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Search Results (1,740)

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Keywords = clinical trial protocol

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16 pages, 1690 KiB  
Article
Effect of Photobiomodulation on Post-Endodontic Pain Following Single-Visit Treatment: A Randomized Double-Blind Clinical Trial
by Glaucia Gonçales Abud Machado, Giovanna Fontgalland Ferreira, Erika da Silva Mello, Ellen Sayuri Ando-Suguimoto, Vinicius Leão Roncolato, Marcia Regina Cabral Oliveira, Janainy Altrão Tognini, Adriana Fernandes Paisano, Cleber Pinto Camacho, Sandra Kalil Bussadori, Lara Jansiski Motta, Cinthya Cosme Gutierrez Duran, Raquel Agnelli Mesquita-Ferrari, Kristianne Porta Santos Fernandes and Anna Carolina Ratto Tempestini Horliana
J. Pers. Med. 2025, 15(8), 347; https://doi.org/10.3390/jpm15080347 - 2 Aug 2025
Viewed by 120
Abstract
The evidence for photobiomodulation in reducing postoperative pain after endodontic instrumentation is classified as low or very low certainty, indicating a need for further research. Longitudinal pain assessments over 24 h are crucial, and studies should explore these pain periods. Background/Objectives: This [...] Read more.
The evidence for photobiomodulation in reducing postoperative pain after endodontic instrumentation is classified as low or very low certainty, indicating a need for further research. Longitudinal pain assessments over 24 h are crucial, and studies should explore these pain periods. Background/Objectives: This double-blind, randomized controlled clinical trial evaluated the effect of PBM on pain following single-visit endodontic treatment of maxillary molars at 4, 8, 12, and 24 h. Primary outcomes included pain at 24 h; secondary outcomes included pain at 4, 8, and 12 h, pain during palpation/percussion, OHIP-14 analysis, and frequencies of pain. Methods: Approved by the Research Ethics Committee (5.598.290) and registered in Clinical Trials (NCT06253767), the study recruited adults (21–70 years) requiring endodontic treatment in maxillary molars. Fifty-eight molars were randomly assigned to two groups: the PBM Group (n = 29), receiving conventional endodontic treatment with PBM (100 mW, 333 mW/cm2, 9 J distributed at 3 points near root apices), and the control group (n = 29), receiving conventional treatment with PBM simulation. Pain was assessed using the Visual Analog Scale. Results: Statistical analyses used chi-square and Mann–Whitney tests, with explained variance (η2). Ten participants were excluded, leaving 48 patients for analysis. No significant differences were observed in postoperative pain at 24, 4, 8, or 12 h, or in palpation/percussion or OHIP-14 scores. Pain frequencies ranged from 12.5% to 25%. Conclusions: PBM does not influence post-treatment pain in maxillary molars under these conditions. These results emphasize the importance of relying on well-designed clinical trials to guide treatment decisions, and future research should focus on personalized dosimetry adapted to the anatomical characteristics of the treated dental region to enhance the accuracy and efficacy of therapeutic protocols. Full article
(This article belongs to the Special Issue Towards Precision Anesthesia and Pain Management)
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10 pages, 1522 KiB  
Case Report
Percutaneous Peripheral Nerve Stimulation in Chemotherapy-Induced Neuropathy: A Case Report
by Sara Mogedano-Cruz, Carlos Romero-Morales, Mónica de la Cueva-Reguera, Kristin L. Campbell and Pablo Herrero
Reports 2025, 8(3), 133; https://doi.org/10.3390/reports8030133 - 1 Aug 2025
Viewed by 188
Abstract
Background and Clinical Significance: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and limiting complication of oncological treatment, particularly in patients receiving oxaliplatin. Its onset can significantly affect the quality of life and compromise the continuity of the antineoplastic therapy. Due to the [...] Read more.
Background and Clinical Significance: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and limiting complication of oncological treatment, particularly in patients receiving oxaliplatin. Its onset can significantly affect the quality of life and compromise the continuity of the antineoplastic therapy. Due to the limited efficacy of available pharmacological therapies, percutaneous electrical nerve stimulation (PENS) has been proposed as a non-invasive alternative for symptom management. Case presentation: We report the case of a 75-year-old woman with colorectal adenocarcinoma who developed CIPN following oxaliplatin administration. She underwent a 12-week course of PENS targeting the median nerve, with weekly sessions conducted without interruption of chemotherapy and without adverse effects. The patient showed progressive improvement in neurosensory symptoms, as measured by the EORTC QLQ-CIPN20 questionnaire. Quantitative sensory testing revealed normalization of thermal and vibratory sensitivity and improved mechanical detection thresholds. The cumulative oxaliplatin dose was maintained throughout treatment. Conclusions: PENS may offer an effective and safe therapeutic option for managing CIPN, enabling symptom control without compromising oncological treatment. This case supports the need for controlled clinical trials to confirm efficacy and establish standardized protocols. Full article
(This article belongs to the Section Oncology)
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18 pages, 385 KiB  
Review
Fetal Supraventricular Tachycardia: What Do We Know up to This Day?
by Sophia Tsokkou, Ioannis Konstantinidis, Vasileios Anastasiou, Alkis Matsas, Eleni Stamoula, Emmanuela Peteinidou, Antonia Sioga, Theodora Papamitsou, Antonios Ziakas and Vasileios Kamperidis
J. Pers. Med. 2025, 15(8), 341; https://doi.org/10.3390/jpm15080341 - 1 Aug 2025
Viewed by 93
Abstract
Fetal tachyarrhythmias, particularly supraventricular tachycardia (SVT) and atrial flutter (AFL), pose significant clinical challenges, especially when complicated by hydrops fetalis. This article provides a comprehensive review of the tachyarrhythmia types, the diagnostic modalities applied, and the therapeutic strategies followed in fetal tachyarrhythmias. Diagnostic [...] Read more.
Fetal tachyarrhythmias, particularly supraventricular tachycardia (SVT) and atrial flutter (AFL), pose significant clinical challenges, especially when complicated by hydrops fetalis. This article provides a comprehensive review of the tachyarrhythmia types, the diagnostic modalities applied, and the therapeutic strategies followed in fetal tachyarrhythmias. Diagnostic techniques such as M-mode echocardiography and fetal magnetocardiography (fMCG) are highlighted for their capacity to provide real-time, high-quality assessments of fetal cardiac rhythms. The review, also, focuses on pharmacologic management via transplacental therapy, discussing the safety and efficacy of the key agents including digoxin, flecainide, and sotalol, under different clinical scenarios, such as hydropic fetus and renal impairment. In addition to transplacental administration, alternative approaches such as direct fetal intramuscular or intravascular injections are examined. These direct methods, while potentially more effective in refractory cases, carry risks that necessitate specialized expertise and careful consideration of maternal and fetal safety. The limitations of current evidence, largely based on small case studies and retrospective analyses, underscore the need for larger, prospective multicenter observational studies and randomized control trials to establish standardized protocols for fetal tachyarrhythmia management. Overall, this review advocates for a personalized, multidisciplinary approach, emphasizing early fetal tachyarrhythmias diagnosis, tailored treatment regimens that balances efficacy with safety, and rigorous monitoring to optimize outcomes for both the fetus and the mother. Full article
(This article belongs to the Special Issue Advances in Prenatal Diagnosis and Maternal Fetal Medicine)
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17 pages, 960 KiB  
Article
Medium-Frequency Neuromuscular Electrical Stimulation in Critically Ill Patients Promoted Larger Functional Capacity Improvement During Recovery than Low-Frequency Neuromuscular Electrical Stimulation: Randomized Clinical Trial
by Pablo Guerra-Vega, Rodrigo Guzmán, Claudio Betancourt, Mario Grage, Cristian Vera, Macarena Artigas-Arias, Rodrigo Muñoz-Cofré, Kaio F. Vitzel and Gabriel Nasri Marzuca-Nassr
J. Clin. Med. 2025, 14(15), 5407; https://doi.org/10.3390/jcm14155407 - 31 Jul 2025
Viewed by 244
Abstract
Background/Objectives: This study aimed to compare the effects of low- and medium-frequency NMES, combined with a standard physical therapy (SPT) program, on functional capacity in critically ill patients. Methods: Fifty-four critically ill patients admitted into Intensive Care Unit (ICU) and on mechanical ventilation [...] Read more.
Background/Objectives: This study aimed to compare the effects of low- and medium-frequency NMES, combined with a standard physical therapy (SPT) program, on functional capacity in critically ill patients. Methods: Fifty-four critically ill patients admitted into Intensive Care Unit (ICU) and on mechanical ventilation participated in this randomized, single-blinded, experimental study. Participants were randomly assigned to a Control group, who received a lower limb SPT program; the Low-frequency NMES group received lower limb SPT + NMES at 100 Hz; and the Medium-frequency NMES group received lower limb SPT + NMES at 100 Hz with a carrier frequency of 2500 Hz. The outcomes, encompassing functional capacity in the hospital, included muscle strength, handgrip strength, functional status, degree of independence for activities of daily living, functional and dynamic mobility, quality of life, and total days hospitalized. Results: Both NMES protocols combined with SPT improved functional capacity compared to the control group. Medium-frequency NMES provided additional benefits on dynamic balance, in the degree of independence to perform activities of daily living and quality of life (all p < 0.001) prior to hospital discharge. It also promoted larger gains on functional status prior to ICU discharge and on knee extension strength (both p < 0.05) prior to intermediate care unit discharge. Medium-frequency NMES also enhanced handgrip strength earlier than low-frequency NMES when compared to the control group. Notably, medium-frequency NMES was the only intervention associated with a significant reduction in total hospital stay duration (p < 0.05). Conclusions: Medium-frequency NMES, along with an SPT program in critically ill patients, showed greater benefits on functional capacity during recovery than low-frequency NMES. (Trial registration: This trial is registered on ClinicalTrials.gov: NCT05287919). Implications for rehabilitation: 1. Medium-frequency NMES may enhance physical functionality and quality of life in critically ill patients with ICU-acquired weakness. 2. Medium-frequency NMES can reduce the number of hospitalization days. 3. NMES combined with SPT represents a feasible and effective option for patients unable to engage in active rehabilitation during critical illness. Full article
(This article belongs to the Section Clinical Neurology)
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40 pages, 1885 KiB  
Review
Potential Application of Plant By-Products in Biomedicine: From Current Knowledge to Future Opportunities
by Silvia Estarriaga-Navarro, Teresa Valls, Daniel Plano, Carmen Sanmartín and Nieves Goicoechea
Antioxidants 2025, 14(8), 942; https://doi.org/10.3390/antiox14080942 (registering DOI) - 31 Jul 2025
Viewed by 271
Abstract
Plant by-products have gained significant attention due to their rich content in bioactive compounds, which exhibit promising antioxidant, antimicrobial, and antitumor properties. In European countries, vegetable waste generation ranged from 35 to 78 kg per capita in 2022, highlighting both the scale of [...] Read more.
Plant by-products have gained significant attention due to their rich content in bioactive compounds, which exhibit promising antioxidant, antimicrobial, and antitumor properties. In European countries, vegetable waste generation ranged from 35 to 78 kg per capita in 2022, highlighting both the scale of the challenge and the potential for valorization. This review provides an overview of key studies investigating the potential of plant residues in biomedicine, highlighting their possible contents of antioxidant compounds, their antimicrobial and antitumor properties, as well as their applications in dermocosmetics and nutraceuticals. However, despite their potential, several challenges must be addressed, such as the standardization of extraction protocols, as bioactive compound profiles can vary with plant source, processing conditions, and storage methods. Effective segregation and storage protocols for household organic waste also require optimization to ensure the quality and usability of plant by-products in biomedicine. Emerging 4.0 technologies could help to identify suitable plant by-products for biomedicine, streamlining their selection process for high-value applications. Additionally, the transition from in vitro studies to clinical trials is hindered by gaps in the understanding of Absorption, Distribution, Metabolism, and Excretion (ADME) properties, as well as interaction and toxicity profiles. Nonetheless, environmental education and societal participation are crucial to enabling circular bioeconomy strategies and sustainable biomedical innovation. Full article
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14 pages, 872 KiB  
Article
Beyond Pain Management: Skin-to-Skin Contact as a Humanization Strategy in Cesarean Delivery: A Randomized Controlled Trial
by José Miguel Pérez-Jiménez, Rocío de-Diego-Cordero, Álvaro Borrallo-Riego, Manuel Luque-Oliveros, Domingo de-Pedro-Jimenez, Manuel Coheña-Jimenez, Patricia Bonilla Sierra and María Dolores Guerra-Martín
Healthcare 2025, 13(15), 1866; https://doi.org/10.3390/healthcare13151866 - 30 Jul 2025
Viewed by 201
Abstract
Background: Postoperative pain management after a cesarean section remains a significant challenge, as inadequate control can delay maternal recovery and hinder early bonding and breastfeeding. While multimodal analgesia is the standard approach, non–pharmacological strategies like immediate skin–to–skin contact (SSC) are often underused despite [...] Read more.
Background: Postoperative pain management after a cesarean section remains a significant challenge, as inadequate control can delay maternal recovery and hinder early bonding and breastfeeding. While multimodal analgesia is the standard approach, non–pharmacological strategies like immediate skin–to–skin contact (SSC) are often underused despite their potential benefits in reducing pain, improving uterine contractions, and increasing maternal satisfaction. Objective: To evaluate the effects of immediate SSC on postoperative pain perception, uterine contraction quality, and maternal satisfaction, and to explore ways to incorporate SSC into routine post–cesarean care to promote recovery and humanized care. Method: A randomized clinical trial was conducted with 80 women undergoing elective cesarean sections, divided into two groups: SSC (40 women) and control (40 women). Postoperative pain was measured using the Visual Analog Scale (VAS) at various intervals, while uterine contraction quality and maternal satisfaction were assessed through clinical observation and a Likert scale, respectively. Results: We found that women in the SSC group experienced significantly lower pain scores (VAS2 and VAS3, p < 0.001), stronger infraumbilical uterine contractions (92.5%, p < 0.001), and higher satisfaction levels (average 9.98 vs. 6.50, p < 0.001). An inverse correlation was observed between pain intensity and satisfaction, indicating that SSC enhances both physiological and psychological recovery. Conclusions: Immediate SSC after cesarean is an effective, humanizing intervention that reduces pain, supports uterine contractions, and boosts maternal satisfaction. These findings advocate for integrating SSC into standard postoperative care, aligning with ethical principles of beneficence and autonomy. Further research with larger samples is necessary to confirm these benefits and facilitate widespread adoption in maternity protocols. Full article
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20 pages, 1220 KiB  
Systematic Review
The Evolving Role of Stem Cells in Oral Health and Regeneration: A Systematic Review
by Gianna Dipalma, Grazia Marinelli, Arianna Fiore, Liviana Balestriere, Claudio Carone, Silvio Buongiorno, Francesco Inchingolo, Giuseppe Minervini, Andrea Palermo, Angelo Michele Inchingolo and Alessio Danilo Inchingolo
Surgeries 2025, 6(3), 65; https://doi.org/10.3390/surgeries6030065 - 30 Jul 2025
Viewed by 278
Abstract
Background: Mesenchymal stem cells (MSCs), multipotent and immune-regulatory cells derived from tissues such as bone marrow, dental pulp, and periodontal ligament, emerged as promising agents in regenerative dentistry. Their clinical applications include endodontic tissue regeneration, periodontal healing, and alveolar bone repair, addressing [...] Read more.
Background: Mesenchymal stem cells (MSCs), multipotent and immune-regulatory cells derived from tissues such as bone marrow, dental pulp, and periodontal ligament, emerged as promising agents in regenerative dentistry. Their clinical applications include endodontic tissue regeneration, periodontal healing, and alveolar bone repair, addressing critical challenges in dental tissue restoration. Methods: A systematic review was conducted following PRISMA guidelines and registered in PROSPERO. We searched PubMed, Scopus, and Web of Science databases for open-access, English-language clinical trials and observational studies published from 2015 to 2025. Studies focusing on the application of MSCs in dental tissue regeneration were included based on predefined eligibility criteria. Results: Out of 2400 initial records, 13 studies met the inclusion criteria after screening and eligibility assessment. Most studies investigated MSCs derived from dental pulp and periodontal ligament for regenerating periodontal tissues and alveolar bone defects. The majority reported improved clinical outcomes; however, variations in MSC sources, delivery methods, sample sizes, and follow-up periods introduced methodological heterogeneity. Conclusions: MSCs show significant potential in enhancing bone and periodontal regeneration in dental practice. Nonetheless, the current evidence is limited by small sample sizes, short follow-up, and inconsistent methodologies. Future large-scale, standardized clinical trials are required to validate MSC-based regenerative therapies and optimize treatment protocols. Full article
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22 pages, 4087 KiB  
Article
Intranasal Administration of Extracellular Vesicles Derived from Adipose Mesenchymal Stem Cells Has Therapeutic Effect in Experimental Autoimmune Encephalomyelitis
by Barbara Rossi, Federica Virla, Gabriele Angelini, Ilaria Scambi, Alessandro Bani, Giulia Marostica, Mauro Caprioli, Daniela Anni, Roberto Furlan, Pasquina Marzola, Raffaella Mariotti, Gabriela Constantin, Bruno Bonetti and Ermanna Turano
Cells 2025, 14(15), 1172; https://doi.org/10.3390/cells14151172 - 30 Jul 2025
Viewed by 363
Abstract
Adipose stem cells (ASCs) are a subset of mesenchymal stem cells with validated immunomodulatory and regenerative capabilities that make them attractive tools for treating neurodegenerative disorders, such as multiple sclerosis (MS). Several studies conducted on experimental autoimmune encephalomyelitis (EAE), the animal model of [...] Read more.
Adipose stem cells (ASCs) are a subset of mesenchymal stem cells with validated immunomodulatory and regenerative capabilities that make them attractive tools for treating neurodegenerative disorders, such as multiple sclerosis (MS). Several studies conducted on experimental autoimmune encephalomyelitis (EAE), the animal model of MS, have clearly shown a therapeutic effect of ASCs. However, controversial data on their efficacy were obtained from I- and II-phase clinical trials in MS patients, highlighting standardization issues and limited data on long-term safety. In this context, ASC-derived extracellular vesicles from (ASC-EVs) represent a safer, more reproducible alternative for EAE and MS treatment. Moreover, their physical characteristics lend themselves to a non-invasive, efficient, and easy handling of intranasal delivery. Using an in vitro setting, we first verified ASC-EVs’ ability to cross the human nasal epithelium under an inflammatory milieu. Magnetic resonance corroborated these data in vivo in intranasally treated MOG35-55-induced EAE mice, showing a preferential accumulation of ASC-EVs in brain-inflamed lesions compared to a stochastic distribution in healthy control mice. Moreover, intranasal treatment of ASC-EVs at the EAE onset led to a long-term therapeutic effect using two different experimental protocols. A marked reduction in T cell infiltration, demyelination, axonal damage, and cytokine production were correlated to EAE amelioration in ASC-EV-treated mice compared to control mice, highlighting the immunomodulatory and neuroprotective roles exerted by ASC-EVs during EAE progression. Overall, our study paves the way for promising clinical applications of self-administered ASC-EV intranasal treatment in CNS disorders, including MS. Full article
(This article belongs to the Section Cells of the Nervous System)
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34 pages, 1059 KiB  
Review
Autism Spectrum Disorder: From Experimental Models to Probiotic Application with a Special Focus on Lactiplantibacillus plantarum
by Giusi Sabatini, Ilenia Boccadoro, Roberta Prete, Natalia Battista and Aldo Corsetti
Nutrients 2025, 17(15), 2470; https://doi.org/10.3390/nu17152470 - 29 Jul 2025
Viewed by 403
Abstract
Background/Objectives: Autism spectrum disorder (ASD) encompasses several neurodevelopmental disorders, whose onset is correlated to genetic and environmental factors. Although the etiopathogenesis is not entirely clear, the involvement of inflammatory processes, the endocannabinoid system, and alterations in the permeability and composition of the intestinal [...] Read more.
Background/Objectives: Autism spectrum disorder (ASD) encompasses several neurodevelopmental disorders, whose onset is correlated to genetic and environmental factors. Although the etiopathogenesis is not entirely clear, the involvement of inflammatory processes, the endocannabinoid system, and alterations in the permeability and composition of the intestinal microbiota are known to occur. Methods: This review systematically explores the literature available to date on the most widely used murine models for the study of ASD, the main biomarkers investigated for the diagnosis of ASD, and the therapeutic potential of probiotics, with a particular focus on the use of strains of Lactiplantibacillus (Lpb.) plantarum in in vivo models and clinical trials for ASD. Results: Several studies have demonstrated that targeting multifactorial biomarkers in animal models and patients contributes to a more comprehensive understanding of the complex mechanisms underlying ASD. Moreover, accumulating evidence supports the beneficial effect of probiotics, including Lpb. plantarum, as a promising alternative therapeutic strategy, capable of modulating gut–brain axis communication. Conclusions: Probiotic supplementation, particularly with selected Lpb. plantarum strains, is emerging as a potential complementary approach for ameliorating ASD-related gastrointestinal and behavioral symptoms. However, further large-scale clinical studies are essential to validate their efficacy and determine optimal treatment protocols and dietary strategies. Full article
(This article belongs to the Special Issue The Effect of Nutrition Interventions on Neuropsychiatric Diseases)
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16 pages, 1920 KiB  
Review
Time-Restricted Eating Improves Glycemic Control in Patients with Type 2 Diabetes: A Meta-Analysis and Systematic Review
by Taegwang Nam, Hyeongbin Oh, Anna Kim and Yongtaek Oh
Int. J. Mol. Sci. 2025, 26(15), 7310; https://doi.org/10.3390/ijms26157310 - 29 Jul 2025
Viewed by 593
Abstract
Time-restricted eating (TRE), a dietary strategy that aligns food intake with circadian rhythms, has emerged as a promising non-pharmacological approach for improving glycemic control in patients with type 2 diabetes. This systematic review and meta-analysis evaluated the effects of TRE on glycemic outcomes [...] Read more.
Time-restricted eating (TRE), a dietary strategy that aligns food intake with circadian rhythms, has emerged as a promising non-pharmacological approach for improving glycemic control in patients with type 2 diabetes. This systematic review and meta-analysis evaluated the effects of TRE on glycemic outcomes by analyzing eight randomized controlled trials involving 312 participants with type 2 diabetes or impaired fasting glucose. Meta-analyses of six eligible studies demonstrated that TRE significantly reduced fasting glucose (mean difference [MD]: −0.74 mmol/L; 95% CI: −1.13 to −0.36) and glycated hemoglobin (ΔHbA1c) (MD: −0.11%; 95% CI: −0.15 to −0.07) and increased time in range (TIR) for blood glucose (MD: +10.51%; 95% CI: 6.81 to 14.21). Improvements in fasting glucose and HbA1c were modest but consistent, while the increase in TIR showed no between-study heterogeneity, suggesting a robust and reproducible benefit of TRE on glycemic stability. These findings support the clinical feasibility and effectiveness of TRE as a dietary intervention in diabetes management. However, further high-quality trials with standardized protocols and longer follow-up are needed to confirm long-term efficacy and inform guidelines. Full article
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26 pages, 2998 KiB  
Review
PSMA-Directed Theranostics in Prostate Cancer
by Salman Ayub Jajja, Nandini Sodhi, Ephraim E. Parent and Parminder Singh
Biomedicines 2025, 13(8), 1837; https://doi.org/10.3390/biomedicines13081837 - 28 Jul 2025
Viewed by 844
Abstract
Following lung cancer, prostate cancer is the leading cause of cancer death in men. High-risk localized tumor burden or metastatic disease often progresses, refractory to initial treatment regimens. There is ongoing development of technology to appropriately identify high-risk patients, stage them correctly, and [...] Read more.
Following lung cancer, prostate cancer is the leading cause of cancer death in men. High-risk localized tumor burden or metastatic disease often progresses, refractory to initial treatment regimens. There is ongoing development of technology to appropriately identify high-risk patients, stage them correctly, and offer appropriate treatments to obtain the best clinical outcomes. Prostate cancer-specific membrane antigen (PSMA) is a transmembrane glutamate carboxypeptidase, which helps regulate folate absorption, and its overexpression is pathologically directly proportional and associated with prostate cancer. Increased PSMA expression is a known independent risk factor for poorer survival, and most metastatic lesions in CRPC are PSMA positive. Over the last decade, several PSMA-based PET radiopharmaceuticals have demonstrated superior sensitivities and specificities compared to traditional imaging methods. These outcomes have been demonstrated by several large clinical trials. As the data emerges, these diagnostics are being integrated into standard of care protocol to facilitate nuanced identification of malignant lesions. PSMA is also being targeted through several therapeutics, including radioligands and immunotherapies such as CAR-T, BiTEs, and ADCs. This review will discuss the landscape of PSMA-based theranostics in the context of prostate cancer. Full article
(This article belongs to the Special Issue Advanced Research on Genitourinary Cancer)
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15 pages, 1173 KiB  
Article
Efficacy and Safety of a Balanced Gelatine Solution for Fluid Resuscitation in Sepsis: A Prospective, Randomised, Controlled, Double-Blind Trial-GENIUS Trial
by Gernot Marx, Jan Benes, Ricard Ferrer, Dietmar Fries, Johannes Ehler, Rolf Dembinski, Peter Rosenberger, Kai Zacharowski, Manuel Sanchez, Karim Asehnoune, Bernd Bachmann-Mennenga, Carole Ichai and Tim-Philipp Simon
J. Clin. Med. 2025, 14(15), 5323; https://doi.org/10.3390/jcm14155323 - 28 Jul 2025
Viewed by 306
Abstract
Background/Objective: Sepsis is a leading cause of death in noncoronary intensive care units (ICUs). Fluids for intravascular resuscitation include crystalloids and colloids. There is extensive clinical evidence on colloid use, but large trials comparing gelatine with crystalloid regimens in ICU and septic [...] Read more.
Background/Objective: Sepsis is a leading cause of death in noncoronary intensive care units (ICUs). Fluids for intravascular resuscitation include crystalloids and colloids. There is extensive clinical evidence on colloid use, but large trials comparing gelatine with crystalloid regimens in ICU and septic patients are lacking. This study aimed to determine whether early, protocol-driven volume resuscitation using a gelatine-based regimen achieves hemodynamic stability (HDS) more rapidly than a crystalloid-based regimen in septic patients. Methods: This prospective, controlled, randomised, double-blind, multinational phase IV study compared two parallel groups of septic patients receiving a gelatine-based regimen (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG each, at a 1:1 ratio) or a crystalloid regimen (Sterofundin® ISO). Primary endpoint was time to first HDS within 48 h after randomisation. Secondary endpoints included fluid overload, fluid balance, and patient outcomes. Results: 167 patients were randomised. HDS was achieved after 4.7 h in the gelatine group and after 5.8 h in the crystalloid group (p = 0.3716). The gelatine group had a more favourable fluid balance at 24 h (medians: 3463.00 mL vs. 4164.00 mL; p = 0.0395) and less fluid overload (medians: 4296.05 vs. 5218.75%; p = 0.0217). No differences were observed in serious adverse events or mortality. Conclusions: The study provided clinical evidence of balanced gelatine solution for volume resuscitation in septic patients, although it was terminated prematurely. The early and protocol-based administration of gelatine was safe and effective in the enrolled patient population. Time to HDS was not different between groups but the gelatine-based regimen led to better fluid balance and less fluid overload. Full article
(This article belongs to the Section Hematology)
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17 pages, 597 KiB  
Review
Dry Needling for Tension-Type Headache: A Scoping Review on Intervention Procedures, Muscle Targets, and Outcomes
by Ana Bravo-Vazquez, Ernesto Anarte-Lazo, Cleofas Rodriguez-Blanco and Carlos Bernal-Utrera
J. Clin. Med. 2025, 14(15), 5320; https://doi.org/10.3390/jcm14155320 - 28 Jul 2025
Viewed by 265
Abstract
Background/Objectives: Tension-type headache (TTH) is the most prevalent form of primary headache. The etiology of TTH is not yet fully understood, although it is associated with the presence of myofascial trigger points (MTPs) in cervical and facial muscles. Dry needling (DN) therapy [...] Read more.
Background/Objectives: Tension-type headache (TTH) is the most prevalent form of primary headache. The etiology of TTH is not yet fully understood, although it is associated with the presence of myofascial trigger points (MTPs) in cervical and facial muscles. Dry needling (DN) therapy has emerged as an effective and safe non-pharmacological option for pain relief, but there are a lack of systematic reviews focused on its specific characteristics in TTH. The aim of this paper is to examine the characteristics and methodologies of DN in managing TTH. Methods: A scoping review was conducted with inclusion criteria considering studies that evaluated DN interventions in adults with TTH, reporting target muscles, diagnostic criteria, and technical features. The search was performed using PubMed, Embase, Scopus, and the Web of Science, resulting in the selection of seven studies after a rigorous filtering and evaluation process. Results: The included studies, primarily randomized controlled trials, involved a total of 309 participants. The most frequently treated muscles were the temporalis and trapezius. Identification of MTPs was mainly performed through manual palpation, although diagnostic criteria varied. DN interventions differed in technique. All studies included indicated favorable outcomes with improvements in headache symptoms. No serious adverse effects were reported, suggesting that the technique is safe. However, heterogeneity in protocols and diagnostic criteria limits the comparability of results. Conclusions: The evidence supports the use of DN in key muscles such as the temporalis and trapezius for managing TTH, although the diversity in methodologies and diagnostic criteria highlights the need for standardization. The safety profile of the method is favorable, but further research is necessary to define optimal protocols and improve reproducibility. Implementing objective diagnostic criteria and uniform protocols will facilitate advances in clinical practice and future research, ultimately optimizing outcomes for patients with TTH. Full article
(This article belongs to the Section Clinical Neurology)
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28 pages, 6648 KiB  
Review
Machine Learning in Gel-Based Additive Manufacturing: From Material Design to Process Optimization
by Zhizhou Zhang, Yaxin Wang and Weiguang Wang
Gels 2025, 11(8), 582; https://doi.org/10.3390/gels11080582 - 28 Jul 2025
Viewed by 438
Abstract
Machine learning is reshaping gel-based additive manufacturing by enabling accelerated material design and predictive process optimization. This review provides a comprehensive overview of recent progress in applying machine learning across gel formulation development, printability prediction, and real-time process control. The integration of algorithms [...] Read more.
Machine learning is reshaping gel-based additive manufacturing by enabling accelerated material design and predictive process optimization. This review provides a comprehensive overview of recent progress in applying machine learning across gel formulation development, printability prediction, and real-time process control. The integration of algorithms such as neural networks, random forests, and support vector machines allows accurate modeling of gel properties, including rheology, elasticity, swelling, and viscoelasticity, from compositional and processing data. Advances in data-driven formulation and closed-loop robotics are moving gel printing from trial and error toward autonomous and efficient material discovery. Despite these advances, challenges remain regarding data sparsity, model robustness, and integration with commercial printing systems. The review results highlight the value of open-source datasets, standardized protocols, and robust validation practices to ensure reproducibility and reliability in both research and clinical environments. Looking ahead, combining multimodal sensing, generative design, and automated experimentation will further accelerate discoveries and enable new possibilities in tissue engineering, biomedical devices, soft robotics, and sustainable materials manufacturing. Full article
(This article belongs to the Section Gel Processing and Engineering)
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11 pages, 768 KiB  
Article
The Efficacy and Central Remodeling Mechanism of a Composite TMS Pattern in First-Episode and Recurrent Depressive Disorders
by Li Pu, Jiang Wu, Shan Huang, Dandan Liu, Xi Tan, Hongmei Yan, Guojian Yan and Dezhong Yao
Brain Sci. 2025, 15(8), 801; https://doi.org/10.3390/brainsci15080801 - 28 Jul 2025
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Abstract
Background: This study aims to evaluate the efficacy of a combined transcranial magnetic stimulation (TMS) protocol incorporating intermittent theta burst stimulation (iTBS) and low-frequency TMS in adults diagnosed with first-episode and recurrent depressive disorders. Methods: A prospective, double-blind, parallel-group trial was conducted involving [...] Read more.
Background: This study aims to evaluate the efficacy of a combined transcranial magnetic stimulation (TMS) protocol incorporating intermittent theta burst stimulation (iTBS) and low-frequency TMS in adults diagnosed with first-episode and recurrent depressive disorders. Methods: A prospective, double-blind, parallel-group trial was conducted involving 42 participants (21 with first-episode depressive disorder and 21 with recurrent depressive disorder) recruited from Chengdu, China. All subjects received 10 sessions of TMS over two weeks. The primary outcome measure was suicidal ideation, assessed using the Beck scale for suicide ideation. Secondary outcomes included sleep quality, depressive symptoms, anhedonia, and cognitive function. Event-related potentials (ERPs) were also recorded. Data were analyzed using SPSS V.21.0, with statistical significance defined as p < 0.05. Results: Both patient groups exhibited significant reductions in suicidal ideation following the composite TMS intervention. Secondary outcomes showed significant improvements in sleep quality, overall depressive symptoms, anhedonia, and cognitive function. Notably, a significant association was found between improvements in sleep quality and depressive symptoms in the first-episode group, suggesting differential underlying mechanisms compared to recurrent depression. Limitations: The relatively short intervention and follow-up period limits the ability to assess the long-term sustainability of the observed benefits. Future studies with extended follow-up periods are warranted to evaluate the persistence of TMS effects and the potential need for maintenance sessions. Conclusions: The combined protocol of iTBS and low-frequency TMS effectively reduces suicidal ideation and improves various clinical outcomes in both first-episode and recurrent depressive disorders, indicating the effectiveness of the physical intervention, especially for the first-episode patients. These findings underscore the importance of personalized treatment strategies based on the clinical history of depressive episodes. Further research with longer follow-up periods is warranted to assess the long-term sustainability of TMS effects. Full article
(This article belongs to the Special Issue Anxiety, Depression and Stress)
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