OBJECTIVES: The aim of the study was to evaluate widespread dietary supplements (DSs) use among the military population. There is no recent study to comprehensively evaluate the prevalence of DS use among the military population. Therefore, this systematic review and meta-analysis aimed to present an overview and estimate of the overall prevalence of DSs use among the military population. METHODS: PubMed, Scopus, Web of Science, and Google Scholar databases were searched up to September 2023 using relevant keywords. All original articles written in English evaluating the prevalence of DSs use among the military population were eligible for this study. The risk of bias assessment of the included studies was done using the Joanna Briggs Institute critical appraisal checklist. The meta-analysis was performed utilizing a random-effects model and STATA software. RESULTS: In total, 32 cross-sectional studies were included in this review. The prevalence rate of DS use in the overall military population was 57% (95% CI: 49-64); this rate was higher in the studies that were carried out in the USA and the studies with a sample size lower than 10,000 members. Eleven studies reported adverse effects (AEs) following DSs use in the military population, the pooled effect size of them was 13.0% (95% CI: 6-20). The most common AEs reported by military personnel were abdominal pain, nausea, vomiting, and diarrhoea, however, they did not include any serious complications. CONCLUSION: The findings indicate that the prevalence of DSs use among the military personnel was high. Moreover, some studies reported AEs following DSs use such as gastrointestinal symptoms. Promotion of knowledge and informed attitudes regarding the DSs use in the military population could be useful.

• MeSH
• Humans MeSH
• Military Personnel * statistics & numerical data   MeSH
• Dietary Supplements * statistics & numerical data   adverse effects   MeSH
• Prevalence MeSH
• Cross-Sectional Studies MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH
• Systematic Review MeSH

BACKGROUND: The oncologic safety of minimally invasive simple hysterectomy in low-risk cervical cancer has not been explored by an adequately powered clinical trial. PRIMARY OBJECTIVE: This study aims to evaluate whether minimally invasive simple hysterectomy affects disease-free survival in low-risk early-stage cervical cancer. STUDY HYPOTHESIS: Minimally invasive simple hysterectomy represents an oncologically safe approach in selected patients with low-risk cervical cancer. TRIAL DESIGN: This is a single-arm trial with stopping rules. All patients must undergo cervical conization. Patients with clear conization margins or absence of residual macroscopic disease at imaging after conization (re-conization is mandatory if these criteria are not met) are submitted to minimally invasive (laparoscopy or robot-assisted laparoscopy) simple hysterectomy with sentinel lymph node biopsy algorithm. Adjuvant therapy is given in case of tumor-involved surgical margins, and/or metastatic lymph nodes, and/or substantial lymphovascular space invasion with depth of stromal infiltration >2/3 (or tumor-free distance ≤3 mm). MAJOR INCLUSION/EXCLUSION CRITERIA: The major inclusion criteria are: squamous cell carcinoma, human papillomavirus-related adenocarcinoma, adenosquamous carcinoma of the uterine cervix; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (≤2 cm) with depth of infiltration ≤10 mm on conization specimen; International Federation of Gynecology and Obstetrics 2018 stage IA2-IB1 (≤2 cm) with depth of infiltration ≤50% at pre-conization magnetic resonance imaging scan or "expert" ultrasound scan. Women are not eligible if they have evidence of metastatic disease, contra-indications to surgery and/or lymph node assessment, or fertility sparing desire. PRIMARY ENDPOINT: The primary end point is 3-year disease-free survival of patients who undergo minimally invasive simple hysterectomy. SAMPLE SIZE: A sample size of 974 patients will give a power of 80% at a significance level of 2.5% (1-sided) to reject the null hypothesis of a 3-year recurrence rate of 2.4%, assuming a 3-year recurrence rate of 1.2%. A maximum of 14 recurrences at 3 years should be observed to reject the null hypothesis. A stopping rule based on the number of recurrences observed at different timepoints will be implemented to avoid a higher recurrence rate with the study procedure. The trial will also be stopped if no recurrences are observed in the first 400 patients followed up for 2 years. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The enrolment will last 60 months. After the surgery, the follow-up time will be ≥3 years. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT06416748) and as ENGOT/MITO trial (ENGOT-cx23).

• MeSH
• Adult MeSH
• Hysterectomy * methods   MeSH
• Conization MeSH
• Laparoscopy methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Minimally Invasive Surgical Procedures methods   MeSH
• Uterine Cervical Neoplasms * surgery   pathology   MeSH
• Robotic Surgical Procedures methods   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial MeSH

BACKGROUND: Avoiding conization may reduce the risk of pre-term labor in future pregnancies, making conservative treatment of high-grade cervical dysplasia an increasingly discussed approach, especially for younger patients. However, data on the integration of individual predictive factors into routine clinical practice remain limited. PRIMARY OBJECTIVE: The primary objective of the Regression of High-Grade Squamous Intraepithelial Cervical Lesions and Associated Risk Factors (RECER) study is to assess the rate of spontaneous regression in high-grade cervical squamous dysplasia (cervical intraepithelial neoplasia [CIN] 2 and 3) and identify associated predictive factors within clinical practice, without necessitating conization. STUDY HYPOTHESIS: We hypothesize that the characterization of cervical lesions, including colposcopic findings and patient-specific factors, along with a sufficient rate of spontaneous regression, will aid in identifying a subgroup of patients who may derive the greatest benefit from conservative management of high-grade cervical lesions. TRIAL DESIGN: The RECER trial is a multi-center prospective cohort study. Patients with histologically confirmed high-grade squamous intraepithelial lesions (CIN 2 or 3) undergo colposcopic assessments every 4 months. Colposcopic images are compared to evaluate lesion dynamics. In case of progression, conization is indicated, whereas in case of regression, documentation of a biopsy with low-grade dysplasia (CIN 1) or no dysplasia is required. Patients with stable disease are further followed up. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients aged 18 to 40 years with bioptically confirmed high-grade lesion (CIN 2 or 3), a fully visible squamo-columnar junction, and a willingness to undergo conservative management can be included. Excluded are patients with unsatisfactory colposcopy, pregnancy, glandular lesions, invasive disease, or a history of treatment for severe cervical dysplasia. PRIMARY ENDPOINT: The primary end point is the regression rate of high-grade cervical dysplasia. SAMPLE SIZE: 300 patients ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: As of October 2024, a total of 127 patients have been recruited from 4 participating sites across 3 countries. Estimated date of last patient enrollment: September 2026; estimated date for results presentation: January 2028. TRIAL REGISTRATION: Clinicaltrials.gov: NCT06147388.

• MeSH
• Squamous Intraepithelial Lesions of the Cervix * diagnosis   pathology   MeSH
• Adult MeSH
• Uterine Cervical Dysplasia * diagnosis   pathology   MeSH
• Colposcopy MeSH
• Conization adverse effects   MeSH
• Humans MeSH
• Young Adult MeSH
• Multicenter Studies as Topic MeSH
• Uterine Cervical Neoplasms * diagnosis   pathology   prevention & control   MeSH
• Observational Studies as Topic MeSH
• Prospective Studies MeSH
• Risk Factors MeSH
• Remission, Spontaneous * MeSH
• Neoplasm Grading MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial Protocol MeSH

BACKGROUND: Cardiometabolic risk factors - including diabetes, hypertension, and obesity - have long been linked with adverse health outcomes such as strokes, but more subtle brain changes in regional brain volumes and cortical thickness associated with these risk factors are less understood. Computer models can now be used to estimate brain age based on structural magnetic resonance imaging data, and subtle brain changes related to cardiometabolic risk factors may manifest as an older-appearing brain in prediction models; thus, we sought to investigate the relationship between cardiometabolic risk factors and machine learning-predicted brain age. METHODS: We performed a systematic search of PubMed and Scopus. We used the brain age gap, which represents the difference between one's predicted and chronological age, as an index of brain structural integrity. We calculated the Cohen d statistic for mean differences in the brain age gap of people with and without diabetes, hypertension, or obesity and performed random effects meta-analyses. RESULTS: We identified 185 studies, of which 14 met inclusion criteria. Among the 3 cardiometabolic risk factors, diabetes had the highest effect size (12 study samples; d = 0.275, 95% confidence interval [CI] 0.198-0.352; n = 47 436), followed by hypertension (10 study samples; d = 0.113, 95% CI 0.063-0.162; n = 45 102) and obesity (5 study samples; d = 0.112, 95% CI 0.037-0.187; n = 15 678). These effects remained significant in sensitivity analyses that included only studies that controlled for confounding effects of the other cardiometabolic risk factors. LIMITATIONS: Our study tested effect sizes of only categorically defined cardiometabolic risk factors and is limited by inconsistencies in diabetes classification, a smaller pooled sample in the obesity analysis, and limited age range reporting. CONCLUSION: Our findings show that each of the cardiometabolic risk factors uniquely contributes to brain structure, as captured by brain age. The effect size for diabetes was more than 2 times greater than the independent effects of hypertension and obesity. We therefore highlight diabetes as a primary target for the prevention of brain structural changes that may lead to cognitive decline and dementia.

• MeSH
• Diabetes Mellitus * epidemiology   pathology   MeSH
• Hypertension * epidemiology   pathology   MeSH
• Cardiometabolic Risk Factors * MeSH
• Humans MeSH
• Magnetic Resonance Imaging MeSH
• Brain * diagnostic imaging   pathology   MeSH
• Obesity * epidemiology   pathology   MeSH
• Aging pathology   MeSH
• Machine Learning MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH
• Systematic Review MeSH

BACKGROUND: Aortic valve replacement (AVR) is the definitive therapy for patients with severe aortic valve stenosis (AoS). The aim of this work is to compare the effect of a mechanical prosthesis (MP) and a bioprosthesis (BP) on the survival of patients aged 50-65 years after AVR. METHODS: The retrospective analysis included 276 patients aged 50 to 65 years who had undergone isolated AVR for AoS; 161 patients were implanted with an MP and 115 with a BP. Patient survival, adjusted for age, gender and risk parameters affecting survival, was assessed. A subgroup analysis was performed on the 208 patients with a modern valve (prosthesis models that are no longer used in clinical practice were removed from the sample). RESULTS: After adjusting for risk factors for overall survival as well as for age and sex, the implantation of an MP did not have a significant effect on overall survival in comparison to a BP, at a median follow-up of 10.3 years (p = 0.477). The size of the MP had no significant effect on overall survival either (HR: 1.29; 95%CI: 0.16-10.21; p = 0.812). However, the indexed effective orifice area of the BP had a positive effect on overall survival (HR: 0.09; 95%CI: 0.01-0.78; p = 0.029). CONCLUSIONS: The estimated survival of patients aged between 50 and 65 years after implantation of a BP with a sufficiently large indexed effective orifice area may exceed that of patients with an MP.

• Publication type
• Journal Article MeSH

BACKGROUND: There is a growing importance of loneliness measurement through valid and reliable instruments. However, to establish valid and reliable measures, there is a need to explore their psychometric properties in different research settings and language environments. For this reason, this study aimed to validate the Three Item Loneliness Scale (TILS) in the Czech Republic within a Slavonic language environment. METHODS: A sample of Czech adults (n = 3236) was used consisting primarily of university students. We utilized Classical Test Theory to assess TILS internal consistency, temporal stability, and factor structure. Item Response Theory (IRT) was used to estimate Differential Item Functioning (DIF), the discrimination and difficulty of the TILS items and to estimate the measurement precision of the whole scale. Construct validity was explored through the Spearman correlation coefficient using personality traits, depression, and anxiety. RESULTS: The results showed satisfactory reliability and validity of the TILS in the Czech Republic. The scale's internal consistency and temporal stability were found to be satisfactory (Cronbach's α = 0.81, McDonald's ω = 0.82, ICC = 0.71). The parallel analysis supported the unidimensionality of the TILS. The IRT results indicated that the highest measurement precision was reached in individuals with lower and above-average levels of loneliness. Significant correlations between the TILS scores, anxiety, depression, and personality traits supported the construct validity of the scale. Although the DIF analysis identified statistically significant differences in responses to items TILS_2 and TILS_3 based on education level and employment status (with no significant differences observed for TILS_1), the effect sizes of these differences were small. This indicates that, despite statistical significance, the practical impact on the scale's validity across these groups is minimal. CONCLUSIONS: The validated TILS provides a reliable and valid tool for assessing loneliness in the Czech Republic. Its brevity makes it a practical option for researchers and clinicians seeking to measure loneliness time-efficiently. Future studies should explore how adding new items could increase the measurement precision of the TILS.

• MeSH
• Depression psychology   diagnosis   MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Loneliness * psychology   MeSH
• Surveys and Questionnaires standards   MeSH
• Psychometrics * MeSH
• Reproducibility of Results MeSH
• Anxiety psychology   diagnosis   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Czech Republic MeSH

Recent reviews have highlighted conflicting findings regarding the validity of finger flexor strength and endurance tests in sport climbers, often due to small sample sizes and low ecological validity of the tests used. To address these gaps, 185 male and 122 female climbers underwent maximal finger flexor strength, intermittent and continuous finger flexor endurance, and the finger hang tests in a sport-specific setting to determine the predictive and concurrent validity of these tests. The finger hang test showed the strongest relationship to climbing ability for both sexes (R ≈ 0.75). However, despite its widespread use as an endurance test, the finger hang was found to be primarily determined by finger strength, explaining 65% and 80% of the variance in males and females, respectively. Finger strength emerged as the dominant factor, explaining the majority of variance in climbing ability (males 68%; females 64%), followed by intermittent endurance (males 28%; females 34%). These findings emphasize finger strength as the primary predictor of climbing ability and highlight the importance of intermittent endurance testing for assessing climbing-specific endurance of the finger flexors. No significant differences were found between male and female climbers in finger flexor strength and endurance when normalized to body mass.

• MeSH
• Adult MeSH
• Physical Endurance * physiology   MeSH
• Mountaineering * physiology   MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Fingers * physiology   MeSH
• Reproducibility of Results MeSH
• Sex Factors MeSH
• Hand Strength physiology   MeSH
• Muscle Strength physiology   MeSH
• Exercise Test methods   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Validation Study MeSH

• MeSH
• Biostatistics MeSH
• Evaluation Studies as Topic MeSH
• Reproducibility of Results MeSH
• Statistics as Topic MeSH
• Health Status Indicators MeSH
• Publication type
• Academic Dissertation MeSH

• Conspectus
• Statistika
• NML Fields
• statistika, zdravotnická statistika

OBJECTIVES: To externally and prospectively validate the International Ovarian Tumor Analysis (IOTA) Simple Rules (SRs), Logistic Regression model 2 (LR2) and Assessment of Different NEoplasias in the adneXa (ADNEX) model in a Portuguese population, comparing these approaches with subjective assessment and the risk-of-malignancy index (RMI), as well as with each other. This study also aimed to retrospectively validate the IOTA two-step strategy, using modified benign simple descriptors (MBDs) followed by the ADNEX model in cases in which MBDs were not applicable. METHODS: This was a prospective multicenter diagnostic accuracy study conducted between January 2016 and December 2021 of consecutive patients with an ultrasound diagnosis of at least one adnexal tumor, who underwent surgery at one of three tertiary referral centers in Lisbon, Portugal. All ultrasound assessments were performed by Level-II or -III sonologists with IOTA certification. Patient clinical data and serum CA 125 levels were collected from hospital databases. Each adnexal mass was classified as benign or malignant using subjective assessment, RMI, IOTA SRs, LR2 and the ADNEX model (with and without CA 125). The reference standard was histopathological diagnosis. In the second phase, all adnexal tumors were classified retrospectively using the two-step strategy (MBDs + ADNEX). Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios and overall accuracy were determined for all methods. Receiver-operating-characteristics curves were constructed and corresponding areas under the curve (AUC) were determined for RMI, LR2, the ADNEX model and the two-step strategy. The ADNEX model calibration plots were constructed using locally estimated scatterplot smoothing (LOESS). RESULTS: Of the 571 patients included in the study, 428 had benign disease and 143 had malignant disease (prevalence of malignancy, 25.0%), of which 42 had borderline ovarian tumor, 93 had primary invasive adnexal cancer and eight had metastatic tumors in the adnexa. Subjective assessment had an overall sensitivity of 97.9% and a specificity of 83.6% for distinguishing between benign and malignant lesions. RMI showed high specificity (95.6%) but very low sensitivity (58.7%), with an AUC of 0.913. The IOTA SRs were applicable in 80.0% of patients, with a sensitivity of 94.8% and specificity of 98.6%. The IOTA LR2 had a sensitivity of 84.6%, specificity of 86.9% and an AUC of 0.939, at a malignancy risk cut-off of 10%. At the same cut-off, the sensitivity, specificity and AUC for the ADNEX model with vs without CA 125 were 95.8% vs 98.6%, 82.5% vs 79.7% and 0.962 vs 0.960, respectively. The ADNEX model gave heterogeneous results for distinguishing between benign masses and different subtypes of malignancy, with the highest AUC (0.991) for discriminating benign masses from primary invasive adnexal cancer Stages II-IV, and the lowest AUC (0.696) for discriminating primary invasive adnexal cancer Stage I from metastatic lesion in the adnexa. The calibration plot suggested underestimation of the risk by the ADNEX model compared with the observed proportion of malignancy. The MBDs were applicable in 26.3% (150/571) of cases, of which none was malignant. The two-step strategy using the ADNEX model in the second step only, with and without CA 125, had AUCs of 0.964 and 0.961, respectively, which was similar to applying the ADNEX model in all patients. CONCLUSIONS: The IOTA methods showed good-to-excellent performance in the Portuguese population, outperforming RMI. The ADNEX model was superior to other methods in terms of accuracy, but interpretation of its ability to distinguish between malignant subtypes was limited by sample size and large differences in the prevalence of tumor subtypes. The IOTA MBDs are reliable in identifying benign disease. The two-step strategy comprising application of MBDs followed by the ADNEX model if MBDs are not applicable, is suitable for daily clinical practice, circumventing the need to calculate the risk of malignancy in all patients. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

• MeSH
• CA-125 Antigen blood   MeSH
• Diagnosis, Differential MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Logistic Models MeSH
• Ovarian Neoplasms * diagnostic imaging   pathology   classification   blood   MeSH
• Adnexal Diseases * diagnostic imaging   MeSH
• Predictive Value of Tests MeSH
• Prospective Studies MeSH
• Reproducibility of Results MeSH
• Retrospective Studies MeSH
• ROC Curve MeSH
• Aged MeSH
• Sensitivity and Specificity MeSH
• Ultrasonography * methods   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Validation Study MeSH
• Geographicals
• Portugal MeSH

BACKGROUND: Patients with advanced/recurrent endometrial cancer have a poor prognosis and limited treatment options. Biomarkers such as tumor protein 53 (TP53) in endometrial cancer can integrate novel strategies for improved and individualized treatment that could impact patient outcomes. In an exploratory analysis of the phase III ENGOT-EN5/GOG-3055/SIENDO study of selinexor maintenance monotherapy 80 mg in advanced/recurrent endometrial cancer, a pre-specified subgroup of patients with TP53 wild type (wt) endometrial cancer showed preliminary activity at long-term follow-up with a generally manageable safety profile (median progression-free survival 27.4 months vs 5.2 months placebo, HR=0.41). PRIMARY OBJECTIVE: To evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer. STUDY HYPOTHESIS: Selinexor administered at 60 mg weekly as maintenance therapy will show manageable safety and maintain efficacy in patients with TP53wt advanced/recurrent endometrial cancer after systemic therapy versus placebo. TRIAL DESIGN: This is a prospective, multicenter, double-blind, placebo-controlled, randomized phase III study designed to evaluate the efficacy and safety of selinexor as a maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have histologically confirmed endometrial cancer, TP53wt confirmed by next-generation sequencing, completed at least 12 weeks of platinum-based therapy with or without immunotherapy, with confirmed partial response or complete response, and primary Stage IV disease or at first relapse. PRIMARY ENDPOINT: The primary endpoint is investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the intent-to-treat population. SAMPLE SIZE: A total of 220 patients will be enrolled. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual is expected to be completed in 2024 with presentation of results in 2025. TRIAL REGISTRATION: NCT05611931.

• MeSH
• Double-Blind Method MeSH
• Hydrazines * administration & dosage   therapeutic use   MeSH
• Clinical Trials, Phase III as Topic MeSH
• Humans MeSH
• Neoplasm Recurrence, Local * drug therapy   pathology   MeSH
• Tumor Suppressor Protein p53 genetics   MeSH
• Endometrial Neoplasms * drug therapy   pathology   MeSH
• Triazoles * administration & dosage   MeSH
• Maintenance Chemotherapy methods   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase III MeSH
• Multicenter Study MeSH
• Clinical Trial Protocol MeSH
• Randomized Controlled Trial MeSH