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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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Trial and Error and Algorithm01:12

Trial and Error and Algorithm

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A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
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Nursing Clinical Information System01:27

Nursing Clinical Information System

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Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
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COPD: Pathogenesis and Clinical Features01:20

COPD: Pathogenesis and Clinical Features

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Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that progressively worsen over time, including chronic bronchitis and emphysema. This cluster of diseases collectively leads to a gradual and irreversible decline in lung function over time.
The primary cause for the onset of COPD is cigarette smoking and exposure to air pollution. These hazardous factors initiate a chain reaction within the lungs, resulting in chronic inflammation, damage to the airways, and a...
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In Silico Clinical Trials for Cardiovascular Disease
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In Silico Clinical Trials for Cardiovascular Disease

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Rivaroxaban and the EINSTEIN clinical trial programme.

Alexander T Cohen1, Rupert Bauersachs2

  • 1Department of Haematological Medicine, Guy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
|March 29, 2019
PubMed
Summary
This summary is machine-generated.

Rivaroxaban effectively treats and prevents recurrent venous thromboembolism (VTE) in adults, offering a safe alternative to standard anticoagulation. Two doses are available for extended VTE prevention, aiding personalized patient care.

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Area of Science:

  • Pharmacology
  • Cardiovascular Medicine
  • Hematology

Background:

  • Direct oral anticoagulants (DOACs) like rivaroxaban are crucial for managing venous thromboembolism (VTE).
  • The EINSTEIN clinical trial program has been pivotal in establishing rivaroxaban's efficacy and safety in adult VTE treatment and prevention.
  • Real-world data increasingly supports rivaroxaban's use in routine clinical practice.

Purpose of the Study:

  • To provide an updated overview of the completed EINSTEIN studies on rivaroxaban in adult VTE.
  • To discuss emerging data from the EINSTEIN Junior program for pediatric VTE.
  • To highlight findings from subanalyses in high-risk patient populations.

Main Methods:

  • Review of pivotal trials: EINSTEIN DVT, EINSTEIN PE, EINSTEIN EXT, and EINSTEIN CHOICE.
  • Analysis of sub-studies focusing on high-risk patients for recurrent VTE.
  • Inclusion of emerging data from the pediatric EINSTEIN Junior program.

Main Results:

  • Rivaroxaban demonstrated efficacy and safety comparable to standard anticoagulation for acute VTE treatment (DVT and PE).
  • Rivaroxaban proved superior to placebo for extended VTE treatment and superior to aspirin for extended prevention of recurrent VTE.
  • Two rivaroxaban doses (20mg or 10mg once daily) are now available for extended VTE prevention, allowing for individualized treatment decisions.

Conclusions:

  • Rivaroxaban is a well-established, effective, and safe treatment option for adult VTE.
  • The availability of two doses for extended prevention allows for tailored VTE management based on patient-specific factors.
  • Ongoing research, including the EINSTEIN Junior program, continues to expand the evidence base for rivaroxaban in VTE.