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Article ; Online: Characterization of Extended-Release Lorazepam: Pharmacokinetic Results Across Phase 1 Clinical Studies.

Mathew, Sanjay J / Jean-Lys, Shedly / Phull, Rupinder / Yarasani, Rama

2023 Volume 43, Issue 4, Page(s) 350–360

Abstract: Purpose/background: Once-daily extended-release (ER) lorazepam was developed to reduce fluctuations in plasma levels compared with lorazepam immediate-release (IR) for short-term anxiety relief. Here we report a series of phase 1 randomized, open-label, ...

Abstract	Purpose/background: Once-daily extended-release (ER) lorazepam was developed to reduce fluctuations in plasma levels compared with lorazepam immediate-release (IR) for short-term anxiety relief. Here we report a series of phase 1 randomized, open-label, multiperiod crossover studies characterizing ER lorazepam pharmacokinetics and safety in healthy adults. Methods/procedures: These phase 1 studies assessed the pharmacokinetics of ER lorazepam administered: (study 1) 3 mg once daily versus IR lorazepam 1 mg 3 times a day (TID; every 8 hours), (study 2) with or without food, and (study 3) intact versus sprinkled onto food. Study 3 further evaluated the proportionality of 1 × 4- versus 4 × 1-mg doses. Safety was also monitored. Findings/results: There were 43, 27, and 29 subjects who completed studies 1, 2, and 3, respectively. The 90% confidence intervals for Cmax,SS , Cmin , and AUC TAU,SS of once-daily ER lorazepam compared with IR given TID were within 80% to 125% limits establishing steady-state bioequivalence. Maximum mean lorazepam concentrations were achieved at 11 hours compared with 1 hour after dosing for ER versus IR lorazepam, respectively. Pharmacokinetic parameters ( Cmax , AUC last or AUC 0- t , AUC inf or AUC 0-inf ) of ER lorazepam were bioequivalent whether taken with or without food, administered intact or sprinkled onto food, or administered as intact 1 × 4- versus 4 × 1-mg capsules. No serious safety concerns were found. Implications/conclusions: Once-daily ER lorazepam provided a pharmacokinetic profile bioequivalent to IR lorazepam given TID and was well tolerated in healthy adults across all phase 1 studies. These data suggest that ER lorazepam could be an alternative for patients currently treated with IR lorazepam.
MeSH term(s)	Adult ; Humans ; Lorazepam/adverse effects ; Delayed-Action Preparations ; Cross-Over Studies ; Area Under Curve
Chemical Substances	Lorazepam (O26FZP769L) ; Delayed-Action Preparations
Language	English
Publishing date	2023-06-19
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	604631-9
ISSN	1533-712X ; 0271-0749
ISSN (online)	1533-712X
ISSN	0271-0749
DOI	10.1097/JCP.0000000000001715
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Article: Impact of Foliar Fungicide Application on the Culturable Fungal Endophyte Community of Soybean Seed in the Midwest United States.

Batzer, Jean Carlson / Shirazi, Amin / Lawson, Maia / Mathew, Febina M / Sureshbabu, Bijula M / Smith, Damon L / Mueller, Daren S

Plant disease

2024 Volume 108, Issue 3, Page(s) 647–657

Abstract: The purpose of our study was to determine whether the application of quinone outside inhibitor (QoI) and pyrazole-carboxamide fungicides as a tank mix would impact the endophyte community of soybean seed. Field trials during 2018 in Iowa, South Dakota, ... ...

Abstract	The purpose of our study was to determine whether the application of quinone outside inhibitor (QoI) and pyrazole-carboxamide fungicides as a tank mix would impact the endophyte community of soybean seed. Field trials during 2018 in Iowa, South Dakota, and Wisconsin, U.S.A., investigated the impact of a single combination fungicide spray at early pod set in soybeans. The composition of culturable endophytic fungi in mature soybean seed was assessed on three cultivars per state, with maturity groups (MGs) ranging from 1.1 to 4.7. An unusually wet 2018 season delayed harvest, which led to a high level of fungal growth in grain. The survey included 1,080 asymptomatic seeds that were disinfested and individually placed on 5-cm-diameter Petri plates of acidified water agar. The survey yielded 721 fungal isolates belonging to 24 putative species in seven genera; taxa were grouped into genera based on a combination of morphological and molecular evidence. The dominant genera encountered in the survey were
MeSH term(s)	United States ; Fungicides, Industrial/pharmacology ; Glycine max ; Endophytes ; Alternaria ; Seeds ; Fusarium ; Iowa ; Saccharomycetales
Chemical Substances	Fungicides, Industrial
Language	English
Publishing date	2024-03-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	754182-x
ISSN	0191-2917
ISSN	0191-2917
DOI	10.1094/PDIS-06-23-1122-RE
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Article ; Online: The effect of changing to Bictegravir on lipids using real world data: A brief report.

Heseltine, Thomas / Hughes, Elen / Mathew, Jean / Murray, Scott / Khoo, Saye

Journal of clinical pharmacy and therapeutics

2022

Abstract: What is known and objective: Cardiovascular disease is of increasing concern in patients living with HIV. The significant advancement in antiretroviral treatment has ensured that patients are now succumbing to traditional diseases of ageing. First ... ...

Abstract	What is known and objective: Cardiovascular disease is of increasing concern in patients living with HIV. The significant advancement in antiretroviral treatment has ensured that patients are now succumbing to traditional diseases of ageing. First generation antiretroviral therapy caused multiple side effects including significant dyslipidaemia. Despite the advancement and improving safety profile of treatment concerns remain about antiretroviral induced dyslipidaemia. We sought to investigate the real-world effect on lipids in patients switching to a Bictegravir based regime. Methods: We conducted a retrospective analysis in patients switching therapy to Biktarvy at the Royal Liverpool University Hospital. Data was collected from the HIV database that is established for clinical use, as an electronic patient record, and audit purposes. Lipid data was cross checked with the Trust electronic reporting system. Participants were included if they were HIV-positive, >18 years and had switched to Biktarvy Patients were also required to have a lipid profile available 52 weeks prior to switching and 100 weeks post switching. Summary statistic were calculated and multiple regressions models were constructed to assess the independent predictors of lipid change. We also performed one way analysis of covariance (ANCOVA) to assess the impact of switching therapy on each quartile of the baseline lipid panel. Results and discussion: There were 135 patients included in the analysis with a mean age of 47. The majority of the population were male (80%). At a mean follow up of 42 weeks post switch there was no significant difference in total cholesterol (p = 0.64), triglyceride (p = 0.64) or high density lipoprotein (HDL) cholesterol (p = 0.08). In the regression analysis the highest quartile of baseline total cholesterol and triglyceride were independently associated with improvement in lipid markers. Switching from protease inhibitor therapy was also significantly associated with improvement in triglyceride. In addition, the ANCVOA demonstrated that the highest quartiles of total cholesterol, triglyceride and the lowest quartile of HDL were associated with significant improvement in lipid markers after switching to Bictegravir. What is new and conclusion: We demonstrated that patients with the most adverse lipid profiles at baseline had significant improvements in lipid profiles. In addition, patient switching away from protease inhibitor therapy also had significant improvements in triglyceride.
Language	English
Publishing date	2022-11-02
Publishing country	England
Document type	Journal Article
ZDB-ID	639006-7
ISSN	1365-2710 ; 0269-4727
ISSN (online)	1365-2710
ISSN	0269-4727
DOI	10.1111/jcpt.13789
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Zs.A 1313: Show issues

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Article ; Online: Mortality in individuals with COPD on long-term home non-invasive ventilation.

Cherian, Mathew / Adam, Veronique / Ross, Bryan / Bourbeau, Jean / Kaminska, Marta

Respiratory medicine

2023 Volume 218, Page(s) 107378

Abstract: Background: Real-world evidence regarding survival of patients with chronic obstructive pulmonary disease (COPD) using chronic non-invasive ventilation (NIV) is scarce.: Research question: How do obesity and other factors relate to mortality in ... ...

Abstract	Background: Real-world evidence regarding survival of patients with chronic obstructive pulmonary disease (COPD) using chronic non-invasive ventilation (NIV) is scarce. Research question: How do obesity and other factors relate to mortality in patients with COPD on chronic NIV? Study design: and Methods: We retrospectively analyzed data from COPD patients enrolled in a home ventilation program between 2014 and 2018. Survival was compared between obese and non-obese groups using the Kaplan-Meier method. Factors associated with mortality were identified using multivariable Cox proportional regression analyses with Least Absolute Selection and Shrinkage Operator (LASSO) regularization. Univariable analyses were also done stratified by obesity. Results: Median survival was 80.0 (95% CI: 71.0-NA) months among obese (n = 205) and 30.0 (95%CI: 19.0-42.0) months in non-obese (n = 61) patients. NIV adherence was high in both groups. Mortality was associated with male gender [HR 1.44], chronic opioids or benzodiazepines use [HR 1.07], home oxygen use [HR 1.82], fixed pressure mode of ventilation [HR 1.55], NIV inspiratory pressure [HR 1.05], and thoracic cancer [HR 1.27]; obesity [HR: 0.43], age [HR 0.99] and NIV expiratory pressure [HR 0.94] were associated with decreased mortality. In the obese, univariable analyses revealed that chest wall disease, thoracic cancer, home oxygen use, FEV Interpretation: Obesity is associated with improved survival in COPD patients highly adherent to NIV. Other factors associated with mortality reflect disease severity and ventilator parameters, with differences between obese and non-obese patients.
MeSH term(s)	Humans ; Male ; Noninvasive Ventilation ; Retrospective Studies ; Pulmonary Disease, Chronic Obstructive/complications ; Obesity/complications ; Neoplasms ; Oxygen ; Respiratory Insufficiency/therapy ; Respiratory Insufficiency/complications
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2023-08-09
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1003348-8
ISSN	1532-3064 ; 0954-6111
ISSN (online)	1532-3064
ISSN	0954-6111
DOI	10.1016/j.rmed.2023.107378
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Article: ER and SOCE Ca

Granzotto, Alberto / McQuade, Amanda / Chadarevian, Jean Paul / Davtyan, Hayk / Sensi, Stefano L / Parker, Ian / Blurton-Jones, Mathew / Smith, Ian

bioRxiv : the preprint server for biology

2024

Abstract: The central nervous system (CNS) is constantly surveilled by microglia, highly motile and dynamic cells deputed to act as the first line of immune defense in the brain and spinal cord. Alterations in the homeostasis of the CNS are detected by microglia ... ...

Abstract	The central nervous system (CNS) is constantly surveilled by microglia, highly motile and dynamic cells deputed to act as the first line of immune defense in the brain and spinal cord. Alterations in the homeostasis of the CNS are detected by microglia that respond by migrating toward the affected area. Understanding the mechanisms controlling directed cell migration of microglia is crucial to dissect their responses to neuroinflammation and injury. We used a combination of pharmacological and genetic approaches to explore the involvement of calcium (Ca
Language	English
Publishing date	2024-01-19
Publishing country	United States
Document type	Preprint
DOI	10.1101/2024.01.18.576126
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Article ; Online: An energy-optimization method to study gel-swelling in confinement.

Joshi, Chaitanya / Giso, Mathew Q / Louf, Jean-François / Datta, Sujit S / Atherton, Timothy J

Soft matter

2023 Volume 19, Issue 37, Page(s) 7184–7191

Abstract: We recast the problem of hydrogel swelling under physical constraints as an energy optimization problem. We apply this approach to compute equilibrium shapes of hydrogel spheres confined within a jammed matrix of rigid beads and interpret the results to ... ...

Abstract	We recast the problem of hydrogel swelling under physical constraints as an energy optimization problem. We apply this approach to compute equilibrium shapes of hydrogel spheres confined within a jammed matrix of rigid beads and interpret the results to determine how confinement modifies the mechanics of swollen hydrogels. In contrast to the unconfined case, we find a spatial separation of strains within the bulk of the hydrogel as the strain becomes localized to an outer region. We also explore the contact mechanics of the gel, finding a transition from Hertzian behavior to non-Hertzian behavior as a function of swelling. Our model, implemented in the
Language	English
Publishing date	2023-09-27
Publishing country	England
Document type	Journal Article
ZDB-ID	2191476-X
ISSN	1744-6848 ; 1744-683X
ISSN (online)	1744-6848
ISSN	1744-683X
DOI	10.1039/d3sm00465a
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Article ; Online: Alcohol and Heart Failure.

Rasoul, Debar / Ajay, Ashwin / Abdullah, Alend / Mathew, Jean / Lee Wei En, Benjamin / Mashida, Knievel / Sankaranarayanan, Rajiv

European cardiology

2023 Volume 18, Page(s) e65

Abstract: Alcohol is the most frequently consumed toxic substance in the world and remains a major global public health issue, with one in three adults consuming it worldwide. Alcohol use is a leading risk factor for disease, contributing to over 60 acute and ... ...

Abstract	Alcohol is the most frequently consumed toxic substance in the world and remains a major global public health issue, with one in three adults consuming it worldwide. Alcohol use is a leading risk factor for disease, contributing to over 60 acute and chronic health conditions, with a particularly complex association with cardiovascular disease. Chronic excessive alcohol consumption is associated with a range of cardiac complications, including decreased myocardial contractility, hypertension, arrhythmias, MI and heart failure. However, low-level alcohol consumption is believed to have a protective effect against ischaemic heart disease and diabetes. In most cohort studies, small to moderate amounts of alcohol consumption have not been linked to heart failure, indicating a threshold effect of alcohol with individual (possibly genetic) predisposition rather than a continuous effect of exposure. This review article explores the potential benefits of alcohol on the heart, the association between alcohol use and alcoholic cardiomyopathy and the epidemiology, clinical correlates and management of alcoholic cardiomyopathy.
Language	English
Publishing date	2023-12-26
Publishing country	England
Document type	Journal Article ; Review
ISSN	1758-3764
ISSN (online)	1758-3764
DOI	10.15420/ecr.2023.12
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Article ; Online: CRISPR generation of CSF1R-G795A human microglia for robust microglia replacement in a chimeric mouse model.

Chadarevian, Jean Paul / Davtyan, Hayk / Lombroso, Sonia I / Bennett, F Chris / Blurton-Jones, Mathew

STAR protocols

2023 Volume 4, Issue 3, Page(s) 102490

Abstract: Chimeric mouse models have recently been developed to study human microglia in vivo. However, widespread engraftment of donor microglia within the adult brain has been challenging. Here, we present a protocol to introduce the G795A point mutation using ... ...

Abstract	Chimeric mouse models have recently been developed to study human microglia in vivo. However, widespread engraftment of donor microglia within the adult brain has been challenging. Here, we present a protocol to introduce the G795A point mutation using CRISPR-Cas9 into the CSF1R locus of human pluripotent stem cells. We also describe an optimized microglial differentiation technique for transplantation into newborn or adult recipients. We then detail pharmacological paradigms to achieve widespread and near-complete engraftment of human microglia. For complete details on the use and execution of this protocol, please refer to Chadarevian et al. (2023).
MeSH term(s)	Adult ; Animals ; Mice ; Infant, Newborn ; Humans ; Microglia ; Brain ; Disease Models, Animal ; Pluripotent Stem Cells ; Point Mutation
Language	English
Publishing date	2023-07-29
Publishing country	United States
Document type	Journal Article
ISSN	2666-1667
ISSN (online)	2666-1667
DOI	10.1016/j.xpro.2023.102490
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Article: A comprehensive, open-source data model for wastewater-based epidemiology.

Therrien, Jean-David / Thomson, Mathew / Sion, Eugen-Sorin / Lee, Ivan / Maere, Thomas / Nicolaï, Niels / Manuel, Douglas G / Vanrolleghem, Peter A

Water science and technology : a journal of the International Association on Water Pollution Research

2024 Volume 89, Issue 1, Page(s) 1–19

Abstract: The recent SARS-COV-2 pandemic has sparked the adoption of wastewater-based epidemiology (WBE) as a low-cost way to monitor the health of populations. In parallel, the pandemic has encouraged researchers to openly share their data to serve the public ... ...

Abstract	The recent SARS-COV-2 pandemic has sparked the adoption of wastewater-based epidemiology (WBE) as a low-cost way to monitor the health of populations. In parallel, the pandemic has encouraged researchers to openly share their data to serve the public better and accelerate science. However, environmental surveillance data are highly dependent on context and are difficult to interpret meaningfully across sites. This paper presents the second iteration of the Public Health Environmental Surveillance Open Data Model (PHES-ODM), an open-source dictionary and set of data tools to enhance the interoperability of environmental surveillance data and enable the storage of contextual (meta)data. The data model describes how to store environmental surveillance program data, metadata about measurements taken on various specimens (water, air, surfaces, sites, populations) and data about measurement protocols. The model provides software tools that support the collection and use of PHES-ODM formatted data, including performing PCR calculations and data validation, recording data into input templates, generating wide tables for analysis, and producing SQL database definitions. Fully open-source and already adopted by institutions in Canada, the European Union, and other countries, the PHES-ODM provides a path forward for creating robust, interoperable, open datasets for environmental public health surveillance for SARS-CoV-2 and beyond.
MeSH term(s)	Wastewater-Based Epidemiological Monitoring ; Environmental Monitoring ; Canada ; Pandemics ; SARS-CoV-2
Language	English
Publishing date	2024-01-12
Publishing country	England
Document type	Journal Article
ZDB-ID	764273-8
ISSN	1996-9732 ; 0273-1223
ISSN (online)	1996-9732
ISSN	0273-1223
DOI	10.2166/wst.2023.409
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Article ; Online: Paliperidone palmitate as model of heat-sensitive drug for long-acting 3D printing application.

Manini, Giuseppe / Benali, Samira / Mathew, Allen / Napolitano, Simone / Raquez, Jean-Marie / Goole, Jonathan

International journal of pharmaceutics

2022 Volume 618, Page(s) 121662

Abstract: In this work, two technologies were used to prepare long-acting implantable dosage forms in the treatment of schizophrenia. Hot-melt extrusion (HME) as well as fused deposition modelling (FDM) were used concomitantly to create personalized 3D printed ... ...

Abstract	In this work, two technologies were used to prepare long-acting implantable dosage forms in the treatment of schizophrenia. Hot-melt extrusion (HME) as well as fused deposition modelling (FDM) were used concomitantly to create personalized 3D printed implants. Different formulations were prepared using an amorphous PLA as matrix polymer and different solid-state plasticizers. Paliperidone palmitate (PP), a heat sensitive drug prescribed in the treatment of schizophrenia was chosen as model drug. After extrusion, different formulations were characterized using DSC and XRD. Then, an in vitro dissolution test was carried out to discriminate the formulation allowing a sustained drug release of PP. The formulation showing a sustained drug release of the drug was 3D printed as an implantable dosage form. By modulating the infill, the release profile was related to the proper design of tailored dosage form and not solely to the solubility of the drug. Indeed, different release profiles were achieved over 90 days using only one formulation. In addition, a stability test was performed on the 3D printed implants for 3 months. The results showed the stability of the amorphous state of PP, independently of the temperature as well as the integrity of the matrix and the drug.
MeSH term(s)	Drug Liberation ; Excipients ; Hot Temperature ; Paliperidone Palmitate ; Printing, Three-Dimensional ; Tablets ; Technology, Pharmaceutical/methods
Chemical Substances	Excipients ; Tablets ; Paliperidone Palmitate (R8P8USM8FR)
Language	English
Publishing date	2022-03-12
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	428962-6
ISSN	1873-3476 ; 0378-5173
ISSN (online)	1873-3476
ISSN	0378-5173
DOI	10.1016/j.ijpharm.2022.121662
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