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Filter by:The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.
GM2 gangliosidoses are a group of autosomal recessive neurodegenerative diseases characterized by a deficiency of the Hex A enzyme to catabolize GM2, thereby causing GM2 accumulation within cellular lysosomes.Hex A is composed of 2 subunits, α- and β-, coded by the HEXA and HEXB genes, respectively. The primary purpose of the current study is to assess the safety and tolerability of TSHA101 administered via IT injection.
Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin interface leading to secondary caries. Time-saving and simplified restorative procedures are an ongoing demand for posterior applications.The bulk-fill resin based composites (BF-RBCs), has been developed with an attempt to speed up the restoration process by enabling up to 4- or 5-mm thick increments to be cured in one step. The photo-polymerized single-step BF-RBC materials seem to have some limitations in terms of adequate polymerization. Therefore, recently, the use of dual-polymeritzed RBCs that are also suitable for bulk-fill application with additional bioactive properties such as acid-neutralizing ion release has been offered as an alternative to photo-polymerized ones. Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) restorative material is one approach that has been introduced as a new material category for this purpose. The hand mixed form is named as Cention N whereas auto-mixed capsule form is Cention. Both of them are resin based composite materials categorised as 'alkasite'. They are self-curing composites with optional photo-polymerzation for full volume (bulk) placement. Their composition is same with only exception of the concentration of the initiators and the powder liquid proportion. Cention is delivered together with Cention Primer to ensures the retention of the filling independent of the preparation. The objective of this prospective clinical trial is to evaluate the clinical performance of Cention and Cention Primer in restoration of Class I and II cavities.
Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology. Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication. Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
This trial is a multicenter, 4-cohort, prospective, Phase II trial conducted in patients with untreated resectable MSI/dMMR carcinomas or EBV+ gastric cancer and aiming to evaluate the safety and the efficacy of ICI (immune checkpoint inhibitor) as neoadjuvant treatment in these patients. We hypothesize that immune checkpoint inhibitors (ICPi) will benefit to MSI/dMMR tumors from the early stages, whatever their anatomical origin. We assume that this neoadjuvant treatment would improve the response rate, providing even high rate of pathological complete responses and prolong patients survival. We anticipated endometrial, colorectal and gastric cancers to be the most frequent recruited and constructed our statistical hypothesis with results in those 3 cancers. However patients with other localized MSI/dMMR tumors could be included.
Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. It accounts for 4% of emergency department admissions and 20% of emergency surgeries
Part 1 Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable disabilities regarding gait, balance, cognition and continence. Analysis of the gait pattern in iNPH has an important part in clinical diagnosing and evaluation of outcome after shunt surgery. The gait pattern is only partly explained and more detailed information about gait in iNPH is needed in relation with ordinary clinical measurements. Part 2 Approximately 70 % of patients with iNPH improve after shunt surgery. Commonly different grading scales and measurements regarding functions are used in the evaluation. To some extent, patients improve in Quality of life after surgery (QoL). In this study, the patient´s own grading of improvements in relation with QoL, sense of coherence (SOC) and symptoms of depression and anxiety are analyzed.
Intratympanic steroid injections are an accepted treatment for Meniere's disease and idiopathic sudden sensorineural hearing loss. This treatment is typically performed using local topical anesthesia. There is very limited research on the differences of medications and application procedures effect on patients' pain during the procedure.Topical Tetracaine solution and topical phenol have been shown to be effective as local anesthesia for the tympanic membrane when used for myringotomy. Currently there is no consensus on medication and technique however focally applied phenol is the more widely used technique. We believe this study can provide valuable information given the disadvantages of topical phenol including burning upon application as well as possible increase in persistent tympanic membrane perforation. The objectives are to determine the effectiveness of tetracaine drops for local anesthesia for intratympanic steroid injections compared to focal topical phenol application and to identify if tetracaine drops provides adequate anesthesia for intratympanic steroid injection with less pain on application than focal phenol.
This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.