Mean Serum Research Articles

Evaluation of serum fibronectin levels and fibronectin gene polymorphism in patients receiving intravesical BCG therapy for non-muscle invasive bladder cancer and its prognostic value

BackgroundBladder cancer continues to be a significant health issue, leading to ongoing research into novel biomarkers and treatment strategies. This study aims to evaluate the potential of serum fibronectin levels and fibronectin gene polymorphisms as biomarkers for predicting the recurrence and treatment response in patients with NMIBC undergoing intravesical BCG therapy.MethodsBetween June 2022 and December 2022, data of 73 patients who applied to the Mersin University Urology Clinic due to NMIBC and were followed and treated in our clinic, receiving intravesical BCG treatment, when necessary, as well as 56 individuals without any malignancy, were prospectively examined. Serum fibronectin levels were measured using the enzyme-linked immunosorbent assay method. PCR testing was applied for the fibronectin gene RS10202709 and RS 35,343,655 gene polymorphisms by using Real-Time PCR.ResultsThe mean serum fibronectin level in the patient group was 76.794 ± 66.998ng/ml. Simultaneously, it was 50.486 ± 25.156ng/ml in the control group, and these differences in serum fibronectin levels were statistically significant(p = 0.003). Out of the 73 patients included in the study, recurrence of bladder cancer was observed in 53 of them. They were divided into two groups based on the recurrence times: early recurrence and late recurrence. The mean fibronectin level in the early recurrence group was 102 ± 86.1 ng/ml, while it was 44.7 ± 11.8 ng/ml in the late recurrence group. Emphasize the significance of the higher fibronectin levels in the early recurrence group by stating, patients with early recurrence exhibited significantly higher serum fibronectin levels compared to those with late recurrence (p < 0.001), suggesting a potential role for fibronectin as a prognostic biomarker.ConclusionsThe statistically higher concentrations of serum fibronectin levels in patients with bladder cancer observed in our study are a noteworthy finding. These findings suggest that serum fibronectin levels could serve as a valuable prognostic biomarker for early recurrence in NMIBC patients, although their predictive value for BCG treatment response remains limited.

A comparative study of hormonal contraceptive use and vitamin D levels at Gondar Town 2023.

Vitamin D deficiency is an emerging public health problem globally, with devastating health consequences. Some studies suggest that exogenous sex hormones, found in hormonal contraceptives, may enhance vitamin D levels. However, the reasons for this association are not fully understood, as women using hormonal contraception may have different lifestyle habits affecting their vitamin D status. Therefore, this study seeks to explore the relationship between hormonal contraceptive use and vitamin D levels. A Facility based comparative cross-sectional study was conducted in Gondar town from February to April 2023, involving a total of 162 women using three types of hormonal contraceptives (Norplant, DMPA, and COC) and 162 age and BMI-matched non-users as controls in a 1:1 ratio. Participants were selected using systematic random sampling. A semi-structured questionnaire was used to collected data regarding the socio-demographic, economic, obstetric, lifestyle, and clinical information. 5 milliliters of blood samples were collected from each participant for Laboratory analysis of serum vitamin D, calcium, and alkaline phosphates using a Beckman Coulter chemistry analyzer. Independent t-tests, ANOVA with post hoc Bonferroni test was used to compare statistics between the two groups, and logistic regression models to identify factors associated with Vitamin D deficiency. The mean serum Vitamin D levels of Norplant, DMPA, and COC users were 24.08 (± 5.17), 24.83 (± 5.52), and 31.90 (± 6.94) respectively; whereas control group has mean Vitamin D level of 22.00 (± 7.97). On the current study the prevalence of Vitamin D deficiency (< 20 ng/ml) among hormonal contraceptive users was found to be 21.6% (35/162), whereas 48.14% (78/162) of non-user controls had vitamin D deficiency. The odds of having Vitamin D deficiency was higher among participants who attained higher education, who never eat fish and have never been used vitamin D Supplements. However, the use of combined oral contraceptives (COC) shown to reduce the odd of having vitamin D deficiency by 90%. Similarly, individuals with normal and hypercalcemia state shown to have lower odd of having Vitamin D deficiency. Users of combined oral contraceptives (COC) had significantly higher mean serum Vitamin D levels compared to users of Norplant and DMPA, as well as non-users. The prevalence of Vitamin D deficiency was lower among COC users compared to non-users, highlighting a potential protective effect of COC use against Vitamin D deficiency.

Sudden death due to aortic rupture in New Zealand sheep

ABSTRACT Case history Over a period of 2 months in the spring and early summer of 2021, 13 cases of sudden death in cull ewes due to aortic rupture were diagnosed at a small number of New Zealand abattoirs. Clinical findings In 12/13 (92%) cases, a large blood clot was present in the thorax, and in one case the blood clot was seen in the tissues dorsal to the heart. There were no obvious signs of external trauma. The pluck (heart and lungs) or fixed aorta was submitted for histological examination in seven cases and in all of these, a tear in the aorta was found. Comparing the microscopic appearance of the proximal aorta in these seven cases to three clinically normal ewes from unaffected farms, the aortic wall thickness appeared thinner in the case ewes than the unaffected ewes. Subjectively, there was increased collagen in the tunica media in 3/7 and decreased elastin fibres in 5/7 case ewes compared to the control ewes. Further investigations on the index farm (where the first cases originated), found that the mean liver and serum Cu concentrations in 10 similarly aged, clinically normal ewes were within the normal reference range for New Zealand sheep. Similarly, the liver Cu concentrations of the seven case ewes were within the normal reference range. Diagnosis Aortic rupture due to an unknown aetiology. Clinical relevance Clinicians should be aware of this condition as a differential diagnosis for sudden death in older sheep and to assist the Ministry for Primary Industries in establishing the extent of this problem in New Zealand.

Association between laboratory markers, clinical and radiological findings in patients with idiopathic intracranial hypertension: case–control study

BackgroundIdiopathic intracranial hypertension (IIH) is a disease of raised intracranial pressure. Contribution of inflammatory mediators has been suggested in IIH pathophysiology. The aim of this study was to estimate certain serum inflammatory markers in IIH patients compared to normal subjects. Also, to examine the correlation between these laboratory parameters and the clinical and radiological characteristics of IIH patients.ResultsBody mass index (BMI) was significantly higher among IIH patients compared to controls. Serum LDH, CRP, NLR and PLR were significantly higher, whereas serum iron was significantly lower in IIH patients compared to healthy controls. IIH patients with stenosis in brain MRV had significantly higher mean serum CRP compared with patients with normal MRV. There was a statistically significant positive correlation between serum CRP and the presence of stenosis in MRV, between serum LDH level and grade of papilledema, and between CRP, TIBC, and NLR with BMI.ConclusionsThere is a significant elevation of inflammatory markers in IIH patients. Moreover, cerebral venous sinus stenosis and BMI were positively associated with higher markers of inflammation as CRP, LDH and NLR indicating the role of inflammation in thrombosis and obesity associated with IIH.

Link Between Ferritin, Vitamin D, Performance, and Eating Attitudes in Female Athletes.

Iron and vitamin D deficiencies can affect athletes' health and performance. However, the epidemiology and associated risk factors remain unclear. Forty-three elite female athletics athletes (20.2 ± 1.9 years) were included. A survey regarding the training schedule and Eating Attitudes Test-26, body composition, bone mineral density, and serum 25-hydroxyvitamin D (25(OH)D) and ferritin levels were assessed. Mean serum 25(OH)D and ferritin levels were 25.2 ± 5.5 ng/mL and 29.0 ± 13.2 ng/mL, respectively, and 83.7% and 41.9 % of athletes had vitamin D and ferritin insufficiency, respectively. Serum 25(OH)D level was negatively correlated with the number of rest days per week (Coefficient, -6.19; 95% confidence interval [CI], -9.82--2.57; p = 0.002), and serum ferritin level was negatively correlated with body mass index (Coefficient, -3.87; 95% CI, -7.57--0.16; p = 0.041). Performance levels were positively correlated with serum vitamin D levels (Coefficients, 7.25; 95% CI, 0.25-14.25; p = 0.043) and negatively correlated with EAT-26 scores (Coefficient, -7.30; 95% CI, -12.61--1.98; p = 0.009) and body fat percentage (Coefficient, -13.26; 95% CI, -24.66--1.86; p = 0.025). Vitamin D and ferritin insufficiencies are prevalent among Japanese female athletics athletes. Serum vitamin D level was related to performance level.

Do Vitamin D Levels Play a Role in Urinary Tract Infection in Children?

Previous studies have shown the protective effects of vitamin D supplementation against urinary tract infection (UTI). However, there are a few contradictory studies on the negative effect of vitamin D supplementation on UTI. Our objective was to establish whether there existed a relationship between serum vitamin D levels and UTIs in children. This study compared the serum 25-hydroxy vitamin D [25(OH)D] levels of children diagnosed with UTIs with those of healthy children (control group). We found a high rate of 25(OH)D deficiency in both the control and case groups (90% and 66.7%, respectively). Therefore, we added the laboratory parameters calcium, phosphate, and parathormone (PTH) to our analysis. We assessed the medical records of 60 patients diagnosed with UTIs and 20 healthy controls. The mean serum 25(OH)D level and PTH level were significantly higher in the patient group than in the control group. The PTH level was significantly lower in the acute pyelonephritis (APN) group than in the control group (p=0.016). Phosphate levels in the APN group were significantly lower than those in the control and cystitis groups (p=0.04, p=0.006 respectively). Because there was no correlation between 25(OH)D level and UTI, we concluded that 25(OH)D had no effect on UTI.

Response to treatment and low serum vitamin D levels in North Indian patients with treatment-naive category I and multi-drug resistant pulmonary tuberculosis

Background Tuberculosis (TB) is a bacterial infection that usually affects the lungs, although it can also affect other parts of the body. Vitamin D deficiency and response to treatment have been demonstrated in patients with active TB in several studies, but not in MDR-TB patients, which is a new observation in the present study. Objective To study the time to initial sputum culture conversion and to associate baseline vitamin D levels and response to treatment in patients with PTB Cat I and MDR-TB. Methods A total of 897 North Indian participants were recruited and divided into three groups: treatment-naïve PTB Cat I, MDR-TB, and healthy controls. Serum biochemistry, including 25-hydroxyvitamin D and calcium, was measured in all participants with PTB, Cat I, and MDR-TB. Results PTB Cat I patients had high bacillary load grading at baseline compared to 2nd month followed by 6th month of treatment. More severe chest radiographic features, such as cavitation and the presence of bilateral disease at baseline. Mean sputum smear conversion times were 0.95 ± 0.7 months and culture conversion to negative occurred at a mean time of 0.8 ± 0.7 in PTB Cat I patients compared to MDR-TB patients on average sputum smear and time of 2.4 ± 3 months. Significantly lower mean serum 25-hyroxyvitamin D concentration was found in the 6th month than in the 2nd month and baseline in PTB Cat I. Conclusion Low serum vitamin D deficiency was observed in both groups during treatment and is one of the important factors responsible for susceptibility to TB in both groups; however, its significance is uncertain. Patients with continuous positive sputum for multidrug-resistant tuberculosis (MDR-TB) had a worse prognosis than those with sputum bacteriology conversion. Two months into a treatment regimen, sputum smear conversions may be a useful indicator of an MDR-TB patient’s prognosis.

Risk Factors of Chronic Kidney Diseases: A Retrospective, Record based Study from a Tertiary Care Hospital in India

Abstract Background: There is a alarming rise of chronic kidney diseases (CKDs) prevalence globally, which is associated with significant morbidity and mortality. The burden of Chronic Kidney Diseases is rapidly rising in developing countries. The study aimed to assess the major risk factors of CKD in patients of a tertiary hospital. Materials and Methods: Hospital-based, retrospective study was conducted at a hospital, in Mumbai, among CKD patients. Medical records of 500 CKD patients were analysed. Results: The mean age of participants was 53.87 years. Majority of the patients had risk factors for CKD such as hypertension and diabetes. The mean serum creatinine was 4.04 mg/dL. Majority of the cases were in G4 and G5 stages of CKD and 201 patients had undergone kidney transplant. Association between age and transplant was significant. Furthermore, association between developing New Onset Diabetes Mellitus After Transplantation (NODAT) was statistically significant. Conclusion: Major risk factors for CKD were hypertension, diabetes and advancing age. Most of the cases of CKD were diagnosed late. There should be increased awareness about CKD among the population with special emphasis on cases of hypertension and diabetes.

Safety and effectiveness of a drug-loaded haemostatic sponge in chronic rhinosinusitis: a randomized, controlled, double-blind study

Some cases of chronic rhinosinusitis (CRS) require surgical treatment and postoperative nasal packing, but bleeding and adhesion are common complications after nasal surgery. Biodegradable drug-loaded implants hold great therapeutic options for the treatment of CRS, but little data are available regarding the safety and efficacy of a novel drug-loaded haemostatic sponge (DLHS) in the sinus. The aim of this study was to investigate the safety and efficacy of DLHS in the sinus. We conducted a prospective, randomized, controlled, double-blind clinical trial. In this clinical trial, 49 patients were enrolled and randomly divided into 2 groups: group A (n = 25) had the DLHS containing 1 mg budesonide and 0.67 mg sodium hyaluronate placed into the sinus, and group B (n = 24) had the Nasopore placed after ESS. Endoscopic follow-up was performed for 12 weeks, and the findings were classified using the discharge, inflammation, polyps/oedema (DIP) endoscopic appearance scores. All patients completed questionnaires to evaluate their sinonasal symptoms by using the sinonasal outcome test-22 (SNOT-22) Chinese version and visual analogue scale (VAS). Serum cortisol concentration in group A was measured prior to surgery and at days 1, 3, 7, and 14 after nasal surgery. Comparing group A and group B, at 2 weeks, no significant differences were observed in either objective or subjective parameters. The mean value of VAS for rhinorrhoea and DIP for oedema and the mean value of nasal adhesion were significantly lower in Group A than in Group B at 6 and 12 weeks, but a significant difference did not occur in SNOT-22 and VAS for dysosmia between the two groups at 6 and 12 weeks. The mean serum cortisol concentrations in group A at the follow-up were within normal limits without remarkable fluctuations. This study demonstrates the safety and efficacy of a novel biodegradable DLHS with the possibility of being used in CRS patients, and this sponge may reduce inflammation and minimize adhesions via controlled local drug delivery without measurable systemic exposure.

The changes in cardiovascular disease risk factors after the implementation of the package of essential non-communicable disease control.

The Package of Essential Non-Communicable (PEN) Disease Control was implemented in the primary healthcare system to manage cardiovascular disease (CVD) risk factors in Iran. This study aimed to evaluate the status of CVD risk factor control following the implementation of the PEN. This historical cohort study was conducted among 60-65-year-old residents to compare hypertension (HTN) control via mean systolic blood pressure (SBP) and diastolic blood pressure (DBP), diabetes mellitus (DM) control via fasting blood sugar (FBS) and HbA1C tests, hyperlipidemia control via serum cholesterol and triglyceride levels, and overweight and obesity via body mass index (BMI) measurement in 2016 (before the implementation of the PEN project) and 2021 (after 5 years). A total of 1,583 residents with a mean age of 62.32±1.70 years were included in the study. In 2021, compared to 2016, there was a significant decrease in the relative frequency of residents with high SBP from 13.7% to 9.3%, high DBP from 11.3% to 3.4%, FBS≥126 mg/dL from 25.6% to 19.7%, and BMI≥30 from 25.7% to 23.4%. Additionally, the mean DBP and the mean serum levels of FBS among all participants decreased significantly. However, the relative frequency of residents with total cholesterol≥200 mg/dL increased significantly from 11.5% to 14.2%. Following the implementation of the PEN, the control of HTN, DM, and obesity improved among 60-65-year-old residents. However, the control of hypercholesterolemia did not improve.

Serum Homocysteine Levels and Their Relationship With Serum Vitamin B12, Folate, and Ferritin Levels in Transfusion-Dependent Thalassemic Children.

The purpose of this study was to assess serum homocysteine levels and their relationship with serum vitamin B12, folate, and ferritin levels in transfusion-dependent thalassemic children. This study was proposed due to a paucity of literature regarding the status of homocysteine levels in thalassemic children and their relationship with the levels of vitamins and iron overload (serum ferritin values). A descriptive observational study was conducted on transfusion-dependent thalassemic children aged 1-18 years, who were registered at the Thalassemia Day Care Centre (TDCC), Umaid Hospital, Dr. SN Medical College, Jodhpur, over a period of six months. A total of 100 children were enrolled in the study, with a mean age of 8.89±4.50 years. The mean pre-transfusion hemoglobin level in the last six months was 8.23±1.02 gm/dL. The mean serum levels of homocysteine, vitamin B12, folic acid, and ferritin were 10.93±3.72 µmol/L, 164.03±80.54 pg/mL, 7.69±5.77 ng/mL, and 2175.78±1341.39 ng/mL, respectively. A statistically significant negative correlation was detected between serum vitamin B12 concentration and serum homocysteine concentration (r=-0.285, p=0.004). Statistically non-significant positive correlations were detected between serum folic acid and serum homocysteine levels (r=0.033, p=0.748) and between serum ferritin and serum homocysteine levels (r=0.179, p=0.075). A statistically significant negative correlation between serum homocysteine and vitamin B12 levels was noted, whereas statistically non-significant positive correlations were observed between serum homocysteine andserum folic acid levels and between serum homocysteine andserum ferritin levels.

Development and validation of a nomogram for predicting the interstitial fibrosis and tubular atrophy in patients with lupus nephritis.

Interstitial fibrosis and tubular atrophy (IFTA) were frequent histologic features of lupus nephritis (LN), and LN patients with IFTA have poor renal outcomes. In this study, we aimed to construct prediction models for the IFTA in LN patients. This retrospective study included 303 patients with biopsy proven LN at the Affiliated Hospital of Qingdao University and Union Hospital of Fujian Medical University. The participants were randomly divided into development and validation cohorts. They were further divided into IFTA and non-IFTA groups. The least absolute shrinkage and selection operator (LASSO) regression model with laboratory test results collected at the time of kidney biopsy was used to optimize feature selection for the risk model. Multivariable logistic regression analysis was applied to build a predicting model incorporating the feature selected in the LASSO regression model. Discrimination, calibration, and clinical usefulness of the predicting model were assessed using the C-index, calibration plot, and ROC curve analysis. Internal validation was assessed using the bootstrapping validation. A nomogram for individual assessment was constructed based on the preferable model. Predictors contained in the prediction nomogram included age, body mass index (BMI), mean arterial pressure (MAP), logANA, C3, eGFR and serum uric acid. The model displayed good discrimination with a C-index of 0.794 (95% CI 0.734-0.854) and good calibration. High C-index value of 0.857 (95% CI 0.776-0.938) could still be reached in the interval validation. A nomogram model based on the LASSO model was created for producing a probability score of IFTA in LN patients. With excellent predictive abilities, the nomogram may provide a simple and reliable tool to distinguish LN patients with IFTA and helps physicians make clinical decisions in their comprehensive assessment.

Role of Serum Magnesium on Insulin Resistance in Overweight and Obese Children.

Background Childhood obesity has become a global epidemic, with projections indicating it could affect 25% of children under 16 by 2050. This rise poses significant health risks, including early onset of type 2 diabetes and cardiovascular diseases. Recent research has shown a correlation between insulin action and magnesium levels, highlighting the link between low serum magnesium levels and obesity. This study aimed to investigate the relationship between serum magnesium levels and obesity in children aged 5-16 years, to compare overweight and obese adolescents with age- and gender-matched controls, and to determine the association between insulin resistance and decreased serum magnesium levels. Methodology At a tertiary hospital, this 1.5-year cross-sectional comparativestudy investigated the relationship between magnesium levels in the blood and insulin resistance in children aged 5-16. Cases met the 2015 revised Indian Academy of Pediatrics (IAP) growth charts for overweight or obesity in comparison to age-matched healthy controls. Exclusions included secondary causes of obesity and medical complications affecting magnesium. Assessments involved clinical history, examination, and fasting blood tests for insulin resistance indices. Results Compared to the controls, overweight children showed that mean serum magnesium levels are lower (1.03 mEq/l vs. 1.85 mEq/l, p<0.001); they were also reflected in higher anthropometric measures, which include body mass index (BMI) and body fat percentage. Cases had significantly higher metabolic markers like fasting insulin, Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) index, and lipid profiles, whereas systolic blood pressure although showing recognized differences did not significantly differ. Conclusion The study underscored the importance of detecting magnesium levels on insulin resistance in overweight and obese children.

Evaluation of Interleukin-6 Levels in Patients with Type 2 Diabetes Mellitus

Background: It has been suggested that inflammatory processes play an important role in the pathogenesis of type 2 diabetes. Individuals who develop type 2 diabetes show signs of low-grade inflammation years before disease onset. This low-grade inflammation has been assumed to be implicated in the pathogenetic mechanisms that cause type 2 Diabetes Mellitus. Inflammatory mediators such as the IL-6 family of cytokines have been proposed to be involved in the events that lead to type 2 diabetes. IL-6 has immunoregulatory actions been proposed to affect glucose homeostasis and metabolism directly and indirectly by action on skeletal muscle cells, adipocytes, hepatocytes, pancreatic b-cells and neuroendocrine cells. Many studies have suggested the role of IL-6 in the pathogenesis of type 2 diabetes mellitus. However, no references have been observed in Bangladesh regarding IL-6 and its association with type 2 diabetes mellitus. It thus may highlight the importance of low-grade inflammation in the pathophysiology of type 2 diabetes mellitus. The purpose of this study was to evaluate type 2 diabetes patients' levels of interleukin-6. Materials and methods: A hospital-based cross-sectional observational study was carried out in the Department of Biochemistry Chittagong Medical College, Department of Endocrinology of Chittagong Medical College Hospital and Chattogram Diabetic Hospital. One hundred (100) type 2 diabetes mellitus patient was included in the study by nonprobability consecutive sampling. Important variables in this study were serum IL-6, BMI, waist circumference and duration of Diabetes Mellitus. Results: The mean serum IL-6 level was 10.08±0.39 pg/ml in patients with type 2 Diabetes Mellitus. Serum IL-6 was positively correlated (r 0.33, p &lt;0.01) with waist circumference and duration of diabetes mellitus (r 0.26, p &lt;0.05). The mean IL-6 was significantly different between BMI groups (F (2,97) =5.39, p=0.006) and was higher in the obese group (10.52±4.00) compared to the overweight and normal BMI (6.78±1.95) and overweight (8.08±3.15) group. Conclusion: It can be concluded that type 2 diabetes mellitus patients had increased serum levels of IL-6. It can give an insight into the possible role of sub clinical inflammation among patients with type 2 Diabetes Mellitus. IAHS Medical Journal Volume 6(2) December 2023; 53-57

Serum Interleukin (IL)-6, Lipid Profile, and Association With Disease Severity in Patients With Psoriasis: A Cross-Sectional Study.

This study estimated the lipid profile and inflammatory biomarker (interleukin-6, IL-6) levels in patients with psoriasis and explored the association between lipid profiles and inflammatory biomarkers (IL-6) in assessing the severity of the disease. This cross-sectional study was conducted in the Department of Biochemistry, in association with the Department of Dermatology, at the Veer Surendra Sai Institute of Medical Sciences and Research, Burla, from November 2022 to June 2023. A fully automated analyzer (Cobas C311, Roche Diagnostics, Mannheim, Germany) was used to estimate the lipid profile, while the enzyme-linked immunosorbent assay (Erba, Transasia Bio-medicals Ltd., Mumbai, India) was used to estimate the inflammatory marker (IL-6). Data were analyzed using Statistical Package for the Social Sciences version 21.0 (IBM Corp., Armonk, NY). An unpaired t-test was conducted to examine the relationship between two variables. A p value of <0.05 was considered significant. The correlation among IL-6, lipid profile, and psoriasis area severity index (PASI) score was analyzed using Pearson's correlation coefficient. Quantitative data were expressed as means and standard deviations. Of the 102 study participants, 68 had psoriasis alone, and 34 had psoriasis with arthritis (psoriatic arthritis, PsA). Higher mean serum concentrations of IL-6, total cholesterol (TC), low-density lipoprotein, and triglycerides were found in patients with PsAcompared to those with psoriasis alone. In patients with PsA, TCand IL-6showed a strong positive correlation with the PASIscore. In contrast, high-density lipoprotein showed a negative correlation with PASI (r = -0.036, p < 0.05). In conclusion, our study revealed lipid profile abnormalities and increased IL-6activity in PsA patients. By measuring inflammatory markers (IL-6) and lipid profiles early in the disease process, we can employ preventive strategies to better manage and improve survival and quality of life in patients with psoriasis.

The Association of Serum Vitamin D Levels with Lung Function, Symptom Severity, and Exacerbations in Stable COPD Patients

Background: Chronic obstructive pulmonary disease (COPD) is a significant health burden associated with a decrease in quality of life. Patients with the disease often have a deficiency of Vitamin D, a fat-soluble vitamin important for respiratory health. A previous study suggested an association between low vitamin D levels and poor lung function, as well as increased exacerbation, and more severe COPD symptom. Therefore, this study aimed to assess serum vitamin D levels in stable COPD patients and explore association with lung function, symptom severity, and frequency of exacerbation. Methods: This was a cross-sectional study conducted from May to July 2023 at Lung Polyclinic of Dr. Zainoel Abidin Regional General Hospital (RSUDZA) Banda Aceh. A total of 30 subjects selected based on specific inclusion and exclusion criteria were included. Results: The results showed that the mean serum vitamin D level was 26.25 ng/mL, with 56.7% of subjects showing vitamin D insufficiency. Statistical analysis showed p-values of 0.58, 0.637, 0.12, and 0.98 for lung function, exacerbation, COPD Assessment Test (CAT), and Modified Medical Research Council (mMRC) dyspnoea scale respectively, indicating no significant association between vitamin D levels and these outcomes. Potential confounding factors include unassessed variables such as medication use, educational background, and psychological status. Conclusion: This study found no significant association between serum vitamin D levels and lung function, symptom severity, or frequency of exacerbation in stable COPD patients. Further studies with a larger sample size and extended follow-up are needed to confirm these results and explore additional influencing factors.

Short Rest Between Flights Is Associated With Increased Serum Stress Hormone Levels in Airline Pilots: A Cross-Sectional Study.

Work-related stress is a critical area of research in civil aviation, given the potential for severe consequences when airline pilots (APs) are overwhelmed or unable to perform optimally. While pilots are traditionally considered to be exposed to various stressors, the impact of specific occupational characteristics on stress in the aviation industry remains inadequately understood. Considering that biomarkers are increasingly being utilized as objective measures of stress in human research, this cross-sectional study investigated the association between occupational variables and serum levels of cortisol and dehydroepiandrosterone sulfate (DHEAS) as stress biomarkers in commercial APs. A total of 120 male APs completed a survey assessing the following work-related characteristics: position (captain vs. first officer), years of experience, total flight hours, flight hours in the preceding year, inter-flight rest duration, and flight route length. Serum cortisol and DHEAS concentrations were determined from venous blood samples obtained between 08:00 and 09:00 a.m., following a minimum eight-hour fasting period. The biomarker data were analyzed in relation to the aforementioned occupational characteristics. The mean serum cortisol and DHEAS concentrations in the entire cohort were 8.5±2.1 µg/dL and 214.6±96.4 µg/dL, respectively. There were no significant differences in the levels of the two stress hormones in relation to position, years of experience, total flight hours, flight hours in the preceding year, or flight route length. However, an inter-flight rest period of less than one hour was significantly associated with elevated serum cortisol (P<0.01) and reduced DHEAS levels (P<0.001) compared to longer rest durations. Notably, a stepwise decrease in DHEAS concentrations was observed for rest periods of <1 hour, 1-4 hours, 4-24 hours, and >24 hours. After adjustment for potential confounders in multivariable analyses, a rest period of <1 hour remained independently associated with both serum cortisol (odds ratio [OR]=1.09, 95% confidence interval [CI]=1.04-1.13, P<0.01) and DHEAS (OR=0.94, 95% CI=0.92-0.97, P<0.001). Serum stress hormones in APs are associated with short inter-flight rest periods. Optimization of rest durations may contribute to improved pilot well-being and performance. Further research is warranted to determine ideal rest period lengths and develop interventions to mitigate the potential adverse effects of abbreviated rest periods between flights.

Long-Term Survival of Patient with End-Stage Renal Disease Using Bayesian Mixture Cure Rate Frailty Models.

Along with the increasing prevalence of ESRD in developing countries, the use of more up-to-date statistical models is highly recommended. It is crucial to control potential cure pattern and heterogenicity among patients. In this longitudinal study, the data of 170 hemodialysis patients who visited the dialysis department of Shafa Hospital in Kerman from 2006 to 2016 were collected. To provides robust estimates the time to event data (death) were analyzed with a gamma frailty mixed cure Weibull model (MC-WG) using Bayesian inference. About 49% of patients experienced the death and median survival time was 37.5 months. Older patients (0.264), female patients (0.269), and patients with higher mean serum urea levels (0.186) had a higher risk of death. Moreover, we observe a decrease in death with increase in Creatine (Cr). In the MC-WG Bayesian model, the diabetes, AST, calcium, phosphorus and uric acid variables had a significant effect on the survival of hemodialysis patients, while they were not significant in the Cox PH model. The results of MC-WG Bayesian model are more consistent with other studies.

Study on the role of iron chelators in the management of iron overload among transfusion-dependent thalassemia (TDT) pediatric patients

This study aims to investigate the efficacy and safety of Deferasirox, an oral iron chelator, in reducing iron burden in pediatric patients with transfusion-dependent beta-thalassemia. Thalassemia syndromes, particularly beta-thalassemia, are inherited hemoglobin disorders requiring regular blood transfusions, leading to iron overload and subsequent complications. Effective management of iron overload is crucial to prevent morbidity and mortality. It was a descriptive observational study on Children between the ages of 2 years and 12 years who present with transfusion-dependent thalassemia and areon blood transfusion and develop iron overload, which is evaluated by serum ferritin levels of more than 2000mcg/l are administered iron chelator Deferasirox (14 mg/kg/d)and patients are evaluated for myocardial, hepatic, pancreatic iron burden and conditions of iron toxicity with the help of Cardiac MRI T2, LIC (Liver Iron Concentration), MRI T2 Pancreas, LVEF (Left Ventricular Ejection Fraction). A total of 22 patients enrolled in the study; significant reductions were observed in mean serum ferritin levels (2,388 mcg/dl to 2,054 mcg/dl, p=0.0009), transferrin saturation (70.45% to 64.32%, p=0.00005), and serum transaminases (44.55 U/L to 40.27 U/L, p=0.003) at 6 months. Cardiac MRI T2* increased from 19.55 ms to 22.95 ms (p=0.045) at the end of 6 months and at the end of 12 months from 19.55 to 28.23 (p=0.0016), and LIC reduced from 20.73 mg Fe/g dw to 11.59 mg Fe/g dw (p=0.00005). Pancreatic T2 improved from 15.96 ms to 20.23 ms at 12 months (p=0.007). A transient increase in serum creatinine was observed at 6 months from 0.64+/-0.14 mg/dL to 0.7+/-0.13mg/dL(p=0.009), which returned to normal at the end of 12 months to 0.63 mg/dL, no additional therapy-related adverse events were reported. Deferasirox has demonstrated significant efficacy in reducing iron overload in pediatric patients with transfusion-dependent beta thalassemia over a 12-month period. The substantial improvements in serum ferritin, cardiac MRI T2*, LIC, transferrin saturation, and pancreatic T2, coupled with its excellent safety profile, support the use of DFX as a cornerstone in the management of iron overload in this vulnerable population.

Abstract C005: Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer

Abstract Background: CM24 (mAb) blocks CEACAM1 interactions, has key roles in cancer progression, immune escape and metastasis. CEACAM1 is part of the neutrophil extracellular trap (NET) complex, involved in tumor immune evasion, metastasis and cancer-associated thrombosis, affecting patient survival. We demonstrated that CM24 binds to NET and suppresses NET-induced migration of cancer cells (AACR Cancer Metastasis Nov.2022) and that CM24+nivolumab (nivo) treatment of pancreatic ductal adenocarcinoma (PDAC) patients markedly reduced serum levels of the NET marker, Myeloperoxidase (MPO; AACR on pancreatic cancer Sept.2023). In a Phase 2 study (NCT04731467) 31 patients with advanced/metastatic PDAC progressed after 1st line therapy, were randomized for CM24 (20mg/kg q2wk), nivo (240mg/kg q2wk) and liposomal irinotecan, 5 fluorouracil and leucovorin (Nal-IRI/5FU/LV, q2wk) treatment (experimental arm) vs Nal-IRI/5FU/LV only (control arm). Interim analysis of the data showed Median OS for the experimental arm was 7.72m (95% CI: 4.00-8.11) vs. 5.62m (95% 3.22 -7.89) for the control arm (HR: 0.74; 95% CI: 0.31-1.77). Median PFS for the experimental group was 3.8m (95% 1.8-5.0) vs. 1.9m (95% 0.9, 3.6) for the control arm (HR 0.72; 95% CI: 0.33-1.60) (ASCO2024-LBA4143). Here we present a subgroup analysis evaluating serum MPO as a potential biomarker for CM24-based therapy. Methods: Patients were randomized as described above. Pre-dose serum samples were collected from 30 out of 31 pts and serum MPO levels were evaluated using ELISA (Cayman), where the measured mean serum MPO in healthy subjects (n=30) was 53 +/-7[SE]. NET-induced blood coagulation was tested using platelet aggregation assay. Results: Mean pre-dose MPO level in patients (n=30) was 359 +/- 46 [SE] and was selected as a threshold for biomarker analysis. OS for patients with MPO levels below the threshold (n=9/16) was 8.1 mo in the experimental arm (HR 0.34; (95% CI: 0.099-1.149)) vs 4.5mo in the control (n=9/15). PFS for patients with MPO levels below the threshold was 4.2mo in the experimental arm vs. 1.7 mo in the control (HR 0.24 (95% CI: 0.20-1.59)). NET-associated blood coagulation and the inhibitory effect of CM24 were tested in vitro. NETs induced platelet aggregation in a dose-dependent manner, and CM24 significantly reduced it (50-70% reduction, p value &amp;lt; 0.0001) at NET levels related to the selected biomarker range (MPO&amp;lt;357) but was less effective at higher NET levels (MPO&amp;gt;500), which relate to MPO above the threshold. These results are in line with the proposed CM24 MoA, affecting NET-related cancer complications. Conclusions: Exploratory biomarker analysis suggests serum MPO as a potential predictive biomarker for CM24-based therapy showing prolonged median OS, PFS and 66% reduction in risk of death vs control in PDAC patients with MPO levels below threshold compared to interim analysis that estimated OS and PFS risk reduction of 26% and 28%, respectively. These findings will be further evaluated in upcoming clinical studies. Citation Format: Teresa Macarulla, Michael Cecchini, Rocio Garcia-Carbonero, Talia Golan, Ruth Perets, Erkut Borazanci, Manuel Pedegral, Mariano Ponz-Sarvisé, Mohammed Najeeb Al Hallak, Shubham Pant, Valentina Boni, Omar Saavedra, María José de Miguel-Luken, Alexis D. Leal, Andrés J. Muñoz Martín, Tamara Sauri-Nadal, Michael Schickler, Hava Ben David, Hadas Reuveni. Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer Research; 2024 Sep 15-18; Boston, MA. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl_2):Abstract nr C005.