- Featured
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**
Phase
3Span
Sponsor
Catania, Catania
Recruiting
- Featured
A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy
For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**
Phase
2Span
Sponsor
Catania, Catania
Recruiting
- Featured
A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.
Phase
3Span
Sponsor
Catania
Recruiting
- Featured
Catania
Recruiting
Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
This is a post-market, multi-centre, prospective, interventional single arm study in Italy. Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance. HbA1c will be tested at the start and end of the study for primary endpoint analysis.
Phase
N/ASpan
54 weeksSponsor
Abbott Diabetes CareCatania
Recruiting
Development of a Natural Language Processing Tool to Enable Clinical Research in Emergency Medicine
BACKGROUND AND RATIONALE FOR THE STUDY Conducting clinical and quality-of-care assessment research in emergency medicine is as difficult as it is important. It is difficult because the vast number of patients that need to be treated and the chronic shortage of staff make ad hoc data collection impractical. It is important because, in the end, research enables emergency physicians and nurses to base their practice on evidence obtained in their own, unique setting, as opposed to evidence obtained in far-removed contexts, as is commonly the case today. The only way to bridge the gap between research needs and availability of robust data is to extract data directly from the electronic health records (EHRs) of emergency departments, avoiding dedicated, time-consuming data collection. This is a difficult task, however, because the most useful information is in free text format (e.g., presence of signs and symptoms, suspected and confirmed diagnosis, anamnesis). Such circumstances and needs require a reliable natural language processing (NLP) tool to derive highly consistent data from free text. Today, large-scale language models are available that can accurately interpret natural language. These models are trained on huge amounts of general knowledge taken mostly from the Internet, however, so their performance in more specialized areas, such as the medical domain, may not be optimal. The present study is part of a larger project called eCREAM (enabling Clinical Research in Emergency and Acute-care Medicine), and aims to develop and validate a language model (called eCREAM_LM) for six languages that can interpret the contents of emergency department EHRs and extract relevant information for research purposes. METHODS The study is an observational, multicenter, retrospective, 24-month study. Thirty centers will participate in the study: 13 from Italy, 4 from Poland, 3 from Greece, Slovakia, Slovenia, and the United Kingdom, and 1 from Switzerland. The centers will not receive any compensation, but their expenses will be covered by project funds. Development and validation of the eCREAM_LM model. eCREAM_LM will be developed through training and fine-tuning of the best overall model, among those open-source, and will proceed in partially parallel phases. Candidate models will be exposed to a huge amount (billions) of medical texts from the scientific literature or other public sources. Simultaneously, the models will also be exposed to a massive amount (millions) of free text notes obtained from medical records in use at participating hospitals. The investigators will then move on to fine-tuning, where a large amount (thousands) of clinical notes, obtained, once again, from the medical records of participating centers, will be used. These notes will be annotated by experienced physicians, which consists of extracting information from the notes to fill in the data items listed in a virtual data collection form (vCRF). The vCRF was created for a related study and contains a set of variables useful in predicting the hospitalization of patients with dyspnea or transient loss of consciousness, which is the objective of the related study. In the current study, the vCRF will serve as a tool for validating the language model. Validation of eCREAM_LM will be carried out using a set of 1,000 clinical notes annotated as described above, but not used in the development phase. These notes will be submitted to the eCREAM_LM model with the task of compiling the vCRF. The concordance in filling in the vCRF between the expert physicians and the eCREAM_LM will be the measure of final validation of eCREAM_LM. Data collection and anonymization Each participating hospital will provide free text notes contained in the medical records of 150-300,000 adult patients treated between 2021 and 2023. Notes referring to different aspects of the same patient (e.g., history, objective examination, test results) will be separated from each other so that it will be impossible to reconstruct the complete profile of the patient. In addition, the notes will be stripped of any reference to the patient (e.g., first name, last name, date of birth) and context (e.g., hospital, date and time of arrival at the center). This process minimizes the likelihood of re-identifying patients and maximizes the protection of their rights. The likelihood of re-identifying a patient within a database depends on how unique his or her characteristics are from other individuals in the database. The likelihood of having unique, and therefore identifiable, patients increases with the amount of information available in the database and decreases with its size. By removing all personal and contextual information from clinical notes and separating each note from the others, each note will only report a few characteristics of the patient. In addition, data collected from hospitals in the same country will be merged so that there is one large database for each language. This effectively zeroes out the probability of there being individuals uniquely identifiable from the notes. Finally, to rule out the possibility that the notes will contain information about third parties, such as names and phone numbers of patients' relatives, a certified anonymization software, specifically designed to remove personal data from free text, will be installed in each hospital. Once anonymized, the data will be centralized for analysis and will also be uploaded to major European language resource sharing platforms in the scientific community. Statistical analysis In the eCREAM_LM validation, the investigators will assess the concordance between expert emergency physicians and the eCREAM_LM itself in filling in the vCRF. The data will refer to a sample of 1,000 notes for each study language. Concordance will be assessed for each variable of the vCRF using Cohen's κ as a measure of agreement. The eCREAM_LM will be considered valid if Cohen's κ is greater than 0.75. Sample size Assuming an excellent agreement (κ=0.80) between eCREAM_LM and the experienced emergency physicians in completing the vCRF, a sample of at least 735 notes will be necessary to achieve sufficient precision to guarantee a good agreement (lower confidence limit of 95% confidence interval of Cohen's κ greater than 0.75). This number is the maximum sample size obtained under different scenarios involving a different number of categories (2 to 5) for each variable and different marginal distributions of the categories in the sample, including balanced distributions (e.g., 5 categories with 20% of the sample in each category) and very imbalanced results (e.g., 5 categories with 1.8%, 7.3%, 16.4%, 29.1% and 45.5% of the sample). Since information of interest may be missing in some notes, the investigators will perform the data validation assessment on 1,000 notes.
Phase
N/ASpan
35 weeksSponsor
Mario Negri Institute for Pharmacological ResearchCatania
Recruiting
Healthy Volunteers
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
This is a phase II, multicentre, single-arm neoadjuvant study in post- menopausal women with ER-positive and HER2-previously untreated early BC. The trial will include approximately 10 sites in Italy. The study plan will include a maximum 28-day screening period prior to start treatment. During the 6 cycles of the on-study intervention period, participants will return to the clinic every 2 weeks (14 ± 3 days) for the first 2 cycles, and then on Day 1 of the subsequent 4 cycles. Surgery should be performed as soon as possible after at least 7 days, from the last dose of abemaciclib and giredestrant, and no later than 30 days. During the short-term follow-up, participants should return for an in-clinic visit 28 days (± 5 days) after surgery. After the short-term follow-up visit, all participants will enter the long-term follow-up period, which will begin the day after the short-term follow-up visit and will continue up to Year1. Visits during the long-term follow-up visits should occur approximately every 3 months for a total of one year. For participants who are unable to attend the required clinic visits, long-term follow-up visits can take place as a phone visit. Blood and tumor samples will be used to investigate the mechanisms of response and resistance to therapy in ER+ and HER2- early BC. For each patient enrolled in the present study, blood samples (mandatory) and tumor biopsies (mandatory) are required and collected at entry in the study, following 14 days and 12 weeks of treatment, and prior to or during surgery. Blood samples are also required to be collected at the short follow up visit, at the end of the long follow-up period after on year (± 28 days) from the last short follow-up visit and at disease progression (suggested but not mandatory).
Phase
2Span
114 weeksSponsor
Fondazione OncotechCatania
Recruiting
Toothpaste With Sodium Carbonate in Patients With Gingivitis
Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.
Phase
N/ASpan
26 weeksSponsor
University of CataniaCatania
Recruiting
Healthy Volunteers
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma
This is a multicentre, prospective and non-interventional study in which all patients treated according to clinical practice will be included. The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery. The study involves medical visits and clinical-radiological re-evaluations according to clinical practice. There are no additional procedures. The clinician will establish the number of visits necessary for each patient according to the needs encountered and depending on the treatment chosen. The participating centers were selected in such a way as to adequately represent all the different geographical areas. The duration of the study is 24 months: 12 months of enrollment plus 12 months of further follow-up.
Phase
N/ASpan
106 weeksSponsor
Federation of Italian Cooperative Oncology GroupsCatania
Recruiting
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Acquired from Horizon in 2024.
Phase
3Span
135 weeksSponsor
AmgenCatania
Recruiting