Surrogate endpoints - PowerPoint PPT Presentation


Zongertinib Trial in HER2 Aberrant Tumors

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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Understanding Procedural Safeguards for Students with Disabilities

This information delves into the procedural safeguards for students with disabilities receiving special education services, covering topics such as laws governing procedural safeguards, parents' rights and responsibilities, abbreviation glossary, and the required Notice of Procedural Safeguards unde

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Titration Colour Changes

This collection features various experiments in chemistry involving titration and solutions. It includes procedures such as standardizing hydrochloric acid using sodium carbonate, titrating hydrochloric acid with sodium hydroxide to produce sodium chloride, determining the concentration of ethanoic

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OCTIVUS Randomized Clinical Trial: OCT-Guided vs IVUS-Guided PCI

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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ARREST Trial: Expedited Transfer for Non-ST Elevation OHCA

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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Comprehensive Bug Hunting Toolkit for Cybersecurity Enthusiasts

Explore a detailed guide on bug hunting tools, techniques, and resources by expert bug hunter Orwa Atyat from Jordan. Learn valuable tips on finding high/critical bugs, conducting basic recon, subdomain enumerations, collecting URLs/endpoints, and searching for backup files. Enhance your cybersecuri

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Efficacy and Safety of Ferric Carboxymaltose for Heart Failure with Iron Deficiency

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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Point-of-Care Ultrasound in Neonatal ETT Positioning

Point-of-care ultrasound (POCUS) is emerging as a potential tool for confirming endotracheal tube (ETT) positioning in neonates, providing a viable alternative to X-ray examination. The study aims to assess the accuracy of POCUS in determining ETT placement, particularly by using the superior aspect

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SISTER Study: Improving Stroke Treatment Response with TS23

SISTER Study led by Eva Mistry aims to identify a safe and effective dose of TS23 for treating ischemic stroke patients with core-penumbra mismatch. The Phase-2 trial involves 300 adults and spans 54 months, with primary endpoints focusing on treatment efficacy and safety. The study is randomized, p

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Extracorporeal Life Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock

This study explores the use of extracorporeal life support (ECLS) in patients with acute myocardial infarction complicated by cardiogenic shock. The researchers investigate the impact of ECLS on mortality and various secondary endpoints such as renal failure, recurrent infarction, and need for revas

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Optimal First Line Therapy for Metastatic Melanoma: Nivolumab and Relatlimab

Discussing the efficacy and safety of Nivolumab and Relatlimab as a superior first-line therapy option for newly diagnosed metastatic melanoma patients, with comparisons to other treatments based on key endpoints and tolerability data presented at ASCO Annual Meeting.

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Overview of Cohort Studies in Epidemiology

Cohort studies are a type of observational study where a group of healthy subjects is followed over time to investigate relationships between exposures and outcomes. They provide valuable insights into disease development and risk factors, offering advantages like assessing multiple exposures and en

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Digital Health Technology-Derived Clinical Outcome Assessments in Regulatory Decision-Making

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 Effects on Heart Failure with Reduced Ejection Fraction: EMPEROR-Reduced Trial Overview

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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Understanding Soliloquy and Dramatic Monologue in Literature

A soliloquy is a form of monologue where a character speaks to themselves, the audience, or a surrogate, revealing inner thoughts. This presentation explores different types of soliloquies and their significance in literary works, including examples from Shakespeare's Hamlet. Additionally, it delves

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Understanding Statistical Methods for Clinical Endpoints in Diabetes Research

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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Comparison of FFR-guided PCI vs Angiography-guided PCI in AMI with Multivessel Disease: FRAME-AMI Trial

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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Understanding the Fundamental Theorem of Calculus

The Fundamental Theorem of Calculus states that if a function is continuous on an interval and has an antiderivative on that interval, then the integral of the function over the interval is equal to the difference of the antiderivative evaluated at the endpoints. This concept is further explored thr

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Back Titration in Analytical Chemistry

Back titration is a technique used in analytical chemistry to determine the concentration of an analyte by reacting it with an excess of another reagent first, followed by titration of the excess reactant. This method is especially useful in cases where direct titration endpoints are difficult to di

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Digital Differential Analyzer (DDA) Algorithm in Computer Graphics

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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Molecularly-Guided Therapy vs Platinum Chemotherapy in CUP Patients

This trial aims to compare the efficacy and safety of molecularly-guided therapy or cancer immunotherapy based on genomic profiling with platinum-based chemotherapy in patients with cancer of unknown primary site. The study design includes multiple treatment regimens guided by genomic profiles, with

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Enhancing User Productivity with Outlook Actionable Messages

Explore how to develop and deploy Outlook Actionable Messages to optimize user productivity. Join Julie Turner, a seasoned professional developer, in learning about connectors, message creation, API endpoints, security, and more, to create targeted and interactive messages within Outlook. Get a hand

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Understanding Biomarkers in Therapeutic Innovation

European Patients Academy on Therapeutic Innovation explains how biomarkers are measurable indicators providing insights into health conditions. Biomarkers like glucose levels in diabetes management and MRI imaging for Multiple Sclerosis play crucial roles. The Academy aims to enhance the medicine d

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Special Education State Complaint Procedures Overview

Explore the procedural safeguards, state complaint procedures, mediation, and due process in special education as outlined by the U.S. Department of Education. Learn about filing complaints, required content, and who can file a complaint. Get insights into the resolution process, surrogate parents,

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Challenges and Recommendations for DHT-derived Endpoints in Clinical Trials

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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Advances in Aviation Fuel Surrogates and Computational Modeling

This study explores the formulation of petroleum and alternative jet fuel surrogates, coupling chemical kinetics with computational fluid mechanics for engine design, and the variability of aviation fuels. It delves into the concept of surrogate fuel models, previous research on jet fuel surrogates,

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Advances in Aortic Valve Development and TAVR Trials

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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Comparison of Valve Types and Anesthesia Strategies in Transcatheter Aortic Valve Implantation

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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Overview of Texas Risk Reduction Program (TRRP) for TPH Environmental Impact

The Texas Risk Reduction Program (TRRP) provides guidelines for managing Total Petroleum Hydrocarbons (TPH) in environmental assessments. Different regulations and programs govern TPH analysis depending on the source, with specific methods like TCEQ Method 1005 and 1006 used for TPH analysis and det

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Analyzing Clinical Trial Results for Rare Diseases: Challenges, Highlights & Missing Data

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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Embryo Transfer in Cattle: Benefits, Process, and Considerations

Embryo transfer (ET) in cattle allows for the production of genetically superior offspring, increasing milk production and weaning weights. While offering advantages like rapid genetic improvement and flexibility in genetics transfer, ET also presents challenges such as increased costs and disease r

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Exploration of Endpoints in Clinical Trials for Alcohol Use Disorder

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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Bayesian Optimization in Ocean Modeling

Utilizing Bayesian optimization in ocean modeling, this research explores optimizing mixed layer parameterizations and turbulent kinetic energy closure schemes. It addresses challenges like expensive evaluations of objective functions and the uncertainty of vertical mixing, presenting a solution thr

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Understanding Pain, Distress, and Humane Endpoints in Animal Research

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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Optimization of Multilayer Perceptron Output with ReLU Activation Function Using MIP Approach

This research focuses on developing a systematic optimization model that incorporates a ReLU activation function-based neural network as input. The model generates a linear output that can be modeled as MILP and solved using a Mixed-Integer Programming approach. By producing scalable surrogate model

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Overview of PaNOSC Workshop API Endpoints & Data Structures

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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Algorithm for Determining Endpoints in Speech Recognition

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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Understanding Clinical Trial Endpoints and Regulatory Basis

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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Guidelines for Scientific Endpoints and Humane Interventions in Animal Research

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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Understanding the Animal Rule in Drug Approval Process

The Animal Rule addresses the approval of new drugs when human efficacy studies are not possible. It serves as a surrogate for human studies, requiring well-controlled animal testing to predict clinical benefits in humans. Safety must still be demonstrated in human trials, and the rule can be bypass

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