Results 101 to 110 of about 188,184 (297)

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

Clinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne, Maurice A. Brookhart, Nancy A. Dreyer   +2 more
wiley   +1 more source

MELD score predicts outcomes in patients with advanced heart failure: A longitudinal evaluation

ESC Heart Failure, Volume 12, Issue 2, Page 839-847, April 2025.
Abstract Aims Advanced heart failure (AHF) is characterized by recurrent episodes of haemodynamic instability and frequent hospitalizations, leading to a progressive decline in quality of life and high mortality rates. The objectives of this study were to evaluate the effect of the model for end‐stage liver disease (MELD) score and its variations in ...
Francesco Curcio, Cristiano Amarelli, Rosaria Chiappetti, Irene Mattucci, Veronica Flocco, Mahmoud Issa Rammal, Ciro Abete, Francesca Mazzella, Ciro Maiello, Pasquale Abete, Francesco Cacciatore   +10 more
wiley   +1 more source

Interventional therapies for chronic heart failure: An overview of recent developments

ESC Heart Failure, Volume 12, Issue 2, Page 1081-1094, April 2025.
Abstract Heart failure (HF), the final manifestation of most cardiovascular diseases, has become a major global health concern, affecting millions of individuals. Despite basic drug treatments, patients present with high morbidity and mortality rates. However, recent advancements in interventional therapy have shown promising results in improving the ...
Bingchen Guo, Si Shi, Yutong Guo, Jie Xiong, Bo Wang, Zengxiang Dong, Dianyu Gao, Yingfeng Tu   +7 more
wiley   +1 more source

Estudio de las propiedades antiinflamatorias de la heparina no fraccionada en la isquemia cerebral [PDF]

, 2007
[spa] INTRODUCCIÓN: La heparina no fraccionada (HNF) se utiliza en el tratamiento del ictus desde varias décadas como fármaco anticoagulante. Los ensayos clínicos aleatorizados no han demostrado eficacia de este tratamiento, por lo que se desaconseja su ...
Cervera Álvarez, Álvaro
core   +1 more source

Real‐world characteristics and treatment of cardiac transthyretin amyloidosis: A multicentre, observational study

ESC Heart Failure, Volume 12, Issue 2, Page 1203-1216, April 2025.
The 366 patients diagnosed with transthyretin amyloidosis cardiomyopathy (ATTR‐CM) were analyzed regarding their clinical characteristics in the first year after approval of tafamidis 61 mg for ATTR‐CM in Germany. Nearly two‐thirds of the patients were in an advanced disease stage and 64% met the key criteria of the “Transthyretin Amyloidosis ...
Richard J. Nies, Svenja Ney, Ingrid Kindermann, Yvonne Bewarder, Angela Zimmer, Fabian Knebel, Katrin Hahn, Sebastian Spethmann, Peter Luedike, Lars Michel, Tienush Rassaf, Maria Papathanasiou, Stefan Störk, Vladimir Cejka, Amin Polzin, Fabian Voss, Malte Kelm, Bernhard Unsöld, Christine Meindl, Michael Paulus, Ali Yilmaz, Bishwas Chamling, Caroline Morbach, Roman Pfister   +23 more
wiley   +1 more source

Continuous versus intermittent anticoagulation during endoscopic treatment of esophageal varices in cirrhosis: a randomized controlled trial

Therapeutic Advances in Gastroenterology
Background: Endoscopic variceal treatment (EVT) in cirrhotic patients carries a risk of periprocedural bleeding, making anticoagulation management challenging in those with acute portal vein thrombosis (PVT).
Yingying He, Zhihong Wang, Jiayi Zhang, Qianqian Zhang, Yaxian Kuai, Yuchuan Bai, Xuecan Mei, Derun Kong   +7 more
doaj   +1 more source

Case Report: Isolated homonymous hemianopia after reversal of anticoagulation with andexanet alfa

Frontiers in Neurology
PurposeClinical scoring systems have been developed (e.g., CHA2DS2-VASc and HAS-BLED) to aid in the perioperative management of anticoagulation therapy.
Paria Malekahmadi, Dina Abdelsalam, Safa Ibrahim, Andrew Go Lee   +3 more
doaj   +1 more source

Long‐term cardiovascular outcomes of immune checkpoint inhibitor‐related myocarditis: A large single‐centre analysis

ESC Heart Failure, Volume 12, Issue 2, Page 1237-1245, April 2025.
Abstract Aims Immune checkpoint inhibitors (ICI) are the cornerstone of modern oncology; however, side effects such as ICI‐related myocarditis (irM) can be fatal. Recently, Bonaca proposed criteria for irM; however, it is unknown if they correlate well with cardiovascular (CV) ICI‐related adverse events.
Lorenzo Braghieri, Ahmad Gharaibeh, Lubika Nkashama, Abdelrahman Abushouk, Osama Abushawer, Amir Mehdizadeh‐Shrifi, Bianca Honnekeri, Cassandra Calabrese, Venu Menon, Pauline Funchain, Patrick Collier, Diego Sadler, Rohit Moudgil   +12 more
wiley   +1 more source

Connecting the dots: A narrative review of the relationship between heart failure and cognitive impairment

ESC Heart Failure, Volume 12, Issue 2, Page 1119-1131, April 2025.
Abstract Large clinical data underscore that heart failure is independently associated to an increased risk of negative cognitive outcome and dementia. Emerging evidence suggests that cerebral hypoperfusion, stemming from reduced cardiac output and vascular pathology, may contribute to the largely overlapping vascular dementia and Alzheimer's disease ...
Mauro Massussi, Maria Giulia Bellicini, Marianna Adamo, Andrea Pilotto, Marco Metra, Alessandro Padovani, Riccardo Proietti   +6 more
wiley   +1 more source

Cardiovascular toxicity induced by TKIs in patients with chronic myeloid leukaemia: Are women and men different?

ESC Heart Failure, Volume 12, Issue 2, Page 1447-1454, April 2025.
This study analyzes 148 patients (66 women and 82 men) with chronic myeloid leukemia treated with tyrosine kinase inhibitors, focusing on cardiovascular adverse events. The risk assessment, performed using the HFA/ICOS score, reveals sex‐specific differences: venous thrombosis is more common in women, while arterial thrombosis predominates in men.
Cristina Madaudo, Daniela Di Lisi, Antonio Cannatà, Federica Manfrè, Celeste Vullo, Marco Santoro, Ciro Botta, Salvatrice Mancuso, Sergio Siragusa, Alfredo Ruggero Galassi, Giuseppina Novo   +10 more
wiley   +1 more source