Publications by authors named "Francesca Schiavone"

Background: Healthcare-associated infections account for substantial neonatal in-hospital mortality. Chlorhexidine gluconate (CHG) whole body skin application could reduce sepsis by lowering bacterial colonisation density, although safety and optimal application regimen is unclear. Emollients, including sunflower oil, may independently improve skin condition, thereby reducing sepsis.

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Article Synopsis
  • Late-phase platform protocols, such as basket and master protocols, are more efficient than traditional two-arm trials but are underutilized; this study shares operational recommendations from successful implementations.* -
  • A meeting of UK clinical trial experts was held to discuss the practical challenges and operational aspects specific to running late-phase platform trials, leading to a set of guidance for trialists.* -
  • The recommendations cover all stages of a platform trial, emphasizing key areas like protocol development, funding, staffing, data management, and effective communication with participants and stakeholders.*
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Background: Standard-of-care first-line chemotherapy for epithelial ovarian cancer is carboplatin and paclitaxel administered once every 3 weeks. The JGOG 3016 trial reported significant improvement in progression-free and overall survival with dose-dense weekly paclitaxel and 3-weekly (ie, once every 3 weeks) carboplatin. However, this benefit was not observed in the previously reported progression-free survival results of ICON8.

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Purpose: Survival in stage I seminoma is almost 100%. Computed tomography (CT) surveillance is an international standard of care, avoiding adjuvant therapy. In this young population, minimizing irradiation is vital.

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Background: There are limited research and literature on the trial management challenges encountered in running adaptive platform trials. This trial design allows both (1) the seamless addition of new research comparisons when compelling clinical and scientific research questions emerge, and (2) early stopping of accrual to individual comparisons that do not show sufficient activity without affecting other active comparisons. Adaptive platform design trials also offer many potential benefits over traditional trials, from faster time to accrual to contemporaneously recruiting multiple research comparisons, added flexibility to focus on more promising research comparisons via pre-planned interim analyses and potentially shorter time to primary results.

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Objective: To overview the phenomenology, etiology, assessment, and treatment of psychotic-like symptoms in trauma-related disorders focusing on the proposed role of temporal lobe dysfunction.

Method: We describe the literature pertaining to (i) psychotic-like symptoms and temporal lobe dysfunction in trauma-related disorders and (ii) psychological testing profiles in trauma-related disorders. We define trauma-related disorders as borderline personality disorder, post-traumatic stress disorder, and the dissociative disorders.

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Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival.

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Importance: The natural history of patients with newly diagnosed high-risk nonmetastatic (M0) prostate cancer receiving hormone therapy (HT) either alone or with standard-of-care radiotherapy (RT) is not well documented. Furthermore, no clinical trial has assessed the role of RT in patients with node-positive (N+) M0 disease. The STAMPEDE Trial includes such individuals, allowing an exploratory multivariate analysis of the impact of radical RT.

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There are compelling reasons to study the addition of both enzalutamide and abiraterone, in combination, to standard-of-care for hormone-naïve prostate cancer. Through a protocol amendment, this will be assessed in the STAMPEDE trial, with overall survival as primary outcome measure.

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Objectives: Current research suggests that effective psychotherapies for Self Injurious Behavior (SIB) in the context of Borderline Personality Disorder (BPD) contain generic common elements which are responsible for their success. Because of the links between BPD, SIB, and child abuse, it is likely that these common elements can also be applied to the psychotherapy of survivors of child abuse who engage in SIB. This article will reviews several common elements which recent literature has suggested are important and suggest techniques by which community practitioners can incorporate these elements into their practice with adult survivors of child abuse who engage in SIB.

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Purpose: To determine which MR technique was the most sensitive to age-related white matter damage. We compared both diffusion tensor imaging (DTI) and magnetization transfer (MT) maps to determine which technique correlated most strongly with cognitive function in a middle-aged and elderly community population.

Materials And Methods: In all, 64 healthy subjects (aged 50-90) underwent MRI and neuropsychology.

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In a first experiment we studied, through a line bisection task, (a) the frequency of the selective disruption of far or near space representations in a group of 28 right brain-damaged patients and (b) the effect of tool use on line bisection error in far and near space in order to clarify whether the kind of action performed by the subject influences the extension of space representation, as suggested by previous studies. In a second experiment, carried out on two neglect patients, we asked whether the representation of "near" and "far" space depends on the sensory feedback during the execution of the action or whether it is independent on sensory feedback and more related to the action programmed as a consequence of the kind of tool used. Our data show (a) that dissociations between far and near space neglect are a frequent observation in right brain damaged patients and that most of these patients are able to recode space representations when tools change the spatial relation between the agent's body and the target object; (b) that spatial remapping can be elicited by the kind of action associated to the tool used and by the sensory feedback (either visual or proprioceptive) available during the execution of the task.

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