Clinical Trials
Category Added in a WPeMatico Campaign
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Development and validation of a nomogram to pediatric postoperative pulmonary complications following thoracic surgery
CONCLUSION: The nomogram, based on four objective and easily assessed factors, demonstrates excellent predictive performance for pediatric postoperative pulmonary complications after one-lung ventilation, enabling early risk assessment and targeted interventions to improve patient outcomes.
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Study protocol of short versus long-term levetiracetam in brain tumors (LIBRA): a phase 3 randomized controlled trial
BACKGROUND: Seizures are common in patients with brain tumors, impacting daily life and healthcare burden. In contemporary neuro-oncology practice, levetiracetam is the most commonly prescribed anti-seizure medication (ASM). Although the practice is widely variable, levetiracetam is usually used for 2-3 years following surgery to prevent further seizures. However, the incidence of seizures post antitumoral treatment…
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Computational modelling and neural correlates of reinforcement learning following three-week escitalopram: a double-blind, placebo-controlled semi-randomised study
Reinforcement learning is a fundamental aspect of adaptive behaviour, since it involves the acquisition and updating of associations between actions and their outcomes based on the rewarding or punishing consequences. Acute experimental manipulations of serotonin have provided compelling evidence for its role in reinforcement learning. However, it remains unknown how more chronic manipulation of serotonin,…
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Effect of acarbose and vildagliptin on plasma trimethylamine N-oxide levels in patients with type 2 diabetes mellitus: a 6-month, two-arm randomized controlled trial
CONCLUSIONS: Both acarbose and vildagliptin treatments significantly reduced TMAO levels in newly diagnosed T2DM patients, with a more pronounced reduction observed in the acarbose group. Furthermore, the decline in TMAO levels correlated significantly with improvements in insulin resistance parameters.
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Psychometric validation of the EORTC QLQ-OES18 in patients with advanced or metastatic esophageal squamous cell carcinoma
CONCLUSION: Overall, a collection of psychometric evidence indicated that the EORTC QLQ-OES18 reliably and validly measured symptom severity in the RATIONALE 302 population. Specifically, the dysphagia domain consistently demonstrated robust psychometric properties. Limitations in data reduced the interpretability of MWPC thresholds and are discussed in detail.
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Results of a Randomized Controlled Trial Examining the Efficacy of Intranasal Oxytocin to Enhance Alcohol Behavioral Couple Therapy
Objective: This study examined the efficacy of intranasal oxytocin (40 IU), compared to matching placebo (saline), when combined with Alcohol Behavioral Couple Therapy (ABCT) for the treatment of alcohol use disorder (AUD).
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Adjuvant nonavalent HPV vaccination in women treated for vulvar HSIL, a randomized placebo-controlled trial; VulVaccin study protocol
BACKGROUND: Each year, 45,000 women worldwide develop vulvar cancer, often occurred from vulvar high-grade squamous intraepithelial lesions (vHSIL), a precancerous stage associated with high- risk human papillomavirus (HPV). Recurrent vHSIL, experienced by over 30% of patients despite treatment, conducting in significant physical and psychosocial challenges. With no established method to reduce recurrence, our study investigates…
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Efficacy of red ointment in wound cavity repair following non-puerperal mastitis debridement
CONCLUSION: The use of red ointment gauze strips for wound cavity filling following NPM debridement demonstrated favorable clinical efficacy and safety, providing a viable option for postoperative drainage management.
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Evaluating the concordance between BICLA and SRI4 in patients with systemic lupus erythematosus from the placebo arms of the EXPLORER and ATHOS trials
CONCLUSIONS: BICLA and SRI4 may be discordant in SLE trials. Arthritis and rash were the primary drivers of the discordance, and serology influenced BICLA and SRI4 response, suggesting the need for evaluation of multiple efficacy endpoints rather than a single measure.
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Study protocol: Mixed-methods evaluation of a cluster-randomized trial on preventing dysregulated screen use in children under 3
BACKGROUND: Screen media use in early childhood is associated with increased risk for health and developmental problems. A preventive intervention during a regular examination in pediatric practices aims to prevent dysregulated screen time by children under three years of age. This protocol describes a process evaluation with the aim of understanding how to implement most…