Medicina
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Randomized Controlled Trial
Acupuncture for Japanese Katakori (Chronic Neck Pain): A Randomized Placebo-Controlled Double-Blind Study.
Background and Objectives: Although acupuncture is listed as a beneficial treatment for neck/shoulder stiffness, which has increased with the spread of information technology, to date, evidence of its efficacy under double-blind conditions has not been shown. This study aimed to assess whether acupuncture treatment with superficial skin piercing is superior to placebo treatment. Materials and Methods: A randomized, double-blind (practitioner-patient) placebo-controlled trial was performed at a single center with four arms (ISRCTN76896018). ⋯ Only genuine acupuncture involves the specific effects of needle insertion into the body. The acupuncture ritual had a significant impact on the subjective improvement of neck/shoulder stiffness; however, improvement with ritual alone versions of placebo acupuncture was not maintained as with superficial skin piercing. Our study provides important evidence of acupuncture efficacy and information regarding inert no-touch placebo control in acupuncture research.
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Randomized Controlled Trial
Ivabradine for the Prevention of Anthracycline-Induced Cardiotoxicity in Female Patients with Primarily Breast Cancer: A Prospective, Randomized, Open-Label Clinical Trial.
Background and Objectives: Cancer therapy containing anthracyclines is associated with cancer-treatment-related cardiac dysfunction and heart failure (HF). Conventional cardioprotective medications can be frequently complicated by their blood-pressure-lowering effect. Recently, elevated resting heart rate was shown to independently predict mortality in patients with cancer. ⋯ However, visual side effects (phosphenes) were reported in 14.3% of patients. Conclusions: Ivabradine is a safe, well-tolerated drug that has shown possible cardioprotective properties reducing the incidence of mild asymptomatic cancer-therapy-induced cardiac dysfunction, characterised by a new rise in troponin concentrations and diminished myocardial performance in anthracycline-treated women with breast cancer and increased heart rate. However, more extensive multicentre trials are needed to provide more robust evidence.
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Randomized Controlled Trial
An Alternative Technique for Topical Application of Acidulated Phosphate Fluoride (APF) Gel: A Two-Years Double-Blind Randomization Clinical Trial (RCT).
Background and Objectives: Dental caries is still a dramatic public health problem. The effectiveness of an alternative technique using acidulated phosphate fluoride (APF) gel pH 3.5 was evaluated and compared with conventional treatments in reducing dental caries incidence. Materials and Methods: A double-blind randomized controlled trial was conducted, involving 180 children aged 4-11 years. ⋯ Occlusal surfaces had the lowest cumulative survival, while other tooth surfaces showed similar performance. Conclusions: The alternative technique of APF gel application with a toothbrush resulted in maintaining dental health over 24 months. This technique can be cost-effective and may offer advantages over traditional fluoride varnish application.
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Randomized Controlled Trial Controlled Clinical Trial
Tixagevimab and Cilgavimab (Evusheld) Boosts Antibody Levels to SARS-CoV-2 in End-Stage Renal Disease Patients on Chronic Hemodialysis: A Single-Center Study.
Background and Objectives: In addition to a suboptimal and rapidly diminishing response to the coronavirus disease 2019 (COVID-19) vaccine, hemodialysis (HD) patients are at risk for developing a severe COVID-19 infection. In 2022, the combination of cilgavimab and tixagevimab (Evusheld, AstraZeneca) was approved for COVID-19 preexposure prophylaxis in high-risk groups. The purpose of this study was to evaluate the humoral response and short-term safety of this antibody combination in a group of HD patients. ⋯ In the control group, ICU admission and mortality were observed, but in the intervention group, the infection was milder with no aggressive consequences. Conclusions: This study demonstrated the short-term safety and efficacy of tixagevimab-cilgavimab for COVID-19 preexposure prophylaxis in HD patients. These findings require more studies with more HD patients and longer follow-up periods.
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Randomized Controlled Trial
Risk Factors and Clinical Outcomes of Osteotomy Plane Violation by D-Hole Screws in Medial Open Wedge High Tibial Osteotomy: A Simulation and Comparative Study.
Background and Objectives: Stable fixation is essential for successful healing after medial open wedge high tibial osteotomy (MOWHTO) to minimize the risk of non-union and correction loss. In Asians, potential complications such as D-hole screw osteotomy plane violation (D-hole violation) and inadequate plate fitting arise due to improper plate size. This study aimed to evaluate the risk factors for D-hole violation and compare the conventional anatomic (CA) plate with an individualized anatomic (IA) plate in MOWHTO procedures. ⋯ Conclusions: This study identified a high risk of D-hole screw osteotomy plane violations in MOWHTO procedures, particularly when the plate is positioned more distally and in individuals with a stature below 155.3 cm. It also revealed that individualized plates provide better tibial fitting compared to conventional anatomic plates, particularly in Asian populations where tibial morphology tends to be shorter than in Western populations. Therefore, evaluating patient stature and selecting tailored plates are essential to optimize plate positioning and minimize plate-related complications in MOWHTO procedures.