Randomized Double Blind Phase 2 Trial of Baby Tamoxifen Versus Baby Exemestane in Post-menopausal Women at High Risk for Breast Cancer. BabyTEARS (Baby Tamoxifen or Exemestane Assessment Randomized Study)

The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life.

开始日期2024-09-01

申办/合作机构

Ente Ospedaliero Ospedali Galliera

[+4]

NCT06033092 / Recruiting临床2期IIT

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion: a Randomized Phase II Biomarker Trial in Subjects at Increased Risk

Circulating levels of Sex Hormone Binding Globulin (SHBG) are significantly associated with a decreased risk of breast cancer.
The main aim of this clinical trial is to verify whether Low Dose Tamoxifen (LDT) increases circulating levels of SHBG more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months in women at increased risk of breast cancer (i.e., healthy participants carriers of a germline pathogenic/likely pathogenetic variant in at least one of the following genes: BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C or RAD51D, or with > 5% breast cancer risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast (IEN).
The secondary aims are:
* to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment (HOMA) index, immune and inflammatory markers, lipid profile, Adiponectin/Leptin (A/L) ratio, quality of life (QoL), Body mass index (BMI), fat body composition, safety and toxicity;
* to verify whether LDT significantly modulates secondary endpoints, such as HOMA-index, immune and inflammatory markers, lipid profile, A/L ratio, QoL, BMI, fat body composition, safety and toxicity;
* to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers, cytokines, immune modulators, and inflammatory proteins in serum;
* to investigate MD (Mammographic Breast Density) changes by LDT vs. LI, with or without ICR. This aim will be performed in a subgroup of participants (not all the participants will undergo mammography due to younger age).

开始日期2024-06-21

申办/合作机构

Istituto Europeo di Oncologia SRL

[+2]

NCT06224556 / RecruitingN/AIIT

A Personalized Prevention Program (PPP) Based on the Comprehensive Geriatric Assessment (CGA) for the Prevention of Multidimensional Frailty Related to Non-communicable Chronic Diseases (NCDs) in Older People: a Practical Approach in Primary Care Setting

* Non-Communicable Diseases (NCDs) can accelerated the aging process and increase the frailty condition
* The Comprehensive Geriatric Assessment (CGA) is the gold standard in the geriatric clinical context
* Recently, in Italy the first Guidelines about the CGA in different settings for older people has been pubblicated
* The CGA can identify older people at high risk of frailty who can benefit from a personalized prevention program
* No studies has been investigated the effects of a personalized prevention program (PPP) based on the CGA in a primary care setting
* The main hypothesis is that the CGA assessment can result in personalized prevention programs for older subjects in primary care settings with an effect in reducing the hospitalization rate and can be related to the biological paramters in NCDs

开始日期2024-06-04

申办/合作机构

Ente Ospedaliero Ospedali Galliera

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366

项与 Ente Ospedaliero Ospedali Galliera 相关的文献（医药）

2024-11-01·HNO

Übersichtsarbeit zur chirurgischen Behandlung des suprastomalen Kollapses bei tracheotomierten Kindern

Review

作者: Fiz, Ivana ; D'Agostino, Roberto ; Fiz, Francesco ; Sittel, Christian ; Rüller, Karina ; Torre, Michele ; Burghartz, Marc

BACKGROUNDSuprastomal collapse (SSC) is considered a major late complication of paediatric tracheostomy and can be responsible for decannulation failure in up to 20% of tracheostomised children. Depending on the severity of SSC, surgery may be required. Various strategies and techniques are available, of which the treating with airway team should be aware.OBJECTIVEThis article intends to summarise the aetiology of SSC, its classification, clinical presentation, and the gold standard diagnostic and therapeutic algorithms according to the current literature.MATERIALS AND METHODSA panel of experts reviewed the available literature on SSC. Published evidence on the different surgical techniques and their advantages and disadvantages was reviewed in detail, and a treatment algorithm created.RESULTSThe gold standard diagnostic procedure for SSC is flexible transnasal laryngotracheoscopy in spontaneous breathing followed by microlaryngoscopy (MLS) under general anaesthesia. Two main types of SSC can be differentiated, which differ in terms of surgical treatment. Purely anterior SSC is usually treated by tracheoplasty using an anterior costal cartilage graft (ACCG). Simple closure of the tracheostomy or excision of SSC with a potassium-titanyl-phosphate (KTP) laser are also described as less invasive approaches. For anterolateral SSC, segmental tracheal resection with end-to-end anastomosis or tracheoplasty with ACCG represent promising treatment options. Tracheal reinforcement with absorbable microplates is also discussed in the literature. With both types of SSC and depending on severity and the age of the child, a watch-and-wait strategy should always be considered.CONCLUSIONDynamic airway endoscopy in spontaneous breathing followed by MLS in general anaesthesia should always be performed before decannulation. It is particularly important to visualise all segments of the airway during spontaneous breathing. The decision regarding the best surgical option for each child is based on the type and localisation of SSC, as well as on the patient's medical and surgical history and age.

2024-09-19·Epilepsia open

A VAMS-based LC-MS/MS method for precise cenobamate quantification in epilepsy (patients).

Article

作者: Molteni, Linda ; de Grazia, Ugo ; Barco, Sebastiano ; Bandettini, Roberto ; Villani, Flavio ; Riva, Antonella ; Mattioli, Francesca ; Striano, Pasquale ; Micalizzi, Elisa ; Pigliasco, Federica ; Cangemi, Giuliana ; Stella, Manuela ; Biondi, Margherita ; Cafaro, Alessia

OBJECTIVECenobamate (CNB), a recently approved antiseizure medication by the European Medicines Agency (EMA), serves as an adjunctive therapy for focal-onset seizures in adult patients unresponsive to at least two other treatments. Administered in polytherapy, CNB can potentially interact with co-administered drugs in epilepsy patients, necessitating dose adjustments and the need for effective therapeutic drug monitoring (TDM).METHODSIn this study, we introduce a novel LC-MS/MS method for precise CNB quantification using Volumetric Absorptive Microsampling (VAMS), following validation according to ICH guidelines M10. VAMS samples are efficiently extracted with 200 μL of methanol, with chromatographic separation achieved using an Acquity UPLC HSS PFP column. The method's efficacy was confirmed through its application to real samples from adult CNB-treated patients.RESULTSOur results demonstrate that the method exhibits linearity within the range of 0.05-30 mg/L, with intra- and inter-run precision ranging from 1% to 8% and accuracy from 1% to 10% based on 30 μL of sample. Furthermore, CNB stability in VAMS is confirmed for up to 15 days at 25°C and -20°C. Importantly, no significant difference was observed between CNB concentrations in VAMS samples and those in plasma obtained from venous blood.SIGNIFICANCEThis VAMS-based LC-MS/MS method presents a robust alternative for TDM in CNB-treated patients. Future investigations should explore CNB concentrations in capillary blood and assess their correlation with plasma levels to further enhance its clinical utility.PLAIN LANGUAGE SUMMARYCenobamate is an antiepileptic drug and used for treatment of focal-onset seizures in adult patients (≥18 age). TDM can prevent drug interactions and minimize drug toxicity. The aim of this work is to evaluate volumetric absorptive microsampling (VAMS) from capillary blood as an alternative strategy for TDM in patients treated with the newly antiepileptic drug. Our method is suitable for TDM, and this study suggests that VAMS allows monitoring of cenobamate concentration and can offer valuable support for personalized therapy in refractory epilepsy.

2024-09-01·Annals of Surgical Oncology

Radiomics of Intrahepatic Cholangiocarcinoma and Peritumoral Tissue Predicts Postoperative Survival: Development of a CT-Based Clinical-Radiomic Model

Article

作者: Ardito, Francesco ; Ferrero, Alessandro ; Giuliante, Felice ; Zamboni, Giulia A ; Vara, Giulio ; Ruzzenente, Andrea ; Viganò, Luca ; Serenari, Matteo ; Mosconi, Cristina ; Russolillo, Nadia ; Ieva, Francesca ; Conci, Simone ; Guglielmi, Alfredo ; Chiti, Arturo ; Boldrini, Luca ; Fiz, Francesco ; Mirarchi, Mariateresa ; Langella, Serena ; Cucchetti, Alessandro ; Ercolani, Giorgio ; Cirillo, Stefano ; Pecorella, Ilaria ; Torzilli, Guido ; Rossi, Noemi ; Cescon, Matteo ; Borzi, Martina ; Sollini, Martina ; Gallo, Teresa ; Mele, Caterina

BACKGROUNDFor many tumors, radiomics provided a relevant prognostic contribution. This study tested whether the computed tomography (CT)-based textural features of intrahepatic cholangiocarcinoma (ICC) and peritumoral tissue improve the prediction of survival after resection compared with the standard clinical indices.METHODSAll consecutive patients affected by ICC who underwent hepatectomy at six high-volume centers (2009-2019) were considered for the study. The arterial and portal phases of CT performed fewer than 60 days before surgery were analyzed. A manual segmentation of the tumor was performed (Tumor-VOI). A 5-mm volume expansion then was applied to identify the peritumoral tissue (Margin-VOI).RESULTSThe study enrolled 215 patients. After a median follow-up period of 28 months, the overall survival (OS) rate was 57.0%, and the progression-free survival (PFS) rate was 34.9% at 3 years. The clinical predictive model of OS had a C-index of 0.681. The addition of radiomic features led to a progressive improvement of performances (C-index of 0.71, including the portal Tumor-VOI, C-index of 0.752 including the portal Tumor- and Margin-VOI, C-index of 0.764, including all VOIs of the portal and arterial phases). The latter model combined clinical variables (CA19-9 and tumor pattern), tumor indices (density, homogeneity), margin data (kurtosis, compacity, shape), and GLRLM indices. The model had performance equivalent to that of the postoperative clinical model including the pathology data (C-index of 0.765). The same results were observed for PFS.CONCLUSIONSThe radiomics of ICC and peritumoral tissue extracted from preoperative CT improves the prediction of survival. Both the portal and arterial phases should be considered. Radiomic and clinical data are complementary and achieve a preoperative estimation of prognosis equivalent to that achieved in the postoperative setting.

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