Articles: prospective-studies.
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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 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.
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Randomized Controlled Trial
The Effect of Japanese Herbal Medicines (Kampo) Goreisan and Saireito on the Prevention of Recurrent Chronic Subdural Hematoma: A Prospective Randomized Study.
Chronic subdural hematoma (CSDH) sometimes recurs after surgical treatment and requires reoperation. In Japan, Japanese herbal medicines (Kampo), such as Goreisan and Saireito, have been used as adjunctive therapies to prevent the recurrence of CSDH. However, no prospective randomized study has proven the efficacy of Kampo medicine in all patients. To investigate whether Goreisan and Saireito reduce the postoperative recurrence of CSDH in a prospective randomized study. ⋯ This is the first study to show that Kampo medicine reduced the recurrence rate of CSDH in an overall population. This study demonstrated that byakujutsu Goreisan and Saireito may have favorable effects, unlike other studies, because byakujutsu has stronger anti-inflammatory activity than sojutsu.
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Paediatric anaesthesia · Dec 2023
Randomized Controlled TrialApplication of behavioral economic strategies to enhance recruitment into a pediatric randomized clinical trial for postoperative pain relief: A randomized clinical trial.
A major challenge in conducting clinical trials is recruitment. Trial under-enrollment leads to underpowered studies. Behavioral economics offers strategies that may enhance trial recruitment. This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial assessing a biofeedback-based virtual reality intervention for postoperative pain management. We hypothesized the behavioral economics-informed approach would increase enrollment into the future trial, intention to adhere to therapy, acceptability of the intervention, and perceived efficacy while decreasing perception of treatment burden and risk. ⋯ Either approach would be sufficient for patient recruitment for this type of clinical trial since the overall intention to enroll rate was 77%.
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Randomized Controlled Trial
Effects of Hot Pack Therapy on Post-Colonoscopy Pain: A Prospective, Randomized, Controlled Study.
Post-colonoscopy pain (PCP) is a negative condition that causes physical and psychological distress to patients and may lead to noncompliance with treatment and follow-up. The most common hypothesis for the cause of PCP is the inflation of the lumen with air to examine the mucosa. There are no previous studies that have examined the effects of thermal therapy in patients with PCP. ⋯ This study showed that the application of HP to patients after colonoscopy is effective in reducing pain in the early period.