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JOURNAL ARTICLE
Xiaoli Ma, Yutong Zou, Jian Zhong, Songlin Yu, Ling Qiu
The lack of individual pure standard has hampered the application of therapeutic drug monitoring (TDM) for multi-component antibiotics in clinical laboratories. Here, we aimed to develop an integrated identification-quantification (ID-Quant) workflow based on ultra-high-performance liquid chromatography coupled with quadrupole/time-of-flight mass spectrometry (UHPLC-QTOF-MS) to enable the comprehensive determination of all teicoplanin components without needing pure standards. The workflow comprises three steps...
April 28, 2024: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
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JOURNAL ARTICLE
Sonia Ares-Gómez, Narmeen Mallah, María-Isolina Santiago-Pérez, Jacobo Pardo-Seco, Olaia Pérez-Martínez, María-Teresa Otero-Barrós, Nuria Suárez-Gaiche, Rolf Kramer, Jing Jin, Leticia Platero-Alonso, Rosa-María Alvárez-Gil, Olga-María Ces-Ozores, Victoria Nartallo-Penas, Susana Mirás-Carballal, Marta Piñeiro-Sotelo, Alberto Malvar-Pintos, Juan-Manuel González-Pérez, Carmen Rodríguez-Tenreiro-Sánchez, Irene Rivero-Calle, Antonio Salas, Carmen Durán-Parrondo, Federico Martinón-Torres
BACKGROUND: Galicia (Spain) was one of the first regions worldwide to incorporate nirsevimab for universal respiratory syncytial virus (RSV) prophylaxis in infants into its immunisation programme. The NIRSE-GAL longitudinal population-based study aimed to assess nirsevimab effectiveness in preventing hospitalisations (ie, admittance to hospital). METHODS: The 2023-24 immunisation campaign with nirsevimab in Galicia began on Sept 25, 2023, and concluded on March 31, 2024...
April 30, 2024: Lancet Infectious Diseases
#3
JOURNAL ARTICLE
Sergio Londoño, Juan Carlos Penagos, Diana Díaz, Pedro Cadena, Paula Rodríguez Ordoñez
OBJECTIVE: To present the baseline clinical and demographic characteristics of CRSwNP patients over the age of 18 enrolled in a Patient Support Program (PSP) prior to biologic treatment. METHODS: Descriptive, cross-sectional study performed in a Colombian CRSwNP asthma PSP sponsored by Sanofi from Aug-2021 to Jul-2022. Data was collected from CRSwNP patients, prior to the start of Dupilumab treatment, who consented to the use of their data. The following information was reported: Age, reporting city, treating medical specialty, comorbidities, and persistence of treatment...
February 1, 2024: Revista Alergia Mexico: Organo Oficial de la Sociedad Mexicana de Alergia e Inmunología, A.C
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JOURNAL ARTICLE
Elizabeth O'Donnell, Clifton Mo, Andrew J Yee, Omar Nadeem, Jacob Laubach, Jacalyn Rosenblatt, Nikhil Munshi, Shonali Midha, Diana Cirstea, Pavlina Chrysafi, Nora Horick, Paul G Richardson, Noopur Raje
BACKGROUND: Isatuximab is a CD38 monoclonal antibody approved for relapsed or refractory multiple myeloma. We aimed to evaluate the addition of isatuximab to weekly carfilzomib (K), lenalidomide (R), and dexamethasone (d; Isa-KRd) in transplant-eligible patients with newly diagnosed multiple myeloma and stratified maintenance by cytogenetic risk. METHODS: This single-arm phase 2 trial was done at three cancer centres (two hospitals and a cancer institute) in Boston (MA, USA)...
April 24, 2024: Lancet Haematology
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JOURNAL ARTICLE
Jennifer P Collins, Samuel J Crowe, Ismael R Ortega-Sanchez, Lynn Bahta, Doug Campos-Outcalt, Jamie Loehr, Rebecca L Morgan, Katherine A Poehling, Lucy A McNamara
Meningococcal disease is a life-threatening invasive infection caused by Neisseria meningitidis. Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer Inc.]), are licensed and available in the United States and have been recommended by CDC's Advisory Committee on Immunization Practices (ACIP). On October 20, 2023, the Food and Drug Administration approved the use of a pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp [Penbraya, Pfizer Inc...
April 18, 2024: MMWR. Morbidity and Mortality Weekly Report
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JOURNAL ARTICLE
Sedera Mioramalala, Lara Mroueh, Pierre-Emile Bruand, Mbolatiana Michèle Raharinivo, Roger Marie Rafanomezantsoa, Daniel Gérard, Arsène Ratsimbasoa, Pierre-Marie Preux, Farid Boumédiène
BACKGROUND: Despite the high prevalence of mental disorders and epilepsy in low- and middle-income countries, nearly 80% of patients are not treated. In Madagascar, initiatives to improve access to epilepsy and mental health care, including public awareness and training of general practitioners (GPs), were carried out between 2013 and 2018. Our study's main objective was to assess the effectiveness of these initiatives, two to five years post-intervention. METHODS: This quasi-experimental study (intervention vs...
April 10, 2024: Comprehensive Psychiatry
#7
JOURNAL ARTICLE
Freja Cordelia Møller Kirsebom, Nick Andrews, Julia Stowe, Gavin Dabrera, Mary Ramsay, Jamie Lopez Bernal
BACKGROUND: The Sanofi/GSK AS03-adjuvanted (VidPrevtyn Beta) vaccine and the Pfizer-BioNTech mRNA (Comirnaty Original/Omicron BA.4-5) bivalent vaccine were offered to adults aged 75 years and over in England from 3rd April 2023. This is the first time an adjuvanted COVID-19 vaccine has been administered as part of a UK COVID-19 vaccination programme. In clinical trials, antibody levels generated were comparable with mRNA vaccines but there are no real-world data on the effectiveness or duration of protection...
May 2024: EClinicalMedicine
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JOURNAL ARTICLE
Shovan Naskar, Hitesh Harsukhbhai Chandpa, Shalini Agarwal, Jairam Meena
Dengue becomes the most common life-threatening infectious arbovirus disease globally, with prevalence in the tropical and subtropical areas. The major clinical features include dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS), a condition of hypovolemic shock. Four different serotypes of the dengue virus, known as dengue virus serotype (DENV)- 1, 2, 3 and 4 can infect humans. Only one vaccine is available in the market, named Dengvaxia by Sanofi Pasteur, but there is no desired outcome of this treatment due the antibody dependent enhancement (ADE) of the multiple dengue serotypes...
April 13, 2024: Vaccine
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RANDOMIZED CONTROLLED TRIAL
Katerina Rok Song, Ram Hari Chapagain, Dipesh Tamrakar, Rajeev Shrestha, Piush Kanodia, Shipra Chaudhary, T Anh Wartel, Jae Seung Yang, Deok Ryun Kim, Jinae Lee, Eun Lyeong Park, Haeun Cho, Jiyoung Lee, Patchara Thaisrivichai, Sridhar Vemula, Bo Mi Kim, Birendra Gupta, Tarun Saluja, Ruchir Kumar Pansuriya, Ravi Ganapathy, Yeong Ok Baik, Young Jin Lee, Suhi Jeon, Youngran Park, Howard L Her, Youngshin Park, Julia A Lynch
BACKGROUND: In October, 2017, WHO launched a strategy to eliminate cholera by 2030. A primary challenge in meeting this goal is the limited global supply capacity of oral cholera vaccine and the worsening of cholera outbreaks since 2021. To help address the current shortage of oral cholera vaccine, a WHO prequalified oral cholera vaccine, Euvichol-Plus was reformulated by reducing the number of components and inactivation methods. We aimed to evaluate the immunogenicity and safety of Euvichol-S (EuBiologics, Seoul, South Korea) compared with an active control vaccine, Shanchol (Sanofi Healthcare India, Telangana, India) in participants of various ages in Nepal...
May 2024: Lancet Global Health
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JOURNAL ARTICLE
Danah Kamphuis, Rik van Eekelen, Nienke van Welie, Kim Dreyer, Joukje van Rijswijk, Machiel H A van Hooff, Jan Peter de Bruin, Harold R Verhoeve, Femke Mol, Wilhelmina M van Baal, Maaike A F Traas, Arno M van Peperstraten, Arentje P Manger, Judith Gianotten, Cornelia H de Koning, Aafke M H Koning, Neriman Bayram, David P van der Ham, Francisca P J M Vrouenraets, Michaela Kalafusova, Bob I G van de Laar, Jeroen Kaijser, Arjon F Lambeek, Wouter J Meijer, Frank J M Broekmans, Olivier Valkenburg, Lucy F van der Voet, Jeroen van Disseldorp, Marieke J Lambers, Rachel Tros, Cornelis B Lambalk, Jaap Stoker, Madelon van Wely, Patrick M M Bossuyt, Ben Willem J Mol, Velja Mijatovic
STUDY QUESTION: What are the costs and effects of tubal patency testing by hysterosalpingo-foam sonography (HyFoSy) compared to hysterosalpingography (HSG) in infertile women during the fertility work-up? SUMMARY ANSWER: During the fertility work-up, clinical management based on the test results of HyFoSy leads to slightly lower, though not statistically significant, live birth rates, at lower costs, compared to management based on HSG results. WHAT IS KNOWN ALREADY: Traditionally, tubal patency testing during the fertility work-up is performed by HSG...
April 10, 2024: Human Reproduction
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JOURNAL ARTICLE
Paul Gougis, Floriane Jochum, Baptiste Abbar, Elise Dumas, Kevin Bihan, Bénédicte Lebrun-Vignes, Javid Moslehi, Jean-Philippe Spano, Enora Laas, Judicael Hotton, Fabien Reyal, Anne-Sophie Hamy, Joe-Elie Salem
BACKGROUND: Immune-checkpoint inhibitors (ICI) have revolutionized cancer treatment by harnessing the immune system but ICI can induce life-threatening immune-related adverse events (irAE) affecting every organ. METHODS: We extracted irAE from VigiBase, the international pharmacovigilance database, first reported in 2008 until 01/2023 to characterize irAE reporting trends, clinical features, risk factors and outcomes. FINDINGS: We distinguished 25 types of irAE (n = 50,347cases, single irAE/case in 84...
April 2024: EClinicalMedicine
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JOURNAL ARTICLE
Jan Biegus, Leszek Szenborn, Robert Zymliński, Michał Zakliczyński, Krzysztof Reczuch, Mateusz Guzik, Szymon Urban, Marta Rosiek-Biegus, Berenika Jankowiak, Gracjan Iwanek, Marat Fudim, Piotr Ponikowski
The safety of simultaneous vaccination for Respiratory Syncytial Virus (RSV) and influenza in vulnerable high-risk heart failure (HF) patients remains unclear. In an open-label, prospective study, 105 patients received concurrent influenza (Vaxigrip Tetra, season 2023/2024, Sanofi) and RSV (Arexvy, GSK) vaccinations from September 15th to November 17th, 2023. Adverse events were collected on the fourth-day post-vaccination. Overall, the vaccination was well tolerated, with the most common reaction being injection site pain (63 %)...
March 25, 2024: Vaccine
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JOURNAL ARTICLE
Niklas Dyrby Johansen, Muthiah Vaduganathan, Ankeet S Bhatt, Simin Gharib Lee, Daniel Modin, Brian L Claggett, Erica L Dueger, Sandrine Samson, Matthew M Loiacono, Rebecca C Harris, Lars Køber, Scott D Solomon, Pradeesh Sivapalan, Jens Ulrik Stæhr Jensen, Cyril Jean-Marie Martel, Tyra Grove Krause, Tor Biering-Sørensen
BACKGROUND: In the NUDGE-FLU (Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake) trial, electronic letters incorporating cardiovascular (CV) gain-framing and repeated messaging increased influenza vaccination by approximately 1 percentage point. OBJECTIVE: To evaluate the effects of the successful nudging interventions on downstream clinical outcomes. DESIGN: Prespecified exploratory analysis of a nationwide randomized implementation trial...
March 19, 2024: Annals of Internal Medicine
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JOURNAL ARTICLE
Caro Minschart, Nele Myngheer, Toon Maes, Christophe De Block, Inge Van Pottelbergh, Pascale Abrams, Wouter Vinck, Liesbeth Leuridan, Sabien Driessens, Chantal Mathieu, Jaak Billen, Christophe Matthys, Annouschka Laenen, Annick Bogaerts, Katrien Benhalima
BACKGROUND: Women with glucose intolerance after gestational diabetes mellitus (GDM) are at high risk to develop type 2 diabetes. Traditional lifestyle interventions in early postpartum have limited impact. We investigated the efficacy of a blended mobile-based lifestyle intervention in women with glucose intolerance after a recent history of GDM. METHODS: Prospective, double-arm, non-masked, multicentre randomised controlled trial (RCT) in which women with glucose intolerance, diagnosed 6-16 weeks after a GDM-complicated pregnancy, were assigned 1:1 to a one-year blended-care, telephone- and mobile-based lifestyle program (intervention) or usual care (control)...
April 2024: EClinicalMedicine
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JOURNAL ARTICLE
Samuel Coster, Ali Shammout, Michael Chaney, Kyra Folkert, Kent Grosh, Saad Shebrain, Gitonga Munene
This study examines the safety and efficacy of using peak anti-Xa levels to achieve prophylactic enoxaparin (Lovenox, Sanofi-Aventis) levels in patients who underwent hepatic surgery. Prospectively enrolled patients undergoing major and minor hepatic procedures received postoperative enoxaparin dosing. The enoxaparin dose was adjusted to attain a peak anti-Xa level ≥ 0.20 U/ml. This group was compared to a historical cohort of patients who underwent similar procedures and received standard postoperative VTE chemoprophylaxis dosing...
March 15, 2024: American Surgeon
#16
JOURNAL ARTICLE
Conrad Safranek, Christina Liu, Rhys Richmond, Trinithas Boyi, Ryan Rimmer, R Peter Manes
OBJECTIVE: The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. STUDY DESIGN: An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database...
March 15, 2024: Otolaryngology—Head and Neck Surgery
#17
REVIEW
Howard Balbi
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections in people of all ages and is the leading cause of hospitalization among infants in the United States. The year 2023 was exciting for RSV prevention. The Food and Drug Administration (FDA) approved 3 new tools for preventing severe lower respiratory tract RSV infections in infants, young children, and elderly persons. In May 2023, the FDA approved 2 vaccines, RSVpreF3 (Arexvy™, GSK) and RSVpreF (Abrysvo™, Pfizer), for adults ages 60 years or older to be given as a single-dose intramuscular injection...
March 2024: Pediatric Allergy, Immunology, and Pulmonology
#18
JOURNAL ARTICLE
Karlijn Verkerk, Birgit S Geurts, Laurien J Zeverijn, Vincent van der Noort, Henk M W Verheul, John B A G Haanen, Astrid A M van der Veldt, Ferry A L M Eskens, Maureen J B Aarts, Carla M L van Herpen, Mathilde Jalving, Jourik A Gietema, Lot A Devriese, Mariette Labots, Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, Egbert F Smit, Haiko J Bloemendal
BACKGROUND: The DRUG Access Protocol provides patients with cancer access to registered anti-cancer drugs that are awaiting reimbursement in the Netherlands and simultaneously collects prospective real-world data (RWD). Here, we present RWD from PD-1 blocker cemiplimab in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (laCSCC; mCSCC). METHODS: Patients with laCSCC or mCSCC received cemiplimab 350 mg fixed dose every three weeks...
April 2024: The Lancet regional health. Europe
#19
JOURNAL ARTICLE
Davood Yadegarynia, Amirreza Keyvanfar, Hossein Keyvani, Shabnam Tehrani, Shahnaz Sali, Sara Abolghasemi
BACKGROUND: This study aimed to evaluate the non-inferiority of the FluGuard (a quadrivalent recombinant vaccine manufactured by Nivad Pharmed Salamat Company in Iran) by comparing its immunogenicity and safety with Vaxigrip Tetra (a quadrivalent inactivated vaccine manufactured by Sanofi Pasteur in France). MATERIALS AND METHODS: In this double-blind, randomized controlled trial, eligible volunteers aged 18-60 were randomized to receive either FluGuard or Vaxigrip Tetra vaccines...
February 29, 2024: Vaccine
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JOURNAL ARTICLE
A R Jones, J Enticott, P R Ebeling, G D Mishra, H T Teede, A J Vincent
STUDY QUESTION: What is the frequency of, and predictors for, osteoporosis, fractures, and osteoporosis management (investigation, treatment) in women with premature ovarian insufficiency (POI; menopause <40 years) and early menopause (EM; menopause 40-44years)? SUMMARY ANSWER: Over the 23-year follow-up duration, at a mean age of 68 years, women with POI/EM had higher osteoporosis/fracture risk and prevalence, higher osteoporosis screening and anti-osteoporosis medication use compared to women with usual age menopause; increasing age was predictive of increased risk of osteoporosis/fracture and menopause hormone therapy (MHT) prior to or at study entry (aged 45-50 years) was protective...
February 23, 2024: Human Reproduction
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