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10 pages, 687 KiB  
Article
The Prevalence and Prognosis of Cachexia in Patients with Non-Sarcopenic Dysphagia: A Retrospective Cohort Study
by Shingo Kakehi, Hidetaka Wakabayashi, Takako Nagai, Shinta Nishioka, Eri Isono, Yukiko Otsuka, Junki Ninomiya and Ryo Momosaki
Nutrients 2024, 16(17), 2917; https://doi.org/10.3390/nu16172917 - 1 Sep 2024
Viewed by 547
Abstract
The purpose of this study was to assess the prevalence and prognosis of cachexia in patients with non-sarcopenic dysphagia. A retrospective cohort study was conducted using the Japanese sarcopenic dysphagia database. Cachexia was diagnosed using the Asian Working Group for Cachexia criteria, sarcopenia [...] Read more.
The purpose of this study was to assess the prevalence and prognosis of cachexia in patients with non-sarcopenic dysphagia. A retrospective cohort study was conducted using the Japanese sarcopenic dysphagia database. Cachexia was diagnosed using the Asian Working Group for Cachexia criteria, sarcopenia using the Asian Working Group for Sarcopenia 2019 criteria, and malnutrition using the Global Leadership Initiative on Malnutrition criteria. Outcomes were death, swallowing function (Food Intake LEVEL Scale (FILS)), and activities of daily living (Barthel Index (BI)). The mean age of the 175 non-sarcopenic dysphagia patients was 77 (±11) years; 103 (59%) were male, 30 (17%) had cachexia, 133 (76%) had whole-body sarcopenia, and 92 (53%) were malnourished. Of the 30 patients with cachexia, 4 and 11 did not have sarcopenia and malnutrition, respectively. No significant associations were found between cachexia, sarcopenia, and malnutrition. Death was notably higher in the cachexia group (5/30; 17% vs. 2/145; 1%, p = 0.002). Median FILS (7 vs. 8, p = 0.585) and median BI (35 vs. 50, p = 0.469) scores did not show significant differences based on cachexia status. The prevalence of cachexia was 17%, and mortality may be higher with cachexia in non-sarcopenic dysphagia patients. Full article
(This article belongs to the Section Clinical Nutrition)
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8 pages, 554 KiB  
Opinion
Oral Anti-Inflammatory and Symbiotic Effects of Fermented Lingonberry Juice—Potential Benefits in IBD
by Pirjo Pärnänen, Ismo T. Räisänen and Timo Sorsa
Nutrients 2024, 16(17), 2896; https://doi.org/10.3390/nu16172896 - 29 Aug 2024
Viewed by 489
Abstract
Microbial dysbiosis may manifest as inflammation both orally and in the gastrointestinal tract. Altered oral and gut microbiota composition and decreased diversity have been shown in inflammatory bowel disease (IBD) and periodontal disease (PD). Recent studies have verified transmission of oral opportunistic microbes [...] Read more.
Microbial dysbiosis may manifest as inflammation both orally and in the gastrointestinal tract. Altered oral and gut microbiota composition and decreased diversity have been shown in inflammatory bowel disease (IBD) and periodontal disease (PD). Recent studies have verified transmission of oral opportunistic microbes to the gut. Prebiotics, probiotics, or dietary interventions are suggested to alleviate IBD symptoms in addition to medicinal treatment. Lingonberries contain multiple bioactive molecules, phenolics, which have a broad spectrum of effects, including antimicrobial, anti-inflammatory, antioxidant, anti-proteolytic, and anti-cancer properties. An all-natural product, fermented lingonberry juice (FLJ), is discussed as a potential natural anti-inflammatory substance. FLJ has been shown in clinical human trials to promote the growth of oral lactobacilli, and inhibit growth of the opportunistic oral pathogens Candida, Streptococcus mutans, and periodontopathogens, and decrease inflammation, oral destructive proteolysis (aMMP-8), and dental microbial plaque load. Lactobacilli are probiotic and considered also beneficial for gut health. Considering the positive outcome of these oral studies and the fact that FLJ may be swallowed safely, it might be beneficial also for the gut mucosa by balancing the microbiota and reducing proteolytic inflammation. Full article
(This article belongs to the Special Issue Role of Probiotics and Prebiotics in Gut Symbiosis)
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11 pages, 1077 KiB  
Article
Efficacy of a Virtual Reality Rehabilitation Protocol Based on Art Therapy in Patients with Stroke: A Single-Blind Randomized Controlled Trial
by Gaetano Tieri, Marco Iosa, Antonio Fortini, Federica Aghilarre, Federico Gentili, Cristiano Rubeca, Tommaso Mastropietro, Gabriella Antonucci and Roberto De Giorgi
Brain Sci. 2024, 14(9), 863; https://doi.org/10.3390/brainsci14090863 - 27 Aug 2024
Viewed by 577
Abstract
Background: Art therapy has a long history of applications in cognitive and motor rehabilitation. More recently, a growing body of scientific literature has highlighted the potential of virtual reality in neurorehabilitation, though it has focused more on the technology itself than on the [...] Read more.
Background: Art therapy has a long history of applications in cognitive and motor rehabilitation. More recently, a growing body of scientific literature has highlighted the potential of virtual reality in neurorehabilitation, though it has focused more on the technology itself than on the principles adopted in digital scenarios. Methods: This study is a single-blind randomized controlled trial conducted on 40 patients with stroke, comparing conventional therapy (physical therapy for the upper and lower limbs, for posture and balance, cognitive therapy, occupational therapy, speech therapy, and specific therapy for swallowing, bowel, and bladder dysfunctions) to a protocol in which the upper limb physical therapy was substituted with art therapy administered by means of virtual reality exploiting the so-called Michelangelo effect. Results: After 12 sessions, patients in the virtual art therapy group showed a significantly greater improvement in independence in activities of daily living, as assessed by the Barthel Index (interaction of time and group: p = 0.001). Significant differences were also found in terms of upper limb muscle strength (Manual Muscle Test, p < 0.01) and reduction in spasticity (Ashworth scale, p = 0.007) in favor of the experimental group. In the virtual art therapy group, the effectiveness of the intervention was significantly correlated with patient participation (Pittsburgh Rehabilitation Participation Scale: R = 0.41), patient satisfaction (R = 0.60), and the perceived utility of the intervention by the therapist (R = 0.43). Conclusions: These findings support the efficacy of virtual art therapy leveraging the Michelangelo effect. Further studies should also focus on cognitive domains that could benefit from this type of approach. Full article
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21 pages, 7200 KiB  
Systematic Review
Not Every Size Fits All: Surgical Corridors for Clival and Cervical Chordomas—A Systematic Review of the Literature and Illustrative Cases
by Rosario Maugeri, Lapo Bonosi, Lara Brunasso, Roberta Costanzo, Samuele Santi, Francesco Signorelli, Domenico Gerardo Iacopino and Massimiliano Visocchi
J. Clin. Med. 2024, 13(17), 5052; https://doi.org/10.3390/jcm13175052 - 26 Aug 2024
Viewed by 363
Abstract
Introduction. Clival chordomas represent a rare but clinically significant subset of skull base tumors, characterized by a locally aggressive nature and a location in proximity to vital neurovascular structures. Surgical resection, often combined with adjuvant therapies, remains the cornerstone of clival chordoma treatment, [...] Read more.
Introduction. Clival chordomas represent a rare but clinically significant subset of skull base tumors, characterized by a locally aggressive nature and a location in proximity to vital neurovascular structures. Surgical resection, often combined with adjuvant therapies, remains the cornerstone of clival chordoma treatment, and various approaches and techniques have evolved to maximize tumor removal while preserving neurological function. Recent advancements in skull base surgery, imaging, and adjuvant therapies have improved outcomes by reducing morbidity and thus enhancing long-term survival. Methods and Results. We have conducted a systematic review on PubMed/Medline following PRISMA guidelines regarding indications, the extent of resection (EOR), and complication rates. Then, we present three illustrative cases from our personal experience, which started 25 years ago with CVJ instrumentation procedures and 15 years ago with anterior decompressive transmucosal procedures performed with the aid of an operative microscope, an endoscope, and neuroradiological monitoring. Conclusions. Traditionally, the transoral approach (TOA) is the most frequently used corridor for accessing the lower clivus and the anterior craniovertebral junction (CVJ), without the need to mobilize or retract neural structures; however, it is associated with a high rate of complications. The endonasal approach (EEA) provides access to the anterior CVJ as well as to the lower, middle, and superior clivus, decreasing airway and swallowing morbidity, preserving palatal function, decreasing postoperative pain, and reducing the incidence of tracheostomy. The submandibular retropharyngeal approach (SRA) allows unique access to certain cervical chordomas, which is better suited when the lesion is located below the clivus and in the midline. Full article
(This article belongs to the Section Orthopedics)
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12 pages, 2881 KiB  
Article
Esophageal Dysmotility in Multiple System Atrophy: A Retrospective Cross-Sectional Study
by Rumi Ueha, Misaki Koyama, Akiko Seto, Taku Sato, Takao Goto, Kenta Orimo, Jun Mitsui and Tatsuya Yamasoba
J. Clin. Med. 2024, 13(17), 5026; https://doi.org/10.3390/jcm13175026 - 25 Aug 2024
Viewed by 383
Abstract
Background/Objective: Multiple system atrophy (MSA) is often associated with dysphagia and esophageal dysmotility (ED). However, ED in patients with MSA is poorly understood. To assess the relationship between ED, dysphagia, and other clinical findings in such patients and investigate the details of ED [...] Read more.
Background/Objective: Multiple system atrophy (MSA) is often associated with dysphagia and esophageal dysmotility (ED). However, ED in patients with MSA is poorly understood. To assess the relationship between ED, dysphagia, and other clinical findings in such patients and investigate the details of ED in MSA using high-resolution manometry (HRM). Methods: Patients from The University of Tokyo Hospital with MSA who underwent swallowing examinations, esophagography, and HRM between 2017 and 2022 were enrolled. A retrospective chart review of patients’ backgrounds, swallowing function, and esophageal motility was performed. ED was evaluated using the Chicago Classification version 4.0. Results: Seventy-four patients with MSA were identified. The median age was 64 years, 48 patients (65%) were male, and the cerebellar variant type was predominant (69%). Abnormal upper esophageal sphincter (UES) resting pressure was observed in 34 patients (46%) and intraesophageal stasis in 65 (88%). High-severity MSA was a risk factor for developing dysphagia, vocal fold movement impairment, and abnormal UES function (p < 0.05). However, no overt clinical risk factors for ED were identified. Various types of ED were detected using HRM, and ineffective esophageal motility was the most frequent disorder. Conclusions: ED is a common occurrence in patients with MSA. Although a high-severity MSA may be a risk factor for developing dysphagia and vocal fold motion impairment, ED can occur regardless of clinical severity. Since ED is rarely detected based on subjective symptoms, careful evaluation of esophageal motility by esophagography or HRM is warranted in patients with MSA. Full article
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5 pages, 1031 KiB  
Reply
Precision in Practice: Enhancing MI-E Therapy Evaluation for Improved Patient Outcomes, Excluding Speech and Swallowing. Reply to Allen et al. Comment on “Chatwin et al. Waves of Precision: A Practical Guide for Reviewing New Tools to Evaluate Mechanical In-Exsufflation Efficacy in Neuromuscular Disorders. J. Clin. Med. 2024, 13, 2643”
by Michelle Chatwin, Jesus Sancho, Manel Lujan, Tiina Andersen and Joao-Carlos Winck
J. Clin. Med. 2024, 13(17), 4992; https://doi.org/10.3390/jcm13174992 - 23 Aug 2024
Viewed by 255
Abstract
We would like to thank Allen et al [...] Full article
(This article belongs to the Section Pulmonology)
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11 pages, 433 KiB  
Article
Feeding and Nutritional Key Features of Crisponi/Cold-Induced Sweating Syndrome
by Roberta Onesimo, Elisabetta Sforza, Federica Palermo, Valentina Giorgio, Chiara Leoni, Donato Rigante, Valentina Trevisan, Cristiana Agazzi, Domenico Limongelli, Francesco Proli, Eliza Maria Kuczynska, Laura Crisponi, Giangiorgio Crisponi and Giuseppe Zampino
Genes 2024, 15(9), 1109; https://doi.org/10.3390/genes15091109 - 23 Aug 2024
Viewed by 383
Abstract
Feeding difficulties are constantly present in patients with Crisponi/cold-induced sweating syndrome type 1 (CS/CISS1). The aim of our study was to describe their prevalence and evolution from birth to adult age. We performed an observational study at the Department of Life Sciences and [...] Read more.
Feeding difficulties are constantly present in patients with Crisponi/cold-induced sweating syndrome type 1 (CS/CISS1). The aim of our study was to describe their prevalence and evolution from birth to adult age. We performed an observational study at the Department of Life Sciences and Public Health, Rome. Fourteen patients were included in this study (six M; mean age: 18 years; SD: 10.62 years; median age: 15 years; age range: 6–44 years); six were adults (43%). Data on oral motor abilities from birth were collected. Meal duration, presence of swallowing reflex, dysphagia symptoms, difficulty chewing, and drooling management were assessed. At birth, all patients needed enteral feeding. Introduction of solid food was postponed beyond the age of 18 months in 43% of patients. During childhood and adolescence, mealtime was characterized by increased duration (43%) accompanied by fatigue during chewing (43%), food spillage from the nasal cavities (21%), sialorrhea (86%), and poor/reduced appetite (57%). A mature rotatory chewing skill was never achieved. This report expands the phenotype description of CS/CISS1 and also improves the overall management and prevention of complications in this ultra-rare disease. Full article
(This article belongs to the Section Human Genomics and Genetic Diseases)
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14 pages, 627 KiB  
Article
Association between the Intake/Type of Cheese and Cognitive Function in Community-Dwelling Older Women in Japan: A Cross-Sectional Cohort Study
by Takao Suzuki, Yosuke Osuka, Narumi Kojima, Hiroyuki Sasai, Kentaro Nakamura, Chisato Oba, Mayuki Sasaki and Hunkyung Kim
Nutrients 2024, 16(16), 2800; https://doi.org/10.3390/nu16162800 - 22 Aug 2024
Viewed by 576
Abstract
While many studies have described the association between cognitive decline and eating habits, little attention has been paid to its association with cheese intake. In this epidemiological study of 1035 community-dwelling women aged ≥ 65, we investigated the association between intake/type of cheese [...] Read more.
While many studies have described the association between cognitive decline and eating habits, little attention has been paid to its association with cheese intake. In this epidemiological study of 1035 community-dwelling women aged ≥ 65, we investigated the association between intake/type of cheese and cognitive function. The anthropometry, functional ability, and the frequency of food intake, including cheese, were assessed. The mini-mental state examination (MMSE) was used to assess cognitive function, and a score of 20–26 was operationally defined as mild cognitive decline. We found that the MMSE score was significantly different between the presence of cheese intake and not (cheese intake: 28.4 ± 1.9; non-cheese intake: 27.6 ± 2.4) and between those who consumed Camembert cheese and those who did not (Camembert cheese: 28.7 ± 1.4; others: 28.3 ± 2.0). After adjusting for confounders, multiple logistic regression identified four independent variables significantly associated with mild cognitive decline: Camembert cheese intake (odds ratio = 0.448, 95% confidence interval = 0.214–0.936), age, usual walking speed, and repetitive saliva swallowing test scores. Our results, while based on cross-sectional data from Japanese community-dwelling older women, identified the significant inverse association between Camembert cheese intake and mild cognitive decline. Full article
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30 pages, 9109 KiB  
Article
Development and Evaluation of a Dry Emulsion of Ostrich Oil as a Dietary Supplement
by Juthaporn Ponphaiboon, Sontaya Limmatvapirat and Chutima Limmatvapirat
Foods 2024, 13(16), 2570; https://doi.org/10.3390/foods13162570 - 17 Aug 2024
Viewed by 464
Abstract
This study aimed to develop a high-quality dry emulsion incorporating omega-3, 6, and 9 fatty acid-rich ostrich oil for use as a dietary supplement. Extracted from abdominal adipose tissues using a low-temperature wet rendering method, the ostrich oil exhibited antioxidant properties, favorable physicochemical [...] Read more.
This study aimed to develop a high-quality dry emulsion incorporating omega-3, 6, and 9 fatty acid-rich ostrich oil for use as a dietary supplement. Extracted from abdominal adipose tissues using a low-temperature wet rendering method, the ostrich oil exhibited antioxidant properties, favorable physicochemical properties, microbial counts, heavy metal levels, and fatty acid compositions, positioning it as a suitable candidate for an oil-in-water emulsion and subsequent formulation as a dry emulsion. Lecithin was employed as the emulsifier due to its safety and health benefits. The resulting emulsion, comprising 10% w/w lecithin and 10% w/w ostrich oil, was stable, with a droplet size of 3.93 ± 0.11 μm. This liquid emulsion underwent transformation into a dry emulsion to preserve the physicochemical stability of ostrich oil, utilizing Avicel® PH-101 or Aerosil® 200 through a granulation process. Although Aerosil® 200 exhibited superior adsorption, Avicel® PH-101 granules surpassed it in releasing the ostrich oil emulsion. Consequently, Avicel® PH-101 was selected as the preferred adsorbent for formulating the ostrich oil dry emulsion. The dry emulsion, encapsulated with a disintegration time of 3.11 ± 0.14 min for ease of swallowing, maintained microbial loads and heavy metal contents within acceptable limits. Presented as granules containing butylated hydroxytoluene, the dry emulsion showcased robust temperature stability, suggesting the potential incorporation of animal fat into dry emulsions as a promising dietary supplement. Full article
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15 pages, 973 KiB  
Article
Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck®, a Non-Endoscopic Esophageal Cell Collection Device
by Abhisek Ghosal, Suman Verma, Ivy T. Le, Victoria T. Lee, Brian J. deGuzman and Lishan Aklog
Diagnostics 2024, 14(16), 1784; https://doi.org/10.3390/diagnostics14161784 - 15 Aug 2024
Viewed by 866
Abstract
Barrett’s esophagus (BE) is a known precursor to esophageal adenocarcinoma (EAC). Guidelines recommend BE screening in populations with multiple risk factors, for which non-endoscopic esophageal cell collection with biomarker testing is considered as an acceptable alternative to esophagogastroduodenoscopy (EGD). The aim of this [...] Read more.
Barrett’s esophagus (BE) is a known precursor to esophageal adenocarcinoma (EAC). Guidelines recommend BE screening in populations with multiple risk factors, for which non-endoscopic esophageal cell collection with biomarker testing is considered as an acceptable alternative to esophagogastroduodenoscopy (EGD). The aim of this study was to evaluate analytical performance characteristics of EsoGuard® (EG), a DNA methylation biomarker assay, as a laboratory-developed test (LDT) in esophageal samples collected with the swallowable EsoCheck® (EC) device. EG is a next-generation sequencing (NGS) assay that evaluates methylated vimentin (VIM) and cyclin A1 (CCNA1), clinically validated biomarkers for the detection of BE and EAC. The studies were conducted according to standards of College of American Pathology (CAP), Clinical Laboratory Improvement Amendments (CLIA), and New York (NY) state requirements for the analytical validation of molecular assays. Comparison to Sanger sequencing showed that EG was 100% accurate at all 31 CpG sites evaluated by the assay. The analytical sensitivity, specificity, and accuracy of the assay were 89%, 100%, and 96%, respectively. Intra- and inter-assay precision was 100%. The limit of detection (LOD) was 1 in 400 methylated cells, and the reference range was 84%. In summary, EsoGuard demonstrates high analytical accuracy, repeatability, and reproducibility in samples collected using the EsoCheck device. Full article
(This article belongs to the Section Pathology and Molecular Diagnostics)
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12 pages, 1284 KiB  
Article
Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Predictors of Dysphagia Severity and Quality of Life in Nasopharyngeal Cancer Patients after Intensity Modulated Radiotherapy (IMRT)
by Salvatore Cocuzza, Federica Maria Parisi, Corrado Spatola, Ignazio La Mantia, Jerome Rene Lechien, Carlos Chiesa-Estomba, Salvatore Ferlito, Gianluca Albanese, Mario Lentini, Miguel Mayo-Yanez, Nicolas Fakhry, Madalina La Rocca and Antonino Maniaci
J. Clin. Med. 2024, 13(16), 4821; https://doi.org/10.3390/jcm13164821 - 15 Aug 2024
Viewed by 442
Abstract
Background: Patients treated with definitive radiotherapy for nasopharyngeal carcinoma (NPC) develop severe dysphagia, affecting their quality of life. Traditional prognosis biomarkers are insufficient, leading to a search for new predictors like neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). Methods: We retrospectively [...] Read more.
Background: Patients treated with definitive radiotherapy for nasopharyngeal carcinoma (NPC) develop severe dysphagia, affecting their quality of life. Traditional prognosis biomarkers are insufficient, leading to a search for new predictors like neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). Methods: We retrospectively enrolled 44 NPC patients who underwent definitive radiotherapy between 2010 and 2018. EQUATOR and STROBE network guidelines were adopted. Pre-treatment evaluations were conducted, and post-treatment oropharyngeal dysphagia was assessed using the Sydney Swallow Questionnaire (SSQ) and FEES, then assigning a Dysphagia Outcome and Severity Scale (DOSS) level. Patients were divided based on NLR and PLR cut-offs, comparing subjective dysphagia (SSQ) scores and DOSS results at baseline and after a 5-year follow-up. Multiple linear regression was used for analysis. Results: At baseline, the mean NLR was 2.52 ± 1.10, and the PLR was 208.40 ± 94.35. Multivariate analysis indicated NLR and PLR as significant predictors of DOSS outcomes (p < 0.001). Conclusions: Baseline inflammation markers, such as NLR and PLR, may be used to predict dysphagia severity in NPC patients undergoing definitive radiotherapy. These markers could help identify patients at higher risk for severe dysphagia and implement tailored therapeutic and rehabilitative strategies to improve their quality of life. Further studies with larger cohorts are needed to confirm these findings and explore additional prognostic factors for dysphagia outcomes in NPC patients. Full article
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13 pages, 1470 KiB  
Article
Reproductive Success of Tree Swallows at Abandoned Mine Drainage Treatment Ponds
by James S. Kellam, Julianna E. Lott, Anna R. Doelling and Isabella Ladisic
Birds 2024, 5(3), 440-452; https://doi.org/10.3390/birds5030030 - 10 Aug 2024
Viewed by 833
Abstract
Abandoned mine drainage treatment ponds could have contrasting effects on the reproductive success of birds living in the vicinity. The ponds and associated vegetation may, like any other body of freshwater, provide beneficial habitats for the insects that the birds use to feed [...] Read more.
Abandoned mine drainage treatment ponds could have contrasting effects on the reproductive success of birds living in the vicinity. The ponds and associated vegetation may, like any other body of freshwater, provide beneficial habitats for the insects that the birds use to feed their young; or instead, the ponds may act as an ecological trap, attracting the birds to a habitat that is poor in quality and negatively impacting their productivity. We monitored nests of an aerial insectivore, the Tree Swallow (Tachycineta bicolor), to determine whether the distance between the ponds and the nests affected various reproductive parameters including clutch size, hatch rate, number of nestlings, nestling size and mass, number of fledglings, fledging rate, and fledge date. Data were collected over two breeding seasons (2022 and 2023) from a swallow population in southwestern Pennsylvania, USA. We found that the nests closest to the treatment ponds had significantly more nestlings and fledglings, earlier fledge dates, and a better fledging rate when compared to nests that were more distant from the ponds. However, all these parameters were well below previously published values, which suggests that the mine drainage ponds provide good nesting habitats relative to what is available in the region but that they do not represent high-quality habitats for this species overall. Full article
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10 pages, 2154 KiB  
Article
Biometric Vibration Signal Detection Devices for Swallowing Activity Monitoring
by Youn J. Kang
Signals 2024, 5(3), 516-525; https://doi.org/10.3390/signals5030028 - 5 Aug 2024
Viewed by 402
Abstract
Swallowing is a complex neuromuscular activity regulated by the autonomic central nervous system, and impairment can lead to dysphagia, which is difficulty in swallowing. This research presents a novel approach that utilizes wireless, wearable technology for the continuous mechano-acoustic tracking of respiratory activities [...] Read more.
Swallowing is a complex neuromuscular activity regulated by the autonomic central nervous system, and impairment can lead to dysphagia, which is difficulty in swallowing. This research presents a novel approach that utilizes wireless, wearable technology for the continuous mechano-acoustic tracking of respiratory activities and swallowing. To address the challenge of accurately tracking swallowing amidst potential confounding activities or significant body movements, we employ two accelerometers. These accelerometers help distinguish between genuine swallowing events and other activities. By monitoring movements and vibrations through the skin surface, the developed device enables non-intrusive monitoring of swallowing dynamics and respiratory patterns. Our focus is on the development of both the wireless skin-interfaced device and an advanced algorithm capable of detecting swallowing dynamics in conjunction with respiratory phases. The device and algorithm demonstrate robustness in detecting respiratory patterns and swallowing instances, even in scenarios where users exhibit periodic movements due to disease or daily activities. Furthermore, peak detection using an adaptive threshold automatically adjusts to an individual’s signal strength, facilitating the detection of swallowing signals without the need for individual adjustments. This innovation has significant potential for enhancing patient training and rehabilitation programs aimed at addressing dysphagia and related respiratory issues. Full article
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15 pages, 1344 KiB  
Article
Preservation of Vocal Function in Amyotrophic Lateral Sclerosis (ALS) Patients Following Percutaneous Dilatational Tracheostomy (PDT) and Adjuvant Therapies
by Jae-Kook Yoo, Soon-Hee Kwon, Sul-Hee Yoon, Jeong-Eun Lee, Jong-Eun Jeon, Je-Hyuk Chung and Sang-Yoon Lee
Biomedicines 2024, 12(8), 1734; https://doi.org/10.3390/biomedicines12081734 - 2 Aug 2024
Viewed by 544
Abstract
The study aimed to evaluate the efficacy of percutaneous dilatational tracheostomy (PDT) combined with adjuvant therapies in preserving vocal function in amyotrophic lateral sclerosis (ALS) patients. Methods: We performed a retrospective analysis of 47 ALS patients who underwent PDT at the Rodem Hospital [...] Read more.
The study aimed to evaluate the efficacy of percutaneous dilatational tracheostomy (PDT) combined with adjuvant therapies in preserving vocal function in amyotrophic lateral sclerosis (ALS) patients. Methods: We performed a retrospective analysis of 47 ALS patients who underwent PDT at the Rodem Hospital from 2021 to 2023. Post-operatively, these patients were provided with a comprehensive treatment plan that included regenerative injection therapy, low-frequency electrical stimulation, respiratory rehabilitation, and swallowing rehabilitation therapy. Additionally, a balloon reduction program was implemented for effective tracheostomy tube (T-tube) management. The preservation of vocal functions was evaluated 4 weeks following the procedure. Results: While some patients maintained or slightly improved their ALSFRS-R speech scores, the overall trend indicated a decrease in speech scores post-PDT. This suggests that PDT in combination with adjuvant therapies may not universally improve vocal function, but can help maintain it in certain cases. Conclusions: Our findings indicate that PDT combined with mesotherapy, low-frequency electrical stimulation, and swallowing rehabilitation therapy may play a role in maintaining vocal function in limb type ALS patients, though further research is needed to optimize patient management and to validate these results. Full article
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17 pages, 9371 KiB  
Article
Commercialization of the Xalkori Pediatric Multiparticulate Product Using Quality-by-Design Principles
by Jeremy Bartlett, Natalie Culver, Xiang Zhang, Brett Waybrant, Hannah Sullivan and Logan Howell
Pharmaceutics 2024, 16(8), 1027; https://doi.org/10.3390/pharmaceutics16081027 - 1 Aug 2024
Viewed by 690
Abstract
A pediatric dosage form for crizotinib (Xalkori) was commercialized using quality-by-design principles in a material-sparing fashion. The dosage form consists of spherical multiparticulates (microspheres or pellets) that are coated and encapsulated in capsules for opening. The crizotinib (Xalkori)-coated pellet product is approved in [...] Read more.
A pediatric dosage form for crizotinib (Xalkori) was commercialized using quality-by-design principles in a material-sparing fashion. The dosage form consists of spherical multiparticulates (microspheres or pellets) that are coated and encapsulated in capsules for opening. The crizotinib (Xalkori)-coated pellet product is approved in the US for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) and unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. The product is also approved in the US for adult patients with non-small cell lung cancer (NSCLC) who are unable to swallow intact capsules. The lipid multiparticulate is composed of a lipid matrix, a dissolution enhancer, and an active pharmaceutical ingredient (API). The API, which remains crystalline, is embedded within the microsphere at a 60% drug loading in the uncoated lipid multiparticulate to enable dose flexibility. The melt spray congealing technique using a rotary atomizer is used to manufacture the lipid multiparticulate. Following melt spray congealing, a barrier coating is applied via fluid bed coating. Due to their particle size and content uniformity, this dosage form provides the dosing flexibility and swallowability needed for the pediatric population. The required pediatric dose is achieved by opening the capsules and combining doses of different encapsulated dose strengths, followed by administration of the multiparticulates directly to the mouth. The encapsulation process was optimized through equipment modifications and by using a design of experiments approach to understand the operating space. A limited number of development batches produced using commercial-scale equipment were leveraged to design, understand, and verify the manufacturing process space. The quality by design and material-sparing approach taken to design the melt spray congeal and encapsulation manufacturing processes resulted in a pediatric product with exceptional content uniformity (a 95% confidence and 99% probability of passing USP <905> content uniformity testing for future batches). Full article
(This article belongs to the Special Issue Advanced Pediatric Drug Formulation Strategies)
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