Trial design - PowerPoint PPT Presentation


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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Insights from the REPRIEVE Trial for Managing Cardiovascular Risk in Patients with HIV

Cardiovascular disease is a growing concern in individuals living with HIV, despite advancements in treatment. The REPRIEVE Trial sheds light on the importance of assessing cardiovascular risk and implementing primary prevention measures in this population. Dr. Grinspoon's financial disclosures and

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The REPRIEVE Trial: Developing Cardiovascular Disease Prevention Strategy for People Living with HIV

The REPRIEVE trial focuses on developing a cardiovascular disease prevention strategy for individuals living with HIV. It addresses the increased risk of CVD in this population, even with good viral suppression. The study evaluates the use of pitavastatin, a statin with anti-inflammatory properties,

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Early Vasopressors in Sepsis Clinical Trial: Improving Patient Outcomes

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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Pragmatic Urinary Sodium-Based Treatment Algorithm in Acute Heart Failure (PUSH-AHF) Trial Overview

The PUSH-AHF trial, conducted at the University Medical Center Groningen, aimed to evaluate the effectiveness and safety of natriuresis-guided diuretic therapy in acute heart failure. The study design was pragmatic, prospective, single-center, open-label, randomized, and controlled. Key outcomes inc

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CLEAR Outcomes Trial: Bempedoic Acid for Cardiovascular Prevention

The CLEAR Outcomes Trial investigated the effects of bempedoic acid, an ATP citrate lyase inhibitor, on cardiovascular outcomes in primary prevention patients. Results showed a reduction in cardiovascular events with bempedoic acid, particularly in patients intolerant to statins. Baseline characteri

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Double-blind, Randomized Trial of Interatrial Shunt in HF Patients

This study details the principal results of the RELIEVE-HF trial, investigating the safety and effectiveness of the V-Wave Ventura interatrial shunt device in patients with heart failure with reduced and preserved ejection fraction. Key inclusion and exclusion criteria are outlined, emphasizing the

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Effective Trial Presentation Tips and Best Practices by Judge Renee A. Goble

Enhance your trial presentation skills with insights from Judge Renee A. Goble of Denver County Court. Learn about trial structure, direct and cross-examination techniques, understanding evidence, objections, and more to improve your courtroom performance.

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Understanding the Definition of Hearsay in Virginia Courts by Gerald I. Fisher, Senior Judge

Preliminary principles and rules regarding hearsay in Virginia courts, including the effective date of the Virginia Rules of Evidence, application of rules in various trial scenarios, criteria for admissibility of evidence by trial judges, and reasons for the legal distrust of hearsay evidence. The

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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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Simulation Techniques in Clinical Trial Design

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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UK Mini Mitral Trial: Minimally Invasive Thoracoscopic Approach vs Conventional Sternotomy for Mitral Valve Repair

The UK Mini Mitral Trial compares the outcomes of minimally invasive thoracoscopic-guided right minithoracotomy versus conventional sternotomy for mitral valve repair. The trial aims to determine if physical function improvement post-surgery at 12 weeks is superior in the minimally invasive approach

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Understanding Different Types of Hearings in the Court Management System

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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STRESS-L Trial: Study on Reversal of Septic Shock with Landiolol

The STRESS-L Trial focuses on reversing septic shock using Landiolol, a beta-blockade treatment. It provides training for non-GCP trained clinicians involved in eligibility review, medical care, and prescribing in the trial. The slides cover key GCP principles, trial agenda, study information, backg

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The CLEAR Trial: Investigating Hypertonic Saline and Carbocisteine in Bronchiectasis

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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Software Engineering Design Principles and Concepts

The chapter discusses the essential principles and concepts in software design, highlighting the four key design models - data design, architectural design, interface design, and component-level design. It emphasizes the importance of traceability to the analysis model, minimizing the gap between so

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ACST-2 Trial: Stenting vs. Surgery for Carotid Artery Stenosis

ACST-2 is a randomized trial comparing carotid artery stenting (CAS) versus carotid artery surgery (CEA) in asymptomatic patients with severe carotid stenosis. The trial, published in The Lancet in August 2021, involved 3625 patients. While surgery has been shown to reduce stroke rates, modern medic

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Understanding the Criminal Trial Process

The Sixth Amendment guarantees various rights during criminal trials, such as a speedy and public trial, trial by jury, notice of accusations, the right to confront witnesses, and the assistance of counsel. Defendants can opt for a bench trial where the judge decides innocence or guilt. Juries, typi

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The CLEAR Trial: Investigating Hypertonic Saline and Carbocisteine in Bronchiectasis

The CLEAR Trial is a 2x2 factorial randomized trial examining 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 study focuses on exacerbation ma

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NCI-MATCH Trial Interim Analysis Results and Status Update

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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Essential Elements of Clinical Trial Protocols

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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Family Law Trial Skills Workshop: Evidence Collection and Trial Techniques

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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Enhancing Clinical Trial Milestone Predictions with nQuery Predict

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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Civil Rights Litigation Steps Overview

Exploring the detailed process of civil rights litigation, covering steps from fact gathering to trial preparation and post-trial activities. The visual presentation showcases key elements such as client retention, complaint filing, discovery phases, trial preparation, and post-trial procedures like

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Civil Jury Trial Simulation: Winter v. TBD, Inc.

Simulation competition where students portray attorneys and witnesses in a civil jury trial based on the case of professional writer Riley Winter suing an online magazine for wrongful termination due to age discrimination. Judges preside over the trial, score performances, and provide feedback, focu

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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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Understanding Modern Non-inferiority Trial Designs in Antibiotic Development

This article discusses the significance of non-inferiority designs in advancing antibiotic development to combat multidrug-resistant bacteria. It emphasizes the importance of distinguishing between UDR, MDR, and XDR bacterial categories in trial design, highlighting challenges in selecting comparato

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Participating in a Mock Criminal Jury Trial Competition

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 Trial: Advanced Airway Management in In-Hospital Cardiac Arrest

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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The CLEAR Trial: Investigating Hypertonic Saline and Carbocisteine for Bronchiectasis

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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Key Aspects of Partnering with a Clinical Trial Unit for Successful Trials

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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The O.J. Simpson Murder Trial

The trial of O.J. Simpson for the brutal murders of Nicole Brown Simpson and Ron Goldman captivated the nation, with overwhelming evidence implicating Simpson. Despite the compelling case against him, Simpson's defense team, led by Johnnie Cochran, raised doubts about the integrity of the evidence a

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Preparation and Roles for the Trial of King Louis XVI

Participants are preparing for the trial of King Louis XVI by researching charges, roles, and responsibilities. The trial process includes reading indictments, opening statements, questioning phases, and final statements. Each role, including Louis, Marie, Robespierre, Marat, and a woman from the 3r

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AMTA Criminal Jury Trial Competition Overview

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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The CLEAR Trial: Investigating Hypertonic Saline and Carbocisteine for Bronchiectasis Patients

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: Investigating Hypertonic Saline and Carbocisteine for Bronchiectasis Treatment

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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Phase II Trial Design in Oncology Drug Development by Wendy R. Parulekar, MD, FRCP

This presentation covers the pivotal role of Phase II trials in oncology drug development, emphasizing the importance of preliminary clinical efficacy screening, adverse event profiling, mechanism of action understanding, and target population definition. It discusses various Phase II trial designs,

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Simeprevir Treatment in HCV Genotype 1: ASPIRE Trial Results

The ASPIRE trial evaluated simeprevir treatment in patients with treatment-experienced chronic HCV genotype 1 infection. The study design included different dosing regimens of simeprevir with peginterferon and ribavirin, compared to placebo. Results showed varying sustained virologic response rates

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Understanding Speedy Trial Rights in Juvenile Cases

Speedy trial rights in juvenile cases are crucial for ensuring timely resolution of legal proceedings. According to Florida laws, the speedy trial time period is 90 days from the date the child was taken into custody or served with a summons. Failure to commence the adjudicatory hearing within this

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