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Filter by:The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.
The aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: Phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with C4-C5 of severity classification). The multicenter randomized controlled trial (RCT) "Thermes & Veines" that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. The French National Academy of Medicine encourages the re-use of data of published RCT when available. In this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. The Control group consists of the 197 patients which were allocated to the Control group of the "Thermes & Veines". All patients enrolled in the current study benefit of 18-days of spa treatment with Mineral Water of Royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.
The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections. The main questions it aims to answer are: - probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections - probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).
This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.
The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.
The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology. The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients. VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months. Study details include - The study duration is approximately 21 months with a 2-month enrollment period. - Study intervention is 2 doses administered 5- 6 months apart. - The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval
In our previous study (title: Expression of Major Histocompatibility Complex Molecules class II- HLA-DR in Squamous Cell Carcinoma of the Head and Neck. ID 2222)the Authors verified that the epithelial cells of squamous cell carcinoma of the head and neck acquire the ability to express HLA-DR. Although the role of the expression of these molecules on neoplastic cells still remains controversial, a positive association between HLA-DR expression and clinical outcome was observed by us in analogy to what was reported by several studies on various types of tumors : in squamous cell carcinoma of the larynx, colorectal cancer , stomach cancer and others. In these tumors the expression of HLA-DR correlates with the presence of immune cells such as CD16+/CD11c macrophage myeloid cells, associated with a good prognosis and T cells which, recalled in the damaged tissue, they determine the formation of an immunogenic microenvironment that could support an anti-tumor immune response. Oncology studies are in fact focusing on the role of the tumor microenvironment which is characterized by different cell populations, among which the most abundant population is represented by tumor-associated fibroblasts (CAF). CAFs are fibroblasts which, in a tumor context, assume a phenotype similar to that of myo-fibroblasts and are distinguishable from normal fibroblasts by a greater expression of α-sma, FAP and FSP-1, which represent their specific markers, as well as a greater expression of vimentin, fibronectin, and type XI collagen. Numerous evidences in different types of tumors have reported both the immunosuppressive role, as these cells are capable in vitro of inhibiting the proliferation of T lymphocytes, to favor their apoptosis or to induce the phenotype of regulatory T lymphocytes; and the pro-tumor role, as they are capable of promoting tumor proliferation and invasion, angiogenesis and metastasis, thus contributing to the worsening of the prognosis. Many studies are directing their research on which factors secreted by CAFs are responsible for their function. In particular, among the many factors secreted by CAFs, there are the interleukins IL-17 and IL-33 which, as it has been demonstrated, can induce the activation of HLA-DR molecules on bone marrow-derived mesenchymal cells . It therefore seems interesting to investigate the role of HLA-DR in relation to the presence of the tumor microenvironment represented by CAFs.
A total of 34 participants, who require replacement of an anterior or posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the control group, the osteotomy site preparation will be prepared by using conventional surgical drills, while the test group site preparation will involve the use of Densah™ Burs (Versah Co., LLC., USA) as per the osseodensification protocol. In addition to evaluating implant stability, the trial will also report on implant and patient outcomes at various time points.
The purpose of this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation.