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Abstract Objectives To evaluate the safety and effectiveness of computed tomography (CT)-guided radioactive 125I seeds brachytherapy (RISB) for lung oligometastases (LO) from colorectal cancer (CRC). Methods Data for 144 LOs from 70 CRC patients who underwent CT-guided RISB were retrospectively analyzed. The primary endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints were technical success, local control rate (LCR), and complications. Kaplan–Meier method was used for survival analysis. Cox model was used to identify the independent predictors of poor prognosis. Results The RISB procedures were successfully performed in all patients, and the success rate was 100%. The median follow-up was 27.8 months. The median PFS was 10.0 months (95% CI: 8.9–11.1) and the 1- and 2-year PFS rates were 32.9% and 5.9%, respectively. On multivariate analysis, serum carcinoembryonic antigen (CEA) ≤ 15 ng/ml (P = 0.048), middle-high differentiated pathological classification (P = 0.015), primary TNM stages I-III (P = 0.001), LO number ≤ 2 (P

ABSTRACT: Objectives: This study aimed to explore the influence of alveolar bone morphologic variables on the outcome of guided bone regeneration (GBR) in the anterior maxilla region. Methods: Twenty-eight patients who received single maxillary anterior tooth delayed implant placed simultaneously with GBR were recruited. Baseline data including age, gender, implant site, implant brand, and bone graft materials were recorded. The resorption rate of the grafted bone (RRGB), labial bone width at 0 mm, 2 mm, and 4 mm apical to the implant platform at Tn (LBW0Tn, LBW2Tn, LBW4Tn), implant angulation (IA), maximum bone graft thickness (MBGT), bone graft volume (BGV), and the initial bone morphologic variables bone concavity depth (BCD) and bone concavity angulation (BCA) were measured. The Pearson correlation analysis, analysis of variance (ANOVA), and optimal binning method were used to explore the potential predictors for GBR. Results: Among 28 patients, the labial bone width of implant and bone graft volume decreased significantly when measured 6 months after surgery. The mean percentage of RRGB was 49.78%. RRGB was not correlated with gender, age, bone graft material, IA, MBGT, bone graft volume at T1, implant site, and implant brand (P > .05). BCD and BCA were each moderately correlated with RRGB (r = −0.872 [P < .001] and r = 0.686 [P < .001], respectively). A BCD ≥1.03 mm and a BCA

Objective(s): The aim of this study is to investigate the potential of Solid lipid nanoparticles (SLNs) to enhance the therapeutic effectiveness of ternary metal complexes of hydroxy acids in the treatment of acne.Materials and Methods: Ternary complexes of Cu (II) and Zn (II) with glycine amino acid (Gly) as a primary ligand, and Hydroxy acids (salicylic acid (L1), lactic acid (L2) or glycolic acid (L3)) as a secondary ligand, were synthesized in a slightly acidic medium and isolated in different ratios. These ternary complexes were loaded into SLNs and evaluated for particle size, polydispersity index, Zeta potential, entrapment efficiency and in vitro release studies. SLN-encapsulated ternary metal complexes were clinically evaluated in acne patients.Results: Scanning Electron Microscopy revealed that SLNs were spherical in shape and varied in size from 115 to 210 nm when measured with a Malvern Zetasizer. The zeta potential was ranged from -41.33 ± -2.5 to -47.32 ± -2.1 mV. The calculated entrapment efficiency (EE%) was 79 - 83% with slow release of the ternary complexes from the prepared SLNs. The in-vivo clinical study disclosed that Zn(L1)(Gly) SLNs outperformed Cu(L1)(Gly) SLNs in terms of acne spot reduction and patient satisfaction.Conclusion: In conclusion, this study demonstrated that SLNs-encapsulated ternary metal complexes are a promising new treatment for acne.

Abstract Background The gliding surface of total knee endoprostheses is exposed to high loads due to patient weight and activity. These implant components are typically manufactured from ultra-high molecular weight polyethylene (UHMWPE). Crosslinking of UHMWPE by ionizing radiation results in higher wear resistance but induces the formation of free radicals which impair mechanical properties after contact with oxygen. Medium-crosslinked UHMWPE enriched with vitamin E (MXE) provides a balance between the parameters for a sustainable gliding surface, i.e., mechanical strength, wear resistance, particle size, and oxidation stability. Therefore, a gliding surface for knee endoprostheses made up from this material was developed, certified, and launched. The aim of this study is to compare this new gliding surface to the established predecessor in a non-inferiority design. Methods This multicenter, binational randomized controlled trial will enroll patients with knee osteoarthritis eligible for knee arthroplasty with the index device. Patients will be treated with a knee endoprosthesis with either MXE or a standard gliding surface. Patients will be blinded regarding their treatment. After implantation of the devices, patients will be followed up for 10 years. Besides clinical and patient-related outcomes, radiological data will be collected. In case of revision, the gliding surface will be analyzed biomechanically and regarding the oxidative profile. Discussion The comparison between MXE and the standard gliding surface in this study will provide clinical data to confirm preceding biomechanical results in vivo. It is assumed that material-related differences will be identified, i.e., that the new material will be less sensitive to wear and creep. This may become obvious in biomechanical analyses of retrieved implants from revised patients and in radiologic analyses. Trial registration ClinicalTrials.gov, NCT04618016. Registered 27 October 2020, https://clinicaltrials.gov/study/NCT04618016?term=vikep&checkSpell=false&rank=1 . All items from the World Health Organization Trial Registration Data Set can be found in Additional file 1.

Aim. To evaluate effectiveness and safety of combination drug containing ambroxol, guaifenesin and levosalbutamol (Ascoril LS), oral solution, in comparison with monocomponent drugs in the treatment of productive cough in adult patients with acute respiratory viral infection (ARVI) and acute bronchitis. Materials and methods. Open randomized study included patients with clinical symptoms of ARVI and acute bronchitis, having productive cough with difficulty in sputum discharge. 160 patients were randomized into 4 groups that received the study drug or comparison drugs (ambroxol, acetylcysteine, Rengalin) 3 times a day for 20 days. After 5, 10, 15 and 20 days of treatment, the doctor assessed subjective complaints and effectiveness of therapy. The primary endpoint was the proportion of patients with high and very high efficacy, recovery from work, and clinically significant cardiovascular events. Results. Satisfaction with clinical effect of therapy with Ascoril LS was noted by 96% of patients, tolerability and ease of administration by 99%. 97% of patients are satisfied with price/quality ratio. The overall percentage of satisfaction with treatment Ascoril LS was 99%. Tolerability of therapy was assessed by all patients as good, without the development of significant adverse events. During therapy for productive cough, a significant decrease in cough was noted in Ascoril LS group already on the 5th day of therapy (57%) and subsequently at all follow-up visits. Restoration of working capacity of patients in Ascoril LS group due to complete regression of productive cough was established in 50% of patients on the 5th day of treatment. On days 10 and 15, 75% and 90% of patients, respectively, were able to begin work due to complete relief of cough, which is significantly more compared to other treatment groups. It is important that in all cases Ascoril LS was prescribed at the very beginning of the disease, which made it possible to achieve the described results Conclusion. The effectiveness of a new combination drug containing ambroxol, guaifenesin and levosalbutamol for the treatment of productive cough in adult patients with ARVI and acute bronchitis exceeds the effectiveness of monocomponent therapy with comparator drugs. The safety profiles of the study drug and comparison drugs were comparable, including in patients with cardiovascular risk.

Background: Ventral hernias comprise the second-most common hernia presentation, or 21–35% of all hernia types in the surgical world. Ventral hernias include incisional, umbilical, epigastric, and spigelian hernias, among others. This study was undertaken to know the different clinical types, age incidence, and predisposing factors for ventral hernia and to study the complications. Aims and Objectives: This study was undertaken to know the different clinical types, age incidence, and predisposing factors for ventral hernia and to study the complications. Materials and Methods: Forty-five cases of ventral hernias treated were studied prospectively from January 2021 to June 2022, in which each patient was evaluated thoroughly and surgery was planned to obtain a satisfactory outcome. The distribution of ventral hernias with respect to age, sex, comorbidities, and risk was recorded. Common presenting symptoms of ventral hernias, diagnosis, and complications were studied. The data collected was entered in a proforma, tabulated, and statistically analyzed. Results: Females were affected much more than males. Out of the three types of hernia that were studied, umbilical hernia showed more incidence (n=23/51%), followed by incisional hernia (n=15/33%), and epigastric hernia (n=7/16%). The most common age presentation was in the fourth and fifth decades. The most common type of mesh repair was pre-peritoneal repair in 28 (62%). The pain was relatively more common post-surgery complications, as noted in 11 (24%). In 100% of the cases, swelling was the complaint, followed by pain (18.8%). Obesity was the most common etiological factor in the development of ventral hernias (60%), followed by diabetes (35%). Conclusion: The most common ventral hernia was an umbilical hernia. Ventral hernias are more common in females. Obesity and diabetes are observed to be the major predisposing risk factors. Good pre-operative evaluation and preparation, sound anatomical knowledge, and meticulous attention to surgical detail are the most important factors for the prevention of postoperative complications. In view of the limited period of follow-up, we were not in a position to comment on recurrence rates, but when proper surgical procedures are adopted along with pre-operative correction of comorbid factors, results will always be excellent.

Abstract Objectives Autogenous and allogeneic blocks for shell augmentation of the jaw have shown comparable results. This observational clinical study aimed to compare both materials for shell augmentation concerning surgery time and intra- and postoperative complications. Material and methods Bone augmentation with the shell technique using autogenous or allogenous bone was performed in 117 patients with segmental jaw atrophy. The primary study parameter was the surgical time, comparing both materials. Subsequently, intra- and postoperative complications were recorded. Results Allogeneic (n = 60), autogenous (n = 52), or both materials (n = 5) were used. The use of allogeneic material led to a significantly shorter operation time (p 0.05). In total, 229 implants were inserted after a healing time of 4–6 months, with a survival of 99.6% after a mean follow-up duration of 9 months. Conclusions Compared to the autogenous technique, allogeneic shell augmentation has a shorter surgical time and a similar rate of intra- and postoperative complications as autogenous bone. Together with its promising clinical results, this technique can be recommended. Graphical Abstract

Background. Hospitals, patients, researchers, and healthcare organizations are producing enormous amounts of data in both the healthcare and drug detection sectors. With continued development of cheap data storage and availability of smart devices in the world, the influence of big data (BD) will continue to grow. This influence has also carried over to healthcare. The volumes of data available in the fields of pharmacology, toxicology, and pharmaceutics are constantly increasing. Therefore, the present study aimed to identify the applications of big data technology in the field of pharmaceutics. Methods. Using the mixed methods approach, this study was conducted in two phases in winter 2023. In the first phase, the applications of big data technology were identified by library search and assessed by content analysis. In the second phase, applications were ranked by a panel of experts, including 17 experts who worked in the Iranian pharmaceutical industry. The stepwise weight assessment ratio analysis (SWARA) method was used for ranking the application of big data in pharmaceutics. Results. The present study examined the importance of big data applications in pharmaceutics. The results showed that drug discovery (0.263) and clinical study analysis (0.224) had the highest importance, followed by drug efficacy and performance (0.197), drug safety (0.170) and drug personalization (0.146). Conclusion. The present study detailed a substantial attempt to review the existing literature regarding the implementation of big data and to rank big data applications in the pharmaceutical industry. Big data can help researchers to better discover and develop drugs and understand the effects of drugs and other chemicals on the human body. As a result, it can help improve the safety and efficacy of drugs and other chemicals. Also, big data can help to improve the accuracy of predictions regarding the effects of drugs and chemicals, which can improve safety in drug development and help to avoid potential adverse drug interactions. The applications considered in this study are ultimately necessary for humanity, and big data may significantly impact the betterment of these domains. Big data has a revolutionary potential, providing new ways to understand and predict the effects of drugs. BD will possibly play an important role in pharmaceutics in future, critically helping to drug discovery and improve drug safety and efficacy.

Abstract Background Recent research has suggested that artemisinin and its derivatives may have therapeutic effects on parasites, viruses, tumors, inflammation and skin diseases. This study aimed to review clinical research on artemisinin and its derivatives except anti-malaria and explore possible priority areas for future development. Methods Relevant articles in English and Chinese published before 28 October 2021 were reviewed. All articles were retrieved and obtained from databases including WanFang, PubMed/MEDLINE, the Cochrane Library, China National Knowledge International, Embase, OpenGrey, the Grey Literature Report, Grey Horizon, and ClinicalTrials.gov. Studies were selected for final inclusion based on predefined criteria. Information was then extracted and analyzed by region, disease, outcome, and time to identify relevant knowledge gaps. Results Seventy-seven studies on anti-parasitic (35), anti-tumor (16), anti-inflammatory (12), anti-viral (8), and dermatological treatments (7) focused on the safety and efficacy of artemisinin and its derivatives. The anti-parasitic clinical research developed rapidly, with a large number of trials, rapid clinical progress, and multiple research topics. In contrast, anti-viral research was limited and mainly stayed in phase I clinical trials (37.50%). Most of the studies were conducted in Asia (60%), followed by Africa (27%), Europe (8%), and the Americas (5%). Anti-parasite and anti-inflammatory research were mainly distributed in less developed continents such as Asia and Africa, while cutting-edge research such as anti-tumor has attracted more attention in Europe and the United States. At the safety level, 58 articles mentioned the adverse reactions of artemisinin and its derivatives, with only one study showing a Grade 3 adverse event, while the other studies did not show any related adverse reactions or required discontinuation. Most studies have discovered therapeutic effects of artemisinin or its derivatives on anti-parasitic (27), anti-tumor (9), anti-inflammatory (9) and dermatological treatment (6). However, the efficacy of artemisinin-based combination therapies (ACTs) for parasitic diseases (non-malaria) is still controversial. Conclusions Recent clinical studies suggest that artemisinin and its derivatives may be safe and effective candidates for anti-tumor, anti-parasitic, anti-inflammatory and dermatological drugs. More phase II/III clinical trials of artemisinin and its derivatives on antiviral effects are needed. Graphical Abstract

Introduction: Carbonated apatite (CO3Ap) has unique properties as an alloplastic bone substitute and has been reported the safety and efficacy for bone regeneration. However, no previous studies reported the clinical application of CO3Ap for periodontal regeneration therapy. The aim of this study was to evaluate the safety and efficacy of periodontal regeneration with CO3Ap in treating intrabony defects, Class II and Class III furcation involvement (FI). Methods: A single-arm and single-center prospective pilot clinical study was performed to verify the safety and efficacy of CO3Ap in patients with periodontitis. A total of four patients with seven teeth, including three deep intrabony defects, two Class II FI, and two Class III FI, were treated with CO3Ap. The clinical parameters, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), tooth mobility (Mo), Plaque index (PI), and Gingival index (GI) were evaluated at baseline, 6 months, and 9 months after the surgery. Radiographic analysis was conducted on images of dental X-ray and cone beam computed tomography (CBCT) at baseline and 9 months post-surgery. Results: The postoperative healing in all cases was uneventful, with no abnormal bleeding, pain, or swelling. The mean PPD reduction and CAL gain were 5.0 ± 1.0 mm, 4.5 ± 0.7 mm, 1.5 ± 0.7 mm, and 4.7 ± 1.2 mm, 4.5 ± 0.7 mm, 0.0 mm for intrabony defect, Class II and Class III FI, respectively. According to radiographic analysis, linear bone height in intrabony defects and vertical subclassification of FI in Class II FI were improved. Conclusions: The clinical application of CO3Ap for the treatment of intrabony defects and Class II FI could be effective for periodontal regeneration, although its efficacy in treating Class III FI might be limited. Despite the limitations of this study, the findings in this study suggested that CO3Ap has the potential to be a promising bone graft substitute for periodontal regeneration.

AbstractContext A Chinese herbal formula, Tiaopi Xiezhuo decoction (TXD), is developed from a classical Chinese prescription Sanhuang Xiexin decoction.Objective To investigate the regulatory effect of TXD on gut dysbiosis, as a treatment of constipation in patients with peritoneal dialysis (PD).Materials and methods The chemical content of TXD was assessed by high-performance liquid chromatography. A total of 29 PD patients were enrolled and treated with TXD orally (3 g crude drug/each/twice/day) for 3 months. Blood and faecal samples were collected at the beginning and end, to determine the changes in biochemical characteristics and gut microbial composition. The stool conditions were asked to be scored. Additional 30 healthy individuals were recruited as a control for the analysis of gut microbiota.Results Although having no significant effects on serum biochemical characteristics, 3-month TXD intervention improved constipation in PD patients: decreased 80% abdominal distention (p

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.

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.

Objectives: To evaluate the safety and effectiveness of computed tomography (CT)-guided radioactive 125I seeds brachytherapy (RISB) for lung oligometastases (LO) from colorectal cancer (CRC). Methods: Data for 144 LOs from 70 CRC patients who underwent CT-guided RISB were retrospectively analyzed. The primary endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints were technical success, local control rate (LCR), and complications. Kaplan–Meier method was used for survival analysis. Cox model was used to identify the independent predictors of poor prognosis. Results: The RISB procedures were successfully performed in all patients, and the success rate was 100%. The median follow-up was 27.8 months. The median PFS was 10.0 months (95% CI: 8.9–11.1) and the 1- and 2-year PFS rates were 32.9% and 5.9%, respectively. On multivariate analysis, serum carcinoembryonic antigen (CEA) ≤ 15 ng/ml (P = 0.048), middle-high differentiated pathological classification (P = 0.015), primary TNM stages I-III (P = 0.001), LO number ≤ 2 (P < 0.001) and cumulative gross tumor volume (GTV) ≤ 40 cm3 (P < 0.001) showed superior PFS. The median OS was 30.8 months (95% CI: 27.1–34.4) and the 1-, 2-, and 3-year OS rates were 95.7%, 67.4%, and 42.5%, respectively. On multivariate analysis, serum CEA ≤ 15 ng/ml (P = 0.004), middle-high differentiated pathological classification (P < 0.001), primary TNM stages I-III (P < 0.001), LO number ≤ 2 (P < 0.001), cumulative GTV ≤ 40 cm3 (P < 0.001) and system treatments combined with chemotherapy and target therapy (P < 0.001) showed superior OS. The LCR for 3, 6, and 12 months was 97.9%, 91.0%, and 83.6%, respectively. There were 4 cases of pneumothorax at 5.7% that required drainage. Conclusions: RISB for LO from CRC is safe and effective, and serum CEA, TNM stage, LO number, cumulative GTV, and system treatments should be emphasized for long OS. Key points: • CT-guided RISB is a new treatment for lung oligometastases from CRC. • RISB can be an alternative therapy for patients who are unsuitable for surgery, ablation, or SBRT. • Serum CEA, TNM stage, LO number, cumulative GTV, and system treatments are prognostic factors. • RISB is a safe method with a curative effect. [ABSTRACT FROM AUTHOR]

Background: The aim of this clinical study was to compare the occlusal caries detection (OCD) performance of the intraoral scanners (IOSs) Trios 4 (TIO, 3Shape) and Emerald S (EME, Planmeca) and the Diagnocam (DIA, KaVo) with the established visual (WHO) examination (VIS, reference method). Methods: Between 08/2022 and 02/2023, 60 children (mean age 9.6 ± 2.5 years) were examined as part of their regular dental checkups. OCD was performed at the tooth level, separately for primary and permanent unrestored teeth. Furthermore, two thresholds were analyzed: sound versus overall caries (pooled data of enamel and dentin caries, TH1) and pooled data of sound and enamel caries versus dentin caries (TH2). Results: The best agreement with the reference method (reliability) in both dentitions was obtained for DIA (ĸ = 0.829/ĸ = 0.846; primary/permanent teeth), followed by EME (ĸ = 0.827/ĸ = 0.837) and TIO (ĸ = 0.714/ĸ = 0.680). Similar results were shown for the diagnostic quality (sensitivity, specificity and area under the curve of the receiver operating characteristic curve), with higher values for TH1 than for TH2. Both IOSs and the DIA showed worse results than the reference method VIS. Conclusions: Currently, IOS should be used as an additional caries detection tool, especially for visualization, and cannot be recommended as a basic tool for diagnosis or invasive/noninvasive therapy decisions in OCD. [ABSTRACT FROM AUTHOR]

• PCV20 elicits robust immune responses in East Asian participants ≥ 60 years old. • PCV20 had a similar safety and tolerability profile to that of PCV13. • These data extend the results of key PCV20 phase 3 trials to East Asian populations. Pneumococcal infections are associated with high disease burden in older individuals in Japan, South Korea, and Taiwan. The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to extend protection beyond earlier pneumococcal vaccines. This phase 3 randomized, double-blind study investigated the safety and immunogenicity of PCV20 in participants ≥ 60 years of age from Japan, South Korea, and Taiwan. Participants were randomized to receive PCV20 or 13-valent pneumococcal conjugate vaccine (PCV13). One month after vaccination, PCV20 recipients received a saline injection and PCV13 recipients received 23-valent polysaccharide vaccine (PPSV23). Primary immunogenicity objectives were to demonstrate noninferiority of PCV20 to PCV13 (13 matched serotypes) or PPSV23 (7 additional serotypes) for serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after vaccination with PCV20, PCV13, or PPSV23. Noninferiority for each serotype was declared if the lower bound of the 2-sided 95% CI for OPA geometric mean ratio (GMR) was > 0.5. Safety endpoints included local reactions, systemic events, adverse events (AEs), and serious AEs. Overall, 1421‬ participants were vaccinated (median age [range]: 65 [60–85] years). PCV20 was noninferior to PCV13 for all 13 matched serotypes and to PPSV23 for 6 of 7 additional serotypes. Although statistical noninferiority was missed for serotype 8 (lower bound of the 2-sided 95% CI for OPA GMR = 0.5, thus not meeting the statistical noninferiority criterion of > 0.5), secondary immunogenicity endpoints for serotype 8 were supportive of a robust immune response. The incidence of AEs and the frequency and severity of local reactions and systemic events were generally similar after PCV20 and PCV13. No safety concerns were identified. PCV20 generated robust immune responses to all vaccine serotypes in older adults in Japan, South Korea, and Taiwan. The safety and tolerability profile was similar to PCV13. PCV20 is expected to help protect against all 20 vaccine serotypes. NCT04875533. [ABSTRACT FROM AUTHOR]

Background: Macular hole (MH) development following scleral buckling (SB) surgery for rhegmatogenous retinal detachment (RRD) repair is rare. This study presents both full-thickness MH (FTMH) and lamellar MH (LMH) cases following SB for the treatment of RRD. Methods: Clinical records of patients undergoing SB surgery for treatment of RRD at the Xi'an People's Hospital (Xi'an Fourth Hospital) from January 2016 to December 2021 were reviewed, and cases with postoperative MH were selected. Clinical features and follow-up data were summarised, and possible causes were analysed. Results: Among 483 identified cases (483 eyes), four eyes (three male patients, one female patient) had postoperative MH, with prevalence, mean age, and mean axial length of 0.83%, 43.5 ± 10.66 years, and 29.13 ± 3.80 mm, respectively. All patients did not undergo subretinal fluid (SRF) drainage. The mean time for detecting MH was 26 ± 15.5 days postoperatively. Macula-off RRD with high myopia and FTMH combined with retinal re-detachment were diagnosed in three patients. One patient had macula-on RRD with outer LMH. The average follow-up duration was 7.25 ± 1.5 months. The FTMH closed successfully after reoperation, while the outer LMH closed without intervention. Visual acuity insignificantly improved or slightly decreased in all patients. Conclusions: Patients with high myopia combined with macula-off RRD might be more susceptible to FTMH, causing MH related retinal detachment. Additionally, LMH following SB was noted in patients with macula-on RRD. Therefore, we should raise awareness of MH following SB for RRD repair. [ABSTRACT FROM AUTHOR]

The comprehensive diagnosis and treatment of advanced breast cancer has entered the era of "accurate classification and precise stratification", and is moving towards the road of personalized precision medicine. In 2023, significant breakthroughs have been achieved in the research on different molecular classifications of advanced breast cancer, influencing clinical guidelines and transforming clinical practice. The primary focus of research for hormone receptor positive advanced breast cancer lies in selecting appropriate treatments for patients who have failed cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors. Advanced breast cancer with low human epidermal growth factor receptor 2 (HER2) expression has emerged as a promising treatment direction, with T-DXd being an important therapeutic option. With the release of results from the PHILA study, a new era has begun for first-line treatment of HER2-positive advanced breast cancer. Simultaneously, T-DXd has become the preferred choice in clinical practice following tyrosine kinase inhibitor failure. Research related to immune and targeted therapy for advanced triple-negative breast cancer (TNBC) is also progressing rapidly, yielding positive outcomes in studies such as TORCHILIGHT and BEGONIA. Additionally, ongoing clinical studies on precision treatment based on the "Fudan classification" for TNBC are expected to revolutionize current treatment approaches. This paper summarized major advancements in clinical research on advanced breast cancer in 2023 according to various molecular classifications, aiming to provide improved reference and guidance for clinical management. [ABSTRACT FROM AUTHOR]

Objective: Ultraviolet radiation (UVR) is a known environmental key factor for premature skin ageing. Only few scientific evidence is available to support the effects of UVR on the skin microbiome. This in vivo pilot study aimed to evaluate the impact on the skin microbiome upon erythemal UV exposure and the protection of UV‐exposed skin microbiome by UV filters. Methods: Ten female volunteers were treated with an sun protection factor (SPF) 20 sunscreen and placebo formulation (without UV filters) on their upper middle backs and irradiated with an erythemal dose (2 MED) by a solar simulator. Skin swabbing samples from four zones (i.e., unexposed, exposed, sunscreen‐ and placebo‐treated on exposed skin) were collected for the microbiome analysis before and 2 h after UV exposure, respectively, and processed via shallow 16S rRNA Amplicon and Shotgun metagenomic sequencing. An in vitro UV method was developed to confirm the protection of isolated bacterial strains by single UV filters and combinations. Results: Alpha diversity was impacted by significant inter‐individual differences and by treatment rather than by irradiation. Cutibacterium acnes was found to be the most abundant and a confounding factor for diversity. On a species level, Lactobacillus crispatus was negatively associated with UVR and placebo treatment, whereas there was a positive association with sunscreen treatment. The sunscreen treatment also favoured an interaction network with central Micrococcus genus. The in vitro results showed that both single UV filters and combinations had specific effects on the survival rates of L. crispatus, C. acnes, and Staphylococcus epidermidis. Conclusion: We identified potential microorganisms and bacterial interactions that were associated with an SPF 20 sunscreen treatment. The specific protection of L. crispatus as a key player in the UV‐exposed skin microbiome and reduction of C. acnes population by UV filters might lead to new cosmetic concepts for photoprotection. [ABSTRACT FROM AUTHOR]

Background: Oral collagen peptides supplementation was reported to improve skin integrity and counteract skin aging. Aims: A randomized, double‐blinded, placebo‐controlled study was conducted to clinically evaluate the impact of low‐molecular‐weight collagen peptides on the human skin. Patients/Methods: Healthy adult participants (n = 100) were randomly assigned to receive a test product containing low‐molecular‐weight collagen peptides or a placebo. Parameters of skin wrinkles, elasticity, hydration, and whitening (melanin and erythema indexes) were measured at baseline and after 4, 8, and 12 weeks. Results: Compared with the placebo group, the average skin roughness, maximum of all peak‐to‐valley values, maximum peak height of the wrinkle, and average maximum height of the wrinkle were significantly improved in the test group. Parameters of skin elasticity, including overall elasticity, net elasticity, and biological elasticity, were also significantly improved in the test group at Week 12 as compared with the placebo group. Moreover, skin hydration and whitening parameters changed more significantly in the test group than in the placebo group. None of the participants experienced adverse events related to the test product. Conclusions: Taken together, these findings suggest that low‐molecular‐weight collagen peptides supplementation can safely ehance human skin wrinkling, hydration, elasticity, and whitening properties. [ABSTRACT FROM AUTHOR]

Background: Natural components that can exert a wide range of anti‐hair loss activity with fewer side effects are in high demand. The objective of this study was to investigate the anti‐hair loss potential of Silybum marianum flower extract (SMFE) in vitro and in vivo. Methods: The effect of SMFE on dermal papilla cells was evaluated by measuring cell proliferation and VEGF production in hair follicle dermal papilla cells (HFDPCs). In addition, to confirm the effect of SMFE on dermal papilla senescence, SA‐β‐gal staining and senescence associated secretory phenotype (SASP) production such as IL‐6 was observed in both replicative and hydrogen peroxide (H2O2)‐induced senescence models. In a clinical study, hair growth was determined by reconstitution analysis after shaving the hair of the clinical subject's scalp and hair area. Results: SMFE increased the proliferation and VEGF production of HFDPCs. It also suppressed cellular senescence of HFDPCs and IL‐6 production in replicative senescence and oxidative stress‐induced senescence models. The hair density and total hair count at 16 and 24 weeks after using hair shampoo containing SMFE were significantly increased compared with those of the placebo group. Conclusion: SMFE has the potential to be used as a natural ingredient for alleviating hair loss. [ABSTRACT FROM AUTHOR]

Introduction: There have been no prior trials directly comparing the efficacy of different calcitonin gene-related peptide (CGRP) antagonists for migraine prevention. Reported are the results from the first head-to-head study of two CGRP antagonists, galcanezumab (monoclonal antibody) versus rimegepant (gepant), for the prevention of episodic migraine. Methods: In this 3-month, double-blind, double-dummy study, participants were randomized (1:1) to subcutaneous (SC) galcanezumab 120 mg per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet (ODT) every other day (q.o.d.) or to rimegepant 75 mg ODT q.o.d. and a monthly SC placebo. The primary endpoint was the proportion of participants with a ≥ 50% reduction in migraine headache days per month from baseline across the 3-month double-blind treatment period. Key secondary endpoints were overall mean change from baseline in: migraine headache days per month across 3 months and at month 3, 2, and 1; migraine headache days per month with acute migraine medication use; Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at month 3; and a ≥ 75% and 100% reduction from baseline in migraine headache days per month across 3 months. Results: Of 580 randomized participants (galcanezumab: 287, rimegepant: 293; mean age: 42 years), 83% were female and 81% Caucasian. Galcanezumab was not superior to rimegepant in achieving a ≥ 50% reduction from baseline in migraine headache days per month (62% versus 61% respectively; P = 0.70). Given the pre-specified multiple testing procedure, key secondary endpoints cannot be considered statistically significant. Overall, treatment-emergent adverse events were reported by 21% of participants, with no significant differences between study intervention groups. Conclusions: Galcanezumab was not superior to rimegepant for the primary endpoint; however, both interventions demonstrated efficacy as preventive treatments in participants with episodic migraine. The efficacy and safety profiles observed in galcanezumab-treated participants were consistent with previous studies. Trial registration: ClinTrials.gov—NCT05127486 (I5Q-MC-CGBD). Plain Language Summary: Galcanezumab and rimegepant are preventive treatments for episodic migraine. The goal of this study was to compare the efficacy of galcanezumab and rimegepant in reducing the number of monthly migraine headaches and to determine if galcanezumab was better than rimegepant. The study provides important information to doctors and their patients when making treatment decisions. People with episodic migraine were assigned to the galcanezumab (given as an injection under the skin) or rimegepant (given as a tablet that dissolves in the mouth) group and treated for 3 months. The doctor and the patient did not know which group they were assigned to, and to keep it unknown to both, people in the galcanezumab group got an injection with real medicine and a fake tablet, and people in the rimegepant group got a tablet with real medicine and a fake injection. The researchers wanted to know how many people in each group had at least a 50% reduction in their monthly migraine headaches. Of the 580 people in the study, 287 were assigned to galcanezumab and 293 to rimegepant. In both groups, most were female and white. After 3 months of treatment, 62% of the people in the galcanezumab group and 61% of people in the rimegepant group had at least a 50% reduction in monthly migraine headaches. Both treatments were effective, but galcanezumab was not better than rimegepant. About 20% of the people in each treatment group had a side effect from the medication, and most were mild or moderate in severity. [ABSTRACT FROM AUTHOR]

Trigonella foenum-graecum (Fenugreek) is an extensively researched phytotherapeutic for the management of Type 2 diabetes without any associated side effects. The major anti-diabetic bioactive constituents present in the plant are furostanolic saponins, which are more abundantly available in the seed of the plant. However, the bioavailability of these components depends on the method of extraction and hence formulation of the phytotherapeutic constitutes a critical step for its success. The present study reports the efficacy of a novel, patented fenugreek seed extract, Fenfuro®, containing significant amount of furostanolic saponins, in an open-labelled, two-armed, single centric study on a group of 204 patients with Type 2 diabetes mellitus over a period of twelve consecutive weeks. Administration of Fenfuro® in the dosage of 500 mg twice daily along with metformin and/or sulfonylurea-based prescribed antidiabetic drug resulted in a reduction of post-prandial glucose by more than 33% along with significant reduction in fasting glucose, both of which were greater than what resulted for the patient group receiving only Metformin and/or Sulfonylurea therapy. Fenfuro® also resulted in reduction in mean baseline HOMA index from 4.27 to 3.765, indicating restoration of insulin sensitivity which was also supported by a significant decrease in serum insulin levels by >10% as well as slight reduction in the levels of C-peptide. However, in the case of the Metformin and/or Sulfonylurea group, insulin levels were found to increase by more than 14%, which clearly indicated that drug-induced suppression of glucose levels instead of restoration of glucose homeostasis. Administration of the formulation was also found to be free from any adverse side effects as there were no changes in hematological profile, liver function and renal function. The study demonstrated the promising potential of this novel phytotherapeutic, Fenfuro®, in long-term holistic management of type-2 diabetes. [ABSTRACT FROM AUTHOR]

Background and aim: A novel study found interferon enhanced antitumor activity of anti-PD-1-based immunotherapy and played a crucial role in improving efficacy on HCC, but the opposite results about the efficacy of interferon on HBV-related HCC were obtained from previous clinical studies and meta-analyses. Thus, this meta-analysis aimed to re-evaluate whether interferon could improve survival and reduce recurrence of patients with HBV-related HCC after curative surgery. Methods: MEDLINE/PubMed, Cochrane Library, EMBASE, Web of Science and CNKI were searched for eligible studies from inception to November 2022 and a meta-analysis was done. Results: 10 trials with a total of 2062 subjects were screened. Interferon significantly improved 1-, 2-, 3- and 5-year OS and 1-, 2- and 3-year DFS, and reduced 2-, 3- and 5-year recurrence rates of patients with HBV-related HCC after curative surgery. However, interferon did not improve 8-year OS and 5-year DFS, did not reduce 1-year recurrence rate. Conclusions: Interferon may significantly reduce recurrence and improve DFS of patients with HBV-related HCC after curative surgery, and finally improve the OS. However, the efficacy advantage may gradually weaken as time goes on. The clinical application of interferon combined with NAs recommended in this meta-analysis is needed to be further studied. [ABSTRACT FROM AUTHOR]

Introduction: In the event-driven FREEDOM-EV trial, oral treprostinil delayed clinical worsening in patients with pulmonary arterial hypertension (PAH). Open-label extension studies offer additional data about tolerability, efficacy, and survival, especially for those initially assigned placebo. The aim of the current study was to determine if oral treprostinil changed survival when considering the parent and extension study, if treprostinil provides functional benefits for participants initially assigned to placebo, and if the benefits observed for those treated with treprostinil were durable. Methods: Both active and placebo participants from FREEDOM-EV could enroll in the FREEDOM-EV open-label extension (OLE) study after experiencing an investigator-assessed clinical worsening event or after parent study closure. All participants in the OLE were offered open-label oral treprostinil. Previously assigned placebo participants titrated to maximally tolerated doses; previously assigned treprostinil participants continued dose titration. We repeated assessments including functional class and 6-min walk distance (6MWD) at 12-week intervals and measured N-terminal pro-brain natriuretic peptide (NT-proBNP) at week 48. Survival was estimated by Kaplan–Meier analysis, and we estimated hazard ratio (HR) using Cox proportional hazards. Results: Of 690 FREEDOM-EV participants, 470 enrolled in the OLE; vital status was available for 89% of initial Freedom-EV participants. When considering the combined parent and open-label data, initial assignment to oral treprostinil reduced mortality (HR 0.64, 95% confidence interval 0.46–0.91, p = 0.013); absolute risk reduction was 9%. Participants randomized to placebo who initiated oral treprostinil after clinical worsening and tolerated treatment through week 48 demonstrated favorable shifts in functional class (p < 0.0001), 6MWD improvements of + 84 m (p < 0.0001), and a reduction in NT-proBNP of − 778 pg/mL (p = 0.02), compared to OLE baseline. Modest trends toward benefit were measured for those initially assigned placebo who did not have clinical worsening, and 132/144 (92%) of treprostinil assigned participants without clinical worsening remained on drug at week 48 in the OLE study. Adverse events were consistent with FREEDOM-EV. Conclusion: Initial treprostinil assignment improved survival in the entire data set; those who began treprostinil after a clinical worsening in the placebo arm and tolerated drug to week 48 enjoyed substantial functional gains. Clinical Trial Registration: ClinicalTrials.gov identifier NCT01560637. [ABSTRACT FROM AUTHOR]

We previously found that fermented extract of Dendrobium officinale using Lactobacillus plantarum GT-17F has a stronger antioxidant effect, especially in free radical scavenging. The result provided a basis for further studies to evaluate the effectiveness of fermented D. officinale in preventing UV-mediated damage and photoaging in humans. Therefore, in this study, we aimed to assess the anti-aging efficacy of D. officinale fermented with GT-17F strain in a clinical trial, which was conducted as a double-blind, placebo-controlled, randomized parallel-group comparative study with 99 volunteers with visible wrinkles. During the study, subjects were instructed to apply one pump of each essence, which contains fermented, unfermented, or no D. officinale extract, evenly to their face, both in the morning and evening, following their cleansing routine. At 28 days post-treatment, compared to baseline, subjects in the fermented extract group demonstrated significant improvements in stratum corneum water content, skin elasticity, skin glossiness, wrinkle area and ratio, erythema area, and erythema area ratio. In contrast, the unfermented extract group showed a significant difference only in improving erythema index levels in the skin. This comprehensive study has rigorously investigated the anti-aging effects of D. officinale and its fermented version on human skin, highlighting a notable contribution to dermatological research. [ABSTRACT FROM AUTHOR]

Introduction: The objective was to evaluate the efficacy of biochemical markers (WBC, CRP and fibrinogen) and the course of odontogenic space infections in 50 patients. Material and Methods: Blood samples were taken preoperatively and postoperatively at day 0, day 4, day 8 and day 12 for measuring the levels of all three biomarkers. The trends of the biomarkers were observed and compared with assessment parameters such as dental etiology, number of teeth involved, number of spaces involved, mouth opening and pain. Active pus discharge, dysphagia, hoarseness and swelling were assessed and scored accordingly. Results: The data were subjected to paired 't' test, McNemar's and Pearson's bivariate correlation as appropriate. Statistical analysis found strong correlation between laboratory values of markers and parameters used to measure severity of infection. All three biomarkers (WBC, CRP and fibrinogen) are significant markers for hospital stay (p < 0.01). Prospective analysis indicates that only one biomarker cannot be used to rule out specific diagnosis. Conclusion: The combination of three biochemical markers assessed in the present study (WBC, CRP and fibrinogen) should be used as prognostic factor in assessment, clinical severity and efficacy of treatment regime for patients as these can reliably predict the clinical course of odontogenic infection. [ABSTRACT FROM AUTHOR]

Background: The gliding surface of total knee endoprostheses is exposed to high loads due to patient weight and activity. These implant components are typically manufactured from ultra-high molecular weight polyethylene (UHMWPE). Crosslinking of UHMWPE by ionizing radiation results in higher wear resistance but induces the formation of free radicals which impair mechanical properties after contact with oxygen. Medium-crosslinked UHMWPE enriched with vitamin E (MXE) provides a balance between the parameters for a sustainable gliding surface, i.e., mechanical strength, wear resistance, particle size, and oxidation stability. Therefore, a gliding surface for knee endoprostheses made up from this material was developed, certified, and launched. The aim of this study is to compare this new gliding surface to the established predecessor in a non-inferiority design. Methods: This multicenter, binational randomized controlled trial will enroll patients with knee osteoarthritis eligible for knee arthroplasty with the index device. Patients will be treated with a knee endoprosthesis with either MXE or a standard gliding surface. Patients will be blinded regarding their treatment. After implantation of the devices, patients will be followed up for 10 years. Besides clinical and patient-related outcomes, radiological data will be collected. In case of revision, the gliding surface will be analyzed biomechanically and regarding the oxidative profile. Discussion: The comparison between MXE and the standard gliding surface in this study will provide clinical data to confirm preceding biomechanical results in vivo. It is assumed that material-related differences will be identified, i.e., that the new material will be less sensitive to wear and creep. This may become obvious in biomechanical analyses of retrieved implants from revised patients and in radiologic analyses. Trial registration: ClinicalTrials.gov, NCT04618016. Registered 27 October 2020, https://clinicaltrials.gov/study/NCT04618016?term=vikep&checkSpell=false&rank=1. All items from the World Health Organization Trial Registration Data Set can be found in Additional file 1. [ABSTRACT FROM AUTHOR]

Clinical studies of herbs are crucial to practice in alternative medicine. However, finding those articles from databases is difficult due to the complexity of terminology. While clinical search filters are helpful, to date there are no search filters specific to clinical studies of herbs. This study aimed to develop search filters to retrieve clinical studies of herbs from PubMed. Relevant clinical study of herb articles from 2019 to 2020 was manually identified from ten selected journals. Search terms were extracted from the articles using PubReMiner, and search strategies composed of one to four search terms were formulated and evaluated. Out of 8,169 articles, 211 were clinical studies of herbs. The two most effective search filters showed 100% sensitivity with 85% specificity and 99% specificity with 55% sensitivity. These queries, respectively, reached 99% sensitivity with 85% specificity and 99% specificity with 60% sensitivity in the validation set. The developed search filters yielded more relevant articles than PubMed's clinical study filter when using the same herb name. Search filters for clinical studies of herbs were developed successfully. The best search strategy is to use these filters with the name of the herb that the researchers desire. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES Chylothorax is a complex condition and many different pharmacological agents have been tried as treatment. Octreotide is used off-label to treat chylothorax, but the efficacy of octreotide remains unclear. A decrease in lymph production is suggested as the mechanism. In this cross-over study, we explore the direct effect of octreotide on human lymphatic drainage. METHODS Pre-clinical: the effect of octreotide on force generation was assessed during acute and prolonged drug incubation on human lymphatic vessels mounted in a myograph. Clinical: in a double-blinded, randomized, cross-over trial including 16 healthy adults, we administered either octreotide or saline as an intravenous infusion for 2.5 h. Near-infrared fluorescence imaging was used to examine spontaneous lymphatic contractions and lymph pressure in peripheral lymphatic vessels and plethysmography was performed to assess the capillary filtration rate, capillary filtration coefficient and isovolumetric pressures of the lower leg. RESULTS Pre-clinical: human thoracic duct (n  = 12) contraction rate was concentration-dependently stimulated by octreotide with a maximum effect at 10 and 100 nmol/l in the myograph chamber. Clinical: spontaneous lymphatic contractions and lymph pressure evaluated by near-infrared fluorescence did not differ between octreotide or placebo (P  = 0.36). Plethysmography revealed similar capillary filtration coefficients (P  = 0.057), but almost a doubling of the isovolumetric pressures (P  = 0.005) during octreotide infusion. CONCLUSIONS Octreotide stimulated lymphatic contractility in the pre-clinical setup but did not affect the spontaneous lymphatic contractions or lymph pressure in healthy individuals. Plethysmography revealed a doubling in the isovolumetric pressure. These results suggest that octreotide increases lymphatic drainage capacity in situations with high lymphatic afterload. [ABSTRACT FROM AUTHOR]

Background: Lysiphyllum strychnifolium (LS), widely known as Ya nang daeng in Thailand, is a traditional herbal remedy that has long been used to promote health and treat diverse health conditions, especially detoxification, by alleviating the severity of symptoms and lowering the risks associated with toxic exposures. Although it is extensively used in Thailand, human safety studies have been lacking. Thus, this study aimed to examine the safety of using LS capsules in healthy participants through a Phase I clinical trial. Objective: This study aimed to investigate the safety of aqueous extract of LS in twenty-four healthy Thai participants. Method: The participants were received 1,000 mg of LS aqueous extract each morning before their meals for seven days. All participants were examined safety assessment including history taking, physical examination, and laboratory tests at day 0, 8 and 14 (follow-up). Results: The findings showed that there were no significant side effects or abnormalities found during the history taking, physical examination, or laboratory evaluation. Particularly, when compared to baseline, participants who received LS experienced statistically significant reductions in blood sugar, triglyceride, LDL cholesterol, and creatinine (P < 0.05), but still within normal ranges. Conclusions: Dietary supplementation with 1,000 mg of LS aqueous extract per day may have a beneficial effect on blood sugar and cholesterol management while remaining safe for healthy people. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the 5-year clinical performance of a glass hybrid restorative system and a nano-hybrid resin composite in moderate to large two-surface class II cavities. Materials and methods: This study was carried out by dental schools in Zagreb, Croatia; Izmir, Turkey; Belgrade, Serbia; and Milan, Italy. A total of 180 patients requiring two class-II two-surface restorations in the molars of the same jaw were recruited. The teeth were randomly restored with either a nano-hybrid resin composite (Tetric EvoCeram, Ivoclar Vivadent) or a glass-hybrid material (EQUIA Forte, GC). During the 5-year follow-up, two calibrated evaluators at each centre scored the restorations annually using the FDI-2 scoring system. The survival rates were calculated using the Kaplan–Meier method and compared using non-parametric matched pair tests (p < 0.05). Results: There were no statistically significant differences between the overall survival and success rates of the two types of restorations (p>0.05). The success rates (FDI-2 scores 1–3) for EQUIA Forte were 81.9% (average annual failure rate: 3.9%) and 90.7% for Tetric EvoCeram (average annual failure rate: 1.9%). The survival rates (FDI-2 scores 1–4) for EQUIA Forte and Tetric EvoCeram were 94.5% and 94.4%, respectively, with an average annual failure rate of 1.1%. Conclusions: In terms of success and survival rates, both the glass-hybrid restorative system and the nano-hybrid resin composite have been shown to perform satisfactorily. Clinical relevance: The results of this study indicate that EQUIA Forte can be one of the therapeutic options for moderate to large two-surface class II restorations of posterior teeth. [ABSTRACT FROM AUTHOR]

Objective(s): The aim of this study is to investigate the potential of Solid lipid nanoparticles (SLNs) to enhance the therapeutic effectiveness of ternary metal complexes of hydroxy acids in the treatment of acne. Materials and Methods: Ternary complexes of Cu (II) and Zn (II) with glycine amino acid (Gly) as a primary ligand, and Hydroxy acids (salicylic acid (L1), lactic acid (L2) or glycolic acid (L3)) as a secondary ligand, were synthesized in a slightly acidic medium and isolated in different ratios. These ternary complexes were loaded into SLNs and evaluated for particle size, polydispersity index, Zeta potential, entrapment efficiency and in vitro release studies. SLN-encapsulated ternary metal complexes were clinically evaluated in acne patients. Results: Scanning Electron Microscopy revealed that SLNs were spherical in shape and varied in size from 115 to 210 nm when measured with a Malvern Zetasizer. The zeta potential was ranged from -41.33 ± -2.5 to -47.32 ± -2.1 mV. The calculated entrapment efficiency (EE%) was 79 - 83% with slow release of the ternary complexes from the prepared SLNs. The in-vivo clinical study disclosed that Zn(L1)(Gly) SLNs outperformed Cu(L1)(Gly) SLNs in terms of acne spot reduction and patient satisfaction. Conclusion: In conclusion, this study demonstrated that SLNs-encapsulated ternary metal complexes are a promising new treatment for acne. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to assess the clinical effectiveness of the ten most often used acupoints, chosen through literature review, for treating knee osteoarthritis (KOA). Additionally, the study aims to monitor and analyse the therapeutic effects of combining electro-acupuncture with these acupoints in the treatment of KOA. Methodology: A total of 80 patients were randomised in a random manner to either the treatment group or the control group, with an equal distribution of 40 patients in each group. The treatment group was administered a combination of electro-acupuncture (EA) and traditional acupuncture (TA), targeting the top ten acupoints often used. A comparative analysis was conducted to assess the clinical effectiveness, WOMAC scores, VAS ratings, and SF-36 scores before and after treatment in both groups. Results: Prior to treatment, there were no statistically significant variations in the three scores between the two groups (P>0.05). Following the therapy, both groups exhibited noteworthy decreases in WOMAC and VAS scores. Notably, the treatment group displayed considerably lower values compared to the control group (P<0.05). In addition, the SF-36 ratings for physical health and mental health showed a significant increase in both groups after treatment. The treatment group achieved significantly higher scores than the control group (P<0.05). Furthermore, the treatment group exhibited a more significant enhancement in scores in comparison to the control group (P<0.05). Significant differences in WOMAC, VAS, and SF-36 scores were seen in the within-group comparisons (P<0.05). The treatment group demonstrated a significantly higher overall success rate of 92.50% (37/40) compared to the control group's success rate of 75.00% (30/40) (P=0.035<0.05). In conclusion, the combination of EA and TA, along with the use of the top ten high-frequency acupoints, effectively enhanced clinical symptoms and signs in patients with KOA, indicating promising therapeutic outcomes. EA had higher clinical efficacy and had a good influence on patients' quality of life, compared to the other strategy. The acupoint prescription was carefully determined by analysing available literature to investigate the patterns of acupoint selection in the treatment of knee osteoarthritis (KOA). This study led to the identification of the 10 most often used acupoints, which were then confirmed through clinical practice. The novel methodology employed by EA, in conjunction with the utilisation of the top ten high-frequency acupoints, holds significant value in terms of its potential for promotion in Malaysia. [ABSTRACT FROM AUTHOR]

Background: This study aims to evaluate factors influencing assessment results in the new Health Technology Assessment (nHTA) in Korea. Methods: We analyzed publicly available nHTA reports obtained from the program's website. A total of 258 reports, encompassing 305 technologies, were included. Reported details were categorized into three main areas: technical characteristics, evaluation methods, and publication types. To investigate differences in evidence level (high, medium, or low) and assessment results (pass or fail) according to these categories, we employed a chi-squared test. Univariate and multivariate logistic regression analyses were further conducted to identify factors associated with evidence level and assessment results. Results: nHTA reports employing meta-analysis and included randomized trials for evidence synthesis exhibited a higher likelihood of achieving high evidence level (odds ratio [OR], 5.008; 95% confidence interval [CI], 1.265-18.826 and OR, 27.052; 95% CI, 7.802-103.330, respectively). Increasing evidence level was significantly associated with a higher possibility of passing the assessment (OR 2.789; 95% CI, 1.284-6.057). However, in univariate analysis, neither performing meta-analysis nor including randomized trials, both of which were associated with evidence level, demonstrated a statistically significant association with assessment results. Conclusion: This study represents the first systematic analysis of factors influencing nHTA assessment results in Korea. While increased evidence level was associated with positive assessment outcomes, factors affecting the evidence level itself did not directly influence assessment results. This suggests the need for further efforts to effectively integrate high-level evidence into assessment decisions within the nHTA program. [ABSTRACT FROM AUTHOR]

The aim of this first randomized clinical trial (RCT) was to determine whether intraoral scans (IOS) can be used as a visual aid to improve the communication of dental findings in pediatric dentistry. Therefore, 60 children (mean age 10.1 ± 3.3 years) and their accompanying parents/primary caregivers (PGs) were examined between July 2022 and February 2023. Patients were randomly allocated to two groups: half of the participants were informed of the children's dental findings including treatment plans by verbal explanation alone (control group, n = 30), while the other half were informed using IOS (Trios 4, 3Shape) as a visual aid to support the verbal explanation (study group, n = 30). Both groups then completed a questionnaire regarding their children's diagnosis, treatment needs, planned therapy, and oral hygiene. Statistical analysis was performed using a t-test (p < 0.05). Overall, there was a significant difference between the two groups (p < 0.001) in terms of understanding the current oral situation of their children. While 85.5 ± 17.3% (mean ± standard deviation) of the answers were correct in the study group, only 57.2 ± 17.8% of the participants in the control group were capable of answering the questions correctly. In particular, the control group had difficulties answering the questions about treatment needs and therapy correctly. Within the limitations of this first pilot study, IOS can be clearly recommended as a visual aid to improve the communication of dental findings with PGs in pediatric dentistry. [ABSTRACT FROM AUTHOR]

Objectives: Autogenous and allogeneic blocks for shell augmentation of the jaw have shown comparable results. This observational clinical study aimed to compare both materials for shell augmentation concerning surgery time and intra- and postoperative complications. Material and methods: Bone augmentation with the shell technique using autogenous or allogenous bone was performed in 117 patients with segmental jaw atrophy. The primary study parameter was the surgical time, comparing both materials. Subsequently, intra- and postoperative complications were recorded. Results: Allogeneic (n = 60), autogenous (n = 52), or both materials (n = 5) were used. The use of allogeneic material led to a significantly shorter operation time (p < 0.001). A more experienced surgeon needed significantly less time than a less experienced surgeon (p < 0.001). An increasing number of bone shells (p < 0.001), an additional sinus floor elevation, and intraoperative complications also significantly increased the operation time (p = 0.001). Combining allogeneic and autogenous shells (p = 0.02) and simultaneous sinus floor elevation (p = 0.043) significantly impacted intraoperative complications. No correlations were found between the included variables for postoperative complications (all p > 0.05). In total, 229 implants were inserted after a healing time of 4–6 months, with a survival of 99.6% after a mean follow-up duration of 9 months. Conclusions: Compared to the autogenous technique, allogeneic shell augmentation has a shorter surgical time and a similar rate of intra- and postoperative complications as autogenous bone. Together with its promising clinical results, this technique can be recommended. [ABSTRACT FROM AUTHOR]

Kaposi sarcoma (KS) is the most common cancer in people living with HIV (PLWH) in many countries where KS‐associated herpesvirus is endemic. Treatment has changed little in 20 years, but the disease presentation has. This prospective cohort study enrolled 122 human immunodeficiency virus (HIV) positive KS patients between 2017 and 2019 in Malawi. Participants were treated with bleomycin, vincristine and combination antiretroviral therapy, the local standard of care. One‐year overall survival was 61%, and progression‐free survival was 58%. The 48‐week complete response rate was 35%. RNAseq (n = 78) differentiated two types of KS lesions, those with marked endothelial characteristics and those enriched in inflammatory transcripts. This suggests that different KS lesions are in different disease states consistent with the known heterogeneous clinical response to treatment. In contrast to earlier cohorts, the plasma HIV viral load of KS patients in our study was highly variable. A total of 25% of participants had no detectable HIV; all had detectable KSHV viral load. Our study affirms that many KS cases today develop in PLWH with well‐controlled HIV infection and that different KS lesions have differing molecular compositions. Further studies are needed to develop predictive biomarkers for this disease. [ABSTRACT FROM AUTHOR]

Background: Recent research has suggested that artemisinin and its derivatives may have therapeutic effects on parasites, viruses, tumors, inflammation and skin diseases. This study aimed to review clinical research on artemisinin and its derivatives except anti-malaria and explore possible priority areas for future development. Methods: Relevant articles in English and Chinese published before 28 October 2021 were reviewed. All articles were retrieved and obtained from databases including WanFang, PubMed/MEDLINE, the Cochrane Library, China National Knowledge International, Embase, OpenGrey, the Grey Literature Report, Grey Horizon, and ClinicalTrials.gov. Studies were selected for final inclusion based on predefined criteria. Information was then extracted and analyzed by region, disease, outcome, and time to identify relevant knowledge gaps. Results: Seventy-seven studies on anti-parasitic (35), anti-tumor (16), anti-inflammatory (12), anti-viral (8), and dermatological treatments (7) focused on the safety and efficacy of artemisinin and its derivatives. The anti-parasitic clinical research developed rapidly, with a large number of trials, rapid clinical progress, and multiple research topics. In contrast, anti-viral research was limited and mainly stayed in phase I clinical trials (37.50%). Most of the studies were conducted in Asia (60%), followed by Africa (27%), Europe (8%), and the Americas (5%). Anti-parasite and anti-inflammatory research were mainly distributed in less developed continents such as Asia and Africa, while cutting-edge research such as anti-tumor has attracted more attention in Europe and the United States. At the safety level, 58 articles mentioned the adverse reactions of artemisinin and its derivatives, with only one study showing a Grade 3 adverse event, while the other studies did not show any related adverse reactions or required discontinuation. Most studies have discovered therapeutic effects of artemisinin or its derivatives on anti-parasitic (27), anti-tumor (9), anti-inflammatory (9) and dermatological treatment (6). However, the efficacy of artemisinin-based combination therapies (ACTs) for parasitic diseases (non-malaria) is still controversial. Conclusions: Recent clinical studies suggest that artemisinin and its derivatives may be safe and effective candidates for anti-tumor, anti-parasitic, anti-inflammatory and dermatological drugs. More phase II/III clinical trials of artemisinin and its derivatives on antiviral effects are needed. [ABSTRACT FROM AUTHOR]

Objective: Evaluate the impact of adjusting the overall dose, Gypsum Fibrosum [Mineral; Gypsum] (ShiGao, SG) dose, and Prunus armeniaca L. [Rosaceae; Semen Armeniacae Amarum] (KuXingRen, KXR) dose on the efficacy of MaXingShiGan Decoction (MXSG) in treating children with bronchial pneumonia (Wind-heat Blocking the Lung), in order to provide strategy supported by high-quality evidence for the selection of rational clinical doses of MXSG. Methods: Based on the basic dose of MXSG, we conducted three randomized, double-blind, dose parallel controlled, multicenter clinical trials, involving adjustments to the overall dose, SG dose, and KXR dose, and included 120 children with bronchial pneumonia (Wind-heat Blocking the Lung) respectively. And the patients were divided into low, medium, and high dose groups in a 1:1:1 ratio, with 40 cases in each group. The intervention period lasted for 10 days. The primary outcome was the clinical cured rate, while the secondary outcomes included the effectiveness in alleviating major symptoms of bronchial pneumonia (including fever, cough, dyspnea, and phlegm congestion). And the occurrence of adverse events was recorded. Results: We first recorded and analyzed the baseline characteristics of the three studies, including age, gender, height, and so on. The results indicated that there were no significant differences among the dose groups within each study. For the study adjusting the overall dose of MXSG, the results showed that both the medium-dose group and high-dose group had significantly higher clinical cured rates compared to the low-dose group (Chi-square value 9.01, p = 0.0111). However, there was no significant benefit between the high-dose group and the medium-dose group (81.58% vs. 81.08%). Regarding phlegm congestion, excluding fever, cough, and dyspnea, both the medium-dose group and high-dose group had significantly higher clinical cured rates than the low-dose group (Chi-square value 6.31, p = 0.0426), and there was no significant benefit between the high-dose group and the medium-dose group (69.23% vs. 75.00%). A total of 5 adverse events were observed, of which only 1 case in the medium-dose group was possibly related to the experimental medication. For the study adjusted the SG dose in MXSG, the results showed that the high-dose group had the highest clinical cured rate, but the inter-group difference was not statistically significant (Chi-square value 3.36, p = 0.1864). The area under the curve (AUC) for cough in the medium-dose group was significantly lower than in the lowdose group and high-dose group (F-test value 3.14, p = 0.0471). Although no significant differences were observed in fever and dyspnea among the groups, the AUC in the high-dose group was lower than in the medium-dose and low-dose groups. In comparing the complete defervescence time, both the high-dose group (p < 0.0001) and the medium-dose group (p = 0.0015) achieved faster than the low-dose group. The high-dose group slightly outperformed the medium-dose group (0.50 (0.50, 0.80) vs. 0.80 (0.40, 1.40)), although the difference was not significant. In the medium-dose group, 1 adverse event was observed, but it was not related to the experimental medication. For the study adjusted the KXR dose in MXSG, the results showed that both the medium-dose group and high-dose group had significantly higher cured rates compared to the low-dose group (Chi-square value 47.05, p < 0.0001). However, there was no significant benefit comparing the high-dose group to the medium-dose group (90.00% vs. 92.50%). Regarding clinical symptoms, the results indicated that for cough (F-test value 3.16, p = 0.0460) and phlegm congestion (F-test value 3.84, p = 0.0243), the AUC for both the medium-dose group and high-dose group were significantly lower than in the low-dose group. Although there was benefit in the high-dose group compared to the medium-dose group, it was not statistically significant. No adverse events were observed during the study period. Conclusion: The synthesis of the three conducted clinical studies collectively indicates that for children with bronchial pneumonia (Wind-heat Blocking the Lung), the basic clinical dose of MXSG may represents an optimal intervention dose based on the accumulated clinical experience of doctors. If the dose is insufficient, the clinical effects might be compromised, but using a higher dose does not significantly enhance benefits. Concerning different symptoms, increasing the overall formula’s dose has a favorable impact on improving phlegm congestion, increasing the SG is effective in improving symptoms such as fever, cough, and dyspnea, while higher dose of KXR is effective in alleviating cough and phlegm congestion. These findings suggest that for MXSG, achieving the optimal intervention dose is crucial to achieve better clinical efficacy. For the SG and KXR, if certain symptoms are more severe, increasing the dose can be considered within safe limits, can lead to significant clinical benefits in symptom improvement. This also explains why the dose of MXSG might vary among clinical doctors, while maintaining a balance between safety and effectiveness. Of course, our study is still exploratory clinical trials, and further studies are needed to confirm our findings. [ABSTRACT FROM AUTHOR]

Objective: This retrospective case series aimed to assess the stability of the papilla around four single crowns supported by narrow‐diameter implants replacing all maxillary incisors. Secondary objectives included assessment of marginal bone level stability, incidence of technical and biological complications, and patient satisfaction. Materials and Methods: Individuals with four adjacent implants in maxillary incisor sites, placed with a 3 mm inter‐implant distance and rehabilitated with single crowns were included. Retrospective data were obtained from photographs and radiographs taken at the delivery of the prosthesis (baseline—T0). Patients were then recalled (≥2 years after T0) for clinical and radiographic examination (follow‐up—T1). Photographs were obtained and patient satisfaction was assessed using a visual analogue scale. Papilla height and marginal bone level were compared over time. Results: Data from 10 patients with medium‐low smile lines and rehabilitated with 40 implants, in function for 5.4 ± 1.9 years, were analyzed. The papilla height between implants (T0: 2.3 ± 0.9 mm; T1: 2.6 ± 0.7 mm; p =.011) and between tooth and implant (T0: 3.4 ± 0.9 mm; T1: 3.8 ± 0.8 mm; p =.025) increased significantly over the years. The marginal bone level remained stable over time (T0: 0.88 ± 0.57 mm; T1: 0.71 ± 0.67 mm; p =.007). Patients were highly satisfied (97.7 ± 0.3%) with the treatment outcome. Conclusion: Within its limitations, this study demonstrated that four single implant‐supported crowns placed at maxillary incisor sites may exhibit soft tissue and marginal bone stability over a long period of time. This treatment approach, however, should be restricted to few patients as it requires a proper case selection and skillful execution of all surgical and prosthetic steps. [ABSTRACT FROM AUTHOR]

Stem cell-based biological treatments are steadily progressing as an approach to promote the fundamental regeneration of tendons. In particular, mesenchymal stem cells (MSCs), which have the least severity of bioethics and carcinogenicity and can be separated relatively easily, have been applied widely. In this review, the efficacy of MSC therapy for tendon regeneration was compared and analyzed in nonclinical and clinical studies published in PubMed data base within the last three years, and the possibility was considered. In light of nonclinical study trends, to improve loss problems after cell transplantation and regeneration, 1) stem cell sheets, 2) use of scaffolds made with biomaterials of low immunogenicity, such as human-derived extracellular matrix and umbilical cord Wharton jelly, or innovative technologies such as three-dimensional printing, 3) stem cell-derived exosomes were directly injected into the body. Various animal models of rotator cuff tear have shown that tendon regeneration was improved when repair combined with these methods compared to a simple repair. In light of clinical study trends, efficacy, and safety evaluation were conducted by administering MSCs obtained through an expansion culture process (stem cell drug) or directly transplanting fresh biomaterials containing MSCs obtained during surgery without an expansion culture process (stem cell procedure). Although MSC therapy has many unresolved problems, the efficacy of MSCs for tendon regeneration has been reported repeatedly through numerous non-clinical and clinical studies. In addition, as new alternatives for the acquisition and transplantation of cells or biological materials have been proposed with the developments in other engineering fields, the possibilities are further increasing. [ABSTRACT FROM AUTHOR]

Amyotrophic lateral sclerosis (ALS) is a devastating and progressive neurodegenerative disease with limited treatment options available. Cerebrolysin is a drug candidate for the treatment of ALS because of its neuroprotective and neuroregenerative effects. We initiated a pilot clinical study of a combination of Cerebrolysin and riluzole to assess the therapeutic benefit of Cerebrolysin as an add-on treatment on clinical signs and symptoms in outpatients with ALS. Twenty patients with a clinically definitive diagnosis of ALS were enrolled and randomly assigned in a 1:1 ratio to receive Cerebrolysin or placebo. All patients received 50 mg of riluzole PO twice daily as a standard treatment. Patients in the Cerebrolysin group received intravenous injections of 10 mL of Cerebrolysin once daily, five days a week for the first month and three days a week for the next two months. Analysis of the ALS Functional Rating Scale - revised at Month 1 (primary outcome measure), showed a significant treatment effect in favor of Cerebrolysin with a 2.3-point improvement from baseline to Month 1 compared to a 0.9-point decrease in patients on placebo (P=0.005). The effect was maintained over the three-month study period, and the beneficial effect of Cerebrolysin over placebo was also evident in the secondary outcome measures. The safety analysis showed that the combination of riluzole and Cerebrolyisn was well tolerated. Our results demonstrate for the first time a significant clinical effect of Cerebrolysin in improving functional outcomes in patients with ALS and suggest that Cerebrolysin has potential as a novel therapeutic option for ALS. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To observe the current status of clinical studies on chimeric antigen receptor T-cell (CAR-T) immunotherapy in the pediatric population, so as to provide reference for domestic studies to perform clinical studies on CAR-T immunotherapy in the pediatric population. METHODS: Registration information of clinical studies on CAR-T was collected by retrieving the American Clinical Trial Database website, and the number of new clinical studies, national distribution, clinical study design, study phase, sponsors, disease types and targets were statistically analyzed. RESULTS: As of Dec. 6th, 2022, a total of 190 clinical studies on CAR-T in pediatric population were screened according to the inclusion and exclusion criteria. China ranked the first in registered studies (122 studies, 64. 2%), followed by the United States (44 studies,23. 2%). Intervention was the main research type (181 studies, 95. 3%). Clinical studies on CAR-T in pediatric population were mostly in the early stage of exploration. Clinical studies were mainly conducted by universities or research institutions and medical institutions, and mainly focused on scientific research and exploration. The types of diseases studied were mainly tumor and tumor-like diseases, with a focus on hematological tumors. CONCLUSIONS: The clinical studies on CAR-T in pediatric population in China has developed rapidly in recent years, and the national and provincial governments have issued different levels of regulations and supporting policies. Although the current regulatory system of gene and cell therapy products in China needs to be further improved and perfected, CAR-T therapy has significant advantages and great potential. [ABSTRACT FROM AUTHOR]

Pompe disease is a rare, autosomal recessive, degenerative neuromuscular disease caused by deficiency of acid α‐glucosidase, a lysosomal enzyme that degrades α‐1,4 and α‐1,6 linkages in glycogen. The objectives of this study (PAPAYA; NCT01410890) were to (1) characterize the pharmacokinetics of 20 mg/kg body weight alglucosidase alfa manufactured at the 4000‐L scale following a single intravenous dose in participants aged less than 18 and 18 years or older with Pompe disease and (2) evaluate the relationship between anti–alglucosidase alfa antibody titers and the pharmacokinetics of alglucosidase alfa. Mean maximum plasma concentration and area under the concentration–time curve from time zero and extrapolated to infinite time were 204 μg/mL and 1110 μg • h/mL for participants aged less than 18 years (n = 10), respectively, and 307 μg/mL and 1890 μg • h/mL for participants aged 18 years or older (n = 10), respectively. Mean terminal half‐life was 5.43 hours in participants aged less than 18 years with a high variability (70%) and 3.84 hours in participants aged 18 years or older with a low variability (21%). Mean maximum plasma concentration and area under the concentration–time curve from time zero and extrapolated to infinite time were 256 μg/mL and 1452 μg • h/mL, respectively, in anti–alglucosidase alfa–negative participants (n = 12) and 262 μg/mL and 1703 μg • h/mL, respectively, in anti–alglucosidase alfa–positive participants (n = 7). The study findings enrich available data from existing information on alglucosidase alfa without changing its known risks and benefits. [ABSTRACT FROM AUTHOR]

Multiple Sulfatase Deficiency (MSD) is a rare autosomal recessive disease with specific clinical findings such as psychomotor retardation and neurological deterioration. No therapy is available for this genetic disorder. Previous studies have shown that N-acetyl-L-leucine (NALL) can improve the neurological inflammation in the cerebellum. In the current study, the effects of NALL on ataxia symptoms and quality of life were explored in a patient with MSD. This study was a crossover case study. The subject, a girl aged 12 years old, received NALL at a dose of 3 g/day (1 g in the morning, 1 g in the afternoon, and 1 g in the evening). A fasting blood sample was taken from the subject to evaluate side effects before the intervention and 4 weeks after taking supplement/placebo in every study stage. The ataxia moving symptoms were evaluated using the Scale for the Assessment and Rating of Ataxia (SARA) score in every study stage. Dietary intake was measured using 24-h dietary recall before and after the intervention. The diet compositions were assessed by Nutritionist IV software. Serum IL-6 level was measured using an ELISA kit. There was no significant change in complete blood count (CBC) and serum biochemical factors in the patient with MSD after receiving NALL (3 g/day) over 4 weeks. The SARA score was reduced by 25%. The gait whose maximum score accounts for approximately one-fifth of the maximum total SARA score (8/40) was decreased. The heel-to-shin slide, the only SARA item performed without visual control, was also improved after therapy. Furthermore, there was a downward trend in the 8MWT (8.71 to 7.93 s). Regarding quality of life assessments, the parent and child reported improved quality of life index, physical health, and emotional function after taking NALL. Moreover, total energy intake was increased with NALL treatment through the study period. Supplementation with NALL at a dose of 3 g/day over 4 weeks was well tolerated and improved ataxia symptoms, quality of life measure, and serum IL-6 levels in the patient with MSD. Further proof-of-concept trials are warranted to confirm the present findings. [ABSTRACT FROM AUTHOR]

Objectives: This retrospective, single-center, practice-based cohort study aimed to analyze factors associated with the success of removable partial dentures retained by telescopic crowns (TRPD). Materials and methods: TRPD which were placed in a single practice of a practice-based research network were analyzed. Data from 139 patients (age (SD): 66 (11) years; 66 female) with 174 TRPD including 488 non-precious alloy telescopic crowns (TC) between 2004 and 2016 were included. TC without any technical complication were considered as successful, and as survived, if they were still in function at the last check-up. Multilevel Cox proportional hazard models were used to evaluate the association between clinical factors and time until failure. Results: Within a mean follow-up period (SD) of 4.2 (3.3) years (min–max: 1 day–12 years), 372 (76%) TC (AFR5years,TC-level: 5.0%) as well as 136 (87%) TRPD (AFR5years,TRPD-level: 5.1%) ("worst-case scenario") and 150 (86%) TRPD (AFR5years,TRPD-level: 3.4%) ("best-case scenario") were considered as successful. The main failure types were recementation (n = 39), endodontic treatment (n = 36), and extraction (n = 35). TC in male patients showed 1.6 times higher risk for failure than in female patients (95%CI: 1.1–2.4; p = 0.023). TC on premolars showed 2.2 times higher risk for failure than on incisors (95%CI: 1.1–5.0; p = 0.023) and TC in dentures with ≤ 3TC showed 2.1 times higher risk for failure than TC in dentures with > 3TC (1.3–3.4; p = 0.042). Furthermore, TC on the most distal tooth in an arch showed 2.4 times higher risk for failure than TC on a more mesial tooth (1.5–3.8; p < 0.001). Conclusion: For removable partial dentures retained by telescopic crowns, high success rates could be found after up to 12 years. Patient-level and tooth-level factors were significantly associated with failure. Clinical relevance: For removable partial dentures retained by telescopic crowns, high success rates could be found after up to 12 years. Patient-level and tooth-level factors were significantly associated with failure. [ABSTRACT FROM AUTHOR]

Background: Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. Methods: In this randomized, split-face, double-blind study, subjects (age: 17–34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 μg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. Results: At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (− 5.9 vs − 2.7; p < 0.0001) with differences between sides noted as early as week 2 (− 1.5 vs − 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity. Conclusions: Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2. Trial Registration: Clinicaltrials.gov NCT04856904. [ABSTRACT FROM AUTHOR]

A Chinese herbal formula, Tiaopi Xiezhuo decoction (TXD), is developed from a classical Chinese prescription Sanhuang Xiexin decoction. To investigate the regulatory effect of TXD on gut dysbiosis, as a treatment of constipation in patients with peritoneal dialysis (PD). The chemical content of TXD was assessed by high-performance liquid chromatography. A total of 29 PD patients were enrolled and treated with TXD orally (3 g crude drug/each/twice/day) for 3 months. Blood and faecal samples were collected at the beginning and end, to determine the changes in biochemical characteristics and gut microbial composition. The stool conditions were asked to be scored. Additional 30 healthy individuals were recruited as a control for the analysis of gut microbiota. Although having no significant effects on serum biochemical characteristics, 3-month TXD intervention improved constipation in PD patients: decreased 80% abdominal distention (p < 0.01), increased 2.6-fold sloppy stools (p < 0.05) and eliminated hard stool completely (p < 0.01). The analysis of gut microbiota showed that, compared to the healthy group, the microbial richness was reduced in PD patients. After a 3-month TXD treatment, this reduced richness was raised, and Paraprevotella clara, Lachnospiraceae bacterium 2-146FA, Phascolarctobaterium succinatutens, Lachnospiraceae bacterium 2-1-58FAA, Fusobacterium mortiferum, and Prevotella copri were accumulated in the intestinal flora. Furthermore, the bacterial species enriched by TXD correlated with the improvement of constipation. TXD treatment may improve constipation by modulating gut dysbiosis in PD patients. These findings provide data to support the further application of TXD in the adjuvant treatment of PD. [ABSTRACT FROM AUTHOR]

The main aim of this case series was to report the clinical and radiographic outcomes of 22 one-piece zirconia dental implants positioned in 19 patients to restore single edentulisms and followed up for at least 2 years. The mean observation period was 58.18 months. At the last follow-up visit, no issues, such as foreign body sensation, discomfort or pain, were reported by the patients. No implant showed signs of infection with suppuration or implant mobility. Marginal bone levels (MBL) were assessed through standardized dental radiographs and a dedicated software. The mean distance between the implant head and the first detectable bone to implant contact was calculated at the mesial and distal aspect of each implant. The mean MBL at baseline was 1.82 ± 0.63 mm while the mean MBL at the last follow-up visit was 2.57 ± 0.72 mm. The results obtained in the present case series over a mean follow-up period of 58.18 months (range 27–96) showed that one-piece zirconia dental implants could be an alternative option to support single crowns in patients requiring metal-free restorations. Nevertheless, further better-controlled research featuring an adequate study design and longer follow-up is needed in order to clarify advantages and limitations which are related to this treatment modality. [ABSTRACT FROM AUTHOR]