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Optical molecular imaging in oral- and oropharyngeal squamous cell carcinoma using a novel uPAR-targeting near-infrared imaging agent FG001 (ICG-Glu-Glu-AE105): An explorative phase II clinical trial.
Theranostics
January 2025
Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging (CMI), Copenhagen University Hospital, Rigshospitalet & Department of Biomedical Sciences, University of Copenhagen, Denmark.
: In oral and oropharyngeal squamous cell carcinoma (OSCC, OPSCC), frequent inadequate surgical margins highlight the importance of precise intraoperative identification and delineation of cancerous tissue for improving patient outcomes. : A prospective, open-label, single-center, single dose, exploratory phase II clinical trial (EudraCT 2022-001361-12) to assess the efficacy of the novel uPAR-targeting near-infrared imaging agent, FG001, for intraoperative detection of OSCC and OPSCC. Macroscopic tumor detection was quantified with sensitivity and intraoperative tumor-to-background ratio (TBR).
View Article and Find Full Text PDFSingle-Dose Psilocybin for Depression With Severe Treatment Resistance: An Open-Label Trial.
Am J Psychiatry
January 2025
Institute for Advanced Diagnostics and Treatment, Sheppard Pratt Health System, Baltimore (Aaronson, Miller, LaPratt, Swartz, Shoultz, Lauterbach); Department of Psychiatry, University of Maryland, Baltimore (Aaronson, van der Vaart, Lauterbach); VA Palo Alto Health Care System and Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine, Palo Alto, CA (Suppes); Departments of Psychiatry and Radiology, Columbia University, New York (Sackeim).
Objective: Depression varies along a difficulty-to-treat spectrum. Patients whose illness fails to respond to at least five treatments may be considered to have severely treatment-resistant depression (TRD). The objective of this study was to document the safety and efficacy of psilocybin in patients with severe TRD.
View Article and Find Full Text PDFSingle (375 mg/m) vs. double dose of rituximab along with mycophenolate mofetil for children with steroid-dependent/frequently relapsing nephrotic syndrome: a multicentre open-label randomized controlled trial.
Pediatr Nephrol
December 2024
Department of Pediatric Nephrology, Great North Children Hospital, Newcastle Upon Tyne, UK.
Background: Optimal dosing of rituximab when given with mycophenolate mofetil (MMF) for frequently relapsing nephrotic syndrome/steroid-dependent nephrotic syndrome (FRNS/SDNS) remains uncertain.
Methods: This was a prospective, non-inferiority, open-label randomized controlled multicentre study. Children (2-18 years old) with difficult FRNS/SDNS were randomized to group A (rituximab 375 mg/m once) or group B (rituximab 375 mg/m twice; 7-14 days apart) followed by continuous MMF and 3 months of tapered steroids.
A Phase I Study of the Pharmacokinetics and Safety of Ipatasertib, an Akt Inhibitor in Chinese Patients With Locally Advanced or Metastatic Solid Tumors.
Clin Ther
December 2024
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, PR China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, PR China. Electronic address:
Purpose: Ipatasertib is a selective inhibitor of Akt, a frequently activated protein kinase that plays a critical role in human cancers. The current clinical trial aimed to assess the pharmacokinetic properties, safety, and tolerability of ipatasertib administered to Chinese patients with locally advanced or metastatic solid tumors.
Methods: A Phase I, single-arm, open-label study was performed in Chinese patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven ineffective.
A phase 1/2 safety and efficacy study of TAK-754 gene therapy: The challenge of achieving durable factor VIII expression in haemophilia A clinical trials.
Haemophilia
December 2024
Investigative Toxicology, Takeda Development Center of the Americas, Cambridge, USA.
Introduction: Haemophilia A is an X-linked bleeding disorder resulting from a deficiency of factor VIII (FVIII). To date, multiple gene therapies have entered clinical trials with the goal of providing durable haemostatic protection from a single dose. TAK 754 (BAX 888) is an investigational AAV8-based gene therapy containing a FVIII transgene.
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