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Filter by:This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.
Health risks of radiation exposure in the moderate-to-high dose range have been well established. However, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. The purpose of this study is to construct a cohort of Korean radiation workers and to assess health effects associated with occupational radiation exposure. The study population is expected to be about 190,000 Korean radiation workers who have been registered with the Nuclear Safety and Security Commission since 1984. The national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data are collected based on the Nuclear Safety Act. Through the linkage of those collected data, we will evaluate radiation-induced health risks including cancer and non-cancer diseases.
Patients with diarrhea-predominant irritable bowel syndrome (IBS) and functional dyspepsia (FD) were examined and received treatment in the study. Severity of complaints and quality of life patients were assessed according to questionnaires. The state of the intestinal barrier (analysis of the protein composition, intestinal mucin levels in biopsies, serum zonulin level in blood), the composition of the gut microbiota (16S rRNA gene sequencing), bacterial metabolic function (short-chain fatty acid levels in feces), and the presence of gut inflammation (levels of lymphocytes and eosinophils in biopsies) were assessed in the patients. Patients were divided into 3 treatment groups: trimebutin + placebo, rebamipide + placebo, trimebutin + rebamipide. The above parameters were compared in patients before and after treatment.
This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.
This is a randomized clinical trial to measure the effect of tidal volume (group 6 ml/kg vs 10 ml/kg) on diaphragm dysfunction on mechanically ventilated critical patient.
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery. This system consists of two medical devices, the M/L-10 Clip Applier and the M/L-10 Clip. The Multi-Fire Clip System is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. This medical device has been marketed in Europe since 2006 and in the United States since 2002, among other places. Laparoscopic surgeries have become the standard of excellence for many surgical procedures as they allow the intervention to be performed in a minimally invasive way, which means significant improvements in factors such as postoperative pain or length of hospital stay compared to open surgeries. Laparoscopic procedures require the use of different hemostatic techniques to minimize blood loss or leakage of other fluids through their respective ducts. Currently, clip and staple placement are the most commonly used procedures for ligation and/or occlusion of blood vessels and other tubular structures. In this context, the Multi-Fire Clip System is presented as an alternative device that can produce significant cost savings due to the reusable design of the M/L-10 Clip Applier. It also provides precise control of bleeding during surgery, which could lead to less potential injury to surrounding structures. The present clinical trial is a PMCF study to evaluate the long-term safety and efficacy of the Multi-Fire Clip System in patients scheduled to undergo laparoscopic surgery in which clip placement is anticipated. During the surgery procedure, the necessary clips will be placed using the aforementioned multi-shot clip system. Participants will be followed up for 6 months after the operation. Through an on-site visit and a telephone call visit, data on possible adverse events related to the device or procedure will be collected in order to assess the long-term safety and efficacy of these devices.
This study will evaluate if a visual biofeedback program leads to improved knee outcomes after anterior cruciate ligament reconstruction. Outcome measures will include biomechanical movement patterns and markers of knee osteoarthritis on magnetic resonance imaging.
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from breastfeeding to formula feeding, using predominantly breastfed infants as a reference group.
This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.
This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.