasopressor infusion despite adequate fluid resuscitation has an extremely high mortality rate. Fever is a frequent disease process during sepsis. Fever increases oxygen consumption and can worsen imbalance between oxygen supply and oxygen...

Oct 14th, 2022 - More than 150,000 Virginians live with dementia. Most persons with dementia (PWD) are cared for by an unpaid family caregiver. These caregivers' provision of daily assistance to PWD is a critical part of the state's dementia care capabilities. Caregivers of PWD experience an array of negative biopsychosocial impacts related to their caregiving responsibilities that undermine their own well-bein...

Oct 14th, 2022 - Alcohol misuse is common in the United Kingdom (UK) Armed Forces (AF), with the prevalence rates higher in the AF than the general population. Research indicates that the trend continues after personnel leave service ('veteran' or 'ex-serving' are used interchangeably in the UK). It has been estimated that more than 50% of those who have left the AF meet the criteria for hazardous alcohol use, ...

Oct 14th, 2022 - This clinical trial evaluates the addition of CAN-2409 plus prodrug for stage III/IV NSCLC patients who are on standard of care first line ICI but with evidence of suboptimal response (either disease progression or stable disease at time of study enrollment). CAN-2409 plus prodrug has been shown to increase the response rate to ICI in animal studies. Safety and tolerability of CAN-2409 plus pro...