This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized Phase of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy to generate pivotal efficacy and safety data in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Randomization will be stratified by PDL1 CPS <20 vs PD-L1 CPS ≥20, and prior chemotherapy (yes vs no).
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Randomized Arm: This is a prospective, open label, randomized, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients enrolled with NYHA Class II Heart Failure. Single Arm:This is a prospective, open label, single arm, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in patients enrolled with NYHA Class III Heart Failure comparedto a Performance Goal (PG).
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 & 3 PH.
This trial will help to determine if either the experimental arm (adjuvant reirradiation plus pembrolizumab, followed by pembrolizumab to complete 12 months total of pembrolizumab and/or pembrolizumab alone for 12 months) significantly improves Overall Survival (OS) compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk patients.
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.
We are investigating whether or not use of TENS device during IUD insertion reduces pain. We will record pain scores at different points in the IUD insertion procedure for patients who choose to use the TENS device and those who do not as part of this study. TENS device uses stickers (electrodes) on the skin to give gentle electrical pulse which has been shown to help with pain in some settings. This has not been studied for use with IUD insertion.
Broadly, the purpose of this project is to evaluate the baseline stroke and dementia risk of those Indvidual identified by NLP and characterize the population identified during the recruitment process through enrollment. Additionally, we seek to assess changes to medical care and medications in the 90-days after being informed of the NLP findings.
The goal of this protocol is to validate a non-contact technology with miniaturized radar integrated with a visible camera in a high-risk neonatal population to ultimately provide a safe alternative to current standard contact vital sign monitoring systems.
we plan to use non invasive ADP (air displacement plethysmography) method to measure body composition in very low birth weight infants and follow their neurodevelopment using HINE (Hammersmith Infant Neurological examination)
Aortic stenosis (AS) affects over 12.6 million adults and causes an estimated 102,700 deaths annually. There is interest in novel approaches to identify valve disease earlier the disease course before symptoms occur. We previously used machine learning (ML) to develop a system for fully automated AS screening. Here we are validating the performance of this new method for identifying AS.
This study is designed to evaluate the safety and efficacy of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.
The primary objective for this early feasibility study is to assess safety and feasibility of the Impella ECP device in adult patients undergoing an elective high-risk percutaneous coronary intervention. To assess safety, special attention is being paid to the effect of the pump on the aortic valve