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This study is to investigate the relationship between the intestinal microbiota and urine levels of the ellagic acid-derived polyphenols, the urolithins, in a cohort of subjects following a three-week walnut dietary intervention. We longitudinally collected fecal and urine samples from 39 subjects before and after walnut consumption (2 oz per day for 21 days). 16S RNA gene sequencing was performed on fecal DNA to study the association between microbiota composition and the levels of nine urolithin metabolites, which were measured using UHPLC/Q-TOF–MS/MS. Fecal microbial composition was found to be significantly different between pre- and post-walnut intervention (beta diversity, FDR-p = 0.018; alpha diversity, p = 0.018). Roseburia, Rothia, Parasutterella, Lachnospiraceae UCG-004, Butyricicoccus, Bilophila, Eubacterium eligens, Lachnospiraceae UCG-001, Gordonibacter, Paraprevotella, Lachnospira, Ruminococcus torques, and Sutterella were identified as the 13 most significantly enriched genera after daily intake of walnuts. We observed 26 genera that were significantly associated with 7 urolithin metabolites, with 22 genera positively correlating after walnut supplementation (FDR-p ≤ 0.05). PICRUSt analysis showed that several inferred KEGG orthologs were associated with 4 urolithin metabolites after walnut intake. In this study, we found that walnut supplementation altered urolithin metabolites, which associates with specific changes in bacterial taxa and inferred functional contents. [ABSTRACT FROM AUTHOR]

Background: A recent phase 2A clinical study of Atractylodes lancea (Thunb.) DC. (AL) in patients with advanced-stage intrahepatic cholangiocarcinoma (iCCA) demonstrated significant reduction of the risk of tumor progression and mortality with a dose ranging from 1,000 to 2,000 mg. The present study aimed to determine the potential dosage regimen of AL for further phase 2B clinical study. Methods: Plasma-concentration time profiles of total AL bioactivity and clinical efficacy in patients with advanced-stage iCCA were obtained from Phase 2 A study. The population pharmacokinetic (pop-PK) model was developed. The pop-PK model and Monte-Carlo (MC) simulation, in conjunction with maximum concentration of AL (Cmax) as a cut-off criterion, was performed and validated with clinical data. The optimal model was used to simulate further dosage regimens and clinical efficacy of AL. Results: The pop-PK properties of total AL bioactivity were best described by a compartmental model with zero-order absorption (without delay) and linear clearance. None of the investigated covariates improved model accuracy.The developed pop-PK with MC simulations following once-daily dosing of 1,000 mg and 2,000 mg adequately predicted the clinical efficacy (tumor progression and mortality). The once-daily dose of 2,500 mg is recommended for further phase 2B clinical study due to its relatively high efficacy on tumor progression inhibition (73%) and mortality rate reduction (71%) without excessive number of the administered capsules (23 capsules) and low risk of toxicities (<5%). Conclusions: The applied pop-PK model with MC simulation, along with the appropriate cut-off pharmacokinetic parameters, can be used as a potential tool for supporting dosage prediction and selection for clinical studies, and thus reducing the rate of drug development failures. Trial registration: www.thaiclinicaltrials.org, WHO ICTRP search, TCTR20210129007, Registed 29 January 2021. [ABSTRACT FROM AUTHOR]

The aim of this prospective, multi-center, practice-based cohort study was to analyze factors associated with the success of implant supported all-ceramic single-unit crowns, made by computer-aided-design/computer-aided-manufacturing (CAD-CAM). All-ceramic crowns placed in a private practice-based research network (Ceramic Success Analysis, AG Keramik) were analyzed. Data from 567patients with CAD-CAM implant supported all-ceramic crowns placed between 2008–2023 by 54dentists were evaluated. Firstly, all crowns with at least one follow-up control were included (n = 907). Secondly, all crowns being followed up for ≥ 5years and all failures were included (n = 151). At the latest follow-up visit, crowns were considered as successful (not failed) if they were still in function without the need for additional therapy. Multi-level Cox proportional hazards models were used to evaluate the association between a range of predictors and time of success. Within a mean follow-up period (SD) of 2.5 (2)years (first scenario) and 6.2 (1.2)years (second scenario) [maximum:12years], 27crowns failed (annual failure rate [AFR]:0.74 %). The main failure types were decementation, (n = 11), fracture of the ceramic (n = 4) or Ti-Base (n = 4). In 5-year-scenario, crowns fabricated in the laboratory had 26times lower failure rate than those fabricated chairside (95 %CI:0.0–0.7;p = 0.038). Furthermore, the use of a silane (HR:0.051;95 %CI:0.0–0.5;p = 0.014) and etching of the ceramic (HR:0.053;95 %CI:0.0–0.8;p = 0.035) resulted in a significantly higher risk for failure than their non-use. For CAD-CAM manufactured implant supported all-ceramic crowns, high success rates were found in up to 12-year evaluation. Furthermore, after 5years, no patient-or implant-level factors, but operative-level factor (i.e.fabrication method, use of silane/etching) were significantly associated with failure. The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00020271). • Implant-supported ceramic crowns showed high success rates (97 %) after up to 12 yrs • After 5 years no patient-level factors were significantly associated with failure • After 5 years no implant-level factors were significantly associated with failure • Lab-side fabricated crowns showed a 26x lower failure rate than chairside ones [ABSTRACT FROM AUTHOR]

Purpose: PSMA/PET has been increasingly used to detect PCa, and PSMA/PET-guided biopsy has shown promising results. However, it cannot be confirmed immediately whether the tissues are the targeted area. In this study, we aimed to develop a novel probe, [123I]I-PSMA-7. First, we hope that [123I]I-PSMA-7 can provide instant confirmation for prostate biopsy. Second, we hope it will help detect PCa. Methods: We synthesized a high-affinity probe, [123I]I-PSMA-7, and evaluated its properties. We included ten patients with suspected PCa and divided them into two groups. The injection and biopsy were approximately 24 h apart. The activity in biopsy lesions was measured as the cpm by a γ-counter. Moreover, we enrolled 3 patients to evaluate the potential of [123I]I-PSMA-7 for detecting PCa. Results: Animal experiments verified the safety, targeting and effectiveness of [123I]I-PSMA-7, and the tumor-to-muscle ratio was greatest at 24 h, which confirmed the results of this study in humans. After injection of 185MBq [123I]I-PSMA-7, 18/55 cores were positive, and the cpm was significantly greater (4345 ± 3547 vs. 714 ± 547, P < 0.001), with an AUC of 0.97 and a cutoff of 1312 (sens/spec of 94.40%/91.90%). At a lower dose, 10/55 biopsy cores were cancerous, and the cpm was 2446 ± 1622 vs. 153 ± 112 (P < 0.001). The AUC was 1, with a cutoff value of 490 (sens/spec of 100%). When the radiopharmaceuticals were added to 370 MBq, we achieved better SPECT/CT imaging. Conclusion: With the aid of [123I]I-PSMA-7 and via cpm-based biopsy, we can reduce the number of biopsies to a minimum operation. [123I]I-PSMA-7 PSMA SPECT/CT can also provide good imaging results. Trial registration: Chinese Clinical trial registry ChiCTR2300069745, Registered 24 March 2023 [ABSTRACT FROM AUTHOR]

Purpose: Olfactory dysfunction is increasingly common among COVID-19 patients, impacting their well-being. Reports have demonstrated decreased levels of cyclic adenosine monophosphate and cyclic guanosine monophosphate among patients with chronic olfactory dysfunction. A prospective randomized clinical trial was developed to demonstrate the efficacy of an oral forskolin regimen treatment, an adenylyl cyclase activator that raises intracellular levels of cyclic adenosine monophosphate, for the treatment of olfactory dysfunction following COVID-19, compared to placebo regimen. Methods: The study enrolled 285 participants with persistent olfactory dysfunction post COVID-19 infection, randomly assigning them to receive either placebo capsules (n = 120) or oral forskolin capsules (n = 165). Follow-up was conducted to track progress, with 18 participants from the placebo group and 12 from the forskolin group lost during this period. Olfactory function was assessed using the "Sniffin' Sticks" test, measuring threshold, discrimination and identification scores before and after treatment. Results: Subjects administered forskolin capsules demonstrated a significant enhancement in their composite TDI (threshold, discrimination and identification) score, suggesting a notable amelioration in olfactory functionality. Moreover, the discrimination and identification scores notably improved within the forskolin group. Conversely, no significant alterations were observed in the threshold scores. Conclusion: This study suggests that forskolin can contribute potentially to improve chronic olfactory dysfunction post COVID-19. Trial registration: DFM-IRB00012367-23-10-001. [ABSTRACT FROM AUTHOR]

Background Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra , have shown promise in alleviating CNSLBP. Objectives Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration. Methods A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy–placebo or placebo–homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight. Discussion The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP. Trial Registration UMIN Clinical Trials Registry – ID: UMIN000051957 [ABSTRACT FROM AUTHOR]

Objective. To analyze the clinical effect of prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate to treat senile diabetic nephropathy (DN). Methods. The clinical data of 110 elderly patients with DN in our hospital from November 2020 to November 2021 were selected for retrospective analysis, and they were divided into the observation group (OG, n = 55) and the control group (CG, n = 55) according to the principle of random grouping. The CG received conventional therapy and calcium dobesilate, and the OG received conventional therapy, calcium dobesilate and prescription used for invigorating spleen, reinforcing kidney and warming yang to evaluate the clinical value of different treatment programs by comparing their clinical indicators after treatment. Results. The total effective rate of clinical treatment in the OG was clearly higher than the CG (P < 0.05). The blood glucose indexes, and the levels of ALB and RBP in the OG were visibly lower than the CG after treatment (P < 0.001). After treatment, the average levels of BUN and Cr in the OG were visibly lower than the CG (P < 0.001), while the average eGFR level was significantly higher than the CG (P < 0.001). Conclusion. The prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate is a reliable method to improve the hemorheology indexes and renal function of DN patients, which benefits patients, and further studies are helpful to establish a better solution for such patients. [ABSTRACT FROM AUTHOR]

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Cannabidiol (CBD) is a non-psychoactive substance that exerts numerous pharmacological benefits, including anti-inflammatory and antioxidant properties. It has received attention as a useful substance for the treatment of intractable pain, seizures, and anxiety, and related clinical trials have continued. However, the CBD pharmacokinetic results between reports are highly variable, making it difficult to clearly identify the pharmacokinetic properties of CBD. The main purpose of this study was to identify CBD clinical pharmacokinetic properties through meta-analysis. In particular, we sought to derive valid, interpretable independent variables and interpret their pharmacokinetic parameter correlations in relation to the large inter-individual and inter-study variability in CBD pharmacokinetics. For this study, CBD-related clinical trial reports were extensively screened and intercomparisons were performed between internal data sets through systematic classification and extraction of pharmacokinetic parameter values. The candidate independent variables associated with interpretation of CBD pharmacokinetic diversity established and explored in this study were as follows: diet, tetrahydrocannabinol (THC) combination, sample matrix type, liver and renal function, exposure route, dosage form, CBD exposure dose, cannabis smoking frequency, multiple exposure. The results of this study showed that CBD pharmacokinetics were influenced (increased plasma exposure by approximately 2–5 times) by diet immediately before or during CBD exposure, and that THC was not expected to have an antagonistic effect on the CBD absorption. The influence of changes in liver function would be significant in CBD pharmacokinetic diversity. Due to decreased liver function, the plasma exposure of CBD increased 2.57–5.15 times compared to healthy adults, and the half-life and clearance showed a 2.58-fold increase and a 5.15-fold decrease, respectively. CBD can be rapidly absorbed into the body (time to reach maximum concentration within 3.18 h) by oral, transdermal, and inhalation exposures, and lipid emulsification and nanoformulation of CBD will greatly improve CBD bioavailability (up to approximately 2 times). The pharmacokinetics of CBD generally follow linear kinetic characteristics. The importance of this study is that it suggests key factors that should be considered in terms of pharmacokinetics in further clinical trials and formulations of CBD in the future. [ABSTRACT FROM AUTHOR]

The objective of this study was to assess the downsides of surgical treatment of scaphoid fracture nonunion in patients with minor preoperative symptoms. Patients were classified with minor symptoms based on the Patient-Rated Hand/Wrist Evaluation questionnaire. Of the 35 included patients, most patients encountered problems with patient-specific activities; 9% reported worse postoperative functional outcomes, 34% were not satisfied with the treatment and 9% were reoperated. The risk of a worse functional outcome after surgery with the need for further operations and the chance of developing wrist osteoarthritis, along with the possibility of poor patient satisfaction and ongoing daily functional impairment, should be considered during preoperative counselling. Level of evidence: III [ABSTRACT FROM AUTHOR]

ABSTRACT Objective Methods Results Conclusions The clinical management of partial bone defects in lower limbs, particularly those resulting from osteomyelitis, remains a significant challenge. This study aimed to systematically evaluate the effectiveness of 3D‐printed porous Ti6Al4V prostheses in addressing osteomyelitis‐induced partial bone defects.We established a comprehensive protocol for utilizing 3D‐printed prostheses for bone defect repair, encompassing 3D simulation of prosthesis implantation and internal fixation, finite element analysis (FEA), and clinical implementation. Mimics software facilitated simulation of fixation patterns and screw lengths. FEA modeled bone defects in the distal metaphyseal femur and distal diaphyseal tibia to assess changes in stress conduction pre‐ and post‐prosthesis implantation. The clinical study involved eight patients (average age: 56.3 years) with an average defect length of 14.9 cm. Postoperative outcomes were evaluated using X‐rays and the Lower Extremity Functional Scale (LEFS).FEA demonstrated that the implanted prostheses effectively shared stress and reduced the load on residual bone in both models, thus lowering the risk of fractures under external forces. The average follow‐up period was 24.5 months, with patients initiating weight‐bearing activities on average 7.8 days post‐surgery. Serial postoperative X‐rays demonstrated long‐term stability of the prostheses, with progressive bone regeneration around and integration with the prostheses. While two patients experienced infection recurrence requiring prosthesis removal and debridement, the remaining six showed significant improvement in LEFS scores, increasing from 31.5 preoperatively to 61.0 at the last follow‐up.3D‐printed porous Ti6Al4V prostheses effectively restore anatomical integrity and optimize stress conduction in lower limbs, resulting in substantial functional recovery. This innovative approach shows promise for wider clinical adoption and warrants further investigation in medical practice. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective Methods Results Conclusions To examine the impact of fluocinonide 0.05% gel formulation for the topical treatment of oral lichen planus (OLP).Through an RCT design, 47 patients with OLP were randomly allocated for topical OLP treatment with fluocinonide 0.05% (n = 23) or placebo (n = 24). Patients were examined for OLP symptoms, signs, disease severity, and extension score changes over 6‐month follow‐up.After 6 months, in comparison with placebo, patients treated with fluocinonide experienced a significant reduction of OLP symptoms (p = 0.024), signs (p = 0.014), and OLP extension score (p = 0.028). The two‐way ANOVA estimation models revealed that treatment with fluocinonide determined, at 6 months, a positive significant effect on the reduced OLP signs (p = 0.017), OLP symptoms (p = 0.026), and OLP extension score (p = 0.028). The multivariate regression analysis highlighted that anxiety, stress, and depression were significant predictors of every analyzed OLP outcome (p < 0.05 for each parameter) and that patients who had baseline anxiety, depression, and stress gained more benefits from fluocinonide at 6‐month follow‐up.Topical fluocinonide 0.05% was more efficacious compared to placebo in reducing OLP outcomes at 6‐month follow‐up. Anxiety, depression, and stress were significant predictors of OLP outcomes and positively impacted the treatment with fluocinonide at 6 months. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Aims Methods Results Conclusion Rosacea is more common in women and Caucasians, leading to little research on rosacea in Asian men. Additionally, there is limited research on the patients across different age groups.The aim of this study is to analyze and compare the characteristics of male patients of rosacea among different age groups.A retrospective analysis was conducted on 215 male patients with rosacea, investigating their characteristics, clinical symptoms, exacerbating factors, complications, psychological status, and treatment, as well as exploring factors influencing the early onset of male rosacea.The patients were divided into three age groups (≤ 30 years, 31–44 years, and ≥ 45 years), with the study revealing an average age of 38.59 ± 13.13 years among the patients. The most common subtype of rosacea in men was erythematotelangiectatic rosacea (ETR), followed by phymatous rosacea (PhR). The main reported features included persistent erythema (87.4%) and telangiectasia (71.2%), predominantly affecting the nose (58.6%) and cheeks (56.3%). Twenty‐six percent of patients reported concurrent skin diseases, with 14.0% reporting systemic diseases. Significant differences were observed among different age groups regarding family history, clinical features, lesion distribution, symptom severity, aggravating factors, presence of systemic diseases, and treatment preferences. Subjective skin typing, Fitzpatrick phototype, and positive family history were identified as factors influencing the age of onset of rosacea in men.Male patients with rosacea exhibit distinct clinical characteristics, with a greater prevalence of nasal involvement and nasal lesions among male patients. Clinical features vary among different age groups, with patients aged ≥ 45 experiencing more complex and severe symptoms. Patients aged ≤ 30 may be more influenced by genetic factors and have higher treatment expectations. [ABSTRACT FROM AUTHOR]

Changes in the expression of cornified envelope (CE) components are a hallmark of numerous pathological skin conditions and aging, underlying the importance of this stratum corneum structure in the homeostasis of the epidermal barrier. We performed a detailed characterisation of LCE6A, a member of the Late Cornified Envelope protein family. Immunohistochemical and immunoblot experiments confirmed that LCE6A is expressed late during epidermal differentiation. Crosslinking assays of recombinant LCE6A performed either in situ on human skin sections or in vitro demonstrated that LCE6A is indeed a substrate of transglutaminases and crosslinked to CEs. LCE6A‐derived peptides containing a glutamine‐lysine sequence retained these properties of the full‐length protein and reinforced the mechanical resistance of CE submitted to sonication. We designed P26, a LCE6A‐derived biomimetic peptide that similarly reinforced CE in vitro, and evaluated its protective properties ex vivo, on human skin explants, and in two double blind and vehicle‐controlled clinical trials. P26 was able to protect the skin from barrier disruption, to limit the damage resulting from a defective barrier, and could improve the signs of aging such as loss of skin firmness and increased skin roughness. Hence, our detailed characterisation of LCE6A as a component of the CE enabled us to develop a LCE6A‐derived peptide, biologically active with a new and original mode of action that could be of great interest as a cosmetic ingredient and a pharmacologic agent. [ABSTRACT FROM AUTHOR]

Background VS-505 (AP301), an acacia and ferric oxyhydroxide polymer, is a novel fiber-iron-based phosphate binder. This two-part Phase 2 study evaluated the tolerability, safety and efficacy of oral VS-505 administered three times daily with meals in treating hyperphosphatemia in chronic kidney disease (CKD) patients receiving maintenance hemodialysis (MHD). Methods In Part 1, patients received dose-escalated treatment with VS-505 2.25, 4.50 and 9.00 g/day for 2 weeks each, guided by serum phosphorus levels. In Part 2, patients received randomized, open-label, fixed-dosage treatment with VS-505 (1.50, 2.25, 4.50 or 6.75 g/day) or sevelamer carbonate 4.80 g/day for 6 weeks. The primary efficacy endpoint was the change in serum phosphorus. Results The study enrolled 158 patients (Part 1: 25; Part 2: 133), with 130 exposed to VS-505 in total. VS-505 was well tolerated. The most common adverse events were gastrointestinal disorders, mainly feces discolored (56%) and diarrhea (15%; generally during Weeks 1–2 of treatment). Most gastrointestinal disorders resolved without intervention, and none was serious. In Part 1, serum phosphorus significantly improved (mean change −2.0 mg/dL; 95% confidence interval −2.7, −1.4) after VS-505 dose escalation. In Part 2, serum phosphorus significantly and dose-dependently improved in all VS-505 arms, with clinically meaningful reductions with VS-505 4.50 and 6.75 g/day, and sevelamer carbonate 4.80 g/day [mean change −1.6 (−2.2, −1.0), −1.8 (−2.4, −1.2) and −1.4 (−2.2, −0.5) mg/dL, respectively]. In both parts, serum phosphorus reductions occurred within 1 week of VS-505 initiation, returning to baseline within 2 weeks of VS-505 discontinuation. Conclusion VS-505, a novel phosphate binder, was well tolerated with a manageable safety profile, and effectively and dose-dependently reduced serum phosphorus in CKD patients with hyperphosphatemia receiving MHD. Clinical Trial registration number NCT04551300 [ABSTRACT FROM AUTHOR]

Simple Summary: Doppler ultrasound is a commonly utilised non-invasive blood pressure measurement technique in dogs under general anaesthesia. This prospective clinical study compared the agreement of values obtained by audible return of pulsatile flow using Doppler ultrasound and visual sphygmomanometer needle oscillation with invasive arterial blood pressure in a clinical population of anaesthetised dogs. Visual sphygmomanometer needle oscillation (SNO) can occur before audible return of pulsatile flow (ARPF) when measuring blood pressure by Doppler ultrasound. The aim was to assess the agreement of SNO and ARPF with invasive blood pressure (iABP) in a clinical population of anaesthetised dogs. A total of 35 dogs undergoing surgery in dorsal recumbency necessitating arterial cannulation were included. Paired measurements of iABP and SNO, and iABP and ARPF, were collected. The agreement of non-invasive blood pressure (NIBP) and iABP measurements was analysed with concordance correlation coefficients (CCCs) and Bland–Altman plots. The proportions of SNO and ARPF measurements between 10 and 20 mmHg of iABP were compared. Both SNO and ARPF demonstrated greater agreement with invasive systolic (iSAP) than invasive mean (iMAP) pressures, and SNO demonstrated greater agreement with iSAP than ARPF measurements. The mean differences (95% limits of agreement) for SNO and APRF were −9.7 mmHg (−51.3–31.9) and −13.1 mmHg (−62.2–35.9), respectively. The CCC (95% CI) for SNO was 0.5 (0.36–0.64) and ARPF was 0.4 (0.26–0.54). A significantly greater proportion of SNO measurements were within 20 mmHg of iSAP compared to ARPF. Both NIBP techniques performed more poorly than veterinary consensus recommendations for device validation. Caution should be used clinically when interpreting values obtained by Doppler ultrasound in anaesthetised dogs. [ABSTRACT FROM AUTHOR]

Gallic acid (GA) proved to produce desired effects topically in the treatment of acne, through its antibacterial, anti-inflammatory and antioxidant characteristics. In the current work, nanovesicular systems; aspasomes loaded with GA were prepared, and evaluated on in-vitro and ex-vivo levels. Formulations were coated with chitosan due to its mucoadhesive properties. Results indicated that the size of the formulations ranged between 273.20 and 855.00 nm, with positively charged zeta potential ranging between 30.60 and 34.40 mV, EE% ranging between 57.651% and 95.20% and good stability after 3-months storage. The formulae provided a sustained drug release of 98.22% over 24 h, 5.4-fold higher ex-vivo skin deposition compared to GA solution, and powerful antioxidant potential compared to the control solution and appeared as spherical bilayer vesicles on being examined using transmission electron microscope. A clinical study was carried out on patients suffering from acne, where the reduction percent of comedones, inflammatory, total acne lesions and infiltrate was calculated. Results revealed that aspasomes exhibited reduction percentages of 72.35%, 80.33%, 77.95% and 90.01% ± for comedones, inflammatory lesions, total lesions, and infiltrate, respectively compared to control solution providing an effective topical delivery system for the management of acne. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the influence of various patient-specific and bracket location-specific factors on bracket survival rates during comprehensive fixed appliance orthodontic treatment. A total of 197 patients (116 females, 81 males; mean age 16.3 years) having completed orthodontic treatment were included in this retrospective cohort study. Patients were treated using stainless steel non-self-ligating brackets, and the treatment duration was 23.7 months on average. The primary outcome was bracket bond failure. Potential predictors for bracket bond failure recorded included age, sex, oral hygiene, treatment duration, and several pre-treatment cephalometric characteristics such as overjet, overbite, and sagittal and vertical skeletal relationships. Factors associated with bracket failure were analysed with Cox regression, and proportional hazard assumptions were assessed using Kaplan–Meier tests. The overall failure rate was 4.4%. Bracket bond failure rates varied among tooth types and seemed to occur more on posterior teeth and on the right side of the arch. Bracket failure was more common in male patients and those with poor oral hygiene. Concerning dentofacial characteristics, bracket failure of anterior teeth was more common in those with an increased overjet and overbite. [ABSTRACT FROM AUTHOR]

Simple Summary: Raman spectroscopy is a label-free optical method that has proven its suitability for the discrimination between cancerous and noncancerous tissue. Bladder cancer diagnosis typically relies on excisional biopsies and histopathology, which are considered the gold standard. Here, we want to use an endoscopic setup to demonstrate the applicability of Raman spectroscopy in a clinical in vivo setting. In the European Union, the regulatory framework is given by the Medical Device Regulation. We describe the path and the necessary effort to be able to conduct a clinical investigation within this framework. The aim of this clinical examination was to perform Raman spectroscopy in the living bladder and to record Raman spectra of normal and tumorous bladder tissue and to determine the degree of bladder tumor in a post-processing step. The open prospective study includes 21 patients and presents preliminary results for the diagnostic abilities of our approach. This work reports on an in vivo Raman-based endoscopy system, invaScope, enabling Raman measurements of healthy and tumor bladder tissue during an endoscopic procedure in the operating theatre. The presented study outlines the progression from the initial concept (validated through previously performed ex vivo studies) to the approval and implementation of a clinical investigational device according to the requirement within the framework of the European Medical Device Regulation (MDR2017/745). The study's primary objective was to employ the invaScope Raman system within the bladder, capturing in vivo spectroscopic Raman data followed by standard histo- and cytopathological examinations of urological tissue (considered the gold standard). The collected data were analyzed and correlated with histopathological findings post-procedure. Additionally, the study aimed to assess the feasibility of using diagnostic equipment, probes, and software for application in a clinical setting, evaluating usability aspects that are important during surgical procedures. This research represents a pivotal step toward advancing Raman spectroscopy for routine clinical use in characterizing bladder lesions. [ABSTRACT FROM AUTHOR]

Dermal allyl isothiocyanate (AITC) administration and whole-body heat stress (WBHS) are two challenge models that are used to evaluate physiological mechanisms of vasodilation and pharmacological activity in humans. Their exact vasodilatory mechanisms in humans are not fully elucidated but are likely to be nitric oxide (NO)-mediated. This study aimed to evaluate whether there is overlap in the vasodilatory pathways of dermal AITC application and WBHS by combining the challenges. In this open-label interventional study, healthy volunteers underwent dermal administration of AITC twice: under basal conditions and during WBHS. Dermal blood flow (DBF) was non-invasively measured using laser speckle contrast imaging four times, once in each of the following situations: baseline, WBHS only, AITC only, and WBHS combined with AITC. A total of 12 male volunteers, aged 18– 61 years, participated in the study. Compared to baseline, following AITC application, their DBF increased by 63.43 AU (baseline: 32.55, 95% CI [17.78, 47.31] AU, AITC only: 95.97, 95% CI [81.21, 110.7] AU, p < 0.0001). During WBHS, the increase in DBF after AITC was 42.76 AU (WBHS only: 87.25, 95% CI [72.49, 102.0] AU, WBHS+AITC: 130.0, 95% CI [115.2, 144.8] AU, p < 0.0001). The combination of WBHS and AITC resulted in a lower DBF than the sum of the DBF responses to AITC and WBHS when applied separately (ED 20.67, 95% CI [− 3.532, 44.88], p = 0.0916). This might point towards the presence of an interaction in the vasodilatory mechanism of AITC application and WBHS, possibly indicating overlap in their NOS-driven vasodilatory pathways. [ABSTRACT FROM AUTHOR]

BACKGROUND: Endocan was reported to affect breast cancer patients negatively and was able to be detected from patients' blood. OBJECTIVE: This study aimed to investigate if the measurement of blood endocan in breast cancer patients with high ESM1 expression could be an effective tool to detect postoperative recurrence compared with existing tumor markers. METHODS: Blood was collected before and after the tumor resection from the mouse models of breast cancer, and endocan levels were measured while visualizing metastatic recurrence with noninvasive luminescence imaging. In clinical settings, blood was withdrawn from 16 breast cancer patients before and after the tumor resection, and the effect of lumpectomy on blood endocan level was evaluated. Additionally, the blood endocan from 20 patients diagnosed with postoperative recurrence was measured, and their positivity rate for endocan was compared with that for serum carcinoembryonic antigen (CEA) or cancer antigen 15-3 (CA15-3). RESULTS: Our preclinical and clinical experiments revealed that blood endocan levels reflected tumor burden. Furthermore, over 60% of patients suffering from postoperative recurrence who tested negative for CEA or CA15-3 were positive for endocan. CONCLUSIONS: Our results support the clinical significance of endocan in breast cancer patients for detecting breast cancer recurrence. [ABSTRACT FROM AUTHOR]

Reproducible and standardised neurological assessment scales are important in quantifying research outcomes. These scales are often performed by non-neurologists and/or non-clinicians and must be robust, quantifiable, reproducible and comparable to a neurologist's assessment. COVID-CNS is a multi-centre study which utilised the Neurological Impairment Scale (NIS) as a core assessment tool in studying neurological outcomes following COVID-19 infection. We investigated the strengths and weaknesses of the NIS when used by non-neurology clinicians and non-clinicians, and compared performance to a structured neurological examination performed by a neurology clinician. Through our findings, we provide practical advice on how non-clinicians can be readily trained in conducting reproducible and standardised neurological assessments in a multi-centre study, as well as illustrating potential pitfalls of these tools. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the radiographic outcomes of lateral sinus floor elevation with simultaneous implant placement at sites without sinus membrane perforation (SMP) and sites with SMP managed with a resorbable membrane. Materials and Methods: One hundred and thirty‐nine patients and 170 implants (56 perforation, 114 non‐perforation) were included. Cone‐beam computed tomography (CBCT) images were taken before surgery (T0), immediately after surgery (T1) and 6 months after surgery (T2). Post‐operative augmentation parameters, including endo‐sinus bone gain (ESBG) along the implant axis, mean new bone height (NBH) surrounding the implant and augmentation volume (AV), were measured at T1 and T2. Results: At T1, there were no significant differences in ESBG, NBH and AV between the two groups. At T2, although ESBG did not significantly differ between the two groups, NBH (8.50 ± 1.99 mm vs. 9.99 ± 2.52 mm, p =.039) and AV (519.37 ± 258.38 mm3 vs. 700.99 ± 346.53 mm3, p <.001) were significantly lower in the perforation group. The shrinkage of graft material from T1 to T2, including ΔESBG (p =.002), ΔNBH (p <.001) and ΔAV (p <.001), was higher in the perforation group. Conclusions: SMP during LSFE with simultaneous implant placement is associated with greater resorption of the grafted area at a 6‐month follow‐up. [ABSTRACT FROM AUTHOR]

Purpose: Several hundreds of patients have been so far treated in clinical trials with boron neutron capture therapy (BNCT). Methods: This is a non-systematic review of clinical trials with BNCT, with special emphasis on the more recent trials. Results: The conducted trials have been relatively small single-arm studies and included mostly the patients with head and neck carcinomas resistant to traditional treatment modalities and glioblastomas. In general, the efficacy results have been promising and BNCT has been relatively well tolerated, even in the patients who have already been treated with conventional radiotherapy or chemoradiation. The most frequent adverse events have been similar to those associated with the conventional radiotherapy. At present, there is no evidence how the efficacy of BNCT would compare to the standard treatment modalities in earlier treatment lines. Conclusions: Most of the existing studies have been performed with reactor-based facilities, but there is now a rapidly increasing number of linear accelerator-based BNCT sites, and the clinical research is apparently activating again. This, combined with the increased knowledge on cancer biology and novel types of oncological therapies, opens possibilities to study innovative boron carriers and to combine BNCT with modern oncological therapies in the future clinical trials. To conduct larger phase III trials, multicenter approaches are encouraged to be applied, keeping in mind the importance of joint instructions and quality control measurements. [ABSTRACT FROM AUTHOR]

Abstract This study is to investigate the relationship between the intestinal microbiota and urine levels of the ellagic acid-derived polyphenols, the urolithins, in a cohort of subjects following a three-week walnut dietary intervention. We longitudinally collected fecal and urine samples from 39 subjects before and after walnut consumption (2 oz per day for 21 days). 16S RNA gene sequencing was performed on fecal DNA to study the association between microbiota composition and the levels of nine urolithin metabolites, which were measured using UHPLC/Q-TOF–MS/MS. Fecal microbial composition was found to be significantly different between pre- and post-walnut intervention (beta diversity, FDR-p = 0.018; alpha diversity, p = 0.018). Roseburia, Rothia, Parasutterella, Lachnospiraceae UCG-004, Butyricicoccus, Bilophila, Eubacterium eligens, Lachnospiraceae UCG-001, Gordonibacter, Paraprevotella, Lachnospira, Ruminococcus torques, and Sutterella were identified as the 13 most significantly enriched genera after daily intake of walnuts. We observed 26 genera that were significantly associated with 7 urolithin metabolites, with 22 genera positively correlating after walnut supplementation (FDR-p ≤ 0.05). PICRUSt analysis showed that several inferred KEGG orthologs were associated with 4 urolithin metabolites after walnut intake. In this study, we found that walnut supplementation altered urolithin metabolites, which associates with specific changes in bacterial taxa and inferred functional contents.

Abstract Background A recent phase 2A clinical study of Atractylodes lancea (Thunb.) DC. (AL) in patients with advanced-stage intrahepatic cholangiocarcinoma (iCCA) demonstrated significant reduction of the risk of tumor progression and mortality with a dose ranging from 1,000 to 2,000 mg. The present study aimed to determine the potential dosage regimen of AL for further phase 2B clinical study. Methods Plasma-concentration time profiles of total AL bioactivity and clinical efficacy in patients with advanced-stage iCCA were obtained from Phase 2 A study. The population pharmacokinetic (pop-PK) model was developed. The pop-PK model and Monte-Carlo (MC) simulation, in conjunction with maximum concentration of AL (Cmax) as a cut-off criterion, was performed and validated with clinical data. The optimal model was used to simulate further dosage regimens and clinical efficacy of AL. Results The pop-PK properties of total AL bioactivity were best described by a compartmental model with zero-order absorption (without delay) and linear clearance. None of the investigated covariates improved model accuracy.The developed pop-PK with MC simulations following once-daily dosing of 1,000 mg and 2,000 mg adequately predicted the clinical efficacy (tumor progression and mortality). The once-daily dose of 2,500 mg is recommended for further phase 2B clinical study due to its relatively high efficacy on tumor progression inhibition (73%) and mortality rate reduction (71%) without excessive number of the administered capsules (23 capsules) and low risk of toxicities (

Objective: This study aimed to explore the clinical effects of music therapy (MT) on premature infants in neonatal intensive care units (NICUs). Methods: A total of 78 premature infants in NICUs admitted from January 2021 to January 2022 in Wuhan Children’s Hospital, Tongji Medical College, and Huazhong University of Science and Technology were selected as the reference group and received routine management. Wuhan Children’s Hospital implemented MT from February 2022 to February 2023, and 74 premature infants in NICUs admitted during the same period were selected as the observation group. The corresponding management mode was implemented on the second day of NICU admission for premature infants. Amplitude-integrated electroencephalogram (aEEG) and neonatal behavioral neurological assessment (NBNA) were adopted to evaluate the brain function, specifically the neurological function of neonates, after the end of management. The degree of parent–child attachment was measured using the pictorial representation of attachment measure (PRAM) in a nonverbal (visual) manner. The temperature, pulse, respiratory rate (RR), the number and duration of crying, and incidence of complications were all compared between the two groups. Results: SPSS showed that no difference existed in the aEEG and NBNA scores between the two groups (P > 0.05). The distance of PRAM self-baby-distance was smaller in the observation group compared with the reference group (P < 0.05). Furthermore, there was no significant difference in temperature between the two groups (P > 0.05). The observation group had significantly lower pulse and RR values than the reference group (P < 0.05). Finally, no significant difference existed in the incidence of complications between the two groups (P > 0.05). Conclusion: MT has a certain application value for premature infants in NICUs and can thus be applied to newborns in other NICUs. However, further studies are required to completely verify the research results.

Background: Hypothyroidism is an endocrine disorder in which the thyroid gland does not produce an adequate amount of thyroid hormones. This study aimed to determine the efficacy of yoga asanas as an add-on therapy for the management of hypothyroidism. Materials and Methods: For this interventional clinical study, a total of 450 study participants were screened for eligibility. Out of this, 170 study participants were found fit for preliminary eligibility following stringent inclusion and exclusion criteria. Further, 58 participants were excluded before randomization. A total of 112 hypothyroidism patients (57 in the control group and 55 in the yoga group) participated in this study. The study participants were further followed up for 8 weeks in both the yoga practice (yoga+ standard care of treatment) and control group (standard care of treatment only). The markers of oxidative stress, inflammation, and thyroid hormones were assessed at baseline and after 8 weeks of follow-up/intervention. Results: After 8 weeks, the study participants in yoga group showed a significant reduction in serum thyroid-stimulating hormone and malondialdehyde levels as compared to baseline (P < 0.05). There was also a positive trend of improvement in other oxidative markers (catalase, superoxide dismutase, and glutathione), and a significant reduction in interleukin-6 levels (P < 0.05) was found in the yoga group as compared to the baseline. However, there was no significant change found in the control group of subjects. Conclusion: Frequent yoga practice can be an effective lifestyle intervention for hypothyroidism, reducing oxidative stress, inflammation, and potentially improving overall well-being.

Background Polycystic ovary syndrome with insulin resistance (PCOS-IR) is recognized as one of the most challenging subtypes of PCOS to treat due to its intricate pathogenesis and significant individual variability. Although Metformin, as a first-line medication, can ameliorate blood glucose levels and enhance insulin sensitivity, its efficacy in regulating hormonal imbalances and improving ovarian function is limited. Additionally, its gastrointestinal side effects often hinder patient adherence. Objective To evaluate the efficacy and safety of Yishen Quzhuo Formula compared to metformin in the treatment of PCOS-IR. Methods A prospective study enrolled 102 PCOS-IR patients from June 2022 to October 2023 at the Department of Gynecology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University. Patients were randomly assigned in a 2∶1 ratio to the experimental group (n=68) treated with Yishen Quzhuo Formula or the control group (n=34) treated with metformin. The comparison was made between the two groups in terms of ovulation rate, pregnancy rate, sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH/FSH ratio, testosterone (T), anti-Müllerian hormone (AMH) ], glucose and lipid metabolism indicators, BMI, waist-hip ratio (WHR), and incidence of adverse reactions. Results After treatment, the basal body temperature (BBT) ovulation rate in the experimental group increased compared to before treatment (P0.05). After treatment, both groups showed a decrease in LH/FSH compared to before treatment (P0.05). After treatment, the waist circumference of the control group was lower than that of the experimental group (P0.05). During treatment, adverse reactions such as hypoglycemia, fatigue, epigastric discomfort, and diarrhea occurred in patients, with a lower incidence of adverse reactions in the experimental group (5/68, 7.35%) than in the control group (15/31, 48.39%) (χ2=20.404, P

Skin injuries are a global healthcare problem. Chronic ulcers do not heal in a timely fashion, so it is essential to help the body with skin repair. There are some treatments that have been applied to chronic ulcers. One of these treatments is growth factor (GF) therapy. Platelet-rich plasma (PRP) and Platelet-poor plasma (PPP) are two types of plasma derivatives containing many GFs important for wound healing. Several works have reported their application in wound healing and tissue regeneration. The use of autologous PRP is now an adequate alternative in regenerative medicine. It was also demonstrated that PPP is a hemostatic agent for wounds. This review has studied the latest clinical studies, which have applied PRP and PPP to patients with chronic wounds.

Background: Wearable sensors have been heralded as revolutionary tools for healthcare. However, while data are easily acquired from sensors, users still grapple with questions about how sensors can meaningfully inform everyday clinical practice and research. Summary: We propose a simple, comprehensive framework for utilizing sensor data in healthcare. The framework includes three key processes that are applied together or separately to (1) automate traditional clinical measures, (2) illuminate novel correlates of disease and impairment, and (3) predict current and future outcomes. We demonstrate applications of the Automate-Illuminate-Predict framework using examples from rehabilitation medicine. Key Messages: Automate-Illuminate-Predict provides a universal approach to extract clinically meaningful data from wearable sensors. This framework can be applied across the care continuum to enhance patient care and inform personalized medicine through accessible, noninvasive technology.

The nicotine pharmacokinetics (PK) of non-combustible tobacco and nicotine products, including e-cigarettes, have been extensively studied, with lower or similar nicotine exposure reported for most products compared with combustible cigarettes (CC). We conducted two clinical studies to evaluate nicotine PK and assess nicotine consumption when using two types of e-cigarettes with different flavor variants in U.S. healthy adults who smoke, under similar study protocols.

Abstract The objective of this study was to evaluate clinical outcomes for patients undergoing IVF treatment where an artificial intelligence (AI) platform was utilized by clinicians to help determine the optimal starting dose of FSH and timing of trigger injection. This was a prospective clinical trial with historical control arm. Four physicians from two assisted reproductive technology treatment centers in the United States participated in the study. The treatment arm included patients undergoing autologous IVF cycles between December 2022–April 2023 where the physician use AI to help select starting dose of follicle stimulating hormone (FSH) and trigger injection timing (N = 291). The control arm included historical patients treated where the same doctor did not use AI between September 2021 and September 2022. The main outcome measures were total FSH used and average number of mature metaphase II (MII) oocytes. There was a non-significant trend towards improved patient outcomes and a reduction in FSH with physician use of AI. Overall, the average number of MIIs in the treatment vs. control arm was 12.20 vs 11.24 (improvement = 0.96, p = 0.16). The average number of oocytes retrieved in the treatment vs. control arm was 16.01 vs 14.54 (improvement = 1.47, p = 0.08). The average total FSH in the treatment arm was 3671.95 IUs and the average in the control arm was 3846.29 IUs (difference = −174.35 IUs, p = 0.13). These results suggests that AI can safely assist in refining the starting dose of FSH while narrowing down the timing of the trigger injection during ovarian stimulation, benefiting the patient in optimizing the count of MII oocytes retrieved.

Abstract Background Pulp stones are a type of pulp calcification, the presence of which tends to hinder endodontic treatment. Thus, this retrospective study aimed to analyze the distribution of pulp stones in the population in southwest China and identify the influencing factors. Materials Cone-beam computed tomography (CBCT) scans of 5066 teeth of 200 patients (91 males and 109 females) aged 16–45 years were evaluated. Pulp stones were marked as either present or absent when distinct radiopaque masses were found in the pulp cavity, then evaluated the occurrence of pulp stones with regard to tooth type, sex, age group, and contact it with tooth status. The Pearson chi-square test and nonparametric test were used for statistical analysis. Results Pulp stones were detected in 49.0% of patients and 7.4% of teeth, respectively. The incidence in females was 1.9 times higher than in males (OR = 1.9, 95% CI = 1.1–3.3, p = 0.001). Pulp stones were most prevalent in patients 36–45 years of age. Furthermore, in the age range of 16–45 years, the likelihood of finding pulp stones increased 1.1 times per year with age (OR = 1.1, 95% CI = 1.0–1.1, p = 0.032). A higher incidence of pulp stones was observed in the maxilla and molars. Of the 5066 teeth studied, pulp stones were more common in non-intact teeth. Conclusion Nearly half of the population in southwest China had pulp stones. Pulp stones were found significantly more often in females, maxilla, and non-intact teeth, and their frequency increased with age. For dentists, understanding the distribution of pulp stones is crucial for the proper design of root canal treatment (RCT). Trial registration This study was approved by the Ethics Committee of the Affiliated Hospital of Stomatology, Southwest Medical University (certificate number: 20220818001).

Introduction: Segmental spinal deformity results from vertebral compression fracture (VCF) and progressive collapse of the fractured vertebral body (VB). The VB stenting (VBS) systemⓇ comprises a balloon-assisted, expandable, intrasomatic, metal stent that helps maintain the restored VB during balloon removal and cement injection, which minimizes cement leakage. We performed a prospective, multicenter, clinical trial of the VBS system in Japanese patients with acute VCF owing to primary osteoporosis. Methods: Herein, 88 patients, 25 men and 63 women aged 77.4±8.3 years, with low back pain, numerical rating scale (NRS) score of 4, and mean VB compression percentage (VBCP) of

Introduction: For deep intrabony defects or Class II furcation involvements (FI), periodontal tissue regenerative therapy combined with bone graft materials and a barrier membrane is recommended. The objective of this study was to assess the safety and efficacy of using carbonate apatite (CO3Ap) granules and absorbable poly(lactic acid/caprolactone) (PLCL) membranes for periodontal regeneration in the treatment of intrabony defects and mandibular Class II FI. Methods: This prospective pilot clinical study, conducted at a single center with a single-arm design, aimed to assess the safety and efficacy of CO3Ap and PLCL membranes in patients with periodontitis. A total of 9 patients with 10 teeth, including seven deep intrabony defects and three Class II FI, were treated with CO3Ap granules and PLCL membranes. Clinical parameters such as probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), tooth mobility (Mo), Plaque Index (PI), and Gingival Index (GI) were assessed at baseline, 6 and 12 months post-surgery. Radiographic analysis was performed using dental X-rays and cone beam computed tomography (CBCT) images taken at baseline, 6, and 12 months post-surgery. Results: Postoperative healing was uneventful in most of the cases. In some cases, membrane exposures were observed. However, there were no signs of inflammation, such as abnormal bleeding, pain, swelling, or pus. These exposures eventually healed well in the end. The mean reductions in PPD at 6 and 12 months were 4.5 ± 1.6 mm and 4.9 ± 1.4 mm, respectively, while the mean gains in CAL were 4.4 ± 1.7 mm at 6 months and 4.6 ± 1.2 mm at 12 months. Radiographic analysis showed improvements in linear bone height within intrabony defects and in the vertical subclassification of FI in Class II FI. Conclusions: Despite the limitations of this study, periodontal regenerative therapy using CO3Ap granules and a PLCL membrane demonstrated promising clinical safety and efficacy for treating intrabony defects and mandibular Class II furcation involvement.

The aim of this study is to investigate the correlation between the incidence of spontaneous tumours of various origins and the localisation in dogs with sex, breed, and age factors. A total of 360 tumours with various localisation were studied pathomorphologically. Histopathologic data sets from 360 dog tissue samples were processed and statistically examined. A chi-square test of independence was conducted to examine the relationships among the various levels of the specified variables. Logistic regression models were employed for dichotomous outcomes to ascertain the influence of certain explanatory variables on the tumour types. Characteristic pathomorphological changes observed during examination of dogs with oncologic diseases were determined. The most common neoplasms were mammary tumours, accounting for 43% of the cases. The mammary gland tumours were most common in mongrel dogs (25%), with German Shepherds (17.3%), Poodles, Dachshunds, Central Asian Shepherds (6.7% each), and Rottweilers (5.7%) following. The highest frequency of these tumours appeared at 8 years of age, predominantly originating from the ductal epithelium, which represented 46.4% of all the malignant cases.

Abstract Background To evaluate the effect of the low-viscosity Icon resin infiltrate application on the color change of white spot enamel lesions (WSLs) over 3-, 6-, and 12-m follow-up periods. Methods Ninety-six teeth diagnosis with WSLs using the ICDAS scoring system in 49 participants were assessed for their color change using the Icon resin infiltration technique. The Icon kit was applied to WSLs as instructed by the manufacturer. Icon-Etch (15% hydrofluoric acid) was applied to the lesions for 2 min, and then, it was rinsed off with copious amount of water for 30 s. Then, Icon-Dry (99% ethanol) was applied to the etched lesions for 30-s followed by the application of the Icon resin infiltrate that was light cured for 40 s. Color change assessment was performed using Vita Easyshade V spectrophotometer at baseline and immediately after Icon resin infiltration, then at 3-, 6-, and 12-m follow-up periods. Analysis of the data was performed using the test of repeated measure ANOVA and the paired sample t test. Results There was a statistically significant difference in ∆E between the different follow-up periods at immediate, 3-m, 6-m, and 12-m. The highest mean value was found in the immediate follow-up period, while the lowest mean value was found in 12-m follow-up period. Conclusions Low-viscosity Icon resin infiltration has the ability for immediate diffusion into the WSLs giving an immediate improvement in the esthetic outcome of the WSLs. However, its long-term outcomes might not be consistent for the color change of the WSLs.

Background: Pulp stones are a type of pulp calcification, the presence of which tends to hinder endodontic treatment. Thus, this retrospective study aimed to analyze the distribution of pulp stones in the population in southwest China and identify the influencing factors. Materials: Cone-beam computed tomography (CBCT) scans of 5066 teeth of 200 patients (91 males and 109 females) aged 16–45 years were evaluated. Pulp stones were marked as either present or absent when distinct radiopaque masses were found in the pulp cavity, then evaluated the occurrence of pulp stones with regard to tooth type, sex, age group, and contact it with tooth status. The Pearson chi-square test and nonparametric test were used for statistical analysis. Results: Pulp stones were detected in 49.0% of patients and 7.4% of teeth, respectively. The incidence in females was 1.9 times higher than in males (OR = 1.9, 95% CI = 1.1–3.3, p = 0.001). Pulp stones were most prevalent in patients 36–45 years of age. Furthermore, in the age range of 16–45 years, the likelihood of finding pulp stones increased 1.1 times per year with age (OR = 1.1, 95% CI = 1.0–1.1, p = 0.032). A higher incidence of pulp stones was observed in the maxilla and molars. Of the 5066 teeth studied, pulp stones were more common in non-intact teeth. Conclusion: Nearly half of the population in southwest China had pulp stones. Pulp stones were found significantly more often in females, maxilla, and non-intact teeth, and their frequency increased with age. For dentists, understanding the distribution of pulp stones is crucial for the proper design of root canal treatment (RCT). Trial registration: This study was approved by the Ethics Committee of the Affiliated Hospital of Stomatology, Southwest Medical University (certificate number: 20220818001). [ABSTRACT FROM AUTHOR]

Background Objective Results Conclusion Use of permanent hair dyes causes unintended oxidative damage during the short time frame of the dyeing process that leads to perceivable changes in the feel, manageability and appearance of hair. Moreover, after hair has been dyed, regular exposure to the sun as a key environmental stressor continues to stimulate additional oxidative damage and to induce newly developed hair colours to fade prematurely or undergo changes in colour quality.To document the utility of acetyl zingerone methyl ether (MAZ) as a newly designed haircare ingredient to afford extra protection against oxidative damage and safeguard the integrity of hair colour.We demonstrate that MAZ is compatible chemically with the high alkaline conditions required for the colouring process and from theoretical calculations preferentially binds Fe and Cu ions relative to Ca or Zn ions. In model Fenton reactions MAZ effectively chelated active redox metals (Fe and Cu ions) in the presence of excess Ca+2 ions to inhibit the production of hydroxyl radicals, and in separate studies, MAZ neutralized singlet oxygen with greater efficiency than α‐tocopherol by a factor of 2.5. When mixed into permanent dyes prior to hair tress application, MAZ significantly reduced combing forces, and SEM images led to substantial reductions in visual signs of surface damage. In a 28‐day clinical study, relative to controls, mixing MAZ into hair dyes prior to application interfered neither with colour development nor with ability to cover grey hair and led to significant improvements in perceived attributes associated with hair's condition immediately following the dyeing process. Over a 28‐day maintenance phase, especially between Day 14 and Day 28, continued use of shampoo and conditioner containing MAZ significantly preserved gloss measurements and hair colour in terms of longevity and colour quality as remaining desired and fresh compared to use of control shampoo and conditioner.This work establishes MAZ as a next‐generation hair care ingredient for use in permanent dyes to attenuate oxidative damage and in shampoos and conditioners to promote longevity of hair colour and to maintain overall health and appearance of hair on a daily basis. [ABSTRACT FROM AUTHOR]

Deficits in N -methyl- d -aspartate receptor (NMDAR) signaling are implicated in the pathogenesis of schizophrenia. Luvadaxistat (TAK-831/NBI-1065844) is an investigational d -amino acid oxidase (DAAO) inhibitor that increases d -serine levels at NMDAR coagonist sites. INTERACT is a phase 2 randomized, placebo-controlled study that evaluated the efficacy and safety of three doses of luvadaxistat, covering a range of DAAO occupancy and d -serine levels, in patients with schizophrenia with persistent negative symptoms. The study included a 14-day, single-blinded placebo run-in period and a 12-week, double-blinded treatment period. The primary efficacy endpoint was the 12-week change from baseline in Positive and Negative Syndrome Scale—Negative Symptom Factor Score (PANSS NSFS). Secondary efficacy endpoints included the 12-week changes from baseline in Brief Assessment of Cognition in Schizophrenia (BACS) score and Schizophrenia Cognition Rating Scale (SCoRS) score. Safety endpoints included adverse event assessments. The full analysis set included all randomized patients (N = 256 [placebo, n = 87; luvadaxistat 50 mg, n = 58; 125 mg, n = 56; 500 mg, n = 55]); 228 patients completed the study. No significant improvements in PANSS NSFS were observed at any dose versus placebo at week 12. Improvements were observed with luvadaxistat 50 mg versus placebo in cognitive endpoints: BACS composite score (nominal one-sided p = 0.031) and SCoRS interviewer total score (nominal one-sided p = 0.011). Luvadaxistat did not significantly improve negative symptoms of schizophrenia. However, luvadaxistat 50 mg met the prespecified secondary endpoints for cognitive performance (BACS) and function (SCoRS), warranting further investigation in patients with cognitive impairment associated with schizophrenia. Luvadaxistat was well-tolerated in INTERACT, with no new safety signals observed. ClinicalTrials.gov : NCT03382639 [ABSTRACT FROM AUTHOR]

Sirtuins 6 (Sirt6) is a defatting acylase that protects against atherosclerosis and ischemic stroke. It has a high clinical reference value in predicting clinical outcomes such as cerebral hemorrhage, cerebral ischemia, and myocardial infarction. This study aimed to investigate the connection between serum Sirt6 levels and short-term prognosis among patients with acute ischemic stroke (AIS) treated with intravenous thrombolysis with tissue-type plasminogen activator (rt-PA). This study involved AIS patients undergoing intravenous thrombolysis by rt-PA, and found that the serum Sirt6 level were significantly lower in the poor prognosis group than in the good prognosis group (p < 0.05), while the poor prognosis group's age, neutrophil count, atrial fibrillation, D-dimer level, and pre-thrombolysis National Institutes of Health Stroke Scale (NIHSS) score were significantly higher (p < 0.05). With a cut-off value of 689 ng/mL, receiver operating characteristic (ROC) analysis revealed that the area under the curve (AUC) of serum sirt6 for predicting a poor prognosis following intravenous thrombolytic therapy in AIS patients was 0.841, with corresponding sensitivity and specificity of 90.74% and 70.06%. Poor outcome was independently influenced by age, pre-thrombolysis NIHSS score, platelet counts, D-dimer, and Sirt6 level (p < 0.05). A nomogram prediction model was created based on multivariate logistic regression results, and its AUC was 0.972. The Hosmer-Lemeshow test (χ² = 5.766, p = 0.673) and calibration curve analysis showed an acceptable fit for the prediction model. Decision analysis curves were also used to confirm the clinical utility of the model. In conclusion, Serum sirt6 was found to be a novel biomarker for predicting AIS patients treated with rt-PA, and sirt6-based nomograms may become a valuable tool for predicting AIS patients' long-term prognosis. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the postoperative clinical and functional outcomes of palatoplasty with three soft palate cleft repairs and analyse the factors potentially impacting these outcomes. A retrospective analysis was conducted on a consecutive series of 337 patients who underwent primary cleft palate repair by palatoplasty modified with either Furlow Z-plasty (P-FZP, n = 77), intravelar veloplasty (P-IVV, n = 110), or combined intravelar veloplasty–Furlow Z-plasty (P-IVV-FZP, n = 150). The postoperative outcomes evaluated included wound healing (complete closure/fistula) and velopharyngeal function. Demographic and surgical data were analysed using both univariate and multivariate analysis. There was no significant difference between the groups with regard to the sex distribution, age at repair, cleft width, cleft type, or follow-up duration. However, relaxing incisions were significantly more common with P-FZP (26.0%) and P-IVV (29.1%) compared to P-IVV-FZP (10%) (P = 0.002 and <0.001, respectively). The complete wound closure rate was significantly higher with P-IVV-FZP (97.3%) compared to P-FZP (88.3%) (P = 0.012) and P-IVV (90%) (P = 0.015). The normal velopharyngeal function rate was comparable for P-IVV-FZP (86.7%) and P-FZP (83.1%), and both rates were significantly better than the rate with P-IVV (73.6%) (P = 0.039 and 0.029, respectively). The cleft type and width were identified as factors influencing postoperative outcomes. In conclusion, it may be appropriate to prioritize the palatoplasty with combined intravelar veloplasty–Furlow Z-plasty whenever feasible. [ABSTRACT FROM AUTHOR]

To conceptualize a composite primary endpoint for parallel-group RCTs of exercise-based cardiac rehabilitation (CR) interventions and to explore its application and statistical efficiency. We conducted a statistical exploration of sample size requirements. We combined exercise capacity and physical activity for the composite endpoint (CE), both being directly related to reduced premature mortality in patients with cardiac diseases. Based on smallest detectable and minimal clinically important changes (change in exercise capacity of 15 W and change in physical activity of 10 min/day), the CE combines 2 dichotomous endpoints (achieved/not achieved). To examine statistical efficiency, we compared sample size requirements based on the CE to single endpoints using data from 2 completed CR trials. Cardiac rehabilitation phase III. Patients in cardiac rehabilitation. Not applicable. Exercise capacity (P max assessed by incremental cycle ergometry) and physical activity (daily minutes of moderate to vigorous physical activity assessed by accelerometry). Expecting, for example, a 10% between-group difference and improvement in the clinical outcome, the CE would increase sample size by up to 21% or 61%, depending on the dataset. When expecting a 10% difference and designing an intervention with the aim of non-deterioration, the CE would allow to reduce the sample size by up to 55% or 70%. Trialists may consider the utility of the CE for future studies in exercise-based CR to reduce sample size requirements. However, perhaps surprisingly at first, the CE could also lead to an increased sample size needed, depending on the observed baseline proportions in the trial population and the aim of the intervention. [ABSTRACT FROM AUTHOR]

Objective: The curve of Spee is deemed important characteristic of the dentition for a balanced occlusion and distribution of masticatory forces, while orthodontic levelling of an accentuated curve of Spee is generally included as a treatment goal for deepbite correction. However, relapse is often seen and can be problematic. Methods: A retrospective longitudinal study of predominantly young patients with a deep curve of Spee, who had been treated orthodontically with 0.018"‐slot Edgewise fixed appliances, was performed. The depth of the curve of Spee was digitally measured before treatment (T1), at debond (T2), and an average of 7 years post‐debond (T3) and analysed statistically at 5%. Results: A total of 157 patients were included (56.7% female; 11.6‐year‐old at T1), 16.6% of which were treated with premolars extractions. Non‐extraction treatment reduced the curve of Spee at the first premolar from 1.87 mm (T1) to 0.22 mm (T2), which relapsed 0.12 mm (T3; P =.04). The respective depths for the second premolar were 2.0 mm (T1), reduced to 0.80 mm (T2). No significant relapse was seen for the second premolar (0.08 mm; P >.05) or the first permanent molar (0.06 mm; P >.05). No overall significant differences in absolute relapse were seen between extraction and non‐extraction patients, but premolar extractions were associated with less clinically relevant relapse at the first molar (odds ratio 0.27; 95%‐confidence interval 0.08‐0.88; P =.003). Conclusion: Steep curves of Spee can be satisfactorily levelled orthodontically with satisfactory stability in the long term, while premolar extractions might be associated with less relapse. [ABSTRACT FROM AUTHOR]

Both cementless and cemented stems have exhibited favorable long-term outcomes in total hip arthroplasty. Nonetheless, in elderly patients, cemented hips offer an advantage due to their reduced risk of periprosthetic fractures. This study aimed to assess the initial outcomes of 28 patients who underwent unilateral cemented total hip arthroplasty utilizing a calcar-guided A2 stem (ARTIQO GmbH, Lüdinghausen, Germany). Various types of antibiotic-loaded bone cement were employed. During follow-up, we recorded demographic data and comorbidities and employed standardized clinical assessment tools, including the Harris Hip Score. Radiographic assessments included preoperative, postoperative, and follow-up imaging to evaluate subsidence, osteolysis, and bone resorption. The results indicated that among the 28 patients, 5 withdrew consent and 2 patients passed away from unrelated causes. Additionally, one prosthesis was explanted due to the undersizing of the cement stopper, which resulted in an inadequate cement mantle. As a result, 20 patients underwent a 1-year follow-up, revealing noteworthy enhancements in clinical scores, with no instances of radiolucent lines or osteolysis. No infections were detected. In summary, our short-term experience with this particular cemented short-stem design yielded promising results, exhibiting excellent functional outcomes, no aseptic loosening attributable to the stem, and no infections. Further clinical studies and registry data are essential to corroborate these findings. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is the main cause of death in middle-aged and older people and is characterized by high morbidity, high mortality, a high rehospitalization rate, and many high-risk groups. Nicotinamide adenine dinucleotide (NAD+) is widely present in the mitochondria of cardiomyocytes and maintains the redox balance in the body, which can effectively treat HF. We sought to evaluate whether NAD+ therapy has some clinical efficacy in patients with HF. Methods: Based on using conventional drugs to treat HF, patients (n = 60) were randomized 1:1 to saline and 50 mg NAD+ with 50 mL of normal saline for 7 days. The baseline characteristics of patients before and after treatment and cardiac function (N-terminal pro B-type natriuretic peptide (NT-proBNP) level and left ventricular ejection fraction (LVEF) value) were analyzed. Serological analysis (sirtuin-1 (SIRT1), sirtuin-3 (SIRT3), sirtuin-6 (SIRT6), reactive oxygen species (ROS), and endothelin) was also performed. Results: Among the 60 patients with HF who were treated with NAD+ for 7 days, the improvement rate in NT-proBNP levels and LVEF values was better than in the saline group, although not statistically significant. These patients were more likely to benefit from NAD+ because of higher levels of anti-oxidative stress (SIRT1, SIRT3, SIRT6, and ROS) and anti-endothelial injury (endothelin) than those in the saline control group. Conclusions: According to the results of this study, it is believed that 7 days of NAD+ injections has a positive effect on improving cardiac function, oxidative stress, and endothelial injury in patients with HF compared with the saline control. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Journal of Clinical Healthcare is the property of Chinese Journal of Clinical Healthcare and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Chinese Journal of Clinical Healthcare is the property of Chinese Journal of Clinical Healthcare and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This study investigates the feasibility of a novel brain–computer interface (BCI) device designed for sensory training following stroke. The BCI system administers electrotactile stimuli to the user's forearm, mirroring classical sensory training interventions. Concurrently, selective attention tasks are employed to modulate electrophysiological brain responses (somatosensory event-related potentials—sERPs), reflecting cortical excitability in related sensorimotor areas. The BCI identifies attention-induced changes in the brain's reactions to stimulation in an online manner. The study protocol assesses the feasibility of online binary classification of selective attention focus in ten subacute stroke patients. Each experimental session includes a BCI training phase for data collection and classifier training, followed by a BCI test phase to evaluate online classification of selective tactile attention based on sERP. During online classification tests, patients complete 20 repetitions of selective attention tasks with feedback on attention focus recognition. Using a single electroencephalographic channel, attention classification accuracy ranges from 70% to 100% across all patients. The significance of this novel BCI paradigm lies in its ability to quantitatively measure selective tactile attention resources throughout the therapy session, introducing a top-down approach to classical sensory training interventions based on repeated neuromuscular electrical stimulation. [ABSTRACT FROM AUTHOR]