Zongertinib (BI.1810631) Phase I Study in Advanced Solid Tumors with HER2 Aberrations focusing on NSCLC. The trial involves dose escalation and expansion, testing different doses in cohorts with varied HER2 mutations. Primary endpoints include MTD, OR, and DLTs.

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The OCTIVUS Randomized Clinical Trial compared the clinical efficacy and safety of Optical Coherence Tomography (OCT)-guided and Intravascular Ultrasound (IVUS)-guided strategies in patients undergoing PCI for significant CAD. The study aimed to determine if OCT-guided PCI is noninferior to IVUS-gui

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This prospective, multicentre, randomised clinical trial led by Dr. Tiffany Patterson aims to determine whether direct delivery to a cardiac arrest centre following non-ST elevation out-of-hospital cardiac arrest reduces deaths compared to delivery to the nearest emergency department. Funded by the

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Iron deficiency is prevalent in heart failure patients with reduced ejection fraction and is linked to poor outcomes. The HEART-FID trial investigates the impact of intravenous ferric carboxymaltose (FCM) on all-cause mortality, heart failure hospitalizations, and exercise capacity in chronic HFrEF

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This UK-wide clinical trial aims to assess the effectiveness of early peripheral norepinephrine infusion in adult patients with septic shock. The study will compare the impact on mortality and other outcomes of targeting a mean arterial pressure (MAP) above 65mmHg within the first 48 hours of admiss

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UW Clinical Trial Office conducts budget reviews to ensure compliance and financial accountability in clinical trials. The office collaborates with various departments to manage billing compliance, financial risks, and institutional policies. The primary focus is on avoiding patient billing errors,

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This session discusses the landscape of DHT-derived novel endpoints in clinical research, focusing on considerations for regulatory decision-making. It explains the use of digital health technology in clinical outcome assessments and highlights the potential benefits of digitally collected COAs, suc

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Empagliflozin's impact on cardiovascular and renal events in heart failure with reduced ejection fraction was assessed in the EMPEROR-Reduced trial led by Milton Packer, MD, and Faiez Zannad, MD. The trial, enriched for patients with severe left ventricular dysfunction, randomized participants to em

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This educational slide module delves into fundamental statistics for analyzing clinical endpoints in diabetes research. It covers the choice of statistical methods, the distinction between statistical and clinical significance, and the importance of different endpoints in evaluating clinical benefit

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In patients with acute myocardial infarction (AMI) and multivessel coronary artery disease, this study aims to compare fractional flow reserve (FFR)-guided PCI with angiography-guided PCI for non-infarct-related artery lesions. The hypothesis is that selective PCI guided by FFR is superior to routin

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Explore the process of simulating clinical trial designs, including traditional and adaptive approaches. Learn how to generate data, conduct analysis, make within-trial decisions, and summarize results using fixed-sample two-arm parallel group trials and group-sequential designs. Dive into methods l

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Explore the various types of hearings available in the Court Management System, such as Motion Calendar, Special Sets, Calendar Call/Trial, Pre-Trial Conference, and Case Management. Learn how to set up new hearings/events and understand the process of generating trial orders and pre-trial conferenc

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In computer graphics, the Digital Differential Analyzer (DDA) Algorithm is utilized as the basic line drawing algorithm. This method involves interpolation of variables between two endpoints to rasterize lines, triangles, and polygons efficiently. The algorithm requires inputting coordinates of two

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Clinical trials are essential research studies that evaluate new tests and treatments to improve human health outcomes. They involve various phases, designs, and purposes, such as treatment trials, prevention trials, and observational studies. Different types of clinical trial designs include experi

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The CLEAR Trial is a 2x2 factorial randomized trial evaluating the effectiveness of hypertonic saline and carbocisteine for airway clearance in bronchiectasis over 52 weeks. Led by Professor Stuart Elborn and Professor Judy Bradley from Queen's University Belfast, the trial focuses on clinical and c

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Adaptable and open clinical trial infrastructure emphasizing collaborative leadership with shared responsibilities for successful trial implementation and data integrity. Encourages respectful ownership by investigators while engaging with NIH and SIREN to develop and fund important trials, includin

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NCI-MATCH is a groundbreaking clinical trial aiming to match tumor gene alterations with targeted therapies. The interim analysis results revealed impressive patient enrollment and site participation exceeding expectations. Despite challenges with pausing new patient registrations for the analysis,

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The National Institutes of Health (NIH) is implementing reforms and initiatives to improve the stewardship of research involving human subjects, particularly in the context of clinical trials. These changes include new forms for data collection, training in Good Clinical Practice, use of a single In

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This study by CTTI explores barriers and solutions for adopting digitally derived endpoints in clinical trials. Through in-depth interviews with industry sponsors, the research identifies gaps, barriers, and recommendations for using DHT-derived novel endpoints as key endpoints in pivotal clinical t

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Understanding the key components of a clinical trial research protocol is essential for conducting successful studies. This includes identifying session objectives, discussing trial protocol contents, exploring observational study elements, and learning about reporting guidelines. Study objectives f

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The presentation discusses various endpoints in aortic valve development and Transcatheter Aortic Valve Replacement (TAVR) trials, including comparisons, study stages, and newer devices. It covers different trial populations, primary and secondary endpoints, and the evaluation of non-inferiority. Su

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In the SOLVE-TAVI trial, patients undergoing transcatheter aortic valve implantation were randomized to receive either self-expandable or balloon-expandable valves under general or local anesthesia. The study aims to compare the effectiveness and safety of different valve types and anesthesia approa

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Enhance your trial skills in family law with a focus on evidence collection, trial strategies, and client examination. Learn best practices for preserving evidence, drafting persuasive statements, and navigating trials confidently. This workshop covers important aspects of evidence collection, such

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Explore the innovative tool nQuery Predict for accurate clinical trial milestone predictions, demonstrated in a webinar hosted by industry experts. Learn about key milestones, adaptive design considerations, enrollment predictions, and the significance of statistical approaches in optimizing trial d

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This analysis delves into the challenges, strengths, weaknesses, and missing data in a clinical trial study focusing on rare diseases. It critiques aspects such as recruitment, study design, surrogate markers, and statistical analysis, offering valuable insights for interpreting clinical trial resul

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In this competition, students simulate a criminal jury trial where they take on roles as attorneys and witnesses in a fictitious jurisdiction called Midlands. This year's case involves State v. Sinclair, focusing on the murder trial of Skyler Sinclair, a suspect in the death of an undercover officer

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AIRWAYS-3 is a multi-centre, open-label, randomized trial evaluating the clinical and cost effectiveness of a supraglottic airway (SGA) versus tracheal intubation during in-hospital cardiac arrest (IHCA). The trial aims to determine the functional status and health-related quality of life outcomes o

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Clinical practice involves measuring quantities to aid in diagnosis, predict patient outcomes, and serve as study endpoints. Errors in measurements can lead to inaccurate results and affect clinical decisions. Trueness and precision, accuracy, bias, and method comparison are essential concepts in as

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This presentation discusses the exploration of endpoints in pivotal clinical trials to treat Alcohol Use Disorder (AUD), focusing on Primary Alcohol Drinking Endpoints like PSNHDD. Evidence supporting PSNHDD as a primary endpoint includes clinical benefit data from alcohol clinical trials and epidem

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This study focuses on understanding the perception and awareness of clinical research among trial participants and the general public in Andhra Pradesh. It highlights the importance of creating awareness about clinical research, previous study results, public attitudes towards clinical trials, and e

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The CLEAR Trial is a 2x2 factorial randomized trial led by Professor Stuart Elborn and Professor Judy Bradley to assess the effectiveness of hypertonic saline and carbocisteine for airway clearance in bronchiectasis patients over 52 weeks. The trial involves various study sites and potential new sit

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Understanding the role and benefits of partnering with a Clinical Trial Unit (CTU) is essential for potential Chief Investigators. A CTU handles various aspects of trial coordination, from developing trial materials to overseeing regulatory permissions and data management. UK Clinical Trials Units (

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Explore the concepts of pain, distress, and humane endpoints in animals through a training program aimed at researchers developing protocols for the welfare of laboratory animals. The program includes pre- and post-assessments to gauge knowledge and learning outcomes, covers scenarios illustrating c

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Simulation of a criminal jury trial where students act as attorneys and witnesses in a fictitious jurisdiction called Midlands. This year's case involves the attempted murder of Kerry Bell-Leon, with witness selection varying in each round. Judges play crucial roles in presiding over the trial, scor

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This project discusses the API endpoints and data structures from the PaNOSC Workshop, focusing on reviewing use cases, required search results/data, actors involved, and the design of endpoints reflecting proposal/experiment processes. It covers detailed discussions on data models, instrument setup

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The CLEAR Trial, led by Professor Stuart Elborn and Professor Judy Bradley, aims to assess the clinical and cost-effectiveness of hypertonic saline and carbocisteine for airway clearance in bronchiectasis patients over 52 weeks. The trial involves a 2x2 factorial design and various study sites acros

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The CLEAR Trial is a 2x2 factorial randomized trial assessing the clinical and cost-effectiveness of hypertonic saline and carbocisteine for airway clearance in bronchiectasis patients over 52 weeks. Led by Professor Stuart Elborn and Professor Judy Bradley, the trial involves randomization, sealed

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This article discusses an algorithm proposed by L.R. Rabiner and M.R. Sambur in 1975 for determining endpoints in isolated utterances. The algorithm focuses on detecting word boundaries in speech through the recognition of silence, which can lead to reduced processing load and increased convenience,

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Eugene J. Sullivan, MD, explains the importance of establishing efficacy in clinical trials based on substantial evidence from well-controlled trials. The discussion includes primary endpoints for Phase 3 trials, legal and regulatory requirements, and the significance of clinically meaningful effect

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These guidelines outline the identification of scientific endpoints, humane intervention points, and cumulative endpoints in animal research. They emphasize the need for protocols approved by animal care committees, consideration of welfare-appropriate endpoints, and adaptation of endpoints during t

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