Standard Group Research Articles

The Impact of Infliximab on Hyperinflammation State in Hospitalized COVID-19 Patients: A Retrospective Study

Background and Objectives: Elevated levels of pro-inflammatory cytokines have been linked to increased mortality in COVID-19 patients. Infliximab, a tumor necrosis factor inhibitor, has been reported to improve outcomes in COVID-19 patients by targeting the hyperinflammatory response. Our objective was to evaluate the effectiveness of incorporating Infliximab into standard care guidelines for the management of COVID-19. Materials and Methods: A retrospective analysis was conducted on 111 participants who were moderate to severe COVID-19 patients admitted to the hospital. Among them, 74 individuals received solely standard treatment, while 37 received standard therapy plus Infliximab. The primary outcomes of the study centered around the changes in laboratory test parameters. The secondary clinical findings included clinical recovery defined as improvement in patient oxygenation, time till recovery, and assessing necessity for ICU admission, and mortality rates. Results: There was no statistical difference observed in the inflammatory markers including, LDH, Ferritin, CRP, neutrophil to lymphocyte ratio (NLR), and P/F ratio between both groups and in the clinical outcomes including clinical recovery (p = 1.0), time to improvement (p = 0.436), and mortality rate (p = 0.601). However, there was a significant increase in secondary infection (45.9%, 20.3%; p = 0.005), and in liver enzymes, ALT (79.5, 50.0 IU/L; p = 0.02) and AST (57.5, 38.0 IU/L; p = 0.019) in the Infliximab group and the standard care group, respectively. Conclusions: Infliximab therapy did not demonstrate significant benefits compared to standard of care in moderate to severe hospitalized COVID-19 patients.

Prediction of prostate cancer recurrence after radiotherapy using a fused machine learning approach: utilizing radiomics from pretreatment T2W MRI images with clinical and pathological information

The risk of biochemical recurrence (BCR) after radiotherapy for localized prostate cancer (PCa) varies widely within standard risk groups. There is a need for low-cost tools to more robustly predict recurrence and personalize therapy. Radiomic features from pretreatment MRI show potential as noninvasive biomarkers for BCR prediction. However, previous research has not fully combined radiomics with clinical and pathological data to predict BCR in PCa patients following radiotherapy.
Purpose: This study aims to predict 5-year BCR using radiomics from pretreatment T2W MRI and clinical-pathological data in PCa patients treated with radiation therapy, and to develop a unified model compatible with both 1.5T and 3T MRI scanners.
Methods: A total of 150 T2W scans and clinical parameters were preprocessed. Of these, 120 cases were used for training and validation, and 30 for testing. Four distinct machine learning models were developed: Model 1 used radiomics, Model 2 used clinical and pathological data, and Model 3 combined these using late fusion. Model 4 integrated radiomic and clinical-pathological data using early fusion.
Results: Model 1 achieved an AUC of 0.73, while Model 2 had an AUC of 0.64 for predicting outcomes in 30 new test cases. Model 3, using late fusion, had an AUC of 0.69. Early fusion models showed strong potential, with Model 4 reaching an AUC of 0.84, highlighting the effectiveness of the early fusion model.
Conclusions: This study is the first to use a fusion technique for predicting BCR in PCa patients following radiotherapy, utilizing pre-treatment T2W MRI images and clinical-pathological data. The methodology improves predictive accuracy by fusing radiomics with clinical-pathological information, even with a relatively small dataset, and introduces the first unified model for both 1.5T and 3T MRI images.

Pre-operative environmental enrichment does not yield a prophylactic effect against traumatic brain injury-induced neurobehavioral deficits

The robustness of environmental enrichment (EE) in ameliorating neurobehavioral and cognitive deficits after experimental traumatic brain injury (TBI) is unequivocal. What is equivocal is whether EE can function as a prophylactic to afford resiliency and neuroprotection against TBI. We hypothesized that pre-operative EE would yield a protective effect against TBI-induced motor, cognitive, and coping deficits, and that further improvements would be conferred when EE is provided before and after TBI. To test the hypotheses, adult male rats received either 4 weeks of EE or standard (STD) housing prior to undergoing a controlled cortical impact of moderate severity (2.8 mm deformation at 4 m/s) or sham injury while under anesthesia. After injury, the rats were randomly assigned to post-operative EE or STD housing. Motor ability, spatial learning, and memory retention were assessed by beam-walk and water maze tests, respectively. Active and passive behavioral coping strategies were evaluated with the shock probe defensive burying (SPDB) test. c-Fos and cortical lesion volume were also quantified. The post-TBI enrichment groups (EE + TBI + EE and STD + TBI + EE) did not differ (p > 0.05) and performed better than the post-TBI STD-housed groups (EE + TBI + STD and STD + TBI + STD) on motor and cognition (p < 0.05). The post-TBI STD groups did not differ, regardless of whether in EE or STD living conditions before injury (p > 0.05). Moreover, both post-TBI enrichment groups performed better in the SPDB test relative to the STD + TBI + STD group (p < 0.05). c-Fos + cells were upregulated in the ipsilateral CA1 in both pre-injury EE groups relative to the pre-injury STD groups (p < 0.05). No statistical differences were observed in cortical lesion volume among the groups. Overall, these data do not support the hypothesis as no neuroprotective effect was observed with 4 weeks of pre-operative EE and no additional benefit was achieved in the TBI group receiving both pre-and-post EE relative to the TBI group receiving only post-EE. However, the data do reinforce the consistency of post-TBI EE in producing robust neurobehavioral benefits, which further supports this paradigm as a relevant preclinical model of neurorehabilitation.

Cost-effectiveness of a patient-reported outcome-based remote monitoring and alert intervention for early detection of critical recovery after joint replacement: A randomised controlled trial.

While the effectiveness of patient-reported outcome measures (PROMs) as an intervention to impact patient pathways has been established for cancer care, it is unknown for other indications. We assessed the cost-effectiveness of a PROM-based monitoring and alert intervention for early detection of critical recovery paths following hip and knee replacement. The cost-effectiveness analysis (CEA) is based on a multicentre randomised controlled trial encompassing 3,697 patients with hip replacement and 3,110 patients with knee replacement enrolled from 2019 to 2020 in 9 German hospitals. The analysis was conducted with a subset of 546 hip and 492 knee replacement cases with longitudinal cost data from 24 statutory health insurances. Patients were randomised 1:1 to a PROM-based remote monitoring and alert intervention or to a standard care group. All patients were assessed at 12-months post-surgery via digitally collected PROMs. Patients within the intervention group were additionally assessed at 1-, 3-, and 6-months post-surgery to be contacted in case of critical recovery paths. For the effect evaluation, a PROM-based composite measure (PRO-CM) was developed, combining changes across various PROMs in a single index ranging from 0 to 100. The PRO-CM included 6 PROMs focused on quality of life and various aspects of physical and mental health. The primary outcome was the incremental cost-effectiveness ratio (ICER). The intervention group showed incremental outcomes of 2.54 units PRO-CM (95% confidence interval (CI) [0.93, 4.14]; p = 0.002) for patients with hip and 0.87 (95% CI [-0.94, 2.67]; p = 0.347) for patients with knee replacement. Within the 12-months post-surgery period the intervention group had less costs of 376.43€ (95% CI [-639.74, -113.12]; p = 0.005) in patients with hip, and 375.50€ (95% CI [-767.40, 16.39]; p = 0.060) in patients with knee replacement, revealing a dominant ICER for both procedures. However, it remains unclear which step of the multistage intervention contributes most to the positive effect. The intervention significantly improved patient outcomes at lower costs in patients with hip replacements when compared with standard care. Further it showed a nonsignificant cost reduction in knee replacement patients. This reinforces the notion that PROMs can be utilised as a cost-effective instrument for remote monitoring in standard care settings. Registration: German Register for Clinical Studies (DRKS) under DRKS00019916.

Intrathecal Nicardipine as Treatment for Severe Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: A Retrospective Clinical Study.

Introduction Vasospasm and delayed cerebral ischemia (DCI) are complications of aneurysmal subarachnoid hemorrhage (aSAH) and contribute up to 23% of the disability and deaths from aSAH. The use of intrathecal nicardipine (ITN) as a possible treatment for DCI has been explored with mixed results. We present a retrospective series comparing standard post-aSAH care to standard care plus ITNtherapy. The primary objective of this study was to assess for any difference in functional outcome in terms of modified Rankin scale (mRS) scorebetween the standard therapy group and ITN group at discharge and one month after discharge. Methods The Institutional Review Board (IRB) approval was obtained for a retrospective chart review of patients with aSAH who were treated at the University of Mississippi Medical Center between January 2012 and June 2019. The inclusion criteria included sufficient available medical documentation, aSAH with documentation of an intracranial aneurysm, and age ≥ 18. The exclusion criteria included non-aSAH, patients with insufficient medical records, and mycotic aneurysms. The decision to treat with ITN was based on the individual practice of a single neuro-intensivist in collaboration with the neurosurgical staff. Results A total of 385 patients were included in the study with 31 patients receiving ITN. Those within the nicardipine group presented with significantly worse Hunt and Hess grades and experienced significantly worse cerebral vasospasm, higher transcranial Doppler (TCD) velocities, higher rates of DCI, and higher rates of hydrocephalus. When controlling for placement of an external ventricular drain, the patients in the ITN group experienced higher rates of ventriculitis (10.0% vs. 2.0%, p < 0.05). There was no significant difference between the two groups in the intensive care unit (ICU) stay, hospital stay, mRS at discharge, or mRS at one-month follow-up. Conclusion In our series, ITN therapy did not significantly alter outcomes in terms of mRS at discharge or at one month after discharge. However, there was a significant increase in ventriculitis among patients who received this therapy.

Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery

Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a significant problem following cardiopulmonary bypass (CPB). Various strategies are proposed to attenuate CSA-AKI, including extracorporeal blood purification (EBP), but little is known about the effect of EBP through an acrylonitrile-sodium methallylsulfonate/polyethyleneimine membrane during CPB. To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB. This double-blind, randomized clinical trial was conducted in 2 tertiary hospitals in Spain. Patients 18 years or older undergoing nonemergent cardiac surgery who were at high risk for CSA-AKI were enrolled from June 15, 2016, through November 5, 2021, with follow-up data through February 5, 2022. Of 1156 patients assessed, 343 patients were randomized (1:1) to either receive EBP or standard care. Nonselective EBP device connected to the CPB circuit. The primary outcome was the rate of CSA-AKI in the 7 days after randomization. Among 343 patients randomized (169 to receive EBP and 174 to receive usual care), the mean (SD) age was 69 (9) years and 119 were females. The rate of CSA-AKI was 28.4% (95% CI, 21.7%-35.8%) in the EBP group vs 39.7% (95% CI, 32.3%-47.3%) in the standard care group (P = .03), with an adjusted difference of 10.4% (95% CI, 2.3%-18.5%) using a log-binomial model (P = .01). No significant differences (P > .05) were observed in most of the predefined clinical secondary end points or post hoc exploratory end points. In a sensitivity analysis, EBP was found to be more effective in terms of CSA-AKI reduction in patients with chronic kidney disease, diabetes, hypertension, low left ventricular ejection fraction (<40%), and lower body mass index (<30). No differences were observed between the groups in adverse events tracking. The use of a nonselective EBP device connected to the CPB circuit in a nonemergent population of patients undergoing cardiac surgery was associated with a significant reduction of CSA-AKI in the first 7 days after surgery. ClinicalTrials.gov Identifier: NCT02518087.

Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT)

ABSTRACT Background Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available. Methods Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups. Results A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15). Conclusion We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle. Clinical trial registration Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).

Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability

One in four older adults report difficulty walking, greatly increasing the risk of future disability and death. Though exercise improves mobility, too few older adults do it. While studies show that brief exercise sessions provide most of the benefit of longer sessions and that older adults note that “time” is a critical barrier to being active, what remains unknown is whether briefer RT sessions can improve mobility as well as, or better than, longer traditional sessions, possibly due to greater adherence. We present the design of a 12-month randomized controlled trial of 700 older adults with self-reported walking difficulty. Participants will be randomly assigned, in a 2 × 2 factorial design, to one of two home-based exercise programs: 1) Standard of Care: 45-min, three-times weekly sessions or 2) Experimental: 5-min daily sessions and to one of two doses of behavior change techniques (Standard or Enhanced) as part of their exercise program. The primary outcome measure is self-reported physical function. Secondary outcome measures include objectively measured lower extremity physical performance, walking endurance, balance, walking speed, strength and physical activity as well as self-reported falls, pain, fatigue and balance. This is one of the first studies to examine the clinical outcomes of brief exercise sessions, which may lead to a new generation of exercise programs that are optimized not only for impact, but for adherence as well.

Ejaculation preserving TURP (Ep-TURP): A viable alternative in sexually active males with BOO-a single centre prospective randomized study.

Benign prostatic hyperplasia (BPH) is a common urological condition, particularly among middle-aged and elderly men. Trans urethral resection of prostate (TURP) has some drawbacks, particularly concerning ejaculatory function. Ejaculation preserving TURP (Ep-TURP) is one such technique that aims at preserving the tissues that are primarily responsible for antegrade ejaculation. In this prospective study, patients with bothersome LUTS were randomized into Ep-TURP and standard TURP groups. Supramontal tissue was preserved in Ep-TURP while standard TURP group had resection of the entire prostatic tissue up to the verumontanum. The outcomes with regard to IPSS, Qmax, IIEF(Q9), Ejaculation and PVR were studied. Ejaculation projection score was separately calculated and assessed. About 60 patients were studied, with 30 in each group. At 6 months' follow-up, complication rates were the same in both groups. The IPSS, Qmax, IIEF were similar and comparable. There was no change in erection in all patients (P = 0.559). The ejaculation was well preserved in Ep-TURP (p<0.001). Ejaculation projection score was maintained at 3.77 in the Ep-TURP group while in the standard group it was 0 (P<0.001). Ep-TURP is a safe and a cost-effective method of preserving ejaculation in patients undergoing TURP. This procedure adds a better quality of life that greatly aids in enhancing the improving his psychological outlook towards life. Ep-TURP has now emerged as the standard procedure of choice in sexually active young males needing TURP, as the degree of ejaculation is largely well preserved in patients undergoing this procedure.

Capabilities of Software Package Gearacl for Design Gearings and Transmission Elements

Creation of a mathematical model of gearing operation belongs to one of the most knowledge-intensive fields of knowledge. Interdisciplinary research is being conducted to develop the model. For practical use, the results of this work are embodied in strength analysis standards. Due to the complexity of the processes occurring in gearings, performing analysis of one pair of gears today requires not only significant time costs from the engineer, but also a deep understanding of hundreds of pages of calculation techniques described by groups of interrelated standards. The calculation formulae include clarifying coefficients, the contribution and values of which are determined by a group of specialists developing the standard, based on research of analysis result coordination, experimental data and calculations performed using the finite element method. To perform the analysis, the designer needs knowledge about the principles of choosing coefficient values and their meaning. Performing the analysis of gearings according to the standard is a time-consuming process that can be correctly performed only by an engineer with experience in designing gearings. To facilitate the work of the engineer, software products both domestic and foreign were created. However, the trends of recent years require replacement of foreign software products. In 2022, the specialists of the Central Institute of Aviation Motors developed the Gearacl software package, which allows replacing foreign products in the volume required by the aviation industry enterprises in the field of cylindrical gearings, shafts and bearings analysis. Modern analysis methods have been introduced into the software package. This article is devoted to the capabilities of the Gearacl software package.

Evaluation of the Dislodgement Resistance of Traditional Adhesive Posterior Bridges Compared With Adhesive Posterior Bridges Prepared With Standard and Modified Slot-Back Dummies: An In Vitro Study.

Background Bridges with minimal preparation have received great acceptance in recent years. Since their first appearance, they have undergone many types of modifications and improvements. Aim This study aimed to compare three types of minimal preparation bridgesin terms of force required for dislodgement and the type of deformation incurred for each of the abutments and prostheses. Materials and methods The research sample consisted of 36 adhesive bridges divided into three equal groups. The first group contained traditional adhesive bridges prepared from the proximal and lingual surfaces with a thickness of 1 mm, the second group contained adhesive bridges with standard slot-back dummies, and the third group contained adhesive bridges with modified slot-back dummies. Each bridge underwent a pressure test, which was directed from the buccal toward the lingual sideand was inclined to the horizontal plane at an angle of 45°. A one-way analysis of variance (ANOVA) test was conducted with a significance level of 0.05. Results The average dislodgement resistance value in the traditional adhesive bridges group was 480,858 N, with no statistically significant difference from the standard slot-back dummy group (p = 1), for which the average dislodgement resistance value was 486,050 N. The average dislodgement resistance valuein the modified slot-back dummy group was 746,733 N, with a statistically significant difference compared with other study groups (p < 0.05). Conclusion The adhesive bridge with the modified slot-back dummy showed higher dislodgement resistance compared to the traditional adhesive bridge and the adhesive bridge with the slot-back dummy.

The effect of probiotic supplementation on non-alcoholic fatty liver disease (NAFLD) fibrosis score in patients attending a tertiary hospital clinic in Cairo, Egypt.

Non-alcoholic fatty liver disease (NAFLD) is characterized by hepatic fat accumulation (> 5% of liver tissue) in the absence of alcohol abuse or other chronic liver diseases. NAFLD can progress to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). This study aimed to assess the efficacy of probiotic (lactobacillus) supplementation on NAFLD fibrosis score. A double-arm randomized controlled trial was conducted in the family medicine clinic of a tertiary hospital, enrolling patients with sonographic evidence of NAFLD. Fifty patients were divided into two groups: the Probiotic group received lifestyle modification instructions along with daily probiotic supplementation for twelve weeks, with regular monthly follow-up visits. The Standard Treatment group received low-fat diet and lifestyle modification instructions only. The mean age of participants was 46.10 years (SD 10.11), with 70% females and 30% males. The study found a statistically significant difference in liver enzymes (ALT and AST) and BMI in the probiotic group before and after intervention. However, there was no significant difference in NAFLD fibrosis score between the two groups. Short-term probiotic treatment resulted in improvements in ALT, AST, and BMI in the probiotic group, but did not significantly affect NAFLD fibrosis score. Further research with larger sample sizes and longer follow-up periods is warranted. The clinical trial was registered at Protocol Registration and Results System with number NCT06074094 (12/09/2021).

Ameliorative Effect of Curcuma longa Ethanolic Extract on the Histology, Hepatic Glycogen Content and Some Biochemical Parameters of the Liver in Streptozotocin-Induced Hyperglycemic Wistar Rats

Introduction: Diabetes mellitus is a life threatening disease that requires immediate medical treatment. Numerous medicinal plants have been known for their anti-diabetic effects and Curcuma longa (turmeric) is one of them. This attribute is possible due to the pharmacological properties of its bio-constituents. In this study, the ameliorative potential of ethanolic extract of Curcuma longa was investigated on the liver of hyperglycemic adult Wistar rats. The objectives were to determine its effects on liver histology, hepatic glycogen content and some liver biochemical parameters. Methods: Forty (40) rats weighing between 120-180g were used for the research. Sixteen (16) rats were used for its acute toxicity study, while twenty-four (24) rats were grouped into four. The groups were labelled A to D and contained six rats each. Group A (normal control) rats were given food pellets and distilled water only. Group B (diabetic control) rats were given 65mg/kg BW of streptozotocin IP. Group C served as the standard group and was given 65mg/kg of streptozotocin IP + 250mg/kg of metformin IP, while Group D (test group) rats were given 65mg/kg BW of streptozotocin IP + 500mg/kg of Curcuma longa extract. Curcuma longa extract was administered through the oral route with the aid of an oral gavage. The administration lasted for twenty-eight (28) days, after which the rats were made to fast overnight with access to only water. The rats were then anaesthetized and whole blood obtained through cardiac puncture for biochemical analysis. Liver tissue was obtained for histological and glycogen content analyses. Results: The results showed severe destruction of hepatocytes with widely spread cytoplasmic vacuolation, loss of hepatic lobules and hepatic inflammation in the diabetic group, whereas it showed prominent nuclei, hepatocytes and distinct sinusoidal spaces in the normal control group. The metformin group showed an intact architecture of the liver tissue with indicating regeneration in the liver, while the Curcuma longa extract group showed a preserved liver cytoarchitecture. There was a significant decrease (p&lt;0.05) in the fasting blood glucose level and liver enzyme activities in the standard and test groups compared to the diabetic group (p&lt;0.05). There was also improvement in glycogen content of the standard and test groups in comparison with the diabetic group (p&lt;0.05). Conclusion: Curcuma longa possesses hepato-protective properties and a strong anti-diabetic potential, therefore it can be considered as an alternative drug in the management of diabetes mellitus and its complications.

Noninvasive ventilation outside the intensive care unit for respiratory rehabilitation after on-pump cardiac surgery: a prospective randomized controlled trial

BACKGROUND: Сardiac surgery with cardiopulmonary bypass is associated with a high risk of postoperative respiratory complications. Perioperative damage to the lungs caused by ischemia and reperfusion, mechanical ventilation, trauma, etc., is a trigger for aseptic inflammation in the lungs, and it makes compromised lungs an easy target for infection. Actively developed methods of protecting the lungs, such as lung-protective ventilation, are limited to the perioperative and resuscitation stages and do not exhaust the entire range of respiratory support required in the later stages of postoperative hospitalization. This indicates the need for methods of respiratory rehabilitation following transfer from the intensive care unit. AIM: To evaluate the effectiveness of respiratory rehabilitation using noninvasive mask lung ventilation performed outside the intensive care unit in cardiosurgical patients compared to standard breathing exercises. MATERIALS AND METHODS: This prospective, randomized, single-center study included 60 patients aged 62±12 years who underwent cardiac surgery with cardiopulmonary bypass (86±17 min) with bypass grafting of 2±1 coronary arteries and required mechanical lung ventilation for more than 6 hours following surgery. After transfer from the intensive care unit, patients in the control group (n=30) underwent standard respiratory rehabilitation, and those in the main group (n=30) additionally received four sessions of noninvasive mask lung ventilation. RESULTS: The patients in the main group had a more rapid respiratory function recovery and, thus, reduced postoperative hospitalization time (10 [8; 15]) compared to those in the standard group (14 [13; 20]). CONCLUSION: The use of noninvasive mask lung ventilation outside the intensive care unit along with the standard respiratory activation protocol is safe and speeds up respiratory rehabilitation and reduces postoperative hospitalization of patients after coronary bypass surgery.

Capybara and Tsubaki: Verifiable Random Functions from Group Actions and Isogenies

In this work, we introduce two post-quantum Verifiable Random Function (VRF) constructions based on abelian group actions and isogeny group actions with a twist. The former relies on the standard group action Decisional Diffie-Hellman (GA-DDH) assumption. VRFs serve as cryptographic tools allowing users to generate pseudorandom outputs along with publicly verifiable proofs. Moreover, the residual pseudorandomness of VRFs ensures the pseudorandomness of unrevealed inputs, even when multiple outputs and proofs are disclosed. Our work aims at addressing the growing demand for post-quantum VRFs, as existing constructions based on elliptic curve cryptography (ECC) or classical DDH-type assumptions are vulnerable to quantum threats. In our contributions, our two VRF constructions, rooted in number-theoretic pseudorandom functions, are both simple and secure over the random oracle model. We introduce a new proof system for the factorization of group actions and set elements, serving as the proofs for our VRFs. The first proposal is based on the standard GA-DDH problem, and for its security proof, we introduce the (group action) master Decisional Diffie-Hellman problem over group actions, proving its equivalence to the standard GA-DDH problem. In the second construction, we leverage quadratic twists to enhance efficiency, reducing the key size and the proof sizes, expanding input size. The scheme is based on the square GA-DDH problem. Moreover, we employ advanced techniques from the isogeny literature to optimize the proof size to 39KB and 34KB using CSIDH-512 without compromising VRF notions. The schemes feature fast evaluations but exhibit slower proof generation. To the best of our knowledge, these constructions represent the first two provably secure VRFs based on isogenies.

Comparative study between the halfway technique and the standard technique for exchange of tunneled hemodialysis catheter.

When indicated, tunneled hemodialysis catheters are usually inserted using the standard technique but, this technique has its complications. The halfway method is performed by exchange of an already-inserted dialysis catheter (tunneled or non-tunneled) to a tunneled one over a guidewire mounted via the old catheter. In this study, we aimed at evaluating the feasibility, safety, and durability of halfway method in comparison to the standard technique (de novo puncture). This prospective study was conducted during the period from May 2020 till May 2022 and included 87 patients with end-stage renal disease (ESRD) on regular hemodialysis (HD) in need for insertion new tunneled dialysis catheters instead of temporary or malfunctioning tunneled ones. According to the technique of catheter insertion, these patients were divided into two groups: group A (the halfway technique: catheters were exchanged over guidewires under fluoroscopic control; 48 patients) and group B (the standard technique: via de novo ultrasound-guided vein puncture; 39 patients). Instant, delayed complications and 12-months patency rates were reported and analyzed. The frequency of peri-operative bleeding complications was better in the halfway group with comparable infection rate and late catheter dysfunction results between the two groups. One year patency rates were 87.5% in halfway technique group compared to 79.5% in standard technique group, yet without statistical significance. However, there was a statistically significant shorter operative time in halfway group (15.54 ± 2.6 min vs 26.97 ± 5.6 min, p < 0.001). The halfway technique may be recommended over the standard technique of tunneled catheter insertion due to shorter operative time, lower rate of hematoma formation, with non-inferior 1-year patency rates and comparable technical success and infection rates. The advantage of access sites preservation for future demand makes this technique of great value to this group of ESRD patients.

Anti-inflammatory effects of proprotein convertase subtilisin/kexin 9 inhibitor therapy in the early phase of acute myocardial infarction.

This study examined the anti-inflammatory and endothelial function-enhancing effects of proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor therapy in the early phase after acute myocardial infarction (AMI) by assessing changes in tumor necrosis factor-α (TNF-α) levels and the L-arginine/asymmetric-dimethylarginine (ADMA) ratio. This retrospective, single-center cohort study included patients who underwent successful timely primary percutaneous coronary intervention (PCI) for first-onset AMI between September 2017 and March 2018. The PCSK9 inhibitor group comprised patients who received 75mg alirocumab up to 7days after AMI, while the standard therapy group comprised patients who did not. We evaluated the change in TNF-α levels and the L-arginine/ADMA ratio at the time of hospital admission and prior to discharge. PCSK9 inhibitor therapy in the early phase after AMI suppressed TNF-α levels (standard therapy group, 1.64 ± 2.14pg/mL vs. PCSK9 inhibitor group, 0.26 ± 0.33pg/mL; p = 0.033) and increased the L-arginine/ADMA ratio (standard therapy group, -13.0 ± 39.7 vs. PCSK9 inhibitor group, 23.2 ± 39.7; p = 0.042). Upon multiple regression analysis adjusted for sex, age, and peak creatine kinase levels, PCSK9 inhibitor therapy was associated with TNF-α suppression (p = 0.025; β = -0.235, 95% confidence interval [CI], -0.436 to -0.033). The L-arginine/ADMA ratio was also analyzed using multiple regression, adjusted for sex, age, peak creatine kinase levels, and smoking, showing a significant improvement in the ratio (p = 0.018; β = 41.913, 95% CI, 10.337-73.491). Moreover, a weak negative correlation was suggested between the change in TNF-α levels and the change in L-arginine/ADMA ratio (r = -0.393, p = 0.058). PCSK9 inhibitor therapy in the early phase after AMI suppresses TNF-α levels and improves the L-arginine/ADMA ratio, potentially indicating anti-inflammatory and endothelial function-enhancing effects.

Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design.

ABSTRACT Background Dapagliflozin prevents myocardial dysfunction in chronic kidney disease patients regardless residual kidney function, We hypothesized that this effect is extensible also to patients on dialysis. Research design and methods The DARE-ESKD-2 is an ongoing, single-center, open-label randomized clinical trial designed to determine the effects of adding dapagliflozin to standard treatment on myocardial function and structure. Eligible patients were adults on a regular dialysis scheme for more than 3 months. Pregnancy, liver failure, allergy to the investigational drug, and prior use of SGLT2i were exclusion criteria. Participants were randomized in a 1:1 ratio to dapagliflozin or standard treatment groups for 24-weeks. The primary goal is to compare the change in NT-proBNP levels between study arms, and secondary goals include comparing the between-group difference in left ventricle global longitudinal strain, indexed mass, ejection fraction, and E/e` ratio, and on symptoms scale and 6-minute walk test distance. An exploratory analysis will evaluate changes in body composition and bone densitometry. Results The trial has finished the enrollment of 80 patients, that are currently being followed-up. Conclusions This trial will provide novel data on myocardial effects of SGLT2i in dialysis recipients. Results from this study may provide evidence to support SGLT2i use in ESKD.

8550 Processing Technique Affects Aromatase Expression in Fat Grafts for Breast Reconstruction

Abstract Disclosure: S. Arbuiso: None. Y. Chen: None. N.A. Vernice: None. A. Zhang: None. I.J. Rhodes: None. C.C. Alston: None. S. Hanif: None. S. Liu: None. P. Bhardwaj: None. D. Janhofer: None. G.G. Black: None. D.M. Otterburn: None. K.A. Brown: None. Introduction: Autologous fat grafting is commonly used in breast reconstruction as it is associated with good cosmetic outcomes, high patient satisfaction, and minimal risks. Adipose tissue is known to support cancer growth via the secretion of adipokines and the modulation of estrogen levels due to aromatase expressed in adipose stromal cells. A higher body mass index (BMI) and postmenopausal status are associated with higher levels of aromatase. With novel processing techniques being developed to increase fat graft retention, there is a need to better understand how these will affect the biology of lipoaspirates for women who have previously had breast cancer. This study aims to assess how different processing techniques used in fat grafting (1) impact aromatase gene expression, (2) affect breast cancer cell proliferation, and (3) affect the cellular composition of the engrafted lipoaspirate. Methods: Patients who underwent breast reconstruction for breast cancer treatment or for prophylactic measures, and were receiving autologous fat grafting, were enrolled in a prospective randomized controlled trial (NCT04891510). Patients were randomized to one of three processing techniques: standard decantation, active filtration, and low-pressure decantation. Conditioned media (CM) was created from each sample. Aromatase mRNA was measured in the lipoaspirate using qRT-PCR for aromatase (CYP19A1) and related to patient BMI or menopausal status. The effect of CM on the proliferation of MCF7 cells (estrogen receptor positive (ER+) breast cancer cell line) was measured using CyQUANT. Formalin-fixed lipoaspirate samples were embedded in HistoGel and paraffin. Adipocyte diameter was measured in hematoxylin and eosin (H&amp;E) stained sections using ImageJ. Results: Aromatase mRNA levels were correlated with BMI and were higher in postmenopausal women (p≤0.05), with the standard decantation group demonstrating a stronger correlation with BMI. Samples processed via active filtration were associated with weaker correlations between aromatase gene expression and BMI and menopausal status. CM induced MCF7 cell proliferation to a similar extent to cells plated in fetal bovine serum-containing media. There was no difference in proliferation patterns between treatment groups. Upon histological assessment, adipocytes were intact, and adipocyte diameter was significantly correlated with patient BMI. Conclusion: Lipoaspirate may contain factors that promote breast cancer cell proliferation, unaffected by processing technique. Caution should be used to ensure local control of the cancer has been achieved prior to reconstruction. Our data suggest that active filtration selects for a lower percentage of adipose stromal cells, which may be beneficial for patients who previously had ER+ breast cancer. Presentation: 6/1/2024

Clinical effect analysis of vertebroplasty with high viscosity and standard bone cement for Kummell disease.

This study aims to observe and compare the effects of high-viscosity bone cement versus standard bone cement on the postoperative outcomes of percutaneous vertebroplasty (PVP) in patients with Kummell disease. A retrospective analysis was conducted on 135 patients with Kummell disease who underwent PVP between January 2019 and May 2023. Patients were divided into 2 groups: the high-viscosity group (group H, 63 cases) received high-viscosity bone cement during surgery, while the standard group (group S, 72 cases) received standard bone cement. Surgery duration, bone cement volume, bone cement leakage rate, as well as preoperative and postoperative evaluations using the Visual Analogue Scale (VAS) for pain, Oswestry Disability Index (ODI), anterior vertebral height, and kyphotic Cobb angle were recorded and compared between the 2 groups. In the group H, significant improvements were observed in VAS scores, ODI, anterior vertebral height, and Cobb angle at 24 hours, 3 months, and 1 year postoperatively compared to preoperative values (P < .01). In the group S, VAS scores and ODI showed significant improvement at 24 hours, 3 months, and 1 year postoperatively (P < .01), but there were no significant differences in anterior vertebral height or Cobb angle compared to preoperative values (P > .05). Comparatively, the group H demonstrated superior outcomes in terms of bone cement volume, leakage rate, recovery of anterior vertebral height, and Cobb angle correction at 24 hours, 3 months, and 1 year postoperatively (P < .05). However, there were no significant differences between the 2 groups in terms of surgery duration, VAS scores, and ODI at the same time points (P > .05). PVP is an effective treatment for Kummell disease, providing significant pain relief and improved spinal function. The use of high-viscosity bone cement allows for greater volume infusion, better restoration of vertebral height, and correction of deformities, while also reducing the risk of cement leakage.