Publications by authors named "Francesco Giuliani"

Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are the standard of care for hormone receptor (HR)+/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer in combination with endocrine therapy. However, the real-world efficacy and safety of standard versus reduced doses in elderly patients remain unclear. This study aims to compare the clinical outcomes of standard versus reduced doses of CDK4/6 inhibitors in elderly patients with metastatic breast cancer.

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Purpose: To investigate whether intermittent treatment after an induction phase of first-line schedule of fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus panitumumab (PAN) prevents or delays the onset of resistance and improves safety and compliance with treatment in patients with unresectable / wild-type (wt) metastatic colorectal cancer (mCRC).

Patients And Methods: IMPROVE (ClinicalTrials.gov identifier: NCT04425239) was an open-label, multicenter, randomized phase II noncomparative trial.

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Article Synopsis
  • Paclitaxel plus ramucirumab is being evaluated as a second-line treatment for patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer, comparing it with continued oxaliplatin and fluoropyrimidine chemotherapy.
  • The ARMANI trial involved 280 patients, who were randomly assigned to receive either the new treatment regimen or continue with their current chemotherapy for an additional 12 weeks.
  • The primary goal of the study was to determine if the new treatment improved progression-free survival compared to the standard chemotherapy, with safety being closely monitored throughout the trial.
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Background: Metastatic HR+/HER2- breast cancer is commonly treated with CDK4/6 inhibitors in combination with endocrine therapy. However, the efficacy and safety of this approach in elderly patients (≥70 years) remain unclear, particularly in the context of real-world clinical practice. This study aims to evaluate the clinical outcomes and tolerability of CDK4/6 inhibitor treatments in this fragile population, which is often under-represented in randomized clinical trials.

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Introduction: Breast cancer (BC) remains a prevalent and challenging malignancy among women, with significant advancements in treatment strategies over the past decades. Traditional chemotherapy has been progressively supplemented by newer modalities, including Antibody-Drug Conjugates (ADCs), Immunotherapy (IO), and Targeted Therapies (TT). Despite these advancements, there remains a critical need for strategies that maintain efficacy while minimizing toxicity.

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Article Synopsis
  • The study explores the impact of technology on reducing loneliness and improving socialization among older adults, emphasizing its potential to promote healthy aging.
  • Researchers evaluated a technology-based socialization service over 6 months, assessing usability and acceptability among older adults and their caregivers in Italy.
  • Results indicated that older adults experienced lower usability and higher anxiety regarding technology compared to their informal and formal caregivers, highlighting the need for better support and training.
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Inflammatory bowel diseases (IBD) are classified into two entities, namely Crohn's disease (CD) and ulcerative colitis (UC), which differ in disease trajectories, genetics, epidemiological, clinical, endoscopic, and histopathological aspects. As no single golden standard modality for diagnosing IBD exists, the differential diagnosis among UC, CD, and non-IBD involves a multidisciplinary approach, considering professional groups that include gastroenterologists, endoscopists, radiologists, and pathologists. In this context, histological examination of endoscopic or surgical specimens plays a fundamental role.

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The advent of immunotherapy and antibody-drug conjugates (ADCs) have revolutionized breast cancer treatment, offering new hope to patients. However, challenges, such as resistance and limited efficacy in certain cases, remain. Recently, the combination of these therapies has emerged as a promising approach to address these challenges.

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Background And Objective: The identification of mutation hot spots in the isocitrate dehydrogenase (IDH) genes is one of the most important cancer genome-wide sequencing discoveries with relevant impact in the treatment of some orphan tumors. These genes were mostly found mutated in lower-grade gliomas (LGGs), acute myeloid leukaemia (AML), myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPNs) and in cholangiocarcinoma. This aberrant genomic condition represents a therapeutic target of great interest in cancer research, especially in AML, given the limitations of currently approved therapies in this field.

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Various extrinsic and intrinsic factors such as drug exposures, antibiotic treatments, smoking, lifestyle, genetics, immune responses, and the gut microbiome characterize ulcerative colitis and Crohn's disease, collectively called inflammatory bowel disease (IBD). All these factors contribute to the complexity and heterogeneity of the disease etiology and pathogenesis leading to major challenges for the scientific community in improving management, medical treatments, genetic risk, and exposome impact. Understanding the interaction(s) among these factors and their effects on the immune system in IBD patients has prompted advances in multi-omics research, the development of new tools as part of system biology, and more recently, artificial intelligence (AI) approaches.

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Background: Social robots are becoming increasingly important as companions in our daily lives. Consequently, humans expect to interact with them using the same mental models applied to human-human interactions, including the use of cospeech gestures. Research efforts have been devoted to understanding users' needs and developing robot's behavioral models that can perceive the user state and properly plan a reaction.

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The European Project GATEKEEPER aims to develop a platform and marketplace to ensure a healthier independent life for the aging population. In this platform the role of HL7 FHIR is to provide a shared logical data model to collect data in heterogeneous living, which can be used by AI Service and the Gatekeeper HL7 FHIR Implementation Guide was created for this purpose. Independent pilots used this IG and illustrate the impact of the approach, benefit, value, and scalability.

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50% of older adults over 60 years old are experiencing social isolation. Assistive technology can provide solutions that promote the connection with their families and other stakeholders. In this context, this paper presents a pilot study of a socialization service with 3 functions tested by 10 older adults and 10 informal caregivers.

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Article Synopsis
  • The study aimed to assess the safety and effectiveness of reirradiation (re-RT) using radiosurgery or fractionated stereotactic radiotherapy in combination with regorafenib for patients with recurrent glioblastoma (GBM).
  • A total of 21 patients were observed, showing a median overall survival of 8.4 months and median progression-free survival of 6 months after treatment, with manageable side effects reported.
  • The findings suggest that this treatment approach is safe, but further prospective trials are needed to establish standard protocols.
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The aim of the SYRIACA project was to test the capability of a social robot to perform specific tasks in healthcare settings, reducing infection risks for patients and caregivers. The robot was piloted in an Intensive Hematological Unit, where the patients' and healthcare operators' acceptability of the robot was evaluated. The robot's functions, including logistics, surveillance, entertainment, and remote visits, were well accepted.

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Social robots represent a valid opportunity to manage the diagnosis, treatment, care, and support of older people with dementia. The aim of this study is to validate the Mini-Mental State Examination (MMSE) test administered by the Pepper robot equipped with systems to detect psychophysical and emotional states in older patients. Our main result is that the Pepper robot is capable of administering the MMSE and that cognitive status is not a determinant in the effective use of a social robot.

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Telemedicine can provide benefits in patient affected by chronic diseases or elderly citizens as part of standard routine care supported by digital health. The GATEKEEPER (GK) Project was financed to create a vendor independent platform to be adopted in medical practice and to demonstrate its effect, benefit value, and scalability in 8 connected medical use cases with some independent pilots. This paper, after a description of the GK platform architecture, is focused on the creation of a FHIR (Fast Healthcare Interoperability Resource) IG (Implementation Guide) and its adoption in specific use cases.

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Breast cancer (BC) in elderly women is an increasing health issue due to demographic changes. BC tends to present later and may receive less than standard treatment options. More often, BC in elderly patients is endocrine-positive (HR+).

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(1) Background: Venous thromboembolism (VTE) is a frequent complication in ambulatory lung cancer patients during chemotherapy and is associated with increased mortality. (2) Methods: We analyzed 568 newly diagnosed metastatic lung cancer patients prospectively enrolled in the HYPERCAN study. Blood samples collected before chemotherapy were tested for thrombin generation (TG) and a panel of hemostatic biomarkers.

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The GATEKEEPER (GK) Project was financed by the European Commission to develop a platform and marketplace to share and match ideas, technologies, user needs and processes to ensure a healthier independent life for the aging population connecting all the actors involved in the care circle. In this paper, the GK platform architecture is presented focusing on the role of HL7 FHIR to provide a shared logical data model to be explored in heterogeneous daily living environments. GK pilots are used to illustrate the impact of the approach, benefit value, and scalability, suggesting ways to further accelerate progress.

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Background: The World Health Organization's strategy toward healthy aging fosters person-centered integrated care sustained by eHealth systems. However, there is a need for standardized frameworks or platforms accommodating and interconnecting multiple of these systems while ensuring secure, relevant, fair, trust-based data sharing and use. The H2020 project GATEKEEPER aims to implement and test an open-source, European, standard-based, interoperable, and secure framework serving broad populations of aging citizens with heterogeneous health needs.

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Prostate cancer (PC) is the most common type of tumor in men. In the early stage of the disease, it is sensitive to androgen deprivation therapy. In patients with metastatic castration-sensitive prostate cancer (mHSPC), chemotherapy and second-generation androgen receptor therapy have led to increased survival.

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Background: Risk assessment models (RAMs) are relevant approaches to identify cancer outpatients at high risk of venous thromboembolism (VTE). Among the proposed RAMs, the Khorana (KRS) and the new-Vienna CATS risk scores have been externally validated in ambulatory patients with cancer.

Objectives: To test KRS and new-Vienna CATS scores in 6-month VTE prediction and mortality in a large prospective cohort of metastatic cancer outpatients during chemotherapy.

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Article Synopsis
  • New medicines called CDK4/6 inhibitors have been approved to treat a common type of breast cancer (HR+/HER2-) and are being tested for use in earlier stages of the disease.
  • Researchers are also looking into how these medicines can help with other types of breast cancer, like triple negative and HER2+.
  • Experts say we need more studies to find out the best ways to use these drugs and to identify which patients will benefit from them the most.
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Assistive devices could promote independent living and support the active and healthy aging of an older population; however, several factors can badly influence the long-term use of new technologies. In this context, this paper presents a two-step methodology called “pre-validation” that aims to identify the factors that can bias the use of new services, thus minimizing the risk of an unsuccessful longer trial. The proposed pre-validation methodology is composed of two main phases that aim to assess the usability and the reliability of the technology assessed in a laboratory environment and the usability, acceptability, user experience, and reliability of the technology in real environments.

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