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A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial
Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An...
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Heparin vs Saline Infusion to Maintain Patency of Arterial Catheters in Children: A Randomized, Double-Blind, Noninferiority Trial
ObjectiveTo determine whether normal saline flush solution is noninferior to heparinised saline for maintaining the patency of arterial intravascular...
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Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial
BackgroundThis open-label, multicentre, phase II/III trial assessed the noninferiority of trifluridine/tipiracil (FTD/TPI) plus bevacizumab vs....
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Channelled versus nonchannelled Macintosh videolaryngoscope blades in patients with a cervical collar: a randomized controlled noninferiority trial
PurposeChannelled blades have the advantage of avoiding stylet use and potential airway injury during videolaryngoscopic intubation. Nevertheless,...
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Ultrasound-guided erector spinae plane block versus thoracic epidural block for postoperative analgesia in pediatric Nuss surgery: a randomized noninferiority trial
PurposeThoracic epidural anesthesia (TEA) is often used for analgesia after thoracic surgery. Erector spinae plane block (ESPB) has been proposed to...
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Interpreting the results of noninferiority trials—a review
Noninferiority trials are becoming increasing common, but are often poorly reported and misunderstood. A better understanding of the new components...
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Innovative and disruptive technologies to prescribe, encourage, and evaluate physical exercise in healthy adults: a protocol of exploratory study followed by a noninferiority, investigator-blinded randomized clinical trial
BackgroundCardiovascular diseases are a leading cause of mortality worldwide. A significant contributing factor to this mortality is the lack of...
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Optimising a multi-strategy implementation intervention to improve the delivery of a school physical activity policy at scale: findings from a randomised noninferiority trial
BackgroundTo maximise their potential health benefits, school-based physical activity policies need to be implemented at scale. This paper describes...
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A noninferiority randomized open-label pilot study of 3- versus 7-day influenza postexposure prophylaxis with oseltamivir in hospitalized children
Short influenza postexposure prophylaxis (PEP) showed high efficacy in adults, but studies in children are lacking. This randomized open-label pilot...
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Low-contrast-dose liver CT using low monoenergetic images with deep learning–based denoising for assessing hepatocellular carcinoma: a randomized controlled noninferiority trial
ObjectiveLow monoenergetic images obtained using noise-reduction techniques may reduce CT contrast media requirements. We aimed to investigate the...
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Efficacy and Safety of a Biosimilar Liraglutide (Melitide®) Versus the Reference Liraglutide (Victoza®) in People with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Clinical Trial
IntroductionLiraglutide effectively controls blood glucose level and reduces body weight. The aim of this study was to compare the efficacy and...
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RAM cannula versus short binasal prongs for nasal continuous positive airway pressure delivery in preterm infants: a randomized, noninferiority trial from low-middle-income country
To determine if RAM cannula is non-inferior to short binasal prongs (SBP) in providing nasal continuous positive airway pressure (CPAP) in preterm...
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Robot-assisted radical resection of colorectal cancer using the KangDuo surgical robot versus the da Vinci ** robotic system: short-term outcomes of a multicentre randomised controlled noninferiority trial
BackgroundThe KangDuo surgical robot (KD-SR-01) was recently developed in China. This study aims to evaluate the short-term outcomes of KD-SR-01 for...
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Noninferiority Trials
In this chapter we provide an overview of non-inferiority trials. We first introduce two motivating examples and describe scenarios for when a...
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Clinical advantages of gradually reducing radius versus multi-radius total knee arthroplasty: a noninferiority randomized trial
BackgroundThe rationale for gradually reducing radius (GR) femoral component aims to prevent flexion instability by gradually change the center of...
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Effects of group mindfulness-based cognitive therapy and group cognitive behavioural therapy on symptomatic generalized anxiety disorder: a randomized controlled noninferiority trial
BackgroundMindfulness-based cognitive therapy (MBCT) is a promising alternative treatment for generalized anxiety disorder (GAD). The objective of...
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Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study
BackgroundRituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the first line treatments for diffuse large...
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Aspin: neurosurgical aspirin intervention prognostic study — perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial
RationaleAspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes...
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Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial
Background/objectiveOsteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has...
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Distal radial artery as an alternative approach to forearm radial artery for perioperative blood pressure monitoring: a randomized, controlled, noninferiority trial
BackgroundThe novel distal radial artery (dRA) approach is a popular arterial access route for interventional cardiology and neurointerventions. We...
