Baseline In Group Research Articles

In Vivo Detection of Lymph Nodes Metastasis of ESCC Using CXCR4-Targeted Tracer [64Cu]Cu-NOTA-CP01.

Esophageal squamous cell carcinoma (ESCC) frequently exhibits skip metastasis to lymph nodes; however, non-invasive imaging techniques capable of directly visualizing metastatic lymph nodes (MLN) are still lacking. Although biopsy is the clinical standard method, it is invasive and poses risks to patient health. This study aims to detect MLN in an intralymphatic tumor metastasis model of ESCC using the CXCR4-targeted tracer [64Cu]Cu-NOTA-CP01. The CXCR4 expression in ESCC cell lines was assessed using Western blot and immunofluorescence. An intralymphatic tumor metastasis model was established and monitored using bioluminescence imaging (BLI). Small animal PET studies and biodistribution studies were performed to evaluate the specificity of [64Cu]Cu-NOTA-CP01 for MLN. Histopathology evaluation was employed to check for the presence of metastatic tumor cells and to assess CXCR4 expression levels in the metastatic lymph nodes. The intralymphatic tumor metastasis model was successfully established using the EC109/Luc cell line, which exhibited high CXCR4 expression, as verified by BLI. PET/CT imaging showed that the MLN uptakes in the baseline group were significantly inhibited in the blocking group. The ratios of MLN/muscle and MLN/blood werealso significantly higher in the baseline group than in the blocking group. Ex vivo PET/CT imaging of MLN corroborated the in vivo data. Biodistribution studies further supported the PET imaging studies, showing rapid clearance of the tracer from the blood and major organs, with significantly higher MLN/muscle and MLN/blood ratios in the baseline group compared to the blocking group. Histopathological staining verified positive CXCR4 expression in these lymph nodes containing metastatic tumor cells. Targeting CXCR4 with [64Cu]Cu-NOTA-CP01 for PET imaging of lymph nodes metastasis represents a promising approach that warrants further investigation. These findings have the potential to enhance diagnostic and therapeutic strategies for individuals with lymph nodes metastasis of ESCC.

Outcomes by race and ethnicity in patients undergoing percutaneous coronary intervention of chronic total occlusion

Abstract Background Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) carries increased risk for worse outcome. There is limited data on whether race and/or ethnicity affect outcomes. Materials and methods We included patients who underwent CTO intervention from 2012 to 2017 at The Mount Sinai Hospital (New York). Data were collected prospectively but examined retrospectively. The patients were stratified by race/ethnicity in Caucasians, African Americans, Asians and Hispanics. The primary end point was major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1 year follow-up. Secondary outcomes included individual components of the MACE (death, MI or TVR), and bleeding. Results A total 1,684 patients were included of which (49.8%) were Caucasians, 168 (10%) were African Americans, 396 (23.5%) were Asians and 281 (16.7%) were Hispanics. African Americans had the highest proportion of female patients (39%) and more often had a history of smoking (26.2%) and insulin-dependent diabetes mellitus (46.6%) compared to the other groups. They had the highest prevalence of in-stent restenosis as the target lesion (Table 1). Caucasians were older (65.9±11.1 years) with more calcified lesions and longest lesion length compared to the other groups. Asians had highest prevalence of multi-vessel coronary disease. Caucasians and Asians had higher Syntax score and more stents implanted. Procedural success was similar between the groups (Table 1). Adjusted analyses did not show any differences in clinical outcomes between groups (Table 2). Conclusion In spite of many differences between racial/ethnical groups in baseline and procedural characteristics, procedural success of CTO intervention and 1-year MACE rates were similar between groups.Procedural characteristicsAdjusted 1-year outcomes

Hypnotherapy modulating early and late event-related potentials components of face processing in social anxiety.

Hypnotherapy has a potential role in modulating attention bias to treat social anxiety disorder (SAD). This study aimed to verify whether hypnotherapy can reduce social anxiety by changing attentional bias. The primary objective of our study is to explore the influence of hypnosis on various aspects of attention processes, specifically focusing on how it affects attention bias and social anxiety. This study included 69 participants with SAD who were assigned to three groups based on their scores on the Liebowitz Social Anxiety Scale (LSAS). The experimental group (n = 23) received a hypnosis treatment once a week, for a total of six sessions, while the control group (n = 23) and the baseline group (n = 23) did not receive any treatment. To evaluate whether hypnosis could alleviate SAD and attention bias towards threatening stimuli, we employed questionnaires and an odd-one-out task accompanied by electroencephalography (EEG) recordings. Under the attention sensitivity conditions, the experimental group exhibited a reduced N170 and LPP at the posttest stage, and a similar N170 and LPP reduction under the attention disengagement conditions. Notably, the symptom improvements were positively correlated with the reduction in N170 and LPP amplitude across conditions. Hypnosis treatment modulates the early face processing and late emotional evaluation of threat-related stimuli in SAD patients. These findings suggest that N170 and LPP are important biomarkers for the treatment of SAD.

Consumption patterns of indebted households: unravelling the relevance of fiscal policy

AbstractWe have investigated the influence of fiscal instruments, notably taxes and government spending, on household consumption in two different samples and two measures of household debt to provide a comprehensive analysis of the topic. We used dynamic panel models and the Generalised Method of Moments (GMM) approach for 24 and 32 advanced and emerging countries from 1995 to 2020. Our findings show that fiscal impulses increase private consumption. However, when households are highly indebted, the effects are different, and the increase in public spending or the reduced taxes discourages household consumption compared to the baseline (lower debt) group. These results suggest a precautionary effect.

Metalinguistic explanations and their impact on incidental grammar acquisition: An eye-movement study

Recent research highlights the value of metalinguistic explanations in facilitating second language (L2) grammar acquisition. Nevertheless, a notable research gap persists regarding how these explanations influence incidental grammar acquisition and their impact on overall reading processes and comprehension. Furthermore, whether the potentially positive effects of metalinguistic explanations transfer to the acquisition of subsequent constructions without explicit guidance is an unexplored domain. This study addresses these research gaps by recruiting 42 Korean undergraduate students and assigning them to the metalinguistic or baseline groups. The metalinguistic group read an English text supplemented with bottom-margin metalinguistic explanations, which elucidated the first half of the target grammar (without explanations for the second half), whereas the baseline group read the same text without explanations. This study used eye-tracking technology to register participants’ eye movements during reading, followed by an announced reading comprehension test and an unannounced error correction test. Statistical analyses using linear mixed-effects models (LMMs) and t-tests revealed that metalinguistic explanations significantly enhanced incidental grammar acquisition in L2 learners without compromising overall reading processes and comprehension. However, the benefits of metalinguistic explanations in the metalinguistic group failed to extend to the incidental learning of other unexplained constructions.

A quality initiative in BRCA testing and timing of BRCA test prior to surgery in HER2- early stage breast cancer.

287 Background: The University of Pittsburgh Medical Center (UPMC) collaborated with Integra Connect PrecisionQ (IC) on a quality initiative to improve BRCA 1/2 (BRCA) testing in patients (pts) with early-stage (I-III) human epidermal growth factor receptor negative (HER2-) breast cancer (BC). The project involved developing a baseline of BRCA testing, reviewing the results with leadership, conducting a focus group with physicians to identify improvements, and then monitoring the results of BRCA testing thereafter during a post-baseline period. The project sought to improve the identification of pts who may be eligible for olaparib given the updated approval on March 11, 2022, for early-stage high-risk germline BRCA mutated pts. We aim to show the improvement in BRCA testing and timing of test in relation to surgery among HER2- BC pts at UPMC. Methods: Using the de-identified IC PrecisionQ database, 202 UPMC pts with early-stage HER2- BC were selected for medical chart curation as baseline group. Pts in the baseline group received surgery between 7/1/2021 to 6/30/2022. The baseline data was reviewed with UPMC clinical leadership and findings were discussed among a focus group of 8 physicians on 7/17/2023. Following the meeting, UPMC practices performed genetic testing at the office as opposed to sending pts to directly to genetic counseling. Post-baseline, we evaluated 70 pts who underwent surgery between 8/1/2023 to 1/31/2024 to assess BRCA rates and timing of BRCA testing in relation to surgery. Descriptive analyses were performed and proportions were compared using a chi-squared test. Results: Among the baseline cohort of 202 pts, 72% were hormone receptor positive (HR+) and 28% were hormone receptor negative (HR-). Among the post-baseline cohort of 70 pts, 77% were HR+ and 23% were HR-. The rate of BRCA testing at baseline was 44% compared to 56% post-baseline (p 0.05). Among HR+ pts, BRCA testing increased from 38% to 50% and among HR- pts, BRCA testing increased from 67% to 81%. The rate of BRCA testing prior to surgery at baseline was 58% (N= 88) compared to 80% (N=40) post-baseline (p <0.01). Among HR+ pts age <65, BRCA testing at baseline was 46% (N=54) compared to 51% (N=35) post-baseline. Among HR- pts age <65 BRCA testing at baseline was 84% (N=25) compared to 100% (N=9) post-baseline. Conclusions: The quality initiative at UPMC that focused on BRCA testing among HER2- BC pts led to an improvement from 44% to 56% of pts being tested. Among those who were tested, there was an increase from 58% to 80% tested prior to surgery. Given the recent updates on January 4 th , 2024 by ASCO and SSO recommending BRCA1/2 testing to all women younger than age 65 with breast cancer, such QIs can be a useful tool to align a practice’s approach to new standards of care.

Outcomes following intensive allied health therapy in the acute hospital for trauma patients

The majority of patients hospitalised for trauma survive their injuries, with the quality of the survival potentially influenced by early acute hospital rehabilitation. The aim of this study was to review the outcomes of patients managed under an intensive Allied Health Model of Care (AHMOC) compared to a baseline cohort.Methods: The AHMOC was commenced in February 2020 on the Trauma ward at Alfred Health for 12 months. The baseline group included patients admitted to the trauma ward in 2019. All patients who were registered by either the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR) or the Victorian State Trauma Registry (VSTR). The association between the groups (AHMOC and baseline) and outcomes were assessed using logistic (discharge destination, 12-month return to work) and linear (length of stay (LOS)) regression.Results: There were 1644 in the baseline group and 1732 in the AHMOC group, of which 70% and 76% respectively were discharged directly home from the acute hospital (p value <0.001). The trauma ward LOS was 4.0 days for each group (p value 0.77). After accounting for confounders, the adjusted odds of discharge home and RTW at 12 months were 53% (AOR 1.53 95% CI 1.29, 1.82) and 65% (AOR 1.65 95% CI 1.24) higher for the AHMOC group compared to baseline, respectively. There was also a 6% reduction in the LOS in the AHMOC group compared to baseline (Adjusted mean difference 6%; 95% CI (0.881, 0.999) p value = 0.050).Conclusion: This study shows an association between an AHMOC for trauma patients with a focus on early and intensive therapy and improved odds of discharge directly home, as well as improved 12 month return to work outcomes.

Efficacy and tolerability of house dust mites subcutaneous immunotherapy with monomeric allergoid: an Italian multicenter study.

Background. Subcutaneous immunotherapy is an effective treatment of respiratory allergy and allergoids offer a treatment option characterized by reduced IgE-binding properties to improve the safety profile. Purpose of this study was to investigate the efficacy and the safety of an injective monomeric allergoid in patients with moderate to severe persistent allergic rhinitis due to house dust mites. Methods. in a perspective, controlled, observational study a suspension of 0.70 mL at 10 BU/mL containing a mixture of carbamylated extract of Dermatophagoides was injected monthly for 12 months, following a 5-weeks build-up phase (0.10-0.20-0.30-0.50-0.70 mL weekly), to 58 patients (mean age 25.1 ± 12.7). A matching group of 60 patients (mean age 34.0 ± 14.2) was observed as control, and both groups were allowed to assume standard pharmacotherapy. After one year, changes from baseline in visual analogue scale for symptoms and drugs intake were compared; satisfaction rate was based on patients' and physicians' judgements. Results. In respect to baseline both groups showed an improvement in symptoms with a significant difference in favor of immunotherapy. Drugs intake was significantly lower in patients receiving injections. High level of agreement was found between doctors and patients on their rate of satisfaction. No serious reactions occurred, and at least a mild episodic local or systemic reaction was reported by a limited number of patients. Conclusions. In routine practice injective monomeric allergoid of house dust mites was safe and associated with a perceived significant clinical benefit in persistent rhinitis shown by objective and subjective outcomes.

Glossed video keyword captions and L2 vocabulary acquisition: an eye-tracking study

The effect of video captions on vocabulary acquisition is a growing topic of interest among L2 researchers. Expanding on this line of inquiry, this study explores how keyword captions enhanced with first language (L1) and second language (L2) glosses (i.e. definitions or brief explanations of unfamiliar words) impact L2 learners’ vocabulary acquisition. This study involved 101 Korean undergraduate students randomly assigned to a baseline (keyword caption only), L1 gloss (keyword caption + L1 gloss), or L2 gloss (keyword caption + L2 gloss) group. The participants viewed a video that corresponded to their group, during which their eye movements were tracked and recorded. Subsequently, the participants completed two vocabulary tests assessing word form and meaning recall. Linear mixed-effects analysis revealed that keyword captions with L1 and L2 glosses resulted in distinct attentional allocation and contributed differently to lexical acquisition. Notably, although the three groups spent similar durations reading the target word forms, the L1 gloss group significantly outperformed the other two groups in word form recall scores. Furthermore, although the L2 gloss group spent three times longer reading L2 glosses compared to the time the L1 gloss group spent reading L1 glosses, the latter had significantly higher scores in the form translation test. These findings have significant implications for L2 pedagogy, particularly regarding the choice between target-language-exclusive or bilingual approaches.

A quality initiative focused on BRCA and HRD testing and use of first line maintenance in advanced ovarian cancer.

286 Background: In May of 2020, the approval of two Poly (ADP-ribose) polymerase inhibitors (PARPi) changed the landscape for treatment among patients (pts) with advanced ovarian cancer (aOC). As such, National Comprehensive Cancer Network guidelines recommend BRCA testing for individuals with epithelial ovarian cancer and Homologous Recombination Repair Deficiency (HRD) testing for pts who are BRCA germline negative to guide the decision of maintenance therapy. Regional Cancer Care Associates (RCCA) conducted a quality initiative (QI) with Integra Connect PrecisionQ to assess the rates of BRCA testing, HRD testing, and use of first line maintenance (LOT 1M) therapy based on biomarker status. This QI focused on interventions to optimize testing and LOT 1M treatment in these pts. We aim to show the improvement in BRCA testing, HRD testing, and rates of LOT 1M therapy use after implementation of the QI, in pts with aOC at RCCA. Methods: Using the de-identified IC PrecisionQ database, 90 RCCA pts with aOC as defined by stage III and IV were selected for medical chart curation at baseline. Pts in the baseline group received first-line treatment between 1/1/2020 to 5/31/2022. The baseline data was reviewed with RCCA clinical leadership and findings were presented at a standing practice clinical meeting on 6/20/2024. Post-baseline, we evaluated 28 aOC pts who started a new first-line of therapy between 7/1/2023 to 4/30/2024 to assess BRCA and HRD testing rates and use of LOT 1M among maintenance eligible (ME) pts. ME was defined by a complete response, partial response, or for those where no response was known and had either received maintenance or had no subsequent treatment after 180 days of completing first line therapy. Maintenance therapies included PARPi(s) and bevacizumab. Descriptive analyses were performed and proportions were compared using a chi-squared test. Results: The baseline cohort had 90 pts of which 66% were stage III and 34% were stage IV. The post-baseline cohort had 28 pts of which 54% were stage III and 46% were stage IV. The rate of BRCA testing at baseline was 86% compared to 93% post-baseline. The rate of HRD testing at baseline was 41% compared to 71% post-baseline (p &lt;0.01). The rate of LOT 1M use among maintenance eligible pts at baseline was 57% (N=76) compared to 78% (N=23) post-baseline. PARPi maintenance at baseline was 67% (N=43) compared to 67% (N=14) post-baseline. While rates of maintenance therapy use remained the same from baseline to post-baseline for BRCA mutated pts at 80%, the use of maintenance increased in HRD positive pts from 71% (N = 7) to 77% (N=13). Conclusions: The QI at RCCA that focused on BRCA and HRD testing and treatment with LOT 1M among aOC pts led to improvements against clinical guidelines. QI programs are critical to transforming cancer care and can be useful tools to drive improvement in testing and treatment.

An in vivo tumour organoid model based on the chick embryonic chorioallantoic membrane mimics key characteristics of the patient tissue: a proof-of-concept study

BackgroundPatient-derived tumour organoids (PDOs) are highly advanced in vitro models for disease modelling, yet they lack vascularisation. To overcome this shortcoming, organoids can be inoculated onto the chorioallantoic membrane (CAM); the highly vascularised, not innervated extraembryonic membrane of fertilised chicken eggs. Therefore, we aimed to (1) establish a CAM patient-derived xenograft (PDX) model based on PDOs generated from the liver metastasis of a colorectal cancer (CRC) patient and (2) to evaluate the translational pipeline (patient – in vitro PDOs – in vivo CAM-PDX) regarding morphology, histopathology, expression of C-X-C chemokine receptor type 4 (CXCR4), and radiotracer uptake patterns.ResultsThe main liver metastasis of the CRC patient exhibited high 2-[18F]FDG uptake and moderate and focal [68Ga]Ga-Pentixafor accumulation in the peripheral part of the metastasis. Inoculation of PDOs derived from this region onto the CAM resulted in large, highly viable, and extensively vascularised xenografts, as demonstrated immunohistochemically and confirmed by high 2-[18F]FDG uptake. The xenografts showed striking histomorphological similarity to the patient’s liver metastasis. The moderate expression of CXCR4 was maintained in ovo and was concordant with the expression levels of the patient’s sample and in vitro PDOs. Following in vitro re-culturing of CAM-PDXs, growth, and [68Ga]Ga-Pentixafor uptake were unaltered compared to PDOs before transplantation onto the CAM. Although [68Ga]Ga-Pentixafor was taken up into CAM-PDXs, the uptake in the baseline and blocking group were comparable and there was only a trend towards blocking.ConclusionsWe successfully established an in vivo CAM-PDX model based on CRC PDOs. The histomorphological features and target protein expression of the original patient’s tissue were mirrored in the in vitro PDOs, and particularly in the in vivo CAM-PDXs. The [68Ga]Ga-Pentixafor uptake patterns were comparable between in vitro, in ovo and clinical data and 2-[18F]FDG was avidly taken up in the patient’s liver metastasis and CAM-PDXs. We thus propose the CAM-PDX model as an alternative in vivo model with promising translational value for CRC patients.Graphical

The effect of Fenugreek seed dry extract supplement on glycemic indices, lipid profile, and prooxidant-antioxidant balance in patients with type 2 diabetes: A double-blind randomized clinical trial.

This study aims to determine the effects of fenugreek seed dry extract (FDE) on the glycemic indices, lipid profile, and prooxidant-antioxidant balance (PAB) in patients with type 2 diabetes (T2D). A double-blind randomized clinical trial was carried out on 54 individuals with T2D. Participants were randomly assigned to a FDE group (received 3 tablets containing 335 mg of FDE daily for 8 weeks) or a placebo group (received tablets containing microcrystalline cellulose). Anthropometric indices, physical activity, diet, fasting blood sugar (FBS), serum insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), triglyceride (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein (HDL-C), and PAB were assessed. An eight-week intake of 3 tablets containing 335 mg of FDE decreased serum insulin (P=0.016, P<0.001), HOMA-IR (P=0.009, P<0.001), TG (P<0.001, P=0.001), and PAB (P<0.001, P<0.001) compared to the baseline, in both placebo and intervention groups respectively. TC decreased significantly compared to the baseline in the placebo group (P=0.028), while HDL-C increased in the FDE group compared to the baseline (P<0.001) and placebo group (P=0.014). In the present study even though changes of parameters were more in intervention group compared to the control group, we did not observe any significant differences between studied groups except for HDL-C. However, the effects might become apparent with a higher dosage, longer study duration, or a larger sample size compared to the placebo group. Further clinical trials are needed in this regard.

Coccygeal Nerve Blockade vs. Impar Ganglion Blockade in Coccydynia: A Randomised Clinical Trial.

Background and objective Coccydynia is a condition that causes pain around the coccyx, severely limiting functionality. Interventional treatment options are available for cases that do not respond to conservative treatment. Coccygeal nerve block (CnB) is a novel method for treating coccydynia. This study compared the efficacy of CnB and ganglion impar block (GiB) and aimed to evaluate the efficacy of CnB in treating coccydynia. Methods The 12-week results of 56 patients were analysed. One group underwent ultrasound (US)-guided CnB, while the other group underwent fluoroscopy (FL)-guided GiB. Pain intensity was assessed using the numerical rating scale (NRS), and functionality was assessed using the PARIS Coccydynia Functionality Questionnaire. Evaluations were conducted before treatment, as well as four and 12 weeks after treatment. Results The baseline median NRS score was eight in both groups, while at week 12, it was three in the CnB group and 2.5 in the GiB group. The median PARIS score at baseline was seven in the CnB group and 6.5 in the GiB group, while at week 12, it was four and three, respectively.At week 12, compared to baseline, both the CNB and GiB groups showed statistically significant improvements in NRS and PARIS scores (p<0.001). When comparing the two groups, no significant difference was observed in the NRS and PARIS scores before and four and 12 weeks after treatment. No serious adverse events were observed in any patient. Conclusions Coccydynia is sometimes refractory to treatment. In our study, we found that CnB, a method recently used in the treatment of coccydynia, was as effective as GiB, which has been used for a long time, and we found no evidence of superiority. The lack of radiation exposure due to its US-guided application, the superficial course of the coccygeal nerves and the low depth of needle penetration make it easier to perform. These advantages suggest that it will be a preferable method in the treatment of coccydynia.

Left ventricular volumes and function in successful and failed His-BundLe Pacing. A comparative prospective study.

Initial data suggest that His Bundle Pacing (HBP) could preserve long-term cardiac structure and function better than Right Ventricular Pacing (RVP), but evidence is limited. We studied consecutive patients with baseline ejection fraction (EF) ≥ 50% who underwent HBP attempt, either successful (HBP group) or failed (RVP group). Two-dimensional (2D) and three-dimensional (3D) echocardiography were carried out at baseline and after 6 months of ventricular pacing burden > 20%. Among 68 patients, 40 underwent successful HBP, and 28 RVP. The HBP and RVP groups did not differ for age, sex and pacing indication. At baseline, the HBP and RVP groups did not differ for 2D EF (62% vs. 62%), 3D EF (60% vs. 63%), 2D (-19% vs. -19%) and 3D global longitudinal strain (GLS) (-15% vs. -16%). After 6 months, 2D EF (-3.86%) and 3D EF (-5.71%) significantly decreased in the RVP group and did not change in the HBP group (p for interaction .006 and <.001, respectively). 2D GLS (3.08%) and 3D GLS (2.22%) significantly increased in the RVP group, but did not change in the HBP group (p for interaction .013 and <.016, respectively). Pacing induced cardiomyopathy (PICM) (EF drop ≥ 10% and EF < 50%) occurred in 14% (RVP) versus 0% (HBP) of patients (p = .025). Successful HBP was superior to RVP in preserving LV systolic function despite a high ventricular pacing burden, and was less frequently associated with PICM.

Responsiveness and Reliability of a Sipping Device to Measure Motivation in Normal-Weight Individuals and Bariatric Surgery Patients.

There is an urgent need to measure the motivation to taste a sweet fluid in order to determine the influence of sweet tastes on the potential choices and consumption of beverages in patients with obesity. Current methods utilize either survey instruments or arbitrary operant tasks. The sipometer enables the participant to utilize an actual ingestive behavioral response to measure motivation during access to beverages on either ad libitum (AL) or progressive time ratio (PR) schedules. We determined the sipometer's responsiveness and reliability as a test of change in motivation for sweet tastes after bariatric surgery. Participants (58 patients and 28 controls, BMI: 18.5-24.9 kg/m2) sham-consumed an aspartame-sweetened (S) and non-sweetened (N) beverage under AL and PR schedules at a pre-surgery/baseline and a 3-month and 24-month visit (patients only). Cumulative pressure (CumPres), a measure of effort, was the sum of the pressures exerted during sipping under each condition. Baseline CumPres for PRS was higher than ALS and ALN in patients (p < 0.03) and higher than PRN in controls (p = 0.009). At 3 months, CumPres did not differ amongst conditions in patients, but CumPres for PRS was higher than all other conditions in controls (p < 0.0005). There were no baseline group differences; however, patients' CumPres for PRS was lower than controls' at 3 months (p = 0.002). Patients' CumPres for PRS decreased non-significantly between the baseline and 3 months but increased at 24 months compared to 3 months (p = 0.025) and was no different from baseline. Controls' CumPres for PRS increased at 3 months (p = 0.0359), but CumPres for all conditions was correlated between visits (p's < 0.038). The sipometer is a reliable and sensitive measure of motivation to consume sweet beverages and may reflect changes in post-operative energy intake.

Efficacy and safety of Bacteroides fragilis BF839 for pediatric autism spectrum disorder: a randomized clinical trial.

The clinical utility of Bacteroides fragilis in treating autism spectrum disorder (ASD) remains unclear. Therefore, this randomized, double-blind, placebo-controlled study aimed to explore the therapeutic effects and safety of B. fragilis BF839 in the treatment of pediatric ASD. We examined 60 children aged 2-10 years diagnosed with ASD, and participants received either BF839 powder (10 g/bar with ≥106 CFU/bar of viable bacteria, two bars/day) or placebo for 16 weeks. The primary outcomes was Autism Behavior Checklist (ABC) score. The secondary outcomes were Childhood Autism Rating Scale (CARS), Social Responsiveness Scale (SRS), Normal Development of Social Skills from Infants to Junior High School Children (S-M), Gastrointestinal Symptom Rating Scale (GSRS) scores, and fecal microbiome composition. Assessments were performed on day 0 and at weeks 8 and 16. Compared with the placebo group, the BF839 group showed significant improvement in the ABC body and object use scores at week 16, which was more pronounced in children with ASD aged <4 years. Among children with a baseline CARS score ≥30, the BF839 group showed significant improvements at week 16 in the ABC total score, ABC body and object use score, CARS score, and GSRS score compared to the placebo group. Only two patients (6.67%) in the BF839 group experienced mild diarrhea. Compared with baseline and placebo group levels, the BF839 group showed a significant post-intervention increase in abundance of bifidobacteria and change in the metabolic function of neuroactive compounds encoded by intestinal microorganisms. BF839 significantly and safely improved abnormal behavior and gastrointestinal symptoms in children with ASD.

Abstract P423: Blood Pressure and Renal Function Outcomes After Revascularization of Renal Artery Stenosis in Patients from 3 Different Clinical Settings

The effects of renal percutaneous transluminal angioplasty (rPTA) of renal artery stenosis (RAS) on BP and renal function are controversial. We aim to search for possible differences in these outcomes in different clinical settings. We conducted an observational analysis of effects of rPTA in patients with RAS diagnosed as a result of: screening patients with peripheral artery disease (Vascular Dpt.; G1, n = 20), patients with resistant hypertension or with clinical suspicion of RAS (Hypertension Unit; G2, n = 28) or kidney transplant patients with renal function impairment and/or elevation of BP (Transplantation Unit; G.3, n = 21). RAS is defined as a reduction of ≥70% of the renal artery lumen. Sixty-nine patients were examined (mean age 67±12yr, 64% male). Overall, mean±S.D. baseline SBP/DBP (mmHg) was 147.4±20.6 and 75.7±1.8, and the estimated glomerular filtration rate (eGFR) was 48.7±27.0 mL/min/1.73m 2 . G.1 exhibited a higher prevalence of smoking patients (90%) and patients with past major vascular events (100%), lower DBP (70.0±9.8 mmHg) and better renal function (eGFR: 62.5±23.2 mL/min/1.73m 2 ), compared to G.2 and G.3. Twelve months after rPTA, BP decreased only in patients in G.2 and G.3: variation of (Δ) SBP(mmHg): mean (95%CI)= -18.9 (-26.7 to -11.0) and -20.0 (-29.8 to -10.1), respectively; p&lt;0.001 for both; ΔDBP (mmHg): mean (95%CI)= -6.6 (-10.7 to -2.4), p=0.003 and -6.3 (-11.7 to -0.8), p=0.027, respectively. Regarding renal function, it only improved in G.3: ΔeGFR (mL/min/1.73m 2 ): mean (95%CI)= 8.9 (1.5 to 16.4), p=0.022. ΔSBP was associated with baseline SBP (r= -0.709, p&lt;0.001) and the origin group (Rho = -0.362, p = 0.003); ΔeGFR was associated with baseline eGFR (r= -0.508, p&lt;0.001) and the origin group (Rho = 0.356, p = 0.004). Overall, median ΔSBP was -11 mmHg, and median ΔeGFR was +1.0 mL/min/1.73m 2 . An ANOVA analyzed factors associated with these changes. After adjusting for confounders, ΔSBP was dependent on baseline SBP and group of origin (both p&lt;0.05; adjusted R 2 0.340). ΔeGFR was dependent on baseline eGFR and diabetes (both p&lt;0.05; adjusted R 2 0.123). Blood pressure decreased in patients with suspected RAS because of resistant hypertension 12 months after rPTA. Both BP and renal function improved after rPTA in kidney transplant patients with diagnosis of RAS. Higher BP levels and lower eGFR correlated with better results. Patients with peripheral artery disease screened for RAS showed no change in BP or renal function after rPTA.

Impact of Bitter Gourd (Momordica charantia) Hypoglycemic Formulation on Biochemical Parameters in Alloxan-induced Diabetic Albino Rats

Introduction: Diabetes mellitus is a widespread endocrine disorder that leads to chronic hyperglycemia, posing significant health challenges globally. Effective management of blood glucose levels remains a critical goal in diabetes treatment. Recent studies have highlighted the potential of natural products in diabetes management. Momordica charantia, commonly known as bitter gourd, has been traditionally used for its purported hypoglycemic effects. This study aims to evaluate the efficacy of a methanolic extract of Momordica charantia in reducing blood glucose levels in an animal model of diabetes and compare its effectiveness to a standard antidiabetic medication, Glizid-M. Materials and Methods: The study utilized alloxan-induced diabetic albino rats to assess the hypoglycemic effects of the methanolic extract of Momordica charantia. Diabetic rats were divided into groups and administered varying doses of the extract: 150 mg/kg, 300 mg/kg, and 600 mg/kg. A control group received Glizid-M, and a baseline group received no treatment. Blood glucose levels were monitored at regular intervals to evaluate the efficacy of the extract in managing hyperglycemia. Results and Discussion: The administration of the methanolic extract of Momordica charantia resulted in a dose-dependent reduction in blood glucose levels. Among the tested dosages, the 600 mg/kg dose demonstrated a statistically significant decrease in blood glucose compared to the lower doses of 150 mg/kg and 300 mg/kg. The 600 mg/kg dosage showed comparable efficacy to the standard antidiabetic drug, Glizid-M, indicating a strong hypoglycemic effect. The results of this study suggest that Momordica charantia has a potent hypoglycemic effect, with its efficacy increasing with dosage. The significant reduction in blood glucose levels at the highest dosage implies that the extract may influence glucose metabolism effectively. The dose-dependent response highlights the importance of optimizing dosage for maximum therapeutic benefit. Comparison with Glizid-M further supports the potential of Momordica charantia as a viable alternative or complementary therapy in diabetes management. Conclusion: This study provides scientific validation for the use of Momordica charantia methanolic extract as a therapeutic agent for diabetes management. The observed dose-dependent reduction in blood glucose levels suggests its potential as an effective natural remedy for controlling hyperglycemia. Further research is warranted to explore the underlying mechanisms and long-term efficacy of this extract in diabetes treatment.

Resilience Intervention Improves Stress-Related Gene Expression in Adolescent and Young Adult HCT Recipients

Overactivation of the stress response can influence cancer outcomes through immune-related pathways. Adolescents and young adults (AYAs) undergoing hematopoietic cell transplantation (HCT) are at risk for poor outcomes, yet there are limited behavioral interventions and no psychosocial biomarker data for this population. The Conserved Transcriptional Response to Adversity (CTRA) is an inflammation-related pattern observed in conditions of heightened stress and is associated with HCT outcomes. The objective of the current study was to explore the CTRA gene regulatory impact of Promoting Resilience in Stress Management (PRISM) intervention among AYAs receiving HCT. We hypothesized that patients who received the intervention would have favorable gene expression signatures compared to those in the control arm. This was an ancillary study within a randomized trial testing the PRISM intervention on psychosocial outcomes among AYAs aged 12 to 24 years receiving HCT (NCT03640325). CTRA was quantified through genome-wide transcriptional profiles obtained from whole blood collected at baseline, 1-, and 3-month post-HCT. Group differences in CTRA gene expression were estimated using mixed-effect linear models. There were no baseline group differences in CTRA expression, but PRISM participants showed a greater decline in CTRA at 1 month compared to controls (β -0.301 ± SE 0.114, P = .016), even when controlling for demographic (Group × Time interaction: F(2, 18) = 7.41, P = .004; β -0.386 ± 0.127, P = .007) and clinical covariates (Group × Time interaction: F(2, 20) = 7.03, P = .005; β -0.480 ± 0.144, P = .003). These differences were not detectable at 3 months (β -0.147 ± SE 0.120, P = .235). There was a change in stress-related gene expression among AYAs randomized to a psychosocial intervention. The stress-inflammation axis may be a targetable pathway in the AYA HCT population.

Evaluating utility of routine ferritin testing in blood donors: A hospital-based blood donor centre experience.

Iron deficiency (ID) poses a prevalent concern among blood donors, especially impacting young donors, premenopausal females and frequent donors. In alignment with recommendations to address ID, routine ferritin testing was implemented in a hospital-based donor centre. Data set, encompassing 26 164 ferritin values from 16 464 blood donors over 33 months, were analysed retrospectively. Ferritin levels were assessed concerning donor characteristics such as sex, age, ethnicity and donation frequency. Ferritin testing revealed age, sex and ethnicity variations, emphasising the heightened risk of ID in young females meeting all donation criteria under 23 year of age who demonstrated the lowest mean baseline ferritin (41% [CI: 34%-48%] < 26 ng/mL; 20% [CI: 14%-25%] < 15 ng/mL). Postmenopausal females exhibited ferritin levels similar to similarly aged males. Irrespective of sex, donors showcased mean ferritin recovery within 6 months. Analysis of ferritin recovery post-donation showed a five-fold increase in risk (compared with first visit) of ID when donors return at a 2-month interval. 'Regular' donors (≥10 visits) approach a median steady ferritin level (~30-35 ng/mL) by the sixth visit. As reliance on regular blood donors increases, donation policies must strike a balance between blood centre resources and the risks posed to both regular and at-risk donors. Frequent blood donation led to donors attaining a mean steady state ferritin level above the threshold for ID. At-risk groups, particularly premenopausal females, were several times more likely to experience ID after donation but demonstrated recovery rates similar to their group's baseline levels. This valuable information informed the development of new donor deferral policies.