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Nevin Manimala Statistics

Optimizing short-term antibiotic treatment in patients with acute cholangitis: study protocol for an open-label randomized controlled trial (the BOLT-P3 trial)

Trials. 2025 Sep 1;26(1):324. doi: 10.1186/s13063-025-09077-1.

ABSTRACT

BACKGROUND: Acute cholangitis (AC) frequently presents as a community-acquired infection and is associated with a high prevalence of antibiotic use among infectious diseases. The Tokyo Guidelines 2018 (TG18) recommend 4-7 days of antibiotic administration after biliary drainage. However, this recommendation lacks strong evidence of its effectiveness and is primarily based on heterogeneous clinical findings and expert opinions. Recent retrospective studies have advocated a shorter 1- to 3-day antibiotic course as effective for AC treatment, prompting the need to reassess the treatment duration to achieve therapeutic efficacy while minimizing resistance and adverse effects.

METHODS: We designed a multicenter, non-blinded, randomized trial to evaluate the efficacy of short-course therapy compared to standard-course therapy for AC management. The short-course therapy group will receive 1-3 days of intravenous (IV) antibiotic treatment after successful biliary drainage compared to 4-7 days of IV antibiotics after successful biliary drainage for the standard-course therapy group. The primary outcome is the clinical cure rate within 14 days from the endoscopic retrograde cholangiopancreatography (ERCP) procedure. Participants will be allocated to either treatment course using a minimization method in a non-blinded, randomized manner, with stratification factors including condition severity and facility. We determined that 210 participants would be required to achieve a statistical power of 90% with a one-sided significance threshold of 2.5% and a non-inferiority limit of 10%.

DISCUSSION: This phase 3 trial aims to determine the non-inferiority of short-course therapy over standard-course therapy. Shortening the duration of antibiotic administration may mitigate the emergence of resistant bacteria, adverse events, and reduce hospital stay length and healthcare costs. https://jrct.niph.go.jp/re/reports/detail/73862 TRIAL REGISTRATION: This study was registered at the Japan Registry of Clinical Trials under registry number jRCT1031230709. Registered on 14 March 2024, https://jrct.niph.go.jp/re/reports/detail/73862.

PMID:40890775 | DOI:10.1186/s13063-025-09077-1

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Insulin resistance as a determinant of fertilization efficiency in polycystic ovary syndrome patients undergoing IVF/ICSI: a retrospective cohort study

Reprod Biol Endocrinol. 2025 Sep 1;23(1):120. doi: 10.1186/s12958-025-01453-5.

ABSTRACT

BACKGROUND: This retrospective cohort study aimed to evaluate the impact of insulin resistance (IR) on clinical outcomes in polycystic ovary syndrome (PCOS) patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.

METHODS: A total of 1,768 PCOS patients undergoing IVF/ICSI cycles at Shenzhen Zhongshan Obstetrics & Gynecology Hospital between October 2010 and November 2024 were stratified into two cohorts: non-IR group (HOMA index < 2.69, n = 867) and IR group (HOMA index ≥ 2.69, n = 901). Baseline characteristics and clinical outcomes were compared between the groups. Linear logistic regression and multivariate logistic regression analysis were conducted to assess the independent impact of IR on fertilization efficiency and pregnancy outcomes.

RESULTS: Patients with IR exhibited significantly higher BMI (25.44 ± 3.55 vs. 21.59 ± 3.20, p < 0.001), longer infertility duration (3.74 ± 2.75 vs. 3.25 ± 2.43, p < 0.001), increased antral follicle counts (26.74 ± 10.74 vs. 25.05 ± 9.79, p < 0.001) and lower basal follicle-stimulating hormone (FSH) level (9.78 ± 3.25 vs. 10.64 ± 3.83, p < 0.001) compared to those without IR. Additionally, the fertilization rate (82.02% vs. 83.86%, p = 0.005) and 2PN rate (81.07% vs. 83.96%, p < 0.001) were significantly lower in PCOS patients with IR. Linear regression indicated that IR had a more pronounced inverse effect on 2PN rate (B: -2.540, p = 0.009) than on fertilization rate (B: -0.664, p = 0.490). Subgroup analysis and interaction analysis demonstrated that IR functioned as an independent risk factor for impaired oocyte fertilization in normal-weight PCOS patients (B: -22.694, p = 0.011). No statistically significant associations between IR status and clinical or live birth pregnancy outcomes were observed in the regression models.

CONCLUSIONS: IR adversely affects oocyte fertilization competence and early embryonic development in normal-weight PCOS patients undergoing assisted reproductive technology (ART). These effects may be attributable to IR-induced metabolic dysregulation, which compromises folliculogenic and cytoplasmic maturation processes critical to gamete competence. These findings underscore the importance of addressing metabolic dysfunction in IR-affected PCOS populations to optimize ART outcomes.

TRIAL REGISTRATION: This is a retrospective study.

PMID:40890764 | DOI:10.1186/s12958-025-01453-5

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Educational determinants of immunization coverage among internally displaced persons (IDPs) in Mogadishu: a cross-sectional study

Arch Public Health. 2025 Sep 1;83(1):222. doi: 10.1186/s13690-025-01707-z.

ABSTRACT

BACKGROUND: Immunization remains a cornerstone of global public health; however, Somalia faces critical challenges in achieving equitable vaccination coverage, particularly among internally displaced individuals (IDPs). The National immunization rates for diseases such as diphtheria-tetanus-pertussis (DTP3), measles, and polio remain below 50%, exacerbated by decades of conflict, fragile healthcare infrastructure, and socioeconomic disparities. IDPs in Somalia encounter unique barriers, including overcrowded living conditions and limited access to healthcare and mobility, which disrupt care continuity. This study examined the immunization coverage disparities between IDPs and urban residents in Somalia, focusing on the sociodemographic and attitudinal determinants of vaccine uptake. By analyzing factors such as education, income, marital status, and vaccine perceptions, this study aimed to inform targeted strategies to improve vaccination access in conflict-affected settings.

METHOD: A cross-sectional study was conducted in March 2025 across two IDP camps (ANFAC and Sahal) in Somalia’s Banadir Region. Using stratified systematic sampling, 384 participants were enrolled, and data were collected via structured questionnaires administered in Somali. Vaccination status was verified through immunization cards or self-reports, and the predictor variables included age, education, occupation, income, marital status, and attitudes toward vaccine safety and efficacy. Statistical analysis employed Chi-square tests and multivariate logistic regression were used to identify the determinants of vaccine uptake with adjustments for confounders.

RESULT: This study revealed significant immunization disparities primarily associated with educational attainment. Participants with secondary education achieved vaccination rates of 72.6% versus 41.2% among those without formal education. Multivariate analysis identified secondary education (AOR = 3.82, 95% CI: 1.74-8.40, p = 0.001) and tertiary education (AOR = 7.95, 95% CI: 3.33-19.01, p < 0.001) as the strongest predictors of full vaccination, followed by marital status (divorced/widowed: AOR = 0.33, 95% CI: 0.14-0.81, p = 0.015). Household income and positive vaccine attitudes showed no significant association in the adjusted model.

CONCLUSION: Educational disparities emerge as the most critical barrier to immunization among Somali IDPs. The findings highlight the need for integrated interventions prioritizing community-led education programs and mobile vaccination clinics with cold chain capacity. These strategies, combined with health system strengthening for mobile populations, could reduce zero-dose children by 50% and advance Immunization Agenda 2030 targets. The study underscores that improving access to education may have greater impact on vaccine uptake than economic interventions alone.

PMID:40890758 | DOI:10.1186/s13690-025-01707-z

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Assessment of maternal age along with other risk factors for childhood disabilities: a cross-sectional study in thirty-eight countries

BMC Pediatr. 2025 Sep 1;25(1):675. doi: 10.1186/s12887-025-05991-0.

NO ABSTRACT

PMID:40890753 | DOI:10.1186/s12887-025-05991-0

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Psychological well-being of medical and dental students in Saudi Arabia post worldwide pandemic: a cross sectional study

BMC Med Educ. 2025 Sep 1;25(1):1238. doi: 10.1186/s12909-025-07817-0.

ABSTRACT

BACKGROUND: Medical and dental students face significant psychological challenges due to rigorous academic demands and clinical responsibilities, which often lead to depression, anxiety, and stress (DAS). The COVID-19 pandemic has worsened these issues internationally, and Saudi Arabia (SA) is not an exclusion. This study aimed to measure the prevalence of DAS among Saudi Arabian medical and dental students and determine significant socio-demographic and academic factors affecting their psychological well-being especially post worldwide pandemics.

METHODS: A cross-sectional survey was carried out among Saudi Arabian medical and dental students in July and August 2021. An online survey that included demographic information and the depression, anxiety, and stress (DASS-21) scale was used to gather data. It was disseminated nationwide via university emails and academic platforms. A total of 715 students participated in the survey, of whom 550 were dental students and 165 were medical students. Statistical analysis, including ordinal regression, was carried out using SPSS to assess the relationships between mental health outcomes and characteristics including study field, academic phase, and geography. Data were documented and statistically analyzed, and statistical significance was set at p < 0.05 for all parameters and tests. Cronbach’s alpha scores for all DASS-21 subscales were more than 0.87, confirming the instrument’s reliability.

RESULTS: The prevalence rates of stress, anxiety, and depression were 88.5%, 67.3%, and 51.3%, respectively. Medical students reported higher levels of extreme stress (38.2%) and anxiety (42.4%) than dental students (30.4% and 24.7%, respectively). Medical students reported considerably higher stress in their clinical phase compared with their counterparts in preclinical phase. Preclinical dental students showed higher anxiety and depression than clinical students. Socio-demographic characteristics such as living conditions and region showed significant differences (p < 0.05), while gender and marital status exhibited no significant differences.

CONCLUSION: This study reveals a high prevalence of psychological distress among medical and dental students in Saudi Arabia, particularly clinical medical and preclinical dental students. These findings emphasize the need for targeted interventions to address academic stress and enhance mental well-being, emphasizing the importance of collaborative efforts to support students’ mental health and resilience.

PMID:40890752 | DOI:10.1186/s12909-025-07817-0

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Satisfaction with elective courses among undergraduate medical students at Al-Azhar and Jazan Universities

BMC Med Educ. 2025 Sep 1;25(1):1236. doi: 10.1186/s12909-025-07728-0.

ABSTRACT

BACKGROUND: Elective courses give medical students opportunities to explore interests beyond core curricula and influence career decisions. The current study aimed to assess undergraduate medical students’ satisfaction with these elective courses and gather their suggestions for improvement in curriculum design.

METHODS: A cross-sectional comparative study was conducted using a validated online and self-administered questionnaire among undergraduate medical students at Al-Azhar University (Egypt) and Jazan University (Saudi Arabia). Satisfaction was measured on a 5-point Likert scale. Statistical analysis included t-tests and chi-square tests (SPSS v25), with p ≤ 0.05 considered significant.

RESULTS: Among 1,027 students (83.1% Egyptians), the overall satisfaction score was 31.9 ± 5.8. A total of 61.1% reported a positive experience. Satisfaction was significantly higher among Saudi students (mean = 35 ± 6.2) compared to Egyptian counterparts (mean = 31.3 ± 5.5; p = 0.001) with a medium to large effect size (Cohen’s d = 0.63). Only (42.4%, 56.5%) felt they achieved course objectives, their expectations were met respectively and 33.2% indicated instructors required further training.

CONCLUSION: Students were moderately satisfied with elective courses, with notable differences across institutions. Curriculum reforms should consider student feedback, expand course options, and improve instructor preparedness.

PMID:40890744 | DOI:10.1186/s12909-025-07728-0

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Associations between dietary index for gut microbiota with COPD prevalence and all-cause mortality: insights from the 1999-2018 NHANES data

BMC Pulm Med. 2025 Sep 1;25(1):417. doi: 10.1186/s12890-025-03908-2.

ABSTRACT

OBJECTIVE: Gut microbiota dysbiosis plays a vital role the pathogenesis of chronic obstructive pulmonary disease (COPD). This study aimed to: (1) examine the cross-sectional association between dietary index for gut microbiota (DI-GM), a novel biomarker reflecting gut microbiota composition and function, and COPD prevalence; and (2) assess the prognostic significance of DI-GM score for all-cause mortality in COPD patients.

METHODS: We analyzed data from the 1999-2018 National Health and Nutrition Examination Survey. DI-GM score was calculated from 24-hour dietary recall. Primary outcomes were COPD prevalence and all-cause mortality risk in COPD patients. Multivariable logistic regression assessed the association between DI-GM and COPD prevalence, while Cox proportional hazards models evaluated all-cause mortality risk in COPD patients.

RESULTS: The prevalence of COPD was 6.87% among the 22,859 participants included. Compared to participants with DI-GM score of 0-3, the odds ratio (95% confidence interval) for DI-GM score of 4, 5, and ≥ 6 were 0.88 (0.70-1.11), 0.78 (0.64-0.97), and 0.75 (0.62-0.90), respectively. During a median follow-up time of 84 months, a total of 570 (28.15%) participants died among the 1,580 COPD participants. Compared to DI-GM score of 0-3, the hazard ratios (95% confidence intervals) for DI-GM score of 4, 5, and ≥ 6 were 0.78 (0.60-1.01), 0.63 (0.47-0.83), and 0.69 (0.56-0.85), respectively.

CONCLUSION: Higher DI-GM scores are significantly associated with both reduced COPD prevalence and improved survival in COPD patients. Our results suggest dietary modifications targeting gut microbiota may represent a novel strategy for COPD prevention and management.

PMID:40890742 | DOI:10.1186/s12890-025-03908-2

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Surrogating tumour cell density in head and neck cancer: [18F]FDG PET- versus ADC (MRI)-based approaches

Radiat Oncol. 2025 Sep 1;20(1):137. doi: 10.1186/s13014-025-02716-6.

ABSTRACT

OBJECTIVE: In this study we examined the correlation between standardized uptake value (SUV) of [18F]fluorodeoxyglucose (FDG) and apparent diffusion coefficient (ADC) within the gross tumor volume (GTV) of patients with head and neck squamous cell carcinoma (HNSCC). In addition, we assessed the comparability of cell density (ρ) estimates obtained from FDG PET and MRI data.

METHODS: Twenty-one HNSCC patients from a prospective FMISO imaging trial underwent pre-treatment PET/CT and MRI. We assessed correlations between FDG SUV (mean, max) and ADC (mean, min) within the GTV using Pearson’s correlation coefficient. The tumor cell density within the GTV was calculated from FDG SUV and from ADC maps. For the estimation of ADC-based cell density, we used a published tumor cell volume fraction (vTC). Agreement between FDG- and ADC-derived cell density estimates was assessed. The best-fitting vTC* was computed to achieve equal mean ρADC and ρFDG for each patient and was compared to the literature.

RESULTS: The SUV and ADC metrics showed up to moderate negative correlations, but none of them were statistically significant at p < 0.05. The correlation of SUVmean vs. ADCmean with Pearson’s correlation coefficient r = -0.426 and p = 0.054 and SUVmax vs. ADCmin with r = -0.414 and p = 0.062 suggested a weak negative trend. The average and standard deviation of mean ρFDG and ρADC across our cohort were (1.8 ± 0.6) × 108 cells/ml and (3.3 ± 0.2) × 108 cells/ml. The difference between the mean ρFDG and ρADC was statistically significant (p < 0.001). To achieve equal mean ρADC and ρFDG for each patient, the mean optimal vTC* with standard deviation was 0.29 ± 0.09. Although significantly lower than the published mean vTC​ (0.54), vTC* lies within the published range of vTC for HNSCCs (0.28 to 0.75).

CONCLUSION: ADC and SUV metrics exhibited moderate but marginally insignificant correlation in this dataset. Although not directly interchangeable, the two methods provide comparable, clinically relevant cell density estimates, offering flexibility to use the most accessible modality for individualized treatment planning.

TRIAL REGISTRATION: Registered at German Clinical Trials Register on 20/08/2015 (DRKS00003830).

PMID:40890739 | DOI:10.1186/s13014-025-02716-6

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The mediating role of psychological resilience in the relationship between workplace violence and job stress among healthcare workers

BMC Public Health. 2025 Sep 1;25(1):3005. doi: 10.1186/s12889-025-23560-z.

ABSTRACT

BACKGROUND: Workplace violence is a widespread, global public healthcare concern among healthcare employees. The present study aimed to examine the mediating role of psychological resilience in the relationship between workplace violence and job stress among healthcare employees.

MATERIALS AND METHODS: The population of the study, which had a descriptive and correlational design, consisted of all healthcare employees working in a hospital in the southeast of Turkey, and the study was completed with 515 healthcare employees. The data were collected between 20.05.2024 and 15.09.2024 using a face-to-face interview technique with a data form consisting of 4 sections. The data collection form consists of 4 sections: socio-demographic characteristics, Psychological Violence Behaviors at Workplace Scale, A Work Stress Scale-20, Brief Psychological Resilience Scale. The data were then analyzed by using the SPSS software. Descriptive statistics and parametric methods, Pearson Correlation Analysis, and Linear Regression were used in the evaluation of the data, and hierarchical regression analyses regarding the mediation effect were made by using the PROCESS Model 4. A p-value < 0.05 was accepted as significant in the analyses.

RESULTS: A total of 55.9% of the participants were female and 44.1% were male. When the occupational distribution was evaluated, the largest group was nurses with 55.3%, followed by midwives with 12.6% and physicians with 7.4%. The total mean score on the Scale of Psychological Violence Behaviors in the Workplace was 37.27 ± 39.51, the total mean score on the Short Psychological psychological resilience Scale was 20.41 ± 4.32, and the total mean score on the Job Stress Scale was 46.51 ± 20.72. A negative and significant relationship was detected between the psychological psychological resilience scale total score and the total score of Psychological Violence Behaviors in the Workplace. A positive and highly significant relationship was detected between the total score of the Job Stress Scale and the total score of Psychological Violence Behaviors in the Workplace. A negative and significant relationship was detected between psychological resilience and job stress. The effect of psychological violence in the workplace on psychological resilience was significant.

CONCLUSION: This study suggests that workplace violence increases job stress by weakening psychological resilience. Psychological resilience plays a partial role in moderating this effect. Reducing the negative impacts of Job Stress and psychological violence on individuals and protecting and developing the psychological resilience of healthcare staff is a critical priority for the well-being of employees and for institutions to achieve their sustainable targets.

PMID:40890731 | DOI:10.1186/s12889-025-23560-z

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Links between Korean baby boomers’ physical activity and health outcomes: a community health survey study

BMC Public Health. 2025 Sep 1;25(1):2988. doi: 10.1186/s12889-025-23998-1.

ABSTRACT

BACKGROUND: This study aimed to explore the association between physical activity (PA) levels and major health issues (obesity, hypertension, and diabetes mellitus) and mental health factors (depression, stress, suicidal thoughts, and cognitive impairment) among South Korean baby boomers (BBs) to help improve national health policies. Given the global trend of aging populations and the increasing burden of non-communicable diseases, understanding the role of PA in promoting healthy aging has become a critical public health issue not only in South Korea but also worldwide.

METHODS: Using 2022 Community Health Survey data, we analysed PA levels (low, moderate, and high) and their associations with health outcomes in BBs aged 59-67 years. PA was assessed using the metabolic equivalent of task of the International Physical Activity Questionnaire. Health outcomes were evaluated based on obesity, hypertension, diabetes, mental health issues, and stress levels. Complex sample logistic regression was used to evaluate the interrelation between PA and health outcomes, adjusting for household income, marital status, and educational level.

RESULTS: In men, moderate and high-intensity PA was associated with lower obesity and diabetes rates compared with low-intensity PA, with only moderate PA levels showing consistent links to reduced obesity. In women, both moderate and high PA levels were associated with reduced obesity, hypertension, and diabetes rates. For mental health, PA at both levels was associated with lower odds of all outcomes in both sexes, with moderate PA showing stronger associations than high PA for stress, suicidal thoughts, and cognitive impairment in women.

CONCLUSIONS: PA is meaningfully associated with health issues and mental well-being among South Korean BBs. These findings underscore the relevance of tailored PA recommendations and community-based strategies that reflect population characteristics. Further research is warranted to explore the effects of different types of physical activities and their impact on health risk factors.

PMID:40890726 | DOI:10.1186/s12889-025-23998-1