Mean Levels Research Articles

Secondhand Smoke Exposure Measured in Urinary Cotinine Levels and Severity of Pediatric Sleep Apnea

Exposure to secondhand smoke has been associated with numerous health problems in children, including obstructive sleep apnea. Secondhand smoke exposure may be a risk factor for increased pediatric sleep apnea severity. To assess the association of secondhand smoke exposure (SHSe), quantified by urinary cotinine levels, with severity of obstructive sleep apnea (OSA) in children. This was a prospective cohort trial including pediatric patients from 3 to 16 years of age with sleep-disordered breathing who underwent a polysomnogram at a tertiary-level children's hospital in the US in either March 2014 to October 2016 or March 2020 to March 2021. Urine specimens were analyzed for cotinine, an important metabolite of nicotine. Each child's caregiver completed a validated SHSe questionnaire. Data were analyzed from February to June 2023. OSA and secondhand smoke. SHSe and severity of pediatric OSA, quantified by urinary cotinine levels and obstructive apnea hypopnea index (AHI) scores. Secondary outcomes were association of urinary cotinine levels with nadir oxygen saturation, sleep-related quality of life measured by the OSA-18 questionnaire, and caregiver-reported smoking habits (collected through a questionnaire). The study included 116 patients with a median (IQR) age of 6 (5-9) years, among whom 51 (45%) had obesity. The median (IQR) AHI was 3.0 (1.2-8.0), with 28 children (30.0%) having severe disease (AHI >10). Thirty-four children (29.0%) were found to have a positive result for urine cotinine screening, with a mean (SD) level of 11.7 (9.4) ng/mL. The percentage of children with SHSe was less than anticipated. There was no association identified between urinary cotinine levels and either AHI (ρ = -0.04; 95% CI, -0.22 to 0.15) or nadir oxygen saturation (ρ = -0.07; 95% CI, -0.26 to 0.11). Furthermore, SHSe was not associated with the presence of severe OSA (odds ratio, 0.70; 95% CI, 0.26 to 1.90). Children whose caregivers reported indoor SHSe were more likely to have a detectable urinary cotinine level (odds ratio, 20.3; 95% CI, 6.67 to 61.8). This cohort study did not identify any clinically meaningful association between SHSe, quantified by urinary cotinine level, and pediatric OSA severity. Future research with a larger number of children with SHSe is needed to confirm these findings and determine whether SHSe affects OSA treatment outcomes in children.

Epigenetic role of LINE-1 methylation and key genes in pregnancy maintenance

Spontaneous abortion is a pregnancy complication characterized by complex and multifactorial etiology. About 5% of childbearing women are globally affected by early pregnancy loss (EPL) and most of them experience recurrence (RPL). Epigenetic mechanisms and controlled inflammation are crucial for pregnancy maintenance and genetic predispositions may increase the risk affecting the maternal–fetal crosstalk. Combined analyses of global methylation, inflammation and inherited predispositions may contribute to define pregnancy loss etiopathogenesis. LINE-1 epigenetic regulation plays crucial roles during embryo implantation, and its hypomethylation has been associated with senescence and several complex diseases. By analysing a group of 230 women who have gone through pregnancy interruption and comparing those experiencing spontaneous EPL (n = 123; RPL, 54.5%) with a group of normal pregnant who underwent to voluntary interruption (VPI, n = 107), the single statistical analysis revealed significant lower (P < 0.00001) LINE-1 methylation and higher (P < 0.0001) mean cytokine levels (CKs: IL6, IL10, IL17A, IL23) in EPL. Genotyping of the following SNPs accounted for different EPL/RPL risk odds ratio: F13A1 rs5985 (OR = 0.24; 0.06–0.90); F13B rs6003 (OR = 0.23; 0.047–1.1); FGA rs6050 (OR = 0.58; 0.33–1.0); CRP rs2808635/rs876538 (OR = 0.15; 0.014–0.81); ABO rs657152 (OR = 0.48; 0.22–1.08); TP53 rs1042522 (OR = 0.54; 0.32–0.92); MTHFR rs1801133/rs1801131 (OR = 2.03; 1.2–3.47) and FGB rs1800790 (OR = 1.97; 1.01–3.87), although Bonferroni correction did not reach significant outputs. Principal Component Analysis (PCA) and logistic regression disclosed further SNPs positive/negative associations (e.g. APOE rs7412/rs429358; FGB rs1800790; CFH rs1061170) differently arranged and sorted in four significant PCs: PC1 (F13A, methylation, CKs); PC3 (CRP, MTHFR, age, methylation); PC4 (F13B, FGA, FGB, APOE, TP53, age, methylation); PC6 (F13A, CFH, ABO, MTHFR, TP53, age), yielding further statistical power to the association models. In detail, positive EPL risk association was with PC1 (OR = 1.81; 1.33–2.45; P < 0.0001) and negative associations with PC3 (OR = 0.489; 0.37–0.66; P < 0.0001); PC4 (OR = 0.72; 0.55–0.94; P = 0.018) and PC6 (OR = 0.61; 0.46–0.81; P = 0.001). Moreover, significant inverse associations were detected between methylation and CKs levels in the whole group (rIL10 = − 0.22; rIL17A = − 0.25; rIL23 = − 0.19; rIL6 = − 0.22), and methylation with age in the whole group, EPL and RPL subgroups (r2TOT = 0.147; r2EPL = 0.136; r2RPL = 0.248), while VPI controls lost significance (r2VPI = 0.011). This study provides a valuable multilayer approach for investigating epigenetic abnormalities in pregnancy loss suggesting genetic-driven dysregulations and anomalous epigenetic mechanisms potentially mediated by LINE-1 hypomethylation. Women with unexplained EPL might benefit of such investigations, providing new insights for predicting the pregnancy outcome and for treating at risk women with novel targeted epidrugs.

Histomorphometric analysis of patients with femoral neck fracture and 25-hydroxyvitamin D deficiency: a cross-sectional study.

Vitamin D deficiency causes osteoporosis, bone mineralization disorders, and osteomalacia. Osteomalacia is diagnosed using blood biochemical tests, clinical symptoms, and imaging; however, accurate detection of mineralization disorders requires tissue observation. We investigated the prevalence of bone mineralization disorders and their relationship with serum 25-hydroxyvitamin D (25OHD) levels in patients with untreated osteoporosis with femoral neck fractures. A non-demineralized specimen was prepared from the femoral head removed during surgery in 65 patients. Bone histomorphometry of cancerous bone in the femoral head center was conducted. Osteoid volume per bone volume (OV/BV) and osteoid thickness (O.Th) were measured as indicators of mineralization disorder. The mean serum 25OHD level (11.9 ± 5.7ng/mL) was in the deficiency range (< 12ng/mL). There were no clinically diagnosed cases of osteomalacia (OV/BV > 10% and O.Th > 12.5µm); however, one case of mineralization disorder, considered histologically pre-osteomalacia (OV/BV > 5% and O.Th < 12.5µm), was observed (OB/BV, 17.6%; O.Th, 12.3µm). Excluding this case, those with severe (25OHD < 12ng/mL, at risk of osteomalacia; n = 39) and non-severe deficiency (25OHD ≥ 12ng/mL; n = 25) did not significantly differ in OV/BV (%; 0.77 ± 0.54 vs. 0.69 ± 0.38, p = 0.484) or O.Th (µm; 5.32 ± 1.04 vs. 5.13 ± 0.78, p = 0.410). Further, 25OHD and OV/BV were not significantly correlated (R = -0.124, p = 0.327). This is the first study in the twenty-first century to examine serum 25OHD concentrations and bone mineralization disorders in Japanese patients with osteoporosis. The results indicate that vitamin D deficiency does not necessarily cause bone mineralization disorders and rarely leads to osteomalacia.

Origins and health risk assessment of PAHs/APAHs/NPAHs/OPAHs in PM2.5 at a background site in North China Plain: Implications for crude oil emissions

In order to investigate the origins and health impact of PAHs/APAHs/NPAHs/OPAHs in PM2.5 at North China Plain (NCP) under the influence of Shengli oil field, PM2.5 samples were collected in winter, spring, summer and autumn from 2018 to 2019 at a background site in NCP, and 19 PAHs, 5 APAHs, 7 NPAHs, and 6 OPAHs were analyzed. The mean level of PAHs, APAHs, NPAHs, OPAHs were 9.13 ± 11.03, 1.33 ± 1.45, 0.23 ± 0.72, 0.48 ± 0.48 ng/m3, respectively. APAHs were the most abundant derivatives of PAHs, which indicated crude oil was an important source. Further, ratios of 1-MN/NAP showed that APAHs emitted from crude oil were relatively fresh. Significant correlations were found among PAHs and APAHs with similar rings. The positive matrix factorization model demonstrated that secondary formation (9.32%), oil industry emissions (32.68%), emissions from steel and vehicles (18.12%), biomass and coal emissions (30.00%), as well as petrogenic sources (9.88%) were the main sources of PAHs/APAHs/NPAHs/OPAHs. Through the analysis of concentration weighted trajectories, it was discovered that the southwestern region of Dongying was the primary potential source of the oil industry, while the Bohai Bay and Shandong coastal area was the primary source region for petrogenic sources. ILCR results indicated that it was highest in winter; adults (30–70 years) were people who had the highest cancer risks.

Effects of rankl inhibitor on hormonal parameters in letrozole induced rat model of polycystic ovary syndrome.

Objective: To study the effect of RANKL inhibitor on serum FSH, LH and testosterone level in Letrozole induced rat model of PCOS. Study Design: Experimental Animal study. Setting: Thirty adult female Wistar Albino rats of 6-8 weeks of age with a weight range of 120–150 gm were recruited from the animal house of Baqai Medical University. Period: February 2022 till August 2022. Material &amp; Methods: The rats were randomly divided into A, B, and C groups and each contained 10 rats. Group A was considered ass control while Group B served as Letrozole induced PCOS group and Group C served as RANKL inhibitor group. Letrozole dissolved in 0.1% CMC and was given at a dose of 1 mg/kg orally for 21 days to induce PCOS. RANKL inhibitor (Denosumab) was given 0.25 mg/kg body weight subcutaneously for 4 weeks after the induction of PCOS i.e from 21 days to 50th days. At the end of the experiment, blood was taken from intra cardiac puncture and analyzed through ELISA. Results: Mean serum level of LH and testosterone level were significantly higher (P&lt;0.001) in Letrozole-treated PCOs group which was significantly decreased (P&lt;0.001) in Denosumab treated animals but significantly higher (P&lt;0.05) than control group. Whereas, mean serum FSH level was significantly (P&lt;0.01) lower in the Letrozole-treated group which was significantly increased in Denosumab treated animals but significantly lower (P&lt;0.05) than the control group. Conclusion: RANKL inhibitor could prevent the hormonal imbalance in letrozole treated PCOs in albino rats.

Correlation between hepatomegaly and transfusion frequency in thalassemia patients: A cross-sectional study.

Objective: To investigate the relationship between transfusion frequency, serum ferritin levels, and hepatomegaly in beta-thalassemia major patients. Study Design: Cross-sectional study. Setting: Thalassemia Center, Liaquat University Hospital, Hyderabad. Period: January 2023 to June 2023. Material &amp; Methods: Among 158 patients, age until 19 years, and β-thalassemia type major was considered as inclusion criteria. Data regarding hematological parameters and hepatomegaly was collected after informed consent. Data was analyzed using SPSS (version 22). Chi-square test was used to investigate the association between ferritin levels and hepatomegaly while Pearson’s correlation was used assess the correlation between ferritin levels and transfusion frequency. P-Value ≤ 0.05 was considered as statistically significant. Results: Majority of the participants were males (58.22%) as compared to females (41.77%). The mean age of the study participants was 9.31±4.47 years, and the mean age at first transfusion was 8.98±0.93 years. Majority of the participants were underweight 107(67.72%). Monthly transfusion rate was 1.95±0.31.The mean serum ferritin levels among the study participants were 2033.06±1309.36 ng/mL. Hepatomegaly was found to be present in 99 (62.65%) of the study participants. Statistically significant positive correlation between the frequency of transfusion and serum ferritin levels (r = 0.71, p&lt;0.05) was observed. The difference of hepatomegaly in low-ferritin vs high-ferritin was also found to be statistically significant (p&lt;0.05). Conclusion: It was concluded that higher transfusion rates were associated with elevated ferritin levels, and there was a significant association between higher serum ferritin levels and the presence of hepatomegaly.

549 - Laboratory parameters in adolescent patients aged 12–17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to week 52: results from the phase 3 ECZTRA 6 trial

Abstract Introduction/Background Tralokinumab, a high-affinity, monoclonal antibody that targets IL-13, is approved in the EU and Canada for adolescents (aged ≥12 years) with inadequately controlled moderate-to-severe atopic dermatitis (AD), and it does not require laboratory monitoring. The phase 3 ECZTRA 6 (NCT03526861) clinical trial demonstrated efficacy and safety up to 52 weeks in that population. Objectives To further characterize the safety profile of tralokinumab by evaluating laboratory parameters of adolescents in the ECZTRA 6 trial. Methods ECZTRA 6 subjects received tralokinumab 150mg (n=98), 300mg (n=97) or placebo (n=94) every 2 weeks (Q2W) from week 0–16 after a loading dose at week 0 (twice the subsequent dose), and then randomized to maintenance [original tralokinumab dose either Q2W or every 4 weeks (Q4W) or placebo Q2W] or open-label (tralokinumab 300mg Q2W) until week 52. Laboratory parameters included hematology, serum biochemistry, and urinalysis throughout the trial (weeks 0, 8, 16, 28, and 52). Results Overall (n= 289 subjects), laboratory baseline parameters were similar across treatment groups. Mean and median changes of most hematology parameters showed minor fluctuations within the normal ranges through week 52, except for eosinophils. At baseline, elevated mean eosinophil counts (&amp;gt;0.5 109/L) were observed for 40.8% (tralokinumab 150mg), 48.5% (tralokinumab 300mg), and 43.6% (placebo) of subjects in each respective treatment group. Some tralokinumab-treated patients had small transient increases in eosinophils (maximum mean change from baseline 0.2×109/L) before week 16. Continued treatment with tralokinumab or placebo did not correspond with further increase in eosinophil levels over time, and no adverse events of eosinophilia were reported. Mean levels of most biochemistry parameters, including electrolytes, renal and liver function parameters, and lipid panel, were within normal range at baseline, and mean and median changes showed minor fluctuations within normal ranges in all treatment arms. Mean lactate dehydrogenase levels were around or above the upper limit of normal at baseline and decreased to within the normal ranges during the trial across all groups. Overall, no clinically meaningful differences were observed in hematology, biochemistry, or urinalysis parameters between active treatment groups or placebo. Conclusions Similar to findings in adult trials, no meaningful changes in laboratory parameters were observed in adolescents through week 52 with tralokinumab treatment. No routine laboratory monitoring is needed for adult or adolescent AD patients treated with tralokinumab.

Diagnostic value of serum amyloid A in differentiating the inflammatory disorders in wild birds.

Rescued wild birds have very high rates of inflammatory diseases; however, there have been limitations in assessing them sensitively. Few studies have examined acute-phase proteins in wild birds. In this study, serum amyloid A (SAA) was evaluated as an inflammatory indicator along with traditional indices such as white blood cell count, albumin, and albumin/globulin ratio. In total, 291 samples from 139 birds of six avian species were analyzed. All samples were divided into four groups (severe, moderate, mild injuries, and clinically healthy) based on clinical examinations and evaluated by group. SAA levels were measured using an anti-chicken SAA ELISA kit and compared with leukocyte counts, albumin concentrations, and albumin/globulin ratios. Differences among groups were evaluated using the Kruskal-Wallis test, followed by a post hoc test using Dunn's multiple comparisons with SPSS V27. Statistical significance was set at a value of p of <0.05. The median concentration and interquartile range (ng/mL) of SAA in each group were 78.10 ng/mL (50.71-109.30), 31.15 ng/mL (19.85-49.24), 9.68 ng/mL (4.71-22.06), and 3.10 ng/mL (1.50-6.00). We observed a significant difference in the mean levels between the groups (p < 0.001), with the same results observed across species. All four indices showed significant differences in mean values between the groups (p < 0.001). In addition, SAA showed rapid changes in periodically collected samples, reflecting either a positive treatment response or the onset of subclinical diseases. SAA can be used to detect inflammatory conditions and asymptomatic disease in wild birds and is helpful in accurately identifying current health status, which is essential for successful treatment and release.

Meaning in life of elite athletes: A person-oriented study

Introduction The concept of meaning in life has gained significant attention in psychology research in recent years due to its correlational relationship with physical and mental well-being (i.e., objective and subjective health measures, e.g., Steger, 2012). While recent attention has been directed toward this concept in sport psychology using qualitative research methods (e.g., Ronkainen et al., 2015), quantitative investigations into the specific sources of meaning engaged by athletes are notably scarce. This study (1) compares athletes with the general population and (2) employs a person-oriented approach to identify distinct profiles of athletes’ meaning in life and the sources they predominantly tap into. Methods A sample of 589 elite athletes from Switzerland (50.9% women, 49.1% men; Mage = 24.86 years, SD = 5.09) participated in this study. Utilizing the Meaning and Purpose Scales (MAPS; Schnell &amp; Danbolt, 2023), participants also provided contextual information about their life situations. The athletes were compared with the general population using t-tests. To identify profiles within the athlete population, we employed a latent profile analysis. Results Compared to the general population, athletes exhibit heightened meaningfulness and lower crisis of meaning and prioritise different sources of meaning. Athletes were higher in Growth and Community and lower in Faith, Sustainability and Security. The analysis yielded a three-profile solution based on theoretical considerations and statistical criteria: (1) athletes with below-average meaning in life and sources (n = 127), (2) athletes with above-average meaning in life and faith (n = 109), (3) athletes with above-average meaning in life with balanced sources (n = 353). Athletes in profiles 2 and 3 were characterized by elevated levels of meaningfulness and sources of meaning, and demonstrated greater life satisfaction and self-esteem, relative to the profile with below-average meaning in life and sources. Discussion/Conclusion The identified relationships with key mental health constructs align with qualitative findings emphasizing the centrality of meaningfulness in athletes’ lives. On a nomothetic level, elite athletes indicate a high degree of meaningfulness (compared to the population), however, there is a high degree of heterogeneity within the sample, which is why group-specific analysis (i.e., LPA) could help understanding meaning and its sources in elite athletes. In the future this approach could be useful to tailor programs aimed at cultivating meaning in life of elite athletes.

Impact of Heartfulness Meditation on Improving Antioxidant Status and Lipid Profile in Patients with Coronary Artery Disease

Introduction Oxidative stress plays an indispensable role in the pathogenesis of coronary artery disease (CAD). Several studies suggest that meditation can reduce oxidative stress and improve antioxidant status. This study was designed to evaluate the impact of heartfulness meditation on antioxidant status and lipid profile in patients with coronary artery disease. Methods Fifty-nine angiographically diagnosed CAD patients were included in the study. Patients who were enrolled practiced heartfulness meditation for a period of six months. Protein thiol (an antioxidant marker), serum total cholesterol (TC), triglycerides (TG), high-density lipoproteins (HDL-C), low-density lipoproteins (LDL-C), and very low-density lipoproteins (VLDL-C) were measured under fasting conditions before and after six months of meditation practice. Results After six months of practice of heartfulness meditation, there was a statistically significant increase in HDL-C (39.10 ± 8.30 vs. 42.85 ± 8.16, p &lt; .01) and an antioxidant marker protein thiol (257.34 ± 39.68 vs. 345.31 ± 57.53, p &lt; .0001). The mean levels of triglycerides (205.81 ± 88.31 vs. 182.53 ± 93.57 mg dl−1), VLDL-C (41.18 ± 17.64 vs. 36.51 ± 18.71 mg dl−1), and total cholesterol (170.02 ± 40.10 vs. 164.46 ± 42.20 mg dl−1) decreased following the intervention, although the differences were not statistically significant. Conclusion Heartfulness meditation is an effective means to decrease free radical formation and improve antioxidant status and lipid profile in CAD patients. As a result of this study, regular meditation practice has the potential to be one of the most effective non-pharmacological strategies for CAD prevention.

Expressive commitments

Abstract Pragmatics has made a Copernican shift from Gricean intentional approaches to normative approaches based in commitments. This has been good news for assertions, and questions of several stripes, but we still don’t know whether the commitment approach can be extended to expressive speech acts in general, and exclamations in particular. In this article, I will show that an approach to exclamations based on commitments at different levels of meaning, namely, the descriptive and expressive level, can be devised and it can offer interesting answers to old issues, like the contribution of exclamations to discourse, or their at-issue status, while raising new theoretical and empirical questions on lying and deceiving and commitment strength.

Structured request form in musculoskeletal radiology examinations (CONCERTO): results of an expert Delphi consensus-structured radiology request form for correct classification of patients to undergo radiological examinations of the Italian Society of Medical and Interventional Radiology (SIRM), the Italian Society of Rheumatology (SIR) and the Italian Society of Orthopedics and Traumatology (SIOT).

To describe a Delphi consensus for the realization of a structured radiology request form for patients undergoing musculoskeletal imaging. A steering committee (four radiologists, a rheumatologist and an orthopedic surgeon) proposed a form to an expert panel (30 members, ten radiologists, ten rheumatologists and ten orthopedic surgeons). Through an online survey, the panelists voted on their level of agreement with the statements of the form using a 10-point Likert scale (1: no agreement; 10: total agreement) in a three-round process. A combination of two distinct criteria, a mean agreement level ≥ 8 and a percentage of at least 75% of responses with a value ≥ 8, was deemed as acceptable. The form achieved high median ratings in all the assessed key features. During the first round, all items met the threshold to be advanced as unmodified in the next round. Additional proposed items were considered and introduced in the next round (six items in Section 1, five items in Section 2, ten items in Section 3, 11 items in Section 4, six items in Section 5, eight items in Section 6, ten items in Section 7 and eight items in Section 8). Of these items, in round 3, only six reached the threshold to be integrated into the final form. Implementation of a structured radiology request form can improve appropriateness and collaboration between clinicians and radiologists in musculoskeletal imaging.

(383) Viewpoints of Patients Regarding Their Reasons for Undergoing a Vasectomy: Impact of the Dobbs vs. Jackson Women’s Health Organization Decision

Abstract Introduction Vasectomy is an inexpensive surgical procedure to achieve permanent contraception. Current literature indicates that couples opt for vasectomy for various reasons, examples include satisfaction with size of family, financial constraints, age barriers, lack of confidence in other contraceptive options, concern about spouse’s health with other methods, and avoidance of unwanted pregnancies. Objective The main objective of this study is to assess the views and reasons that our patients choose a vasectomy to evaluate if there have been changes to reasons to get this procedure after the recent Dobbs decision to overturn Roe vs. Wade. Methods An anonymous survey was sent via REDCap to patients who have received vasectomy treatment from our institution’s Department of Urology in the last two years (N=57, 52.6% pre-Dobbs ruling). Participants provided demographics, current contraceptive methods, and reasons and duration they considered a vasectomy procedure. Results Study Sample. Patients were 93.4% Caucasian, 87.3% heterosexual, 95.1% non-Hispanic or Latino, with a mean age of 37.5 (SD=5.92). All spoke English as a first language. 79.7% were married and the majority (77.1%) had been in their current relationship for more than 6 years. 77.3% had at least one child and 78.0% had at least one child over the age of 2 years. Mean income was $70,000-$100,000 and mean level of education obtained was a bachelor’s degree. Survey Results. We asked patients why they chose to have a vasectomy procedure and compared responses pre- vs. post-Dobbs-ruling. Patients after the Dobbs ruling were significantly more likely to indicate that they chose to have a vasectomy due to a concern about an inability to obtain abortion access (p=0.026). Patients after the Dobbs ruling were also significantly more likely to indicate that they chose to have a vasectomy because they did not want to bring children into the current political climate (p=0.002). Critically, other reasons for obtaining a vasectomy (e.g., feeling too old to have children, limited resources, lack of confidence in other contraceptive methods, health concerns) did not differ pre- vs. post-Dobbs ruling (ps&amp;gt;0.1). Conclusions In our study, we found that patients demonstrated concern for abortion inaccessibility after the Dobbs ruling and were more likely to obtain vasectomy due to this reason. Understanding patient viewpoints and reasons for seeking specific procedures and types of healthcare can better prepare our providers and surgeons to provide this care moving forward. Disclosure No.

(095) Comparative Analysis of Absolute Risk in Testosterone versus Clomiphene Therapy: A Bayesian Analysis of Adverse Effects

Abstract Introduction Clomiphene is a selective estrogen receptor modulator used to induce ovulation by increasing luteinizing (LH) and follicle-stimulating hormone (FSH) levels. Since the 1970’s, it has been used in males with hypogonadism as an alternative to testosterone therapy as it does not suppress the hypothalamic-pituitary-gonadal axis. Objective While there have been systematic reviews looking at the effectiveness of clomiphene, we sought to better characterize the average testosterone levels, as well as the rate of deep venous thrombosis (DVT), myocardial infarction (MI), stroke, and polycythemia in clomiphene vs. testosterone users. Methods We performed a retrospective chart review for 537 men with a hypogonadism diagnosis that were seen by two urology providers at our center. Of these 537 patients, 84 presented with prior use or were prescribed clomiphene. We measured the incidence of DVT, MI, stroke, polycythemia and average testosterone levels with clomiphene. Statistical analysis was conducted using both a beta binomial and linear model. Results Patients receiving testosterone (n=217) versus clomiphene (n=84) demonstrated a 99% chance of higher mean levels of testosterone (Difference=216.55, 95% CrI = 20.67-408.16). Among those taking testosterone or clomiphene at the final visit (N=237; testosterone n=185; clomiphene=52) adverse events included, polycythemia (n=28), one DVT, VTE’s (n=4), MI’s (n=4), and strokes (n=4). The absolute risk (AR) of experiencing at least one of these events (i.e. polycythemia, DVT, VTE, MI or stroke) was 13.8% (95% CrI = 10.1-17.9%) and 3.1% (95% CrI = 0.44-9.4%) for testosterone and clomiphene respectively (Absolute Risk Difference (ARD) = 10.5% (95% CrI = 3.4-15.7%); Posterior Probability (ARD&amp;gt;0) &amp;gt; 0.99. The AR of polycythemia was 12.6% (95% CrI = 8.9-16.7%) and 1.5% (95% CrI = 0.1-7.4%) for testosterone and clomiphene respectively (ARD = 10.7% (95% CrI = 4.3-15.6%); Posterior Probability (ARD &amp;gt; 0) &amp;gt; 0.99. The AR of stroke was 0.94% (95% CrI = 0.14-2.98%) and 1.56% (95% CrI = 0.1-7.4%) for testosterone and clomiphene respectively (ARD = -0.6% (95% CrI = -6.5-2.1%); Posterior Probability (ARD &amp;lt; 0) = 0.64. The AR of MI was 1.4% (95% CrI=0.33-3.8%) and 1.5% (95% CrI=0.1-7.4%) for testosterone and clomiphene respectively (ARD = 1.3% (95% CrI = -0.36-3.73%); Posterior Probability (ARD &amp;gt; 0) = 0.96. The AR of DVT was 0.37% (95% CrI = 0.01-1.99%) and &amp;lt;0.00001% (95% CrI = &amp;lt;0.00001-1.6%) for testosterone and clomid respectively (ARD = 0.30% (95% CrI = -1.24-1.92%); Posterior Probability (ARD &amp;gt; 0) = 0.88. Conclusions The absolute risk of experiencing at least one of the events was found to be significantly higher in patients receiving testosterone compared to those receiving clomiphene. The results should be interpreted with caution, given the broad credible intervals due to its small size. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.

(166) Safety of Flibanserin in Men with Hypoactive Sexual Desire Disorder

Abstract Introduction Flibanserin possesses unique properties and displays selective agonistic and antagonistic activity against serotonin receptors. Originally, its primary application was in the treatment of hypoactive sexual desire disorder (HSDD) in women, where it showed promising results in improving sexual desire. However, as our understanding of its mechanism of action has expanded, researchers have begun to explore its potential utility in treating HSDD in males. This emerging trend has led to an increased interest in the use of flibanserin as a potential therapeutic option for men experiencing a decline in sexual desire. Objective We aimed to elucidate the demographic profiles, clinical attributes, and comprehensive safety implications of men receiving off-label flibanserin at our institution. Methods A retrospective analysis encompassing a cohort of men who initiated flibanserin treatment between July 2022 and July 2023 was performed. Basic demographic information, levels of total and free testosterone, pertinent medical history, scores from the International Index of Erectile Function (IIEF) and Patient Health Questionnaire-9 (PHQ-9), and overall manifestation of side effects were collected. Descriptive statistics were performed. Results A total of 26 patients were identified, with a mean age of 57.9 years (range, 31–80 years). Among these patients, seven had a prior diagnosis of depression and had previously received treatment with selective serotonin reuptake inhibitors (SSRIs). The mean levels of total testosterone and free testosterone were found to be 611.3 ng/dL and 116.8 pg/mL, respectively. Notably, a significant majority of patients (22 of 26 [81.4 %]) were diagnosed with erectile dysfunction. Importantly, all patients exhibited euthyroid status. The mean baseline score on the PHQ-9 was 5.30 (ranging, 0–17), indicating mild depressive symptoms, whereas the mean IIEF total score was 40 (range, 6–67). Furthermore, the mean score on the IIEF-desire subdomain was 5.65 (ranging: 2–10), reflecting relatively diminished levels of sexual desire. Upon conducting a follow-up assessment at the 3-month mark, it was observed that seven patients discontinued flibanserin medication, with reasons such as ineffectiveness and high cost being cited as the primary factors. Notably, only one patient (3.8%) discontinued the medication because of side effects. Conclusions In summary, our study sheds light on the fundamental characteristics associated with off-label utilization of flibanserin in men with HSDD, underscoring the increasing interest in investigating its potential therapeutic advantages within this specific population. However, additional research is warranted to comprehensively elucidate the clinical benefits and potential risks of flibanserin administration in men. Such investigations will contribute to a more thorough understanding of its efficacy and safety profile. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Disclosures: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.

(349) Shining a Light on Women's Sexual Health: Insights from Patients Presenting with Sexual Dysfunction

Abstract Introduction Sexual health is an essential component of overall health and wellbeing, and its importance in women's lives has often been neglected in clinical practice due to cultural, social, and educational barriers. Fortunately, in recent years, there has been a growing awareness and emphasis on women's sexual health, with increasing research attention dedicated to addressing this issue. Objective In this context, this study aims to contribute to the growing body of knowledge on women's sexual health by examining the characteristics of women who present for treatment of sexual dysfunction. Methods Women who presented with sexual dysfunction to our clinic from July 2022 to June 2023 were enrolled in this study and administered the PHQ-9 and FSFI surveys. In addition, hormone levels, demographic data, and pertinent medical history were collected at this time. Descriptive statistics and logistic regression analyses were used to identify factors associated with presentation for treatment. Results A total of 26 women with a mean age of 52 (SD=2.4) participated in this study. 10 (38.5%) women presented with low estradiol levels, and 4 (15.4%) women with low testosterone, although mean levels thereof were 53.7 (SD=18.9) and 72 (SD=16.8), respectively. Most women (15, 57.7%) reported mild to moderate depressive symptoms on PHQ-9 with a mean score of 7.53 (SD=1.08), but only 2 reported a formal diagnosis of depression. Somewhat expectedly, 24 (92.3%) women report an FSFI score less than 26 (mean=17.9, SD=1.63), corroborating their subjective experience. Additionally, logistic regression demonstrates that depressive symptoms have a strong relationship (R=0.63) with increased pain during intercourse (p=0.014) and decreased sexual satisfaction (p=0.002). Conclusions These results provide valuable insights into the characteristics of women who present for treatment of sexual dysfunction. The findings suggest that low hormone levels, particularly estradiol, may be a contributing factor to sexual dysfunction in some women. The high prevalence of depressive symptoms reported in our study highlights the need for clinicians to recognize and address the mental health concerns of these patients as well. It also underscores the importance of comprehensive sexual health assessments, including hormone level evaluations and mental health screenings, in the management thereof, though our findings are limited by a small sample size and lack of follow up and further studies are still needed. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast.

Selenium Concentrations in Patients with Depression: A Case-Control Study

Background: Evidence suggests that dietary micronutrients may be associated with depression. The role of selenium as a risk or protective factor for depression was contradictory. Therefore, this study aimed to investigate the association between serum selenium concentrations and depression. Methods: This case-control study was conducted from 2018 to 2020 in Shahrekord, Iran. The case and control groups included patients with or without depression, respectively. Seventy-two participants were selected using the conventional method. In addition to recording demographic variables, the blood selenium concentration of the participants was measured. Results: There was no difference between case and control groups in terms of mean levels of blood selenium (P&gt;0.05). Results showed that there was no statistically significant interaction between the effects of gender and group (P=0.51), age and group (P=0.13), Body mass index (BMI) and group (P=0.52) on blood selenium concentrations. However, females had significantly more selenium concentrations than males in both groups (P=0.005). Conclusion: Despite some confirming evidence for the association of depression and blood selenium concentration, this study did not show such a relationship. However, blood selenium concentration was higher in women than men in both groups.

Parasympathetic Nervous System Functioning Moderates the Associations between Callous-Unemotional Traits and Emotion Understanding Difficulties in Late Childhood.

Callous-unemotional (CU) traits are characterized by low empathy, guilt, and prosociality, putting children at risk for lifespan antisocial behavior. Elevated CU traits have been linked separately to difficulties with emotion understanding (i.e., identifying emotional states of others) and disrupted parasympathetic nervous system (PNS) functioning. However, no study has investigated how PNS functioning and emotion understanding are jointly related to CU traits. We explored associations between CU traits, emotion understanding, and PNS functioning (indexed via respiratory sinus arrhythmia [RSA]) among children aged 7-10 years old (n = 55). We also tested whether deficits in emotion understanding differ across specific emotions (i.e., fear, pain, happiness, anger). Each child's RSA was continuously recorded while they watched a film that included emotionally evocative social interactions. To assess emotion understanding, children identified emotions replayed in 1s animations of scenes from the film. Parents reported on child CU traits, conduct problems, and demographic information. Higher CU traits were related to lower emotion understanding (β = -0.43, p = 0.03). PNS activity during the film moderated this association (β = -0.47, p < 0.001), such that CU traits were associated with lower emotion understanding among children with mean (B = -0.01, t = -2.46, p = 0.02) or high (i.e., 1 SD > M; B = -0.02, t = -3.00, p < 0.001) RSA levels during the film, but not among children with low RSA levels (i.e., 1 SD < M; B = 0.00, t = -0.53, p = 0.60). Moreover, we found that the observed moderated associations are driven by deficits in fear, specifically. The link between poorer emotion understanding, fear understanding in particular, and CU traits was attenuated for children who demonstrated patterns of PNS functioning consistent with attentional engagement while viewing the emotion stimuli.

Association between Genetic Variants Linked to Premature Ovarian Insufficiency and Inflammatory Markers: A Cross-Sectional Study.

Premature menopause (PM) is the cessation of ovarian function before age 40. PM women are more likely to have cardiovascular diseases (CVDs), diabetes, and mental disorders. This is the first study that assessed the association of single nucleotide polymorphisms (SNPs) with anti-heat shock protein 27 (Hsp27), High-sensitivity C-reactive protein (hs- CRP), and PM and serum pro-oxidant-antioxidant balance (PAB), as putative risk factors for CVDs. We aimed to explore the association of oxidative stress markers with eight different SNPs shown to be related to premature menopause. In this cross-sectional research, we included 183 healthy women and 117 premature menopausal women. We determined baseline characteristics for all participants and measured serum hs-CRP, anti-HSP-27 antibody titer, and PAB levels using the established methods. Genotyping for eight SNPs was done using the tetra amplification refractory mutation system polymerase chain reaction (Tetra-ARMS PCR) and allele-specific oligonucleotide PCR (ASO-PCR) methods. We found a significant difference between mean serum PAB levels and the genetic variant of rs16991615 (P=0.03). ANCOVA showed a significant effect of the genotypes rs4806660 and rs10183486 on hs-CRP serum levels in the case and control groups, respectively (P=0.04 and P=0.007). ANCOVA also showed an association between rs244715 genotypes and anti-hsp27 serum levels in the case group (P=0.02). There was a significant effect of the genotypes of rs451417 on the serum hs-CRP level in the control group (P=0.03). There was a significant association of the genetic variants related to PM with oxidative stress and inflammatory markers (serum PAB, anti-hsp27 antibody, and hs-CRP). Accordingly, this seems to be an effective approach to predicting susceptible subjects for cardiovascular and mental disorders as well as various cancers.

Social exclusion and suicide intention in Chinese college students: a moderated mediation model.

Given the growing incidence rates of suicide among college students and the potential lifelong consequences of suicide, it is imperative to better understand the factors that reduce the rates at which college students in a clinical sample engage in suicide. This study examines the relationship between social exclusion and suicide intention, the mediating effect of depression, and the moderating effect of meaning in life. Two hundred and ninety-nine Chinese college students, aged from 18 to 22 years (56.86% female, M age = 20.14, SD = 1.27) completed questionnaires assessing their social exclusion, suicide intention, depression, and meaning in life. The result revealed that social exclusion was positively associated with suicide intention, and depression mediated this relationship. In addition, this mediating effect of depression was moderated by meaning in life. That is, the mediation effect was stronger for students with a higher level of meaning in life. These findings provide educational suggestions for preventing and intervening in suicide intention among college students.