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  1. Article ; Online: Clinical Trials and Machine Learning: Regulatory Approach Review.

    Dri, Diego Alejandro / Massella, Maurizio / Gramaglia, Donatella / Marianecci, Carlotta / Petraglia, Sandra

    Reviews on recent clinical trials

    2021  Volume 16, Issue 4, Page(s) 341–350

    Abstract: Machine Learning, a fast-growing technology, is an application of Artificial Intelligence that has provided important contributes to drug discovery and clinical development. In the last few years, the number of clinical applications based on Machine ... ...

    Abstract Machine Learning, a fast-growing technology, is an application of Artificial Intelligence that has provided important contributes to drug discovery and clinical development. In the last few years, the number of clinical applications based on Machine Learning has been constantly growing and this is now affecting the National Competent Authorities during the assessment of most recently submitted Clinical Trials that are designed, managed or that are generating data deriving from the use of Machine Learning or Artificial Intelligence technologies. We review current information available on the regulatory approach to Clinical Trials and Machine Learning. We also provide inputs for further reasoning and potential indications, including six actionable proposals for regulators to proactively drive the upcoming evolution of Clinical Trials within a strong regulatory framework, focusing on patient's safety, health protection and fostering immediate access to effective treatments.
    MeSH term(s) Artificial Intelligence ; Drug Discovery ; Humans ; Machine Learning
    Language English
    Publishing date 2021-07-29
    Publishing country United Arab Emirates
    Document type Journal Article ; Review
    ZDB-ID 2251879-4
    ISSN 1876-1038 ; 1574-8871
    ISSN (online) 1876-1038
    ISSN 1574-8871
    DOI 10.2174/1574887116666210715114203
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Nivolumab in pretreated pleural mesothelioma: Results from an observational real-world study of patients treated within the AIFA 5% Fund.

    Cerbone, Luigi / Delfanti, Sara / Crivellari, Stefania / De Angelis, Antonina Maria / Mazzeo, Laura / Proto, Claudia / Occhipinti, Mario / Lo Russo, Giuseppe / Dellepiane, Chiara / Biello, Federica / Alabiso, Irene / Verderame, Francesco / Gauna, Roberta / De Simone, Irene / Cuppone, Federica / Petraglia, Sandra / Pasello, Giulia / Ceresoli, Giovanni Luca / Garassino, Marina Chiara /
    Torri, Valter / Grosso, Federica

    Tumori

    2024  , Page(s) 3008916241229287

    Abstract: Background: Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural ... ...

    Abstract Background: Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural mesothelioma, achieving a response rate between 10-20%, median progression-free survival of 2-5 months and median overall survival of 7-13 months.
    Patients and methods: A retrospective, multi-institutional study of pleural mesothelioma patients treated with nivolumab in second and further line was performed. The endpoints of the study are response rate, disease control rate, progression free survival and overall survival.
    Results: Sixty-five patients with pleural mesothelioma treated with nivolumab in second and further line were enrolled at seven Italian institutions. The response rate was 8%, disease control rate was 37%, median progression free survival was 5.7 months (95% CI: 2.9-9.0) and median overall survival was 11.1 (95% CI 6.2-19.9) months. A higher neutrophils and neutrophils to lymphocytes ratio at baseline were associated with worse prognosis.
    Conclusion: Nivolumab as a single agent is fairly active in a cohort of unselected pretreated pleural mesothelioma patients. Further investigations on clinical and translational factors are needed to define which patient might benefit most from nivolumab treatment in pleural mesothelioma.
    Language English
    Publishing date 2024-02-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 280962-x
    ISSN 2038-2529 ; 0300-8916
    ISSN (online) 2038-2529
    ISSN 0300-8916
    DOI 10.1177/03008916241229287
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: A nationwide prospective registry of bortezomib-based therapy in light chain (AL) amyloidosis.

    Palladini, Giovanni / Celant, Simone / Milani, Paolo / Summa, Valentina / Affronti, Giovanni / Olimpieri, Pier Paolo / Petraglia, Sandra / Foli, Andrea / Nuvolone, Mario / Merlini, Giampaolo / Russo, Pierluigi

    Leukemia & lymphoma

    2021  Volume 63, Issue 1, Page(s) 205–211

    Abstract: Until recently, no drug was labeled for AL amyloidosis. In 2011, the Italian Medicines Agency started a program to grant access to upfront bortezomib to patients with AL amyloidosis. All subjects were enrolled in a prospective online registry. Response ... ...

    Abstract Until recently, no drug was labeled for AL amyloidosis. In 2011, the Italian Medicines Agency started a program to grant access to upfront bortezomib to patients with AL amyloidosis. All subjects were enrolled in a prospective online registry. Response was evaluated after two cycles to assess the possibility of continuing treatment. A total of 764 patients were included until 2019, and 615 were evaluable. Sixteen percent of patents had advanced (stage-IIIb) heart involvement, and 27% had severe or end-stage renal failure. Bortezomib delivery was possible in stage-IIIb patients at a reduced dose. Bortezomib discontinuation was associated with increasing age, advanced heart involvement and bi-weekly administration. Fifty-nine percent of subjects attained a hematologic response and 14% a cardiac response. Bortezomib-based therapy tends to be discontinued early in elderly patients and in advanced disease. Nevertheless, early response to therapy is possible in this challenging population.
    MeSH term(s) Aged ; Amyloidosis/diagnosis ; Amyloidosis/drug therapy ; Bortezomib ; Dexamethasone ; Drug Therapy, Combination ; Humans ; Immunoglobulin Light-chain Amyloidosis/diagnosis ; Immunoglobulin Light-chain Amyloidosis/drug therapy ; Registries ; Treatment Outcome
    Chemical Substances Bortezomib (69G8BD63PP) ; Dexamethasone (7S5I7G3JQL)
    Language English
    Publishing date 2021-08-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1042374-6
    ISSN 1029-2403 ; 1042-8194
    ISSN (online) 1029-2403
    ISSN 1042-8194
    DOI 10.1080/10428194.2021.1971215
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2997: Show issues Location:
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  4. Article: Valacyclovir for prevention and treatment of fetal CMV infection: inclusion in the Law 648/96 list and launch of the Italian multicentre observational prospective study "MEGAL-ITALI".

    Zammarchi, Lorenzo / Lazzarotto, Tiziana / Di Tommaso, Mariarosaria / Tomasoni, Lina / Pasquini, Lucia / Galli, Luisa / Simonazzi, Giuliana / Castelli, Francesco / Borchi, Beatrice / Campolmi, Irene / Ornaghi, Sara / Bartoloni, Alessandro / Andreoni, Massimo / Pagano, Immacolata / Petraglia, Sandra / Ramenghi, Luca / Clerici, Pierangelo / Tavio, Marcello / Trotta, Michele

    Le infezioni in medicina

    2021  Volume 29, Issue 2, Page(s) 299–303

    Abstract: Not available. ...

    Abstract Not available.
    MeSH term(s) Antiviral Agents/therapeutic use ; Cytomegalovirus Infections/congenital ; Cytomegalovirus Infections/drug therapy ; Cytomegalovirus Infections/prevention & control ; Humans ; Infant, Newborn ; Italy ; Valacyclovir/therapeutic use
    Chemical Substances Antiviral Agents ; Valacyclovir (MZ1IW7Q79D)
    Language English
    Publishing date 2021-06-01
    Publishing country Italy
    Document type Journal Article ; Multicenter Study ; Observational Study
    ZDB-ID 2041081-5
    ISSN 1124-9390
    ISSN 1124-9390
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5576: Show issues Location:
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  5. Article: Moving towards a customized approach for drug development: lessons from clinical trials with immune checkpoint inhibitors in lung cancer.

    Pilotto, Sara / Carbognin, Luisa / Karachaliou, Niki / Garassino, Marina / Cuppone, Federica / Petraglia, Sandra / Rosell, Rafael / Tortora, Giampaolo / Bria, Emilio

    Translational lung cancer research

    2015  Volume 4, Issue 6, Page(s) 704–712

    Abstract: Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by ...

    Abstract Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by the usual outcome measures, thus requiring a deep reflection about the appropriateness of the traditional statistical methodologies in this context. The intrinsic biological differences existing both in terms of mechanism of action and kinetic between immunotherapy and chemotherapy or targeted therapy, impact on patients' outcome, requiring a global revolution in the way to design clinical studies with the ideal aim to evolve towards trials carefully 'customized' on the basis of the investigational drug, the specific disease and the biological background. The exciting data recently obtained with immune checkpoint inhibitors, offer an ideal context and background to explore the major questions and future perspectives about the development of immunotherapeutic agents. In this regard, the choice of adequate endpoints, the use of modified statistical methods and the potential introduction of predictive biomarkers for immunotherapy clinical trials, will be discuss in this review in order to provide practical and rationale suggestions aimed to improve the existing model for cancer immunotherapy investigation.
    Language English
    Publishing date 2015-12-01
    Publishing country China
    Document type Journal Article ; Review
    ZDB-ID 2754335-3
    ISSN 2226-4477 ; 2218-6751
    ISSN (online) 2226-4477
    ISSN 2218-6751
    DOI 10.3978/j.issn.2218-6751.2015.10.08
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes.

    Carrai, Paola / Morelli, Cristina / Cordone, Gabriella / Romano, Antonietta / Tamé, Mariarosa / Lionetti, Raffaella / Pietrosi, Giada / Lenci, Ilaria / Piai, Guido / Russo, Francesco Paolo / Coppola, Carmine / Melazzini, Mario / Montilla, Simona / Pani, Luca / Petraglia, Sandra / Russo, Pierluigi / Trotta, Maria Paola / Martini, Silvia / Toniutto, Pierluigi

    Transplant international : official journal of the European Society for Organ Transplantation

    2017  Volume 30, Issue 12, Page(s) 1253–1265

    Abstract: Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3-F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir ... ...

    Abstract Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3-F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child-Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child-Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.
    MeSH term(s) Analysis of Variance ; Antiviral Agents/therapeutic use ; Cohort Studies ; Compassionate Use Trials ; Confidence Intervals ; Disease Progression ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Hepatitis C, Chronic/diagnosis ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/epidemiology ; Humans ; Italy ; Liver Cirrhosis/prevention & control ; Liver Cirrhosis/virology ; Liver Function Tests ; Logistic Models ; Male ; Multivariate Analysis ; Prognosis ; Recurrence ; Ribavirin/therapeutic use ; Risk Assessment ; Severity of Illness Index ; Sofosbuvir/therapeutic use ; Treatment Outcome
    Chemical Substances Antiviral Agents ; Ribavirin (49717AWG6K) ; Sofosbuvir (WJ6CA3ZU8B)
    Language English
    Publishing date 2017-09-07
    Publishing country England
    Document type Comparative Study ; Journal Article ; Observational Study
    ZDB-ID 639435-8
    ISSN 1432-2277 ; 0934-0874
    ISSN (online) 1432-2277
    ISSN 0934-0874
    DOI 10.1111/tri.13018
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2358: Show issues Location:
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  7. Article ; Online: The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience.

    Martini, Silvia / Donato, Maria Francesca / Mazzarelli, Chiara / Rendina, Maria / Visco-Comandini, Ubaldo / Filì, Daniela / Gianstefani, Alice / Fagiuoli, Stefano / Melazzini, Mario / Montilla, Simona / Pani, Luca / Petraglia, Sandra / Russo, Pierluigi / Trotta, Maria Paola / Carrai, Paola / Caraceni, Paolo

    Liver international : official journal of the International Association for the Study of the Liver

    2017  Volume 38, Issue 4, Page(s) 733–741

    Abstract: Background & aims: This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program.: Methods: ... ...

    Abstract Background & aims: This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program.
    Methods: Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma (HCC) receiving daily SOF/R until LT or up a maximum of 48 weeks.
    Results: Of 100 transplanted patients, 51 were HCV-RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for <4 weeks or still viraemic at transplant: 34 patients continued treatment after LT (bridging therapy) (SVR12: 88%), while 15 stopped treatment (SVR12: 53%). 98 patients completed SOF/R without LT (SVR12: 73%). In patients with advanced decompensated cirrhosis (basal MELD ≥15 and/or C-P ≥B8), a marked improvement of the scores occurred in about 50% of cases and almost 20% of decompensated patients without HCC reached a condition suitable for inactivation and delisting.
    Conclusions: These real-life data indicate that in waitlisted patients: (i) bridging antiviral therapy can be an option for patients still viraemic or negative <4 weeks at LT; and (ii) clinical improvement to a condition suitable for delisting can occur even in patients with advanced decompensated cirrhosis.
    MeSH term(s) Adult ; Aged ; Antiviral Agents/therapeutic use ; Carcinoma, Hepatocellular/drug therapy ; Compassionate Use Trials ; Drug Therapy, Combination ; Female ; Hepacivirus/genetics ; Hepatitis C, Chronic/drug therapy ; Humans ; Italy ; Kaplan-Meier Estimate ; Liver Cirrhosis/surgery ; Liver Cirrhosis/virology ; Liver Neoplasms/surgery ; Liver Neoplasms/virology ; Liver Transplantation ; Male ; Middle Aged ; Prospective Studies ; Ribavirin/therapeutic use ; Sofosbuvir/therapeutic use ; Waiting Lists
    Chemical Substances Antiviral Agents ; Ribavirin (49717AWG6K) ; Sofosbuvir (WJ6CA3ZU8B)
    Language English
    Publishing date 2017-10-06
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Observational Study
    ZDB-ID 2102783-3
    ISSN 1478-3231 ; 1478-3223
    ISSN (online) 1478-3231
    ISSN 1478-3223
    DOI 10.1111/liv.13588
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