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JOURNAL ARTICLE
Asanthi M Ratnasekera, Sirivan S Seng, Daniel Kim, Wenyan Ji, Christina L Jacovides, Elinore J Kaufman, Hannah M Sadek, Lindsey L Perea, Christina Monaco Poloni, Ilya Shnaydman, Alexandra Jeongyoon Lee, Victoria Sharp, Angela Miciura, Eric Trevizo, Martin G Rosenthal, Lawrence Lottenberg, William Zhao, Alicia Keininger, Michele Hunt, John Cull, Chassidy Balentine, Tanya Egodage, Aleem T Mohamed, Michelle Kincaid, Stephanie Doris, Robert Cotterman, Sara Seegert, Lewis E Jacobson, Jamie Williams, Melissa Moncrief, Brandi Palmer, Caleb Mentzer, Nichole Tackett, Tjasa Hranjec, Thomas Dougherty, Shawna Morrissey, Lauren Donatelli-Seyler, Amy Rushing, Leah C Tatebe, Tiffany J Nevill, Michel B Aboutanos, David Hamilton, Diane Redmond, Daniel C Cullinane, Carolyne Falank, Mark McMellen, Chris Duran, Jennifer Daniels, Shana Ballow, Kevin M Schuster, Paula Ferrada
BACKGROUND: In patients with severe traumatic brain injury (TBI), clinicians must balance preventing venous thromboembolism (VTE) with the risk of intracranial hemorrhagic expansion (ICHE). We hypothesized that low molecular weight heparin (LMWH) would not increase risk of ICHE or VTE as compared to unfractionated heparin (UH) in patients with severe TBI. METHODS: Patients ≥ 18 years of age with isolated severe TBI (AIS ≥ 3), admitted to 24 level I and II trauma centers between January 1, 2014 to December 31, 2020 and who received subcutaneous UH and LMWH injections for chemical venous thromboembolism prophylaxis (VTEP) were included...
April 9, 2024: Injury
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JOURNAL ARTICLE
Piers Klein, Liqi Shu, Erik Lindgren, Maria A de Winter, James E Siegler, Alexis N Simpkins, Satareh Salehi Omran, Mirjam R Heldner, Adam de Havenon, Mohamad Abdalkader, Sami Al Kasab, Christoph Stretz, Teddy Y Wu, Duncan Wilson, Syed Daniyal Asad, Eyad Almallouhi, Jennifer Frontera, Lindsey Kuohn, Aaron Rothstein, Ekaterina Bakradze, Nils Henninger, Adeel S Zubair, Richa Sharma, Deborah Kerrigan, Yasmin Aziz, Eva A Mistry, Mayte Sanchez van Kammen, Turgut Tatlisumak, Katarzyna Krzywicka, Diana Aguiar de Sousa, Katarina Jood, Thalia S Field, Shadi Yaghi, Jonathan M Coutinho, Thanh N Nguyen
OBJECTIVES: Prognostication for cerebral venous thrombosis (CVT) remains difficult. We sought to validate the SI2 NCAL2 C score in an international cohort. MATERIALS AND METHODS: The SI2 NCAL2 C score was originally developed to predict poor outcome (modified Rankin Scale (mRS) 3-6) at 6 months, and mortality at 30 days and 1 year using data from the International CVT Consortium. The SI2 NCAL2 C score uses 9 variables: the absence of any female-sex-specific risk factors, intracerebral hemorrhage, central nervous system infection, focal neurological deficits, coma, age, lower level of hemoglobin, higher level of glucose, and cancer...
April 11, 2024: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
#3
JOURNAL ARTICLE
Tianyu Liang, Sen Xu, Renyang Liu, Xiaoping Xia
BACKGROUND: Intracerebral hemorrhage (ICH) comprises primary and secondary injuries, the latter of which induces increased inflammation and apoptosis and is more severe. Activating transcription factor 6 (ATF6) is a type-II transmembrane protein in the endoplasmic reticulum (ER). ATF6 target genes could improve ER homeostasis, which contributes to cryoprotection. Hence, we predict that ATF6 will have a protective effect on brain tissue after ICH. METHOD: The ICH rat model was generated through autologous blood injection into the right basal ganglia, the expression of ATF6 after ICH was determined by WB and IF...
April 10, 2024: Aging
#4
JOURNAL ARTICLE
Chirag Ojha, Pankaj Sharma, Vinay Jain
This research aims to develop and assess the anti-arthritic properties of a topically herbal gel including leaf extracts from Cardiospermum halicacabum and Ricinus communis L . in rats. Utilizing gelling agents carbopol 940 (2.5, 5, 7.5 g), nine herbal gel compositions were created. Prepared formulations were then assessed for physical appearance, spreadability, viscosity, net content, pH, extrudability, in vitro diffusion profile, and main skin irritant tests. According to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) recommendations, the stability research for the topical herbal gel composition was completed, and Freund's Complete Adjuvant (FCA) induced arthritis technique was used to assess the anti-arthritic efficacy...
April 13, 2024: Journal of Biomaterials Science. Polymer Edition
#5
Xinyu Yang, Xiaolong Tang, Guangyu Jia, Ye Wang, Li Yang, Yuanyuan Li, Miaojing Wu, Zhe Zhang, Yamei Yu, Yao Xiao, Xingen Zhu, Shiyong Li
No abstract text is available yet for this article.
April 13, 2024: ACS Applied Materials & Interfaces
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JOURNAL ARTICLE
Tsveta Sarafska, Stanislava Ivanova, Todor Dudev, Christo Tzachev, Vesselin Petrov, Tony Spassov
The ability of β-CD to form inclusion complexes with ibuprofen (IBU) and at the same time to make a two-phase system with citric acid was explored in the present study for achieving improved solubility and dissolution rate of IBU. Mechanical milling as well as mechanical milling combined with thermal annealing of the powder mixtures were applied as synthetic methods. Solubility and dissolution kinetics of the complexes were studied in compliance with European Pharmacopoeia (ICH Q4B). β-CD and citric acid (CA) molecules were shown to interact by both ball milling (BM), thermal annealing, as well as BM with subsequent annealing...
April 6, 2024: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
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JOURNAL ARTICLE
Alexandrina Mateeva, Magdalena Kondeva-Burdina, Emilio Mateev, Paraskev Nedialkov, Karolina Lyubomirova, Lily Peikova, Maya Georgieva, Alexander Zlatkov
In the current study, chromatographic and in silico techniques were applied to investigate the biotransformation of ethyl 5-(4-bromophenyl)-1-(2-(2-(2-hydroxybenzylidene) hydrazinyl)-2-oxoethyl)-2-methyl-1 H -pyrrole-3-carboxylate ( 11b ) in hepatocytic media. The initial chromatographic procedure was based on the employment of the conventional octadecyl stationary phase method for estimation of the chemical stability. Subsequently, a novel and rapid chromatographic approach based on a phenyl-hexyl column was developed, aiming to separate the possible metabolites...
March 26, 2024: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
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JOURNAL ARTICLE
Tommaso Bucci, Francesco Del Sole, Danilo Menichelli, Gioacchino Galardo, Flavio Giuseppe Biccirè, Alessio Farcomeni, Gregory Y H Lip, Pasquale Pignatelli, Daniele Pastori
Objectives : To review the evidence on the effectiveness and safety of low-dose-rivaroxaban 2.5 mg twice daily (LDR) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD) taking antiplatelets. Methods : We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Efficacy endpoints were cardiovascular events (CVEs), myocardial infarction, stroke, all-cause, and cardiovascular death. Any, major, fatal bleeding, and intracranial hemorrhage (ICH) were safety endpoints...
March 31, 2024: Journal of Clinical Medicine
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JOURNAL ARTICLE
Mariangela Piano, Olav Jansen, Gaultier Marnat, Benjamin Gory, Hannes Nordmeyer, Bernd Eckert, Alessandro Pedicelli, Christophe Cognard, Christian Loehr, Matteo Zanoni, Axel Schaefer, Antonio Macera, Jens Fiehler, Karen Doyle, Kyriakos Lobotesis
BACKGROUND: A direct aspiration first pass technique (ADAPT) is an effective alternative to stent retriever thrombectomy for patients with large vessel occlusion (LVO). The PERFECT study evaluated direct aspiration with the EMBOVAC large bore aspiration catheter in patients with LVO strokes. METHODS: PERFECT was a prospective, post-market, single-arm, multicenter, observational study of patients enrolled across 11 European centers between October 2020 and July 2022...
April 12, 2024: Journal of Neurointerventional Surgery
#10
JOURNAL ARTICLE
Frank Kohne, Astrid Schwantes
This session deals with the rational design of viral clearance studies for biopharmaceuticals including recombinant proteins such as monoclonal antibodies and, as new in scope of the symposium, also viral clearance for adeno-associated viral (AAV) vectors. For recombinant proteins, large datasets were accumulated over the last decades and are intended to be used for accelerated product process development and streamlining of viral clearance studies. How to utilize prior knowledge in viral clearance validation and how it can be used in a risk assessment tool to decide whether additional virus clearance studies are necessary during product development is being addressed by three of the presentations of this session...
2024: PDA Journal of Pharmaceutical Science and Technology
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JOURNAL ARTICLE
David Roush, Glen Bolton
The 2023 Viral Clearance Symposium (VCS) was hosted by Takeda on 24 and 25 May 2023 in Vienna, Austria. The present conference extended the structure of the previous biennial symposia held between 2009 and 2019. As recapitulated in the introductory session, the genesis of the VCS, as described in the Proceedings of the 2009 VCS was "the worldwide regulatory and industry recognition that challenges, gaps, and opportunities exist, that it formally addressed could benefit the field as whole." This report provides a synopsis of the progress achieved at the conference resulting from detailed technical discussions and the pending questions that still require attention to address...
2024: PDA Journal of Pharmaceutical Science and Technology
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JOURNAL ARTICLE
Thomas R Kreil
At the time of the 2023 Viral Clearance Symposium in Vienna, the ongoing revision of ICH Guideline Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin clearly was the dominant regulatory topic. At the symposium, the changes expected for Q5A(R2) to mirror advances of scientific knowledge, for example, the inclusion of new products, including viral-vector-derived ones, that can be subject to virus clearance, deliberations around continuous manufacturing processes, the use of prior knowledge to supplement or in part replace virus validation studies, and new molecular methods for detection of adventitious viruses, were discussed by a European and a US regulator as well as representatives from industry associations that had been involved with the drafting process...
2024: PDA Journal of Pharmaceutical Science and Technology
#13
JOURNAL ARTICLE
Johanna Kindermann, Thomas R Kreil
The Cell Banks, Advanced Technologies (ATMPs, NGS) session at the 2023 Viral Clearance Symposium (VCS) focused on the assurance of high virus safety profiles of advanced technology medicinal products (ATMPs) by implementation of advanced virus detection methods using rapid and sensitive technologies, such as next-generation sequencing (NGS). All presentations in this session made the need to replace in vivo testing for viruses by new technologies that have been demonstrated to be incomparably broad in their detection capabilities and can even detect unknown viruses...
2024: PDA Journal of Pharmaceutical Science and Technology
#14
JOURNAL ARTICLE
Liang Cao, Wenjun Pi, Yi Zhang, Leiluo Yang, Qing Li, V Wee Yong, Mengzhou Xue
The evidence supports a strong link between immune cells and intracerebral hemorrhage (ICH). Nonetheless, the specific cause-and-effect associations between immune cells and ICH remain indeterminate. Here, our primary investigation compared immune cell infiltration in the ICH and sham groups using the GSE24265 dataset. Afterward, we extensively examined the relationship between immune cells and ICH by applying a two-sample Mendelian randomization (MR) analysis to identify the particular immune cells that may be associated with the initiation and advancement of ICH...
April 11, 2024: International Immunopharmacology
#15
JOURNAL ARTICLE
Masashi Fujino, Teruo Noguchi, Takako Torii-Yoshimura, Yoshinori Okuno, Yoshiaki Morita, Kunihiro Nishimura, Fumiyuki Otsuka, Yu Kataoka, Yasuhide Asaumi, Hiroshi Yamagami, Satoshi Yasuda
INTRODUCTION: Cerebral microbleeds (CMBs) on brain magnetic resonance imaging (MRI) are predictive of intracerebral hemorrhage (ICH). However, the risk of ICH in patients with CMBs who undergo percutaneous coronary intervention (PCI) while receiving dual antiplatelet therapy (DAPT) is unclear. MATERIALS AND METHODS: We conducted a study on 329 consecutive patients with coronary artery disease who underwent PCI and were evaluated using a 3T MRI scanner. Based on T2*-weighted imaging, patients were classified into three groups: no CMBs, < 5 CMBs, or ≥ 5 CMBs...
April 12, 2024: Heart and Vessels
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REVIEW
Amrou Sarraj, Deep K Pujara, Bruce Cv Campbell
Stroke is the chief differential diagnosis in patient presenting to the emergency room with abrupt onset focal neurological deficits. Neuroimaging, including non-contrast computed tomography (CT), magnetic resonance imaging (MRI), vascular and perfusion imaging, is a cornerstone in the diagnosis and treatment decision-making. This review examines the current state of evidence behind the different imaging paradigms for acute ischemic stroke diagnosis and treatment, including current recommendations from the guidelines...
April 12, 2024: Annals of Neurology
#17
JOURNAL ARTICLE
Yasmin N Aziz, Heidi Sucharew, Mathew J Reeves, Joseph P Broderick
BACKGROUND: We performed a review of acute stroke trials to determine features associated with premature termination of trial enrollment, defined by the authors as not meeting preplanned sample size. METHODS AND RESULTS: MEDLINE was searched for randomized clinical stroke trials published in 9 major clinical journals between 2013 and 2022. We included randomized clinical trials that were phase 2 or 3 with a preplanned sample size ≥100 and a time-to-treatment within 24 hours of onset for transient ischemic attack, ischemic stroke, or intracerebral hemorrhage...
April 12, 2024: Journal of the American Heart Association
#18
JOURNAL ARTICLE
Jia-Yuan Zhang, Zhang-Song Yan, Xiu-Juan Sun, Yong-Ze Liu, Yan-Ke Yin, Ming-Huan Su, Qiu-Ling Li, Ying-Chang Mi, Da-Peng Li
Objectives This study aimed to identify the association between lactate dehydrogenase (LDH) levels and 30-day mortality in patients with intracranial hemorrhage (ICH) with acute leukemia during the induction phase. Methods This cohort study included patients with acute leukemia with ICH during induction. We evaluated serum LDH levels upon admission. Multivariable Cox regression analyzed the LDH 30-day mortality association. Interaction and stratified analyses based on factors like age, sex, albumin, white blood cell count, hemoglobin level, and platelet count were conducted...
June 2024: Global medical genetics
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Sayaka Ito, Yoshinori Maki, Kazushi Higuchi
Scuba diving has become a common and popular activity, and adverse events can occur following this activity. Among those events, intracranial hemorrhage is very rare, and only intracerebral hemorrhage and subarachnoid hemorrhage are reported. However, the occurrence of chronic subdural hematoma (CSDH), possibly as an adverse event following scuba diving, has not been described. A 49-year-old man with no significant medical history visited our hospital complaining of memory disturbance and aphasia. He had experienced a minor head trauma five months before and had gone scuba diving six times between the traumatic episode and the visit to our hospital...
March 2024: Curēus
#20
JOURNAL ARTICLE
Hany A Batakoushy, Hani M Hafez, Marwa M Soliman, Tahany F Mohamed, Amal B Ahmed, Mohamed A El Hamd
In the present study, a first validated and green spectrofluorimetric approach for its assessment and evaluation in different matrices was investigated. After using an excitation wavelength of 345 nm, Roxadustat (ROX) demonstrates a highly native fluorescence at an emission of 410 nm. The influences of experimental factors such as pH, diluting solvents, and different organized media were tested, and the most appropriate solvent choice was ethanol. It was confirmed that there was a linear relationship between the concentration of ROX and the relative fluorescence intensity in the range 60...
April 2024: Luminescence: the Journal of Biological and Chemical Luminescence
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