Risultati per: La FDA approva il sistema di riabilitazione dell’ictus

All’Unità spinale del Cto di Torino, sensorialità da stimolare

Background
Recent reports of the utilisation of pyrvinium pamoate (PP), an FDA-approved anti-helminth, have shown that it inhibits pancreatic ductal adenocarcinoma (PDAC) cell growth and proliferation in-vitro and in-vivo in preclinical models. Here, we report about an ongoing phase I open-label, single-arm, dose escalation clinical trial to determine the safety and tolerability of PP in PDAC surgical candidates.

Methods and analysis
In a 3+3 dose design, PP is initiated 3 days prior to surgery. The first three patients will be treated with the initial dose of PP at 5 mg/kg orally for 3 days prior to surgery. Dose doubling will be continued to a reach a maximum of 20 mg/kg orally for 3 days, if the previous two dosages (5 mg/kg and 10 mg/kg) were tolerated. Dose-limiting toxicity grade≥3 is used as the primary endpoint. The pharmacokinetic and pharmacodynamic (PK/PD) profile of PP and bioavailability in humans will be used as the secondary objective. Each participant will be monitored weekly for a total of 30 days from the final dose of PP for any side effects. The purpose of this clinical trial is to examine whether PP is safe and tolerable in patients with pancreatic cancer, as well as assess the drug’s PK/PD profile in plasma and fatty tissue. Potential implications include the utilisation of PP in a synergistic manner with chemotherapeutics for the treatment of pancreatic cancer.

Ethics and dissemination
This study was approved by the Thomas Jefferson Institutional Review Board. The protocol number for this study is 20F.041 (Version 3.1 as of 27 October 2021). The data collected and analysed from this study will be used to present at local and national conferences, as well as, written into peer-reviewed manuscript publications.

Trial registration number
ClinicalTrials.gov: NCT05055323.

Criticità segnalate in questi mesi da alcune sigle sindacali

Evitabili 8 morti su 10 per malattie cardiovascolari. Il 29 giornata mondiale

Giornata Mondiale Cuore,consigli Società Italiana di Cardiologia

This Viewpoint discusses why the US Food and Drug Administration (FDA) should include e-cigarettes in its proposed cap of the nicotine concentration in combustible cigarettes to address the public health problem of vaping among adolescents.

Saranno disponibili da questa settimana. Ok del Canada a Moderna

Al via un progetto pilota di riabilitazione al Santa Lucia Irccs

Al via un progetto pilota di riabilitazione al Santa Lucia Irccs

This Special Communication examines relevant legal precedents on the Centers for Medicare & Medicaid Services’ approaches to limit coverage and recent decisions Medicare has issued affecting coverage for US Food and Drug Administration-regulated products.

Modificando 5 fattori di rischio, dal fumo al sovrappeso

Modificando 5 fattori di rischio, dal fumo al sovrappeso

Danni cardiaci con sedentarietà, aumenta rischio fino al doppio

Danni cardiaci con sedentarietà, aumenta rischio fino al doppio

Danni cardiaci con sedentarietà, aumenta rischio fino al doppio