Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50% A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning system to detect lung transplant rejection. The SENTINEL trial is being funded by £2m in partnership with the Medical Research Council and the National Institute for Health and Care Research. Lung transplant rejection is commonly monitored through lung function tests, blood tests, X-rays and lung biopsies. However, until it is advanced, lung transplant rejection can be challenging to identify. The new trial aims to investigate the new early warning system to identify early signs of rejection to be rolled out to all lung transplant recipients, cutting rejection by up to 50%. Set to be carried ...
Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders. By Frank Vinluan When women experience pain or fever during pregnancy, many clinicians recommend acetaminophen for relief. But concerns about a possible link between these medicines and neurodevelopmental disorders have lingered. A multi-year study sponsored by the National Institutes of Health has results that add to the scientific consensus that these medicines aren’t the cause of neurodevelopmental problems. Acetaminophen is the active pharmaceutical ingredient in some prescription products and popular over-the-counter pain relievers, notably Tylenol and Excedrin. While nonsteroidal anti-inflammatory drugs offer an alternative approach to pain relief, these drugs aren’t recommended during pregnancy because they can cause low levels of amniotic fluid among other problems. The ...
Don Tracy, Associate Editor Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio. The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy. The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, placebo-controlled Phase III VISIBLE 2 trial, which evaluated 409 patients who were treated with an injection of Entyvio or placebo every two weeks. At the end of the trial, 48% of patients treated with Entyvio experienced clinical remission.1,2 “Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve ...
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample. However, tumors are heterogeneous, containing multiple subpopulations of cells, or clones, each potentially responding differently to treatments. This variability may explain why some patients either fail to respond to certain treatments or develop resistance. Single-cell RNA sequencing offers higher-resolution data than bulk sequencing, capturing data at the single-cell level. This approach to identify and target individual clones may lead to more lasting drug responses, although, single-cell gene expression data are more expensive to generate and less accessible in clinical environments. In a proof-of-concept study, researchers at the National Institutes of Health (NIH, Bethesda, MD, US) have developed an artificial intelligence (AI) tool that leverages data from individual tumor cells to predict how well a person’s cancer might respond to ...
Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate-to-severe acute pain. The company announced its plans to submit an NDA following positive Phase III results from two clinical trials investigating the drug in patients who had undergone bunionectomy (NCT05553366) or abdominoplasty (NCT05558410) surgery. Both trials met the primary endpoints, and suzetrigine demonstrated a favourable safety profile with no serious adverse events reported. Vertex has started the rolling submission process and aims to finish by Q2 2024. With FDA fast track and breakthrough therapy designations already secured for the drug to treat acute pain, Vertex is now focusing on neuropathic pain, where positive Phase II results have been achieved. Following a successful end-of-Phase II meeting with the FDA, Vertex is planning a Phase III pivotal programme for patients with diabetic peripheral neuropathy (DPN) later ...
The Tyche model could help clinicians and researchers capture crucial information in images Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image. Funded by the National Institute of Health, the Eric and Wendy Schmidt Center and Quanta Computer, the Tyche machine-learning model could help clinicians and researchers capture crucial information. In biomedicine, AI models help clinicians by highlighting pixels that show signs of a certain disease or anomaly. However, these types of models usually only provide one answer. “Having options can help in decision-making” and “so it is important to take this uncertainty into account,” said MIT computer science PhD candidate, Marianne Rakic. Researchers developed Tyche after modifying a straightforward neural network architecture. After feeding the tool a few examples of segmentation tasks, such ...
Mike Hollan The Health Cube will increase remote and virtual care options for populations living in remote areas. AI is helping to expand healthcare solutions to rural areas. While people living in or near highly populated areas tend to have more options when it comes to healthcare, the lack of options in rural areas can be a real issue. For patients living in a state like Alaska, getting access to the proper care can involve traveling long distances, delays in obtaining medication, and sometimes being unable to find the proper specialists. One way that the industry is attempting to solve this issue is by bringing more telehealth and virtual options to these areas. New technologies, such as AI, are making this easier, as the algorithms are better able to match patients with the proper care providers through virtual sessions, while also making it easier to find ways to get the ...
Recently, Chiatai Tianqing Pharmaceutical Group has reached the primary endpoint in the pivotal registration clinical study of Rovadicitinib (TQ05105), a Class 1 innovative drug independently developed by Chiatai Tianqing Pharmaceutical Group, for the treatment of intermediate- to high-risk myelofibrosis (MF). The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application for TQ05105 tablets and has obtained the CDE’s consent to submit a marketing application for this product, which will be submitted in the near future. TQ05105 is a JAK/ROCK inhibitor with a new chemical structure developed by the company. In vitro test results show that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation level of STAT3 and STAT5 in cells, thus inhibiting the JAK/STAT signaling pathway conduction and thus exerting anti-tumor activity. The Company announced data from a Phase I ...
Infections from soil-transmitted helminths (STHs), commonly known as intestinal parasitic worms, are among the most widespread neglected tropical diseases and impose a significant health burden in low- and middle-income countries, particularly among school-aged children. These infections often lead to chronic health issues that can cause disability, social stigma, and for their substantial economic impacts on communities. STHs are notorious role in nutrient loss, which can contribute to neurocognitive impairments, stunted growth and development, and persistent fatigue in affected children. Additionally, these parasites are a major cause of morbidity and complications during pregnancy. The standard diagnostic method for STHs involves manual microscopy, which requires up to 10 minutes per slide and is hindered by a lack of skilled professionals and access to necessary equipment and lab infrastructure in highly affected regions. There is a pressing need for improved diagnostic techniques, particularly for detecting infections of mild intensity, to effectively manage and ...
Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond Street Hospital, University College London Hospital and the Royal Free Hospital. Researchers focused on the early effects of the SARS-CoV-2 infections using the human nasal epithelial cells (NECs) gathered from children aged up to 11 years, adults aged 30 to 50 years, as well as elderly people aged over 70 years. After using specialised techniques to regrow these cells into the different types usually found in the nose, researchers used single-cell RNA sequencing to identify the genetic networks and functions of thousands of individual cells to identify 24 epithelial cell types. The cell cultures from each age group were then either mock-infected or infected with SARS-CoV-2. After three ...
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