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Filter by:This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating: 1. the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction; 2. the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.
The goal of these series of N-of-1 trials is to compare the effects of three tea interventions on cognition, mood, and sleep, in healthy adult participants. The main questions they aim to answer are: - What are the short-term effects of, and differences between, three different black tea interventions on cognition, mood, and sleep, in individual participants? - What are the short-term effects of, and differences between, three different green tea interventions on cognition, mood, and sleep, in individual participants? - Are there any other lifestyle factors that influence the relationship between tea intake and cognition, mood, or sleep, and to what extent do they have an effect? Participants will be asked to drink three different tea interventions in four blocks of three weeks, where each week is assigned one tea intervention. At regular intervals three times per day, seven days per week, for the 12-week study duration, participants will be asked to complete a sleep questionnaire, mood questionnaire, personalised questionnaire (with questions pertaining to physical activity and work, for example), a tea consumption recall questionnaire, and two cognitive tasks based on attention (lasting one minute each). These questionnaires and tasks comprise one measurement point and take approximately five to six minutes to complete.
The main aim of this study is to assess and describe the safety outcomes, including newly diagnosed malignancies, of patients with CALD treated with eli-cel in the post-marketing setting (tradename Skysona) and to describe major functional disability (MFD)-free survival over time in participants with more advanced early active CALD. All enrolled participants with CALD treated with eli-cel in the post-marketing setting will be followed in this study for 15 years. No investigational drug product will be administered in this study. This study will enroll 120 participants with CALD treated with eli-cel in the post-marketing setting. A subpopulation of 24 participants with more advanced early active CALD will be specifically enrolled as required by the US FDA as a condition of accelerated approval and will be considered as a separate cohort for effectiveness outcomes.
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration
Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC
The goal of this clinical trial is to test the effectiveness of probiotic bacterial supplements as an additional therapeutic modality in patients with small intestine bacterial overgrowth who receive oral antibiotic treatment (rifaximin) The main questions it aims to answer are: 1 To evaluate the effectiveness of a dietary intervention using pro-biotic bacterial strains as an adjunct to treatment of SIBO with rifaximin. 2. Evaluation of ultrasonographic imaging of mesenteric lymph nodes in patients with SIBO. 3. Evaluation of the effect of rifaximin treatment and dietary intervention on non-alcoholic fatty liver disease activity parameters in patients with coexisting NAFLD and SIBO. According to the study schedule, a total of 3 visits will be made within 3 months. Visit 1, after 6 weeks Visit 2 and after another 6 weeks, Visit 3. Patients will also be invited to a follow-up Visit 4, three months after completing participation in the study. All study participants will receive treatment recommendations for SIBO in accordance with standard practice - a 14-day antibiotic treatment with Rifaximin. In addition, a randomly selected half of the study participants will receive probiotic therapy and half a placebo. - An ultrasound examination of the mesenteric root lymph nodes will be performed at each visit, - followed by a lier steatosis/fibrosis assessment using SWE elastography or FibroScan. - Blood sampling is required on each visit. All study participants will receive detailed guidelines during dietary consultations at each visit for the use of a low FODMAP diet. - Each participant will receive a paper diary on how to assess the severity of bloating and evaluate bowel movements, which must be filled out daily. - In addition, at the visits the patient will be asked to fill out an additional questionnaire on other gastrointestinal complaints and mental health.
Background: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation. Objective: To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers. Eligibility: People aged 18 years and older with newly diagnosed throat cancer associated with HPV. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken. All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles. Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle. Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery.
Diabetes mellitus (DM) is a complex chronic illness associated with a state of high blood glucose level, or hyperglycemia, occurring from deficiencies in insulin secretion, action, or both. Diabetes mellitus is the name given to a wide spectrum group of disorders characterized by raised plasma glucose.Type 1 diabetes is characterized by an absolute insulin deficiency due to autoimmune destruction of insulin producing beta cells in the pancreas. most adults with diabetes have type 2, characterized by a relative insulin secretory defect, and target tissue resistance to the effects of insulin.
Facioscapulohumeral muscular dystrophy (FSHD) is characterized by clinical diversity, with FSHD1 being the most common form. It is associated with a toxic gain of function of the Double homeobox 4 (DUX4) gene, leading to muscle cell death and weakness. Despite the lack of approved treatments, recent studies highlight inflammation's role in early FSHD progression, triggered by inappropriate DUX4 expression. In understanding inflammation's pivotal role in FSHD, a study assessed serum cytokines in 100 adult FSHD1 patients. Out of the 20 cytokines examined, 10 showed significantly altered expression levels compared to healthy controls of similar age and sex. FSHD1 patients exhibited heightened levels of inflammatory cytokines and diminished anti-inflammatory cytokines, signaling chronic inflammation. Notably, Interleukin-6 (IL-6) emerged as a promising disease activity biomarker, displaying robust correlations with established clinical severity and functional scores. Given the pathological significance of inflammation and the correlation of IL-6 levels with disease severity, the ReInForce study will explore the satralizumab, an IL6-receptor (IL6-R) antagonist, for its efficacy in specifically reducing muscle and systemic inflammation. By antagonizing IL-6R downstream signaling, satralizumab holds promise in mitigating inflammation and potentially curtailing fibrofatty degeneration in FSHD.
This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee