Articles: prospective-studies.
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Pediatr Crit Care Me · Jan 2025
Randomized Controlled Trial Comparative StudyProspective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.
To test feasibility of a randomized controlled trial (RCT) with an endpoint of time at goal anticoagulation in children on extracorporeal membrane oxygenation (ECMO) randomized to receive bivalirudin vs. unfractionated heparin. ⋯ In this single-center pilot RCT carried out 2018-2021, we found that the test of anticoagulation therapy of bivalirudin vs. heparin during ECMO was feasible. Larger multicenter studies are required to further assess the safety and efficacy of bivalirudin for pediatric ECMO.
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Randomized Controlled Trial Multicenter Study Comparative Study
Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial.
Observational studies of survivors of breast cancer and prospective trials of aspirin for cardiovascular disease suggest improved breast cancer survival among aspirin users, but prospective studies of aspirin to prevent breast cancer recurrence are lacking. ⋯ Among participants with high-risk nonmetastatic breast cancer, daily aspirin therapy did not improve risk of breast cancer recurrence or survival in early follow-up. Despite its promise and wide availability, aspirin should not be recommended as an adjuvant breast cancer treatment.
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Randomized Controlled Trial
Application of intraoperative neurophysiological monitoring (IONM) for preventing dysphagia after anterior cervical surgery: A prospective study.
To evaluate the clinical value of intraoperative nerve monitoring (IONM) for dysphagia after anterior cervical surgery with and without IONM. ⋯ IONM is a promising tool for identifying and protecting the spinal cord and nerves during anterior cervical surgery. Our research revealed that IONM significantly reduced the occurrence of swallowing disorders 12 weeks after surgery, but the effect was not significant at the third or sixth week after surgery.
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Randomized Controlled Trial
Empowering Low-Income Patients with Home Blood Pressure Monitors to Improve Hypertension Control.
Effective management of hypertension (HTN) is a priority in primary care. With telehealth now considered a staple care delivery method, uninsured and low-income patients without home blood pressure (BP) monitors may need additional attention and resources to achieve successful HTN control. ⋯ The provision of free home BP monitors to low-income patients may feasibly and effectively improve BP control and therapy adherence.
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Randomized Controlled Trial Multicenter Study
Development of a Randomized Trial Comparing Intracranial Pressure Monitor-Based Management of Severe Pediatric Traumatic Brain Injury With Management Based on Imaging and Clinical Examination Without Intracranial Pressure Monitoring-Research Algorithms.
The efficacy of our current approach to incorporating intracranial pressure (ICP) data into pediatric severe traumatic brain injury (sTBI) management is incompletely understood, lacking data from multicenter, prospective, randomized studies. The National Institutes of Health-supported Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial will compare outcomes from pediatric sTBI of a management protocol based on ICP monitoring vs 1 based on imaging and clinical examination without monitoring. Because no applicable comprehensive management algorithms for either cohort are available, it was necessary to develop them. ⋯ We will study these protocols in the Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial in low- and middle-income countries. Second, we present them here for consideration as prototype pediatric sTBI management algorithms in the absence of published alternatives, acknowledging their limited evidentiary status. Therefore, herein, we describe our study design only, not recommended treatment protocols.