Wilcoxon Matched-pairs Signed-rank Test Research Articles

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers

PurposeTo characterize the safety, efficacy, and potential role of genicular artery embolization (GAE) as a disease-modifying treatment for symptomatic knee osteoarthritis (OA). Materials and MethodsThis is an interim analysis of a prospective, single-arm clinical trial of patients with symptomatic knee OA who failed conservative therapy for greater than 3 months. Sixteen patients who underwent GAE using 250-μm microspheres and had at least 1 month of follow-up were included. Six patients completed the 12-month follow-up, and 10 patients remain enrolled. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was evaluated at baseline and at 1, 3, and 12 months. Serum and plasma samples were collected for biomarker analysis. The primary end point was the percentage of patients who achieved the minimal clinically important difference (MCID) for WOMAC pain score at 12 months. Baseline and follow-up outcomes were analyzed using the Wilcoxon matched-pairs signed-rank test. ResultsTechnical success of the procedure was 100%, with no major adverse events. The MCID was achieved in 5 of the 6 (83%) patients at 12 months. The mean WOMAC pain score decreased from 8.6 ± 2.7 at baseline to 4.9 ± 2.7 (P = .001), 4.4 ± 2.8 (P < .001), and 4.7 ± 2.7 (P = .094) at 1, 3, and 12 months, respectively. There was a statistically significant decrease in nerve growth factor (NGF) levels at 12 months. The remaining 8 biomarkers showed no significant change at 12 months. ConclusionsGAE is a safe and efficacious treatment for symptomatic knee OA. Decreased NGF levels after GAE may contribute to pain reduction and slowing of cartilage degeneration.

Dynamics of training and acute exercise-induced shifts in muscular glucose transporter (GLUT) 4, 8, and 12 expression in locomotion versus posture muscles in healthy horses.

Important changes in glucose transporter (GLUT) expression should be expected if the glucose influx plays a pivotal role in fuelling or connecting metabolic pathways that are upregulated in response to exercise. The aim was to assess GLUT4, 8, and 12 dynamics in response to training and acute exercise. Methods: Sixteen untrained Standardbred mares (3-4year) performed an incremental SET at the start and end of 8weeks harness training. M. pectoralis (PM) and M. vastus lateralis (VL) muscle biopsies were taken before and after each SET, allowing for comparing rest and acute samples in untrained (UT) and trained (T) condition using Western Blot for GLUT quantification and Image Pro v.10 for Blot analysis. Data were normalized against GAPDH. Basal GLUT-levels of PM versus VL were analysed with the Wilcoxon matched-pairs signed rank test. The effect of acute exercise or training was assessed using the Friedman test with a post hoc Dunn's. Results: Basal GLUT4 and GLUT12 protein expression were significantly higher in the VL compared to the PM (PGLUT4 = 0.031 and PGLUT12 = 0.002). Training had no effect on basal GLUT4 expression, neither in the VL (p > 0.9999), nor the PM (p > 0.9999). However, acute exercise in trained condition significantly decreased GLUT4 expression in the VL (p = 0.0148). Neither training nor acute exercise significantly changed total GLUT8 protein expression. Training significantly decreased total GLUT12 protein expression in rest biopsies, only visible in the VL (p = 0.0359). This decrease was even more prominent in the VL after acute exercise in trained condition (PVL = 0.0025). Conclusion: The important changes seen in GLUT12 expression downregulation, both in response to training and acute exercise in the horse, the downregulation of GLUT4 expression after acute exercise in trained condition and the lack of differential shifts in GLUT8 expression in any of the studied conditions, questions the importance of glucose as substrate to fuel training and exercise in healthy horses. These findings encourage to further explore alternative fuels for their involvement in equine muscular energetics.

Liver parenchymal changes detected by MR elastography and diffusion-weighted imaging after stereotactic body radiotherapy for hepatocellular carcinoma.

Stereotactic body radiotherapy (SBRT) is a local treatment option for hepatocellular carcinoma (HCC). SBRT-induced focal reactions on the liver parenchyma have not been thoroughly evaluated using quantitative magnetic resonance imaging (MRI). To quantitatively evaluate liver parenchymal changes caused by SBRT for HCC using magnetic resonance elastography (MRE) and diffusion-weighted imaging (DWI). We retrospectively evaluated 22 adult patients who received SBRT for HCC and 27 who received locoregional therapy other than SBRT (controls). Liver stiffness by MRE and apparent diffusion coefficient (ADC) values by DWI of the liver parenchyma were measured before and after SBRT. Regions of interest (ROIs) were drawn on the two areas of radiation dose distribution levels, > 30 Gy and ≤ 30 Gy; a ROI was drawn in the control group. The two indices were compared before and after SBRT using a Wilcoxon matched-pairs signed-rank test. Liver stiffness and ADC values were significantly increased after SBRT in the dose areas of > 30 Gy compared with those before SBRT (4.05 vs 4.85 kPa; p < 0.05 in liver stiffness, and 1.10 vs 1.40 ×10-3 s/mm2; p < 0.05 in ADC values). In the dose area of ≦ 30 Gy, liver stiffness showed a significant increase in one reader (p = 0.033) but not in another reader (p = 0.085); ADC value showed no significant difference before and after SBRT as per both readers (p > 0.05). The control group demonstrated no significant differences before and after treatment (p > 0.05). MRE and DWI can be used to detect SBRT-induced liver parenchymal changes.

Kidney Biopsy Utility: Patient and Clinician Perspectives from the Kidney Precision Medicine Project

Limited data exist on patient perspectives of the implications of kidney biopsies. We explored patients' perspectives alongside those of clinicians to better understand how kidney biopsies affect patients' viewpoints and the clinical utility of biopsies. Prospective Cohort Study. Patient participants and clinicians in the Kidney Precision Medicine Project, a prospective cohort study of patients who undergo a research protocol biopsy, at 9 recruitment sites across the United States. Surveys were completed at enrollment before biopsy and additional timepoints after biopsy (participants: 28 days, 6 months; clinicians: 2 weeks). Kappa statistics assessed prebiopsy etiology concordance between clinicians and participants. Participant perspectives after biopsy were analyzed using a thematic approach. Clinician ratings of clinical management value were compared to prebiopsy ratings with Wilcoxon matched-pairs signed-rank tests and paired t tests. A total of 167 participants undergoing biopsy (124 participants with chronic kidney disease [CKD], 43 participants with acute kidney injury [AKI]) and 58 clinicians were included in this study. CKD participants and clinicians had low etiology concordance for the 2 leading causes of CKD: diabetes (k=0.358) and hypertension (k=0.081). At 28 days postbiopsy, 46 (84%) participants reported that the biopsy affected their understanding of their diagnosis, and 21 (38%) participants reported that the results of the biopsy affected their medications. Participants also shared biopsy impressions in free-text responses, including impacts on lifestyle and concurrent condition management. The biopsy positively shifted clinician perceptions of the procedure's clinical management benefits, while perceptions of prognostic value decreased and diagnostic ratings remained unchanged. Our study did not have demographic data of clinicians and could not provide insight into postbiopsy experiences for participants who did not respond to follow-up surveys. Participant perspectives of the personal implications of kidney biopsy can be integrated into shared decision-making between clinicians and patients. Enhanced biopsy reports and interactions between nephrologists and pathologists could augment the management and prognostic value of kidney biopsies. The utility of kidney biopsy is debated among clinicians, and patients' perspectives are even less explored. To address these gaps, we synthesized perspectives from clinicians and patient participants of the Kidney Precision Medicine Project (KPMP). Both before and after biopsy, clinicians were surveyed on how the procedure affected their clinical management, diagnosis, and prognosis. After biopsy, participants shared how the procedure affected their diagnosis, medication, and lifestyle changes. Clinicians and patients shared an appreciation for the biopsy's impact on medical management but diverged in their takeaways on diagnosis and prognosis. These findings highlight the need for greater collaboration between patients and clinicians, particularly as they navigate shared decision-making when considering kidney biopsy.

The impact of acute SARS-CoV-2 on testicular function including insulin-like factor 3 (INSL3) in men with mild COVID-19: A longitudinal study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may affect the male reproductive system as it uses angiotensin-converting enzyme (ACE)2, which is expressed in testicular tissue, as an entry point into the cell. Few studies have evaluated the long-term effects of mild coronavirus disease 2019 (COVID-19) on testicular function, and insulin-like factor 3 (INSL3) levels have not previously been assessed during acute SARS-CoV-2 infection. The aim of the study was to assess the impact of acute SARS-CoV-2 infection on testicular function including INSL3 and the presence of SARS-CoV-2 RNA in semen in non-hospitalised men with mild COVID-19. This longitudinal study included 36 non-hospitalised SARS-CoV-2-positive men (median age 29 years). Inclusion was within seven days following a positive SARS-CoV-2 reverse-transcription polymerase chain reaction test. Reproductive hormone levels, semen parameters, and the presence of SARS-CoV-2 RNA in oropharyngeal and semen samples were assessed during acute SARS-CoV-2 infection (baseline) and at three- and six-month follow-up. Wilcoxon matched-pair signed-rank (two samples) test was used to assess time-related alterations in reproductive hormone levels and semen parameters. Lower plasma testosterone (T) (total and calculated free (c-fT)) and higher luteinising hormone (LH) concentrations were observed during acute SARS-CoV-2 infection (baseline) compared to three- and six-month follow-up. Consequently, ratios of c-fT/LH were lower at baseline compared to three- and six-month follow-up (p<0.001 and p=0.003, respectively). Concomitantly, lower INSL3 concentrations were observed at baseline compared to three-month follow-up (p=0.01). The total number of motile spermatozoa was also lower at baseline compared to six-month follow-up (p=0.02). The alterations were detected irrespective of whether the men had experienced SARS-CoV-2-related fever episodes or not. No SARS-CoV-2 RNA was detected in semen at any time point. This study showed a reduction in testicular function, which was for the first time confirmed by INSL3, in men mildly affected bySARS-CoV-2 infection. The risk of transmission of SARS-CoV-2 RNA via semen seems to be low. Febrile episodes may impact testicular function, but a direct effect of SARS-CoV-2 cannot be excluded.

Knee Osteotomy Decreases Joint Inflammation Based on Synovial Histology and Synovial Fluid Analysis

To examine the biological changes in the joints of patients with knee osteoarthritis (OA) before and after around-knee osteotomy (AKO), focusing on synovial fluid (SF) and synovial pathological changes. Patients who underwent AKO for medial compartment knee OA between 2019 and 2021 were examined. SF and synovium were obtained at the time of AKO and plate removal after bone union (mean, 16.8 months [range: 11-38 months] postoperatively). SF volume and interleukin (IL)-6 concentrations in SF were assayed using enzyme-linked immunosorbent assay. Synovitis was assessed histologically using a semiquantitative scoring system. Macrophage infiltration was assessed by immunohistochemistry using a semiquantitative score for F4/80 expression. The M1/M2 ratio was calculated using percentage of cells positive for CD80 and CD163. The expression of proinflammatory cytokines was assessed by the percentage of IL-1β- and IL-6-positive cells. The number of vascular endothelial growth factor-positive luminal structures was counted to assess angiogenesis. The change in each parameter was compared before and after AKO using the Wilcoxon matched-pairs signed-rank test. Twenty-four knees of 21 patients were included. SF volume and IL-6 concentration significantly decreased postoperatively (12.6 ± 2.1 mL vs 4.2 ± 0.6 mL; P < .0001 and 50.5 ± 8.6 pg/mL vs 20.7 ± 3.8 pg/mL; P= .0001, respectively). A significant reduction in synovitis score (P= .0001), macrophage infiltration (P < .0003), M1/M2 ratio (P < .0007), angiogenesis (P < .0001), and the percentage of IL-1β- and IL-6-positive cells in the intima (P < .008 and P < .002, respectively) was found after AKO. SF volume and IL-6 concentrations in the SF decreased and inflammatory synovium pathology improved after AKO. In addition to biomechanical changes, the biological environment of the joint can be improved after AKO. Level IV, retrospective therapeutic case series.

A comparative clinical study of Janu Basti (medicated oil retention over knee) and Matra Basti (medicated oil enema) with Sahachara Taila along with Adityapaka Guggulu on osteoarthritis of knee joint

Background: Osteoarthritis (OA) of knee is a chronic inflammatory condition of knee joints characterized by pain, swelling, and functional restriction of the joint. In Ayurveda, it can be correlated with Sandhigata Vata. The two most promising therapies for the Ayurveda management are Janu Basti (medicated oil retention over knee) and Matra Basti (medicated oil enema). The present study was conducted to assess the comparative effect of the two Ayurveda procedure which could assist in clinical decision-making for maximum benefit and minimum discomfort for variable requirements of the patients. Aim: The aim of the study was to ascertain the better management among the two therapies. The objective of the study was to assess changes in pain in knee joints through the Visual Analog Scale (VAS) and disability through Western Ontario and McMaster Universities OA Index (WOMAC) from baseline to 30th day in both the therapies and compare the effect of the both therapies on pain and disability. Materials and methods: In this study, a total of 30 patients having the complaints of OA of knee joint were randomly divided into two groups. Fifteen patients were treated in group A with Janu Basti (external oleation through retention of oil over knee joints for 30 min) with Sahachara Taila along with Adityapaka Guggulu (oral medication) and 15 patients were treated in group B with Matra Basti (enema with medicated oil) with Sahachara Taila along with Adityapaka Guggulu. For the assessment, VAS for pain scoring, WOMAC for disability, Ritchie articular index for tenderness were used, and X-ray were graded on the basis of Kellgren–Lawrence system for OA severity. All the results were calculated by using InStat GraphPad 3 software. For intra-group comparison nonparametric data; “Wilcoxon matched-pairs signed ranks test” and “Paired-t-test” was used. For calculating the inter-group comparison, “Mann–Whitney test” and “unpaired-t-test” was used. All the statistical tests were interpreted as significance at 5% level (P &lt; 0.05). Results: There were significant changes in VAS, WOMAC score, and tenderness of the affected joint in both the groups. On intergroup comparison, Matra Basti with Sahachara Taila in group B has provided better relief in Sandhigatavata of Janu Snadhi along with Adityapaka Guggulu. Conclusion: The result shows that Ayurvedic management with Matra Basti and Janu Basti along with Adityapaka Guggulu are effective in the management of osteoarthritis (OA) of knee joint. However, Matra Basti along with Adityapaka Guggulu is a better management option than Janu Basti.

Effects of Moringa oleifera Seed Oil on Cultured Human Sebocytes In Vitro and Comparison with Other Oil Types.

The seeds of Moringa oleifera (horseradish tree) contain about 40% of one of the most stable vegetable oils (Moringa seed oil). Therefore, the effects of Moringa seed oil on human SZ95 sebocytes were investigated and were compared with other vegetable oils. Immortalized human SZ95 sebocytes were treated with Moringa seed oil, olive oil, sunflower oil, linoleic acid and oleic acid. Lipid droplets were visualized by Nile Red fluorescence, cytokine secretion via cytokine antibody array, cell viability with calcein-AM fluorescence, cell proliferation by real-time cell analysis, and fatty acids were determined by gas chromatography. Statistical analysis was performed by the Wilcoxon matched-pairs signed-rank test, the Kruskal-Wallis test and Dunn's multiple comparison test. The vegetable oils tested stimulated sebaceous lipogenesis in a concentration-dependent manner. The pattern of lipogenesis induced by Moringa seed oil and olive oil was comparable to lipogenesis stimulated by oleic acid with also similar fatty acid secretion and cell proliferation patterns. Sunflower oil induced the strongest lipogenesis among the tested oils and fatty acids. There were also differences in cytokine secretion, induced by treatment with different oils. Moringa seed oil and olive oil, but not sunflower oil, reduced the secretion of pro-inflammatory cytokines, in comparison to untreated cells, and exhibited a low n-6/n-3 index. The anti-inflammatory oleic acid detected in Moringa seed oil probably contributed to its low levels of pro-inflammatory cytokine secretion and induction of cell death. In conclusion, Moringa seed oil seems to concentrate several desired oil properties on sebocytes, such as high content level of the anti-inflammatory fatty acid oleic acid, induction of similar cell proliferation and lipogenesis patterns compared with oleic acid, lipogenesis with a low n-6/n-3 index and inhibition of secretion of pro-inflammatory cytokines. These properties characterize Moringa seed oil as an interesting nutrient and a promising ingredient in skin care products.

Comparison of pharmacy student, evaluator, and standardised patient assessment of Objective Structured Clinical Examination (OSCE) performance

Objective: The study aimed to (1) determine if standardised patient (SP) assessment of student communication differs from faculty assessment and (2) identify factors that may affect their assessment scoring since differences between evaluator scoring could impact students’ learning and feedback. Methods: Students completed four OSCEs in spring 2022. Communication skills were scored using a global assessment rubric completed by a faculty evaluator, SP, and student. SPs and students rated their confidence in student recommendations on a scale of 1-5 (1=lowest; 5=highest). Spearman correlation and Wilcoxon matched-pairs signed rank tests were used for analysis. Results: SP global assessment scores were statistically significantly higher than faculty scores. SP global assessment and confidence scores were strongly correlated. Conclusion: Differences in OSCE scoring among evaluator types and factors that may impact scoring are important to explore. SP scores were consistently higher than faculty scores, which should be considered when using OSCEs as assessments.

Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant

AbstractVitamin D deficiency is common in childhood, pervasive before and after bone marrow transplant, and is associated with increased incidence of graft-versus-host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplant (HSCT). Numerous barriers impede replacement, including malabsorption secondary to gut GVHD, mucositis, inability to take capsules, kidney disease, liver disease, and infection; many patients remain refractory despite vitamin D therapy. We hypothesized that a different formulation of cholecalciferol, administered on the tongue as a readily dissolving oral thin film (OTF), would ease administration and facilitate therapeutic vitamin D levels (>35 ng/mL) in patients who are refractory. In this prospective pilot study, we evaluated 20 patients after HSCT (range, day +21 - day +428 at enrollment) with serum vitamin D levels ≤35 ng/mL. Cholecalciferol OTF strips were administered for 12 weeks. Dosing was based on patient body weight and titrated per individual pharmacokinetics. Wilcoxon matched-pairs signed-rank test demonstrated marked improvement in all 20 patients who were formerly refractory, increasing from a median baseline vitamin D level of 29.2 ng/mL to 58 ng/mL at end of study (P < .0001). All patients demonstrated improvement in serum vitamin D level by week 4 on study, some of whom had been refractory for years prior. Median dose was 1 OTF strip (40 000 IU) per week. No toxicity was observed. This formulation proved to be safe, effective, efficient, and well received. We are eager to explore other patient populations, which might benefit from this promising development, and other therapeutics that might be optimized using this mode of delivery. This trial was registered at www.clinicaltrials.gov as #NCT04818957.

Therapeutic Effects of Apremilast on Enthesitis and Dactylitis in Real Clinical Setting: An Italian Multicenter Study.

Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life. The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in patients treated with apremilast. Patients affected by PsA from fifteen Italian rheumatological referral centers were screened. The inclusion criteria were: (a) enthesitis or dactylitisphenotype; (b) treatment with apremilast 30 mg bid. Clinical and treatment history, including PsA disease activity, were recorded. Mann-Whitney and chi-squared tests were used to assess the differences between independent groups, and Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value of <0.05 was considered statistically significant. The Eph cohort consisted of 118 patients (median LEI 3); the Dph cohort included 96 patients with a median dactylitis of 1 (IQR 1-2). According to an intention to treat analysis, 25% and 34% of patients with enthesitis achieved remission (i.e., LEI = 0) in T1 and T2. The remission of dactylitis was 47% in T1 and 44% in T2. The per protocol analysis (patients observed for at least 12 months) showed that both dactylitis and LEI significantly improved in T1 (median LEI 1 (IQR 1-3)) and T2 (median LEI 0 (IQR 1-2)). Eph and Dph PsA patients treated with apremilast experienced a significant improvement in enthesitis and dactylitis activity. After 1 year, enthesitis and dactylitis remission was achieved in more than one-third of patients.

Retrospective Cohort Analysis of the Impact of Puberty on Plexiform Neurofibroma Growth in Patients with Neurofibromatosis Type 1

To assess the hypothesis that plexiform neurofibroma (PN) growth rates increase during puberty. PN growth rates before and during puberty were compared in a retrospective cohort of children with neurofibromatosis type 1 with puberty defined by Tanner staging. Of 33 potentially eligible patients, 25 had adequate quality magnetic resonance imaging for volumetric analysis and were included in ≥1 anchor cohort. Volumetric analysis was performed for all available imaging studies within the 4years before and after puberty, and before and after 9- and 11-year-old anchor scans. Linear regression was performed to estimate the slope of change (PN growth rate); growth rates were compared with paired t test or Wilcoxon matched-pairs signed rank test. There were no significant difference in rates of PN growth in milliliters per month or milliliters per kilogram per month in the prepubertal vs pubertal periods (mean,1.33±1.67 vs 1.15±1.38 [P=.139] and -0.003±0.015 vs -0.002±0.02 [P=.568]). Percent increases of PN volumes from baseline per month were significantly higher prepubertally (1.8% vs 0.84%; P=.041) and seemed to be related inversely to advancing age. Puberty and its associated hormonal changes do not seem to influence PN growth rate. These findings support those previously reported, but from a typical population of children with neurofibromatosis type 1 with puberty confirmed by Tanner staging.

Antibody Responses Against Emerging SARS-CoV-2 Omicron Lineages After the Fourth Dose of mRNA Vaccine in Kidney Transplant Recipients.

Antibody Responses Against Emerging SARS-CoV-2 Omicron Lineages After the Fourth Dose of mRNA Vaccine in Kidney Transplant Recipients.

(123) Novel Low Intensity Shockwave Therapy Sham Delivery Method (Zero Energy) Assessed Objectively by Grayscale and Doppler Ultrasound Results

Abstract Introduction Most ED LiSWT studies use the IIEF as a primary outcome. While clinically relevant, the IIEF does not directly assess erectile tissue structure. To establish a more objective parameter, we investigated the estimation of hypoechoic area in grayscale ultrasound images of erectile tissue as an objective primary outcome for clinical trials assessing the efficacy of LiSWT. During erection, grayscale imaging of the penis demonstrates corpora cavernosa (CC) that is homogenous in healthy men and heterogeneous to varying degrees in men with ED. A critical aspect of using grayscale ultrasound is to determine that sham treatment reliably results in no significant improvement in erectile tissue structure. Other studies have used sham probes with cotton wadding or non-penetrable gel pads to dampen delivery of shockwave energy flux density, however a small amount of energy may still be delivered. We report a novel sham-controlled methodology in LiSWT RCT for ED. Objective To evaluate erectile tissue heterogeneity as an endpoint in LiSWT sham-controlled trials using grayscale analysis of percent hypoechoic regions in CC after sham delivery of zero energy flux density. Methods A single-blind, sham-controlled, randomized prospective study was performed in men with ED naïve to any kind of acoustic wave therapy. Those meeting inclusion/exclusion completed baseline assessments and were randomized to active or sham within each treatment arm. This interim sub-analysis only examined the sham group (n = 7). For each treatment, the shockwave device was already on in the exam room. When the subject was ready a curtain was suspended above his mid-section blocking the device, and noise cancelling headphones provided. When the probe was placed on the penis, a high-quality recording of shockwave sounds was activated for sham treatment. Twenty weeks after zero energy sham treatment, grayscale and DUS imaging using a 15.4 MHz probe under pharmacologic erection 3-4/4 hardness was performed before unblinding. Grayscale percent hypoechoic regions within the CC were assessed by computer-assisted histometry using Image J. (Fig 1) The IIEF was also administered to all patients at baseline and week 20. Grayscale data were analyzed by two-way repeated measures ANOVA. IIEF-EF scores and bloodflow values (PSV and EDV) were compared using the Wilcoxon matched-pairs signed rank test. Results Compared to baseline, there were no significant changes (p&amp;gt;0.7; see figure) at week 20 in hypoechoic area in the proximal, middle, and distal erect penile shaft. (Fig 2) Furthermore, there were no significant changes in PSV (p&amp;gt;0.15), EDV (p&amp;gt;0.2), or IIEF-EF (p&amp;gt;0.6) from baseline to week 20. Conclusions Using computer-assisted histometry to determine hypoechoic area in grayscale ultrasound images to assess penile erectile tissue heterogeneity, we demonstrated that a novel sham treatment protocol that ensures zero energy delivery does not change erectile tissue integrity. The lack of improvement in PSV, EDV, and IIEF-EF further support our findings with grayscale ultrasound. Future studies will assess the appropriateness of grayscale ultrasound image analysis as a primary endpoint in LiSWT clinical trials. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: TRT, Cynosure.

Evaluation of the effectiveness of tube drain on postoperative discomfort in mandibular third molar surgery: prospective randomized split-mouth study

Introduction The present randomized split-mouth study aimed to investigate the clinical effectiveness of postoperative discomfort of the use of a surgical drain after lower third molar extraction. Materials and methods It was conducted a prospective randomized split-mouth study involving 30 patients with bilateral symmetric lower third molar. Each patient underwent two operations for the extraction of impacted teeth: test site (tube drain) and control site (conventional total closure of surgical flap), resulting in 30 cases in the test group, and 30 cases in the control group. Pain, swelling, and mouth opening were evaluated immediately before the surgeries, after 1, 3 and 7 days postoperatively in both groups. Data were analyzed with non-parametric test (Kruskal-Wallis test and the post hoc Dun test, and Wilcoxon matched-pairs signed rank test). Results Facial swelling (p < .001) was significantly less in test group compared with the control group on all examined days. Trismus is significantly reduced only on the third day (p < .001); Pain measurements did not differ statistically significantly between the two groups on all post-operative days (p > .05). Conclusion The use of the tube drain reduced facial swelling and trismus, but had no influence on the subjective perception of postoperative pain.

Melanoma: Does It Present Differently in Darker Skin Tones?

There are vast differences in clinical presentations of melanoma across skin tones. Individuals with darker skin tones tend to have a higher prevalence of advanced-stage melanoma, which correlates with increased mortality. We designed this interactive workshop to increase nursing and medical trainees' awareness of the epidemiology, prevention, and treatment of melanoma in individuals of darker skin tones. The Kern model was used in the design, implementation, and evaluation of the workshop. The 75-minute workshop consisted of a PowerPoint presentation, video-based reflection activities, and case studies. Evaluation consisted of pre- and postworkshop questionnaires. The workshop was implemented two times among 63 nursing students, 11 medical students/residents, and six medical faculty. Seventy-one participants completed the pre- and postworkshop evaluations. A comparison of pre- and postworkshop responses utilizing the Wilcoxon matched-pair signed rank test showed a statistically significant increase in learners' confidence to address each learning objective. Through this interactive educational presentation, medical and nursing trainees can gain heightened awareness of melanoma across various skin tones, especially unique presentations in darker skin tones.

OC-006 INTRAOPERATIVE FASCIA TRACTION FOR THE TREATMENT OF LARGE ABDOMINAL WALL/INCISIONAL HERNIAS (W3, EHS)

Abstract Aim To evaluate the effectiveness, clinical practicability, and complication rate of the fascial traction procedure for the treatment of large ventral hernias. Method This observational study evaluated 90 patients from 1 specialised center with an intraoperatively measured fascial distance of more than 10 cm who were treated by Intraoperative Fascia Traction – IFT- (abdominal wall stretching) using the fasciotens® hernia traction procedure. Results Fascial gap measured pre-operatively ranged from 10 to 44 cm, with most patients (94%) having a fascial above 15 cm (W3 according to the European Hernia Society classification). The mean fascial distance was reduced from 16.1 ± 0.8 to 5.8 ± 0.7 cm (stretch gain 10.2 ± 0.7 cm, p &amp;lt; 0.0001, Wilcoxon matched-pairs signed-ranks test). A reduction in fascial distance of at minimum 50% was achieved in three quarters of the patients, and in half of the treated patients the reduction in fascial distance amounted to even more than 70% The closure rate achieved by fascial traction after a mean surgical duration of 207.3 ± 11.0 minutes was 90% (81/90). Postoperative complications occurred in 7 patients (8%). Re-operation was required in 4 patients (4.5%). Conclusion This described intraoperative fascia traction (IFT) method is a new, promising procedure for abdominal wall closure in large ventral hernias. The presented results demonstrate a high effectiveness, a good clinical practicability and a low complication rate of the Intraoperative fascia traction (IFT) method.

Dynamics of CD4+ T-Cells and Neutralizing Antibody Responses to Three Consecutive Doses of Inactivated COVID-19 Vaccines in PLWH.

Comprehensive characterization of safety and immune responses to vaccines is crucial for the prevention and treatment of COVID-19 among people living with HIV (PLWH). This study aimed to investigate the dynamic changes in SARS-CoV-2-specific CD4+ T-cell subsets and neutralizing antibody after three consecutive doses of inactivated COVID-19 vaccines (BBIBP-CorV) among PLWH. The blood samples were collected from 165 PLWH, including 66 PLWH in the 3-month interval between the second and third dose (cohort 1) and 99 PLWH in the 5-month interval (cohort 2). Blood collection for immunogenicity analysis was performed at 1-month post-2nd vaccination, pre-3rd vaccination, and within 2-month post-3rd vaccination. Wilcoxon matched-pairs signed-rank test was applied to compare the SARS-CoV-2-specific CD4+ T cell subsets and neutralizing antibody level at different time points. The relationship among CD4+ T-cells, Tregs subpopulations and SARS-CoV-2-specific neutralizing antibody level were evaluated with Spearman non-parametriccorrelationtest. No serious adverse reactions were found among PLWH. After two-dose or three-dose inactivated COVID-19 vaccination, the absolute counts of CD4+ T-cells and Tregs subpopulations (CD4+CD25HighCD127Low Tregs, CD45RA+ rTregs and CD45RO+ eTregs) increased in two cohorts. Satisfactory SARS-CoV-2-specific neutralizing antibody responses to the third-dose vaccination were found in two cohorts, including significantly enhanced neutralizing antibody level and high neutralizing antibody seroconversion rate. In addition, SARS-CoV-2-specific neutralizing antibody level were positively associated with the absolute counts of CD4+ T-cells and Tregs subpopulations as well as the frequency of CD45RO+ eTregs in PLWH after three doses of vaccinations. The three doses of inactivated COVID-19 vaccination were both safe and effective to increase SARS-CoV-2-specific CD4+ T-cells and neutralizing antibody in two PLWH cohorts with different inoculation intervals.

A comparative clinical study of Erandbeejadi Gutika and Pippalyadi Gana Kashaya with external application of modified Ruksha Pottali Sweda in the management of Amavata

Background: Amavata is a very challenging and burning problem in society. The clinical presentation of Amavata is closely related to the special variety of musculoskeletal disorder rheumatoid arthritis (RA). There is no medical system that is successful in providing a complete cure for the disease, so the Ayurvedic approach toward the treatment of Amavata is needed in the present era. The prevalence of RA is approximately 1% of the total population. For the management of RA in allopathic science, DMARDs &amp; steroids are used frequently. Due to the lack of effective drugs and major problem in society, this disease for the study has been selected. Aim and Objectives: To study the efficacy of Erandbeejadi Gutika and Pippalyadi Gana Kashaya with modified Ruksha Sweda in the management of Amavata (RA). Methodology: It will be a single-center, randomized, open-clinical study. In this study, 60 clinically diagnosed patients of Amavata were selected and randomly divided into two groups by coin method. Erandbeejadi Gutika will be given in the dose of two tablets (each 500 mg) four times in a day with lukewarm water before meal for 90 days along with the modified Ruksha Pottali Sweda, while Pippalyadi Gana Kashaya will be given 50 ml two times in a day before the meal along with the modified Ruksha Pottali Sweda. Statistical analysis will be done using the Wilcoxon matched-pairs signed ranks test for the analysis of nonparametric data, while paired t-test will be used for parametric data analysis, and mann-whitney test and unpaired t-test will be used for intergroup comparison.

Effect of Intracoronal Sealing Biomaterials on the Histological Outcome of Endodontic Revitalisation in Immature Sheep Teeth—A Pilot Study

The influence of intracoronal sealing biomaterials on the newly formed regenerative tissue after endodontic revitalisation therapy remains unexplored. The objective of this study was to compare the gene expression profiles of two different tricalcium silicate-based biomaterials alongside the histological outcomes of endodontic revitalisation therapy in immature sheep teeth. The messenger RNA expression of TGF-β, BMP2, BGLAP, VEGFA, WNT5A, MMP1, TNF-α and SMAD6 was evaluated after 1 day with qRT-PCR. For evaluation of histological outcomes, revitalisation therapy was performed using Biodentine (n = 4) or ProRoot white mineral trioxide aggregate (WMTA) (n = 4) in immature sheep according to the European Society of Endodontology position statement. After 6 months' follow-up, one tooth in the Biodentine group was lost to avulsion. Histologically, extent of inflammation, presence or absence of tissue with cellularity and vascularity inside the pulp space, area of tissue with cellularity and vascularity, length of odontoblast lining attached to the dentinal wall, number and area of blood vessels and area of empty root canal space were measured by two independent investigators. All continuous data were subjected to statistical analysis using Wilcoxon matched-pairs signed rank test at a significance level of p < 0.05. Biodentine and ProRoot WMTA upregulated the genes responsible for odontoblast differentiation, mineralisation and angiogenesis. Biodentine induced the formation of a significantly larger area of neoformed tissue with cellularity, vascularity and increased length of odontoblast lining attached to the dentinal walls compared to ProRoot WMTA (p < 0.05), but future studies with larger sample size and adequate power as estimated by the results of this pilot study would confirm the effect of intracoronal sealing biomaterials on the histological outcome of endodontic revitalisation.