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Background: This study aimed to analyze the effect of cardiac rehabilitation programs on the health-related quality of life of patients after a coronary cardiac event using patient-reported outcome measures (PROMs) for up to 6 months of evaluation. Methods: A comprehensive search was carried out in the MEDLINE, CINAHL, CENTRAL, and Web of Science databases for randomized controlled trials comparing the cardiac rehabilitation program with usual care. Two independent reviewers assessed the studies for inclusion, risk of bias using the Cochrane tool, and quality of evidence through the GRADE system. A meta-analysis was performed on studies assessing health-related quality of life with the SF-12 (Physical Component Summary and Mental Component Summary) up to 6 months after the program. Results: Twelve studies encompassed 2260 patients who participated in a cardiac rehabilitation program after a coronary event, with a mean age of 60.06 years. The generic PROMs used to assess quality of life were the SF-12, SF-36, EQ-5D-3L, EQ-5D-5L, and GHQ, and the specific coronary heart disease PROMs were MacNew and HeartQoL. There was a positive effect of participation in cardiac rehabilitation on the physical component of health-related quality of life at 6 months (MD [7.02]; p = 0.04] and on the mental component (MD [1.06]; p = 0.82) after applying the SF-12. Conclusions: This study highlights the significant benefits of cardiac rehabilitation programs on health-related quality of life, particularly in the physical domain at 6 months. Assessing outcomes over time through PROMs after coronary heart events is essential, thus making it possible to personalize patients' care and improve their health status. [ABSTRACT FROM AUTHOR]

Background/Objectives: Reducing visceral fat is a critical factor in preventing obesity-related health complications. In this study, we evaluated the effectiveness of our previously reported novel dietary intervention program, "Optimized Nutri-Dense Meals", designed according to the Dietary Reference Intakes (DRIs) in Japan in reducing visceral fat. Method: This open-label, randomized controlled trial included 100 Japanese males with obesity or overweight. In total, 50 participants were assigned to a control group that continued their usual diets, and the other 50 consumed test meals twice per week for four weeks (test group). Result: The primary outcome, visceral fat area, significantly decreased in the test group compared to that in the control group (−7.5 cm2, confidence interval [CI]: −14.3 to −0.6). In addition, we measured the changes in gut flora and work productivity. The abundance of Bifidobacterium (+1.5%, CI: 0.3–2.7) and Christensenellaceae (+0.4%, CI: 0.01–0.8) increased significantly in the test group compared with those in the control group. Work Limitation Questionnaire Japanese version scores representing presenteeism also significantly increased in the test group (+1.2 points, CI: 0.2–2.3) compared with the control group. Conclusions: These findings suggest that dietary interventions based on Japanese DRIs can effectively decrease visceral fat and improve health outcomes over the short term without the need for a complete dietary overhaul. [ABSTRACT FROM AUTHOR]

As obesity evolves as a global pandemic, the use of drugs to treat it is booming. The latest among these are Glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Along with their use, the incidence of adverse events has become more common. Although severe effects have been mentioned, details and associations are unclear regarding some of them. We performed a systematic review of studies related to GLP-1 RA drugs. Drugs that have been the subject of at least three studies meeting all our criteria were included. Analysis of GLP-1 RA therapies across eight studies, involving 4422 subjects, indicated varying rates of Serious Adverse Events (SAEs). Semaglutide demonstrated an SAE incidence of 8.9%, compared to 6.2% for Liraglutide. These results were not statistically significant. For both drugs, no clear association with pancreatitis or neoplasm was established. Discontinuation rates due to adverse effects were 10.3% for Semaglutide and 8.3% for Liraglutide. Severe adverse effects with GLP-1 RA use are not uncommon, and warrant further close monitoring when patients are started on treatment. Further studies are required to analyze the difference between the adverse effect profiles of each drug and to assess whether or not each of these severe adverse effects is dose dependent. [ABSTRACT FROM AUTHOR]

The results of a prospective, multi-institutional randomized trial developed to assess the equality of sublobar resection versus standard lobectomy were first published in 1995. They concluded that, compared with lobectomy, sublobar resections did not show any significant improvement either in terms of postoperative morbidity and mortality nor in terms of late post-resectional cardiorespiratory function. Moreover, due to the higher mortality and local recurrence rate related to sublobar resection, lobectomy had to be judged as the best surgical option for patients diagnosed with peripheral early-stage non-small-cell lung cancer. Since then, lobectomy has been considered the best surgical option for fit patients suffering from early-stage non-small cell lung cancer. In 2022 and 2023, three non-inferiority randomized trials were published, comparing lobectomy with the sublobar resection in T1a N0 patients whose tumors were up to 2 cm in size. Although presenting some important differences, all three trials met their primary endpoints, disclosing the non-inferiority of sublobar resections in terms of overall and disease-free survival. This narrative review aims to compare the newly published results of these trials as well as to report results from recent non-randomized studies on this topic. [ABSTRACT FROM AUTHOR]

Background: In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to the standard of care (SoC) in patients with severe COVID-19 pneumonia. Methods: We conducted a randomized clinical trial in patients admitted to eight Spanish tertiary hospitals. Patients were stratified into two severity categories and randomized in a 1:1 ratio to receive a corticosteroid-based standard therapy with or without CsA. The primary endpoint was FiO2 recovery by Day 12 without relapses. Results: 109 patients were included and randomized, and 98 of them considered for the mITT population (51 assigned to the CsA + SoC group and 47 to the SoC group). A total of 35 (68.6%) patients from the CsA + SoC group and 32 (71.1%) patients from the SoC group reached the primary endpoint in the mITT analysis. No differences were found after stratification into age groups, in the severity level at admission, or in a combination of both. Overall, the time to FiO2 normalization was 7.4 days vs. 7.9 days in the experimental and control groups, respectively. Global mortality was 8.2%. Severe adverse events were uncommon and equally distributed between arms. Conclusion: The addition of CsA did not show differences over a corticosteroid-based treatment in the clinical course of the included patients. A better identification of candidates who will benefit from receiving immunomodulatory drugs is necessary in future studies. [ABSTRACT FROM AUTHOR]

Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the "Open Science Framework (OSF)" website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being "other information" (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The "results" section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p < 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs. [ABSTRACT FROM AUTHOR]

Background: There has been growing interest in exploring combined interventions to achieve a more effective heparin-free treatment approach. Aim: to evaluate combination of interventions compared to standard practice (intermittent flushes) to prevent clotting and consequently reduce premature interruptions of hemodialysis. Methods: This open-label randomized controlled trial recruited chronic hemodialysis patients with contra-indication to systemic heparinization. Participants were randomized into one of five groups to receive different strategies of heparin-free hemodialysis treatment for up to three sessions. Primary endpoint: the successful completion of hemodialysis without clotting. Secondary outcomes: the clotting of the air traps assessed by a semi-quantitative scale, online KT/V, and safety of the interventions. Results: Forty participants were recruited and randomized between May and December 2020. Participants showed similar baseline biochemistry results and coagulation profiles. The highest success rates were observed in group 3 (heparin-coated dialyzers combined with intermittent flushes) (100%) and group 5 (hemodiafiltration with online predilution combined with heparin-coated dialyzers), with 91% vs. the control (intermittent flushes) (64%). Group 2 (heparin-coated dialyzers alone) had the poorest success rate, with 38% of the sessions being prematurely terminated due to clotting. KT/V and clotting scores were similar between groups. No adverse events related to the trial interventions were observed. Conclusions: The proposed combination of interventions may have had additive effects, leading to less frequent clotting and the premature termination of an HD/HDF session. Our study supports the feasibility of conducting a larger randomized controlled trial focusing on the efficacy of combined interventions for heparin-free HD in patients with a high risk of bleeding. [ABSTRACT FROM AUTHOR]

Telomeres are ribonucleoprotein structures that form a protective buffer at the ends of chromosomes, maintaining genomic integrity during the cell cycle. A decrease in average telomere length is associated with with age and with aging-related diseases such as cancer and cardiovascular disease. In this study, we conducted a randomized, double-blind, placebo-controlled trial over six months to compare the effects of the Astragalus-based supplement versus a placebo on telomere length (TL) in 40 healthy volunteers (mean age 56.1 ± 6.0 years). Twenty subjects received the supplement, and 20 received placebo capsules. All participants completed the study, and no adverse side effects were reported at six months. Subjects taking the Astragalus-based supplement exhibited significantly longer median TL (p = 0.01) and short TL (p = 0.004), along with a lower percentage of short telomeres, over the six-month period, while the placebo group showed no change in TL. This trial confirmed that the supplement significantly lengthens both median and short telomeres by increasing telomerase activity and reducing the percentage of short telomeres (<3 Kbp) in a statistically and possibly clinically significant manner. These results align with a previous open prospective trial, which found no toxicity associated with the supplement's intake. These findings suggest that this Astragalus-based supplement warrants further investigation for its potential benefits in promoting health, extending life expectancy, and supporting healthy aging. [ABSTRACT FROM AUTHOR]

Background/Objectives: Lacticaseibacillus rhamnosus HN001 (HN001) is a probiotic strain widely studied for its potential to improve human health. Previous studies have demonstrated promising results for HN001 in the improvement of mental well-being, particularly in terms of increased happiness and support for stress management in healthy adults. Methods: To further explore these findings, a double-blind, placebo-controlled trial was conducted with 120 participants aged ≥ 18 years with mild to high stress measured by the Perceived Stress Scale (PSS). The participants were randomly assigned to receive either HN001 or placebo for 28 days. Psychological assessments, including the Oxford Happiness Questionnaire (OHQ), were completed at baseline, day 14, and day 28. Secondary outcomes included changes in PSS scores, as well as depression, anxiety, stress, and total score levels measured by the DASS-21 questionnaire. Results: While not statistically significant, participants who received HN001 showed an improvement in OHQ (mean change, 13.3) and PSS total scores (mean change, −8.1) over time compared with the placebo group (mean change, 10.2 and −6.6, respectively). Furthermore, 39% of the participants moved from not happy to happy, compared with only 29% in the placebo group. Post-hoc analysis showed a statistically significant interaction between intervention and study day for OHQ and PSS total scores, with p-values of 0.014 and 0.043, respectively. No adverse effects were observed. Conclusions: HN001 showed improvements in both happiness and PSS scores. Furthermore, sex subgroup analysis revealed statistically significant differences in both outcomes, emphasizing the need for larger and longer intervention studies. [ABSTRACT FROM AUTHOR]

Background: The Foods with Function Claim was introduced in Japan in April 2015 to make more products available that are labeled with health functions. A product's functionality of function claims must be explained by the scientific evidence presented in clinical trials (CTs) or systematic reviews, but the quality of recent CTs is unclear. The purpose of this study was to evaluate the risk of bias (RoB) using "a revised tool to assess risk (RoB 2)" published in 2018 for notifications based on all recent CTs published on the Consumer Affairs Agency website. Methods: A total of 38 submitted papers based on CTs that were published on the Consumer Affairs Agency website during the period from 1 January 2023 to 30 June 2024 were eligible. The RoB 2 tool provides a framework for considering the risk of bias in the findings of any type of randomized trial. This tool with five domains was used to evaluate the quality of research methods. Results: Eligible CTs were assessed as "low risk" (11%, n = 4), "medium risk" (13%, n = 5), and "high risk" (76%, n = 29). A number of highly biased papers were published. Bias occurred in all five domains, especially "bias in selection of the reported result (Domain 5)", which was the most serious ("high risk"; 75%). For elements correlated with RoB, there was no significant difference (p = 0.785) in the RoB 2 score between for-profit and academic research in the author's affiliated organization. There was no significant difference (p = 0.498) in the RoB score between the published year categories of 2000–2019 and 2020–2024, and no significant difference (p = 0.643) in the RoB score between English and Japanese language publications. Conclusion: Overall, the quality of the latest CTs submitted after 2023 was very low, occurring in all five domains, and was most serious for "bias in selection of the reported result (Domain 5)". [ABSTRACT FROM AUTHOR]

Background. Despite technical advancements, patients with sequential or diffuse coronary lesions undergoing percutaneous coronary intervention (PCI) have an increased risk of cardiovascular events at follow-up. We aimed to analyze the utility of a SyncVision/iFR (S-iFR)-guided PCI strategy versus an angiography-guided strategy in patients with this type of lesions. Methods. Randomized, multicenter, controlled, and open-label trial to compare S-iFR versus angiography-guided PCI in patients with sequential or diffuse angiographic coronary stenosis (ClinicalTrials.gov identifier: NCT04283734). The primary endpoint was the implanted stent length. The main secondary endpoint was targeting vessel failure (TVF) at one year. Results. A total of 100 patients underwent randomization, with 49 patients assigned to the S-iFR group and 51 to the angiography-guided PCI group. There were no differences between groups regarding clinical and anatomical characteristics. The baseline iFR was 0.71 ± 0.16 vs. 0.67 ± 0.19 (p = 0.279) in the S-iFR and angiography group, respectively. The mean lesion length was 42.3 ± 12 mm and 39.8 ± 12 (p = 0.297). The implanted stent length was 32.7 ± 17.2 mm in the S-iFR group and 43.1 ± 14.9 mm in the angiography group (mean difference, −10.4 mm; 95% confidence interval [CI], −16.9 to −4.0; p = 0.002). At one year, target vessel failure (TVF) occurred in four patients: three (6.1%) in the S-iFR group vs. one (1.9%) in the angiography group (p = 0.319). Conclusions. Among patients with sequential or long diffuse coronary lesions, a S-iFR-guided PCI strategy resulted in a reduction of the total stent length compared to an angiography-guided PCI strategy. A nonsignificant increase in TVF was observed in the S-iFR group. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis of randomized controlled trials (RCTs) with trial sequential analysis (TSA) aimed to comprehensively evaluate and compare the efficacy of the prophylactic administration of tropisetron in the prevention of the incidence of post-operative nausea and vomiting (PONV) in patients undergoing surgery under general anesthesia. This study was registered with PROSPERO (CRD42024372692). RCTs comparing the efficacy of the perioperative administration of tropisetron with that of a placebo, other anti-emetic agents, or a combination of anti-emetic injections were retrieved from the databases of Ovid-MEDLINE, Ovid-EMBASE, the Cochrane Central Register of Controlled Trials, and Google Scholar. The frequency of rescue anti-emetic use (RA) and the incidence of PON, POV, and PONV (relative risk [RR]: 0.718; 95% confidence interval [CI] 0.652–0.790; I2 = 0.0, RR: 0.587; 95% CI 0.455–0.757; I2 = 63.32, RR: 0.655; 95% CI 0.532–0.806; I2 = 49.09, and RR: 0.622; 95% CI 0.552–0.700; I2 = 0.00, respectively) in the tropisetron group were lower than those in the control group; however, the incidence of complete response (CR) was higher in the tropisetron group (RR: 1.517;95% CI 1.222–1.885; I2 = 44.14). TSA showed the cumulative Z-curve exceeded both the conventional test and trial sequential monitoring boundaries for RA, PON, POV, and PONV between the tropisetron group and the control group. Thus, the prophylactic administration of tropisetron exhibited superior efficacy in the prevention of PON, POV, and PONV. Furthermore, a lower incidence of RA and a higher incidence of CR were observed with its use. [ABSTRACT FROM AUTHOR]

The objective was to compare the color match and color stability behavior of single- and multi-shade resin-based composites (RBCs) used for direct restorations. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized clinical trials evaluating the shade performance of single-shade RBCs in direct restorations were included. A search of the scientific literature was performed in five databases (April 2024). The meta-analysis was performed using RevMan 5.4, calculating the risk difference (RD) and 95% confidence interval (CI) of the dichotomous outcome using a random effects model. Bias was assessed using the RoB 2.0 tool, and certainty of evidence was assessed using the GRADEpro tool. Four studies were selected, with 263 restorations analyzed. The results showed comparable performance between single-shade RBCs and multi-shade RBCs in terms of color match and color stability over 12 months. Three studies had a low risk of bias with all expected results, and one study had some concerns. The certainty of evidence for color stability was considered low for all follow-up periods due to the small number of events and sample size. According to the United States Public Health Service Evaluation (USPHS) and the World Dental Federation (FDI), there is comparable clinical color performance between single-shade and multi-shade RBCs over 12 months. [ABSTRACT FROM AUTHOR]

This study compares the clinical performances of two lithium disilicate (Initial LiSi press vs. Initial LiSi Block, GC Corp.) and a 3D printed resin (Temp Print, GC Corp.) partial crown using modified United States Public Health Service (USPHS) evaluation criteria and survival rates after one year of clinical service. Eighty-nine partial adhesive restorations on posterior teeth were realized using different materials: Group 1 used Initial LiSi press, Group 2 used Initial LiSi Block, and Group 3 used Temp Print. An analog workflow was used to realize the restoration of Group 1, while a fully digital workflow was used for Groups 2 and 3. The modified USPHS parameters, together with periodontal parameters, were collected at baseline and at the one-year recall. Contingency tables to assess for significant differences of success over time in each group were used. All modified USPHS parameters showed Alpha or Bravo; no Charlie was recorded. No statistically significant difference emerged between the three groups in any of the assessed variables (p > 0.05). All modified USPHS scores were compatible with the outcome of clinical success, no restoration was replaced or repaired, and the survival rate was 100% at the one-year recall. No difference was found between the traditional and digital workflows used to fabricate the restorations. [ABSTRACT FROM AUTHOR]

As the global demographic shifts toward an aging population, aging-related problems, particularly in older individuals with dynapenia, are increasingly gaining attention. However, interventional studies focusing on physical and cognitive function and sleep quality in such individuals are limited, indicating a need for further exploration. The present study investigated the effects of whole-body vibration (WBV) training on physical and cognitive function and sleep quality in older people with dynapenia residing in long-term care institutions. This study was a randomized controlled trial. The experimental group underwent WBV training three times a week for 3 months, whereas the control group continued with their regular daily care routine. Statistical analyses were performed using the Traditional Chinese version of SAS Statistics version 9.4. Paired t tests, a one-way analysis of variance, independent t tests, and generalized estimating equation analysis were performed. The results revealed that compared with the control group, the experimental group experienced significant improvements in grip strength, instrumental activities of daily living, cognitive function, and sleep quality in terms of latency and duration. These findings suggest that 3 months of WBV training can effectively enhance physical and cognitive function and sleep quality in older people with dynapenia residing in long-term care institutions. [ABSTRACT FROM AUTHOR]

Contact dermatitis is a common inflammatory skin disease that often requires prescription therapy and is associated with adverse reactions. Omega fatty acids have been recognized for their anti-inflammatory effect and could serve as a safer option in contact dermatitis treatment. Therefore, the aim of this randomized controlled study, conducted at the University of Split School of Medicine, was to evaluate the efficacy and safety of omega fatty acids containing topical products in an experimental model of irritant contact dermatitis. This study was registered with ClinicalTrials (NCT06189144) and is closed. The primary outcomes were levels of transepidermal water loss, skin hydration, and skin erythema, all measured using an MPA6 device in 25 healthy participants. A significant difference was observed between the hydration values of the intervention (45.7 ± 12.4) and control groups (31.6 ± 12.3) (p < 0.05) on final measurements (day 10). Moreover, higher erythema levels were observed in participants who were smokers, compared to non-smokers. No adverse drug reactions were observed during the study period. In conclusion, omega fatty acids topical product use shows promise in the treatment of irritant contact dermatitis, and further studies are needed to evaluate efficacy in a larger sample of patients. [ABSTRACT FROM AUTHOR]

In recent decades, there has been a rising demand for anti-aging interventions aimed at postponing or potentially reversing indicators of skin aging. The use of collagen-based nutraceutical supplements has gained popularity as they have shown promise in enhancing skin health and reducing signs of aging. The aim of this randomized, placebo-controlled, blinded study was to investigate the effects of 2.5 g COLLinstant® LMW, a novel cosmeceutical containing low-molecular-weight (≤1000 Da) collagen peptides, on skin aging and health. The trial was conducted with 80 healthy women aged 30 years and older. They received a daily oral dose of either the food supplement (n = 40) or placebo (n = 40) for six weeks. Skin assessment was performed based on validated objective methods, such as Visioface 1000D (skin wrinkling), cutometry (elasticity and fatigue), and corneometry (skin hydration) at baseline (T0) and at week 6 (T6). After 6 weeks, participants that received collagen had significant improvements in biometric skin wrinkle parameters from baseline, with a reduction in volume by 46%, in area by 44%, and in depth by 9%, along with a greater increase in skin moisturization (by 34%) than those in the placebo group (p < 0.001). The food supplement did not significantly modify skin firmness or fatigue and had only slight beneficial effects on skin elasticity. The investigational product was well tolerated. The observed effects aligned closely with the subjective assessments reported by study participants. The study provides substantiated evidence supporting the efficacy of low-molecular-weight collagen peptides in restoring altered skin biometric parameters, as objectively assessed. Thus, regular supplementation with this nutraceutical may contribute to achieving smoother and more radiant skin. [ABSTRACT FROM AUTHOR]

(1) Background: Given the autoimmune nature of Alopecia Areata (AA) and the immunomodulatory properties of probiotics, this trial was conducted to evaluate the efficacy of a probiotic mixture, consisting of Lactobacillus rhamnosus and Bifidobacterium longum strains, as an adjuvant treatment in a group of AA patients. (2) Method: This study was a 24-week, randomized, double-blind, placebo-controlled clinical trial. Twenty-six patients with AA were included in this study, and their clinical progression, along with changes in gut and skin microbiota, were analyzed. (3) Results: A higher proportion of AA patients treated with the probiotic formula showed improvement compared to the placebo group, based on both the reduction in the number of AA plaques (56% vs. 30%) and the affected scalp surface area (45% vs. 20%). For "activity", "inactivity", and "regrowth", an improvement in 55%, 67%, and 55% of patients was, respectively, observed in the probiotic group, compared to 50%, 40%, and 30% in the placebo group. No changes were observed in the gut microbiota during the intervention period. Regarding skin microbiota, changes were detected in the probiotic group, with reductions in characteristic genera during the study. (4) Conclusions: To our knowledge, this is the first clinical trial assessing the efficacy of a probiotic product in patients with AA. This probiotic mixture in a routine clinical practice setting appears to improve the course of patients. In addition, the skin microbiota of scalp lesions was modified using the probiotic treatment. [ABSTRACT FROM AUTHOR]

Schizophrenia is a chronic psychiatric disorder severely affecting patients' functioning and quality of life. Unlike positive symptoms, cognitive impairment and negative symptoms cannot be treated pharmacologically and represent consistent predictors of the illness's prognosis. Cognitive remediation (CR) interventions have been applied to target these symptoms. Brain stimulation also provides promising yet preliminary results in reducing negative symptoms, whereas its effect on cognitive impairment remains heterogeneous. Here, we combined intermittent theta burst stimulation (iTBS) with CR to improve negative symptoms and cognitive impairment in schizophrenia spectrum patients. One hundred eligible patients were invited, and twenty-one participated. We randomized them into four groups, manipulating the stimulation condition (real vs. sham) and CR (no training vs. training). We delivered fifteen iTBS sessions over the left dorsolateral prefrontal cortex for three weeks, followed (or not) by 50 min of training. Consensus-based clinical and cognitive assessment was administered at baseline and after the treatment, plus at three follow-ups occurring one, three, and six months after the intervention. Mixed-model analyses were run on cognitive and negative symptom scores. The preliminary findings highlighted a marginal modulation of iTBS on negative symptoms, whereas CR improved isolated cognitive functions. We herein discuss the limitations and strengths of the methodological approach. [ABSTRACT FROM AUTHOR]

Early rehabilitation has beneficial impacts on functional outcomes for patients with acute stroke. However, whether the addition of virtual reality (VR) training could further improve these patients' muscle strength, functional recovery, and psychological health is unknown. A randomized controlled trial was conducted on 33 patients with first-time acute ischemic stroke. The patients were randomly assigned using a 1:1 randomization ratio to either the experimental group (EG) or the comparison group (CG). Both groups received early rehabilitation, and the EG received extra VR training during their stay in the hospital. Muscle strength, functional status, and psychological health were assessed before the intervention and at discharge. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group. After adjusting for potential covariates, the EG showed a more significant decrease in depression at discharge than the CG (ß = 3.77, p = 0.011). There were no differences in muscle strength and functional recovery between groups after intervention. Adding VR training into early rehabilitation facilitates substantial positive effects on psychological health, specifically depression, but not muscle strength and functional recovery, compared to receiving early rehabilitation alone in patients with first-time acute stroke during their hospitalized period. [ABSTRACT FROM AUTHOR]

Individuals afflicted with advanced kidney dysfunction who require dialysis for medical management exhibit different degrees of native kidney function, called residual kidney function (RKF), ranging from nil to appreciable levels. The primary focus of this manuscript is to delve into the concept of RKF, a pivotal yet under-represented topic in nephrology. To begin, we unpack the definition and intrinsic nature of RKF. We then juxtapose the efficiency of RKF against that of hemodialysis in preserving homeostatic equilibrium and facilitating physiological functions. Given the complex interplay of RKF and overall patient health, we shed light on the extent of its influence on patient outcomes, particularly in those living with advanced kidney dysfunction and on dialysis. This manuscript subsequently presents methodologies and measures to assess RKF, concluding with the potential benefits of targeted interventions aimed at preserving RKF. [ABSTRACT FROM AUTHOR]

Self-regulated learning (SRL) is a crucial competence in our rapidly changing society, yet its systematic promotion in the classroom remains limited. Addressing this gap, this study reports on a teacher-led intervention to promote SRL within reading tasks among 5th and 6th grade students. Although some interventions have been implemented to promote SRL, little attention has been paid to promoting SRL in primary schools. Building on a previous SRL intervention, the current study added cooperative learning among students and parental involvement, two aspects that are assumed to add value when fostering SRL. A randomized controlled field trial was designed to evaluate the effect of an intervention using pre-test, post-test and follow-up measures. A total of 757 students from 40 classes participated in the study. The data were analyzed using a multilevel approach. This study revealed no significant difference in SRL or reading comprehension outcomes in the post-test and the follow-up test between students of the experimental and control group. Further investigations showed that several aspects of treatment integrity had a significant impact on SRL outcome. This study encourages future SRL and reading intervention studies to assess and analyze the multiple aspects of treatment integrity. [ABSTRACT FROM AUTHOR]

Using a randomized controlled trial, we examined the impact of a teacher professional learning (PL) program on English as a Second Language (ESL) teachers' use of evidence-based instructional strategies for multilingual learners, collaboration with classroom teachers, and incorporation of Latino multilingual learners' cultural wealth into their classrooms. The analyses included 29 ESL teachers from 29 elementary schools in three school districts. The teachers completed pre–post surveys, and trained observers rated classroom instruction and cultural wealth for two cohorts of teachers in the yearlong program. The results showed that the PL program had a significant effect on the ESL teachers' use of evidence-based instructional strategies. We also found a significant effect on the ESL teachers' collaboration processes, including their use of an intentional framework for collaboration and their alignment with classroom teachers' instruction. We did not find significant differences between the PL group and the control group on the ESL teachers' incorporation of cultural wealth in their classroom environment or on the reported frequency of their collaboration. [ABSTRACT FROM AUTHOR]

With increasing age, dyslipidemia becomes a common health problem in the middle-aged and elderly population, posing a significant risk of cardiovascular disease. Aerobic exercise, as a non-pharmacological intervention, is considered to be effective in improving blood lipid levels, but the extent to which different types of aerobic exercise affect blood lipids is not clear. This study aims to investigate the effects of 12 different aerobic exercises on total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in middle-aged and elderly people aged 45 years and over through systematic review and Bayesian network Meta-analysis of randomized controlled trials. We systematically searched relevant databases and included eligible randomized controlled trials. Bayesian network meta-analysis was used to compare the effects of 12 types of aerobic exercise on lipid levels. A total of 487 randomized controlled trials involving middle-aged and elderly people over 45 years old were included. The results of the network meta-analysis showed that all types of aerobic exercise could reduce blood lipid levels compared with no intervention in middle-aged and elderly people. In terms of total cholesterol, triglyceride, and low-density lipoprotein cholesterol, swimming had the most significant effect. For HDL cholesterol, dance showed a better effect. Studies have shown that swimming and dancing have a positive effect on improving blood lipid levels in middle-aged and elderly people. It is recommended to choose the appropriate type of exercise according to personal preference and physical condition. [ABSTRACT FROM AUTHOR]

Heart failure (HF) is a complex clinical syndrome caused by structural or functional dysfunction of the ventricular filling or blood supply. Diabetes mellitus (DM) is an independent predictor of mortality for HF. The increase in prevalence, co-morbidity and hospitalization rates of both DM and HF has further fueled the possibility of overlapping disease pathology between the two. For decades, antidiabetic drugs that are known to definitively increase the risk of HF are the thiazolidinediones (TZDs) and saxagliptin in the dipeptidyl peptidase-4 (DPP-4) inhibitor, and insulin, which causes sodium and water retention, and whether metformin is effective or safe for HF is not clear. Notably, sodium-glucose transporter 2 (SGLT2) inhibitors and partial glucagon-like peptide-1 receptor agonists (GLP-1 RA) all achieved positive results for HF endpoints, with SGLT2 inhibitors in particular significantly reducing the composite endpoint of cardiovascular mortality and hospitalization for heart failure (HHF). Further understanding of the mutual pathophysiological mechanisms between HF and DM may facilitate the detection of novel therapeutic targets to improve the clinical outcome. This review focuses on the association between HF and DM, emphasizing the efficacy and safety of antidiabetic drugs and HF treatment. In addition, recent therapeutic advances in HF and the important mechanisms by which SGLT2 inhibitors/mineralocorticoid receptor antagonist (MRA)/vericiguat contribute to the benefits of HF are summarized. [ABSTRACT FROM AUTHOR]

In schizophrenia, cognition is closely linked to social competence and influences long-term prognosis. Thus, treatment should target cognitive improvement to enhance the patient's societal adaptation. This study evaluated the effects of computer-assisted cognitive remediation therapy (CR) using RehaCom® on cognition in patients with schizophrenia. Thirty patients were randomized, with 15 assigned to the CR and treatment as usual (TAU) group and 15 to the TAU-alone group. Over 12 weeks, patients received CR twice weekly, including two computer sessions and one verbal session. The outcomes measured were cognition using the Brief Assessment of Cognition in Schizophrenia and Schizophrenia Cognition Rating Scale, intrinsic motivation using the Quality of Life Scale and Intrinsic Motivation Inventory, psychiatric symptoms using the Positive and Negative Syndrome Scale, negative symptoms using the Scale for the Assessment of Negative Symptoms, and functional level using the modified Global Assessment of Functioning scale for Functioning. The CR + TAU group demonstrated considerable improvements in cognition, intrinsic motivation, and functional level compared to the TAU-alone group. These findings indicate that the CR using RehaCom® enhances cognition and other outcomes in schizophrenia. [ABSTRACT FROM AUTHOR]

Background and Objectives: Unfavorable intrabony defects (IBDs) are associated with the progression of periodontal disease and tooth loss. Growing scientific evidence has demonstrated the effectiveness of platelet concentrations in periodontal treatment. The aim of our study was to demonstrate the non-inferiority of an autogenous bone graft (ABG) associated with leukocyte- and platelet-rich fibrin (L-PRF) compared to ABG + Collagen Membrane in the treatment of IBDs. Material and Methods: Sixty-four patients with at least one IBD were randomly assigned to two groups: ABG+L-PRF and CM+ABG. Clinical and radiographic evaluations were performed at baseline and 12-month follow-up. Clinical attachment level (CAL), gingival recession (GR), probing pocket depth (PPD), and radiograph defect bone level (DBL) were compared between the two treatments. To evaluate the effectiveness of ABG+L-PRF, a non-inferiority margin of =1 mm (−1 mm for GR) was chosen; a second non-inferiority margin of =0.5 mm (−0.5 mm for GR) was set for clinical relevance. Results: At 12-month follow up, both treatments showed clinical and radiographic improvements. The 90% confidence intervals of the CM+ABG–L-PRF+ABG mean difference for CAL gain (−0.0564 mm [−0.316 to 0.203]), DBL gain (−0.433 mm [−0.721 to −0.145]), and PPD reduction (0.232 mm [0.015 to 0.449]) were below the 0.5 mm non-inferiority margin; the GR increase (0.255 mm [0.0645 to 0.445]) stayed above the −0.5 mm. Conclusions: the L-PRF+ABG treatment of unfavorable IBDs is non-inferior with respect to the CM+ABG therapy for CAL gain, but with a lower GR, a slightly higher PPD, and DBL gain. [ABSTRACT FROM AUTHOR]

Background: There is a high incidence of nonspecific Low Back Pain (LBP) in patients visiting Emergency Departments (EDs), but there is a lack of knowledge regarding emergency physiotherapy for LBP. The effect of on-site physiotherapy in these patients was therefore never demonstrated. We assessed short-term outcomes, feasibility and patient satisfaction with physiotherapy in ED patients presenting with nonspecific LBP. Methods: A block-randomized, controlled, open-label trial with a follow-up of 42 days. Patients aged 18 years or older presenting to an ED with nonspecific LBP were prospectively enrolled. Both groups received the same booklet with written information on LBP management and exercises. Patients in the intervention group were given additional instructions by a certified physiotherapist. Results: We included 86 patients in the primary analysis. The median age was 40, and 40.7% were female. At day 7, the median Oswestry Disability Index (ODI) was 2 points lower in the intervention group compared to the control group, which was not statistically significant. There was no between-group difference in pain at day 7. Patients who received physiotherapy felt significantly more confident with the exercises they were taught (p = 0.004, effect size = 0.3 [95% CI 0.1 to 0.5]). Conclusions: On-site physiotherapy in ED patients presenting with nonspecific low back pain is associated with higher patient satisfaction, compared to standard of care. The effect of physiotherapy was small, with only minimal improvement in disability, but without a reduction in pain. Despite the very small effect size, physiotherapeutic interventions should be investigated in larger cohorts with an extended intervention including patient education, exercises, and other physiotherapeutic modalities. [ABSTRACT FROM AUTHOR]

Simple Summary: In the last days and weeks of life, many patients with cancer develop delirium with fluctuating confusion, altered levels of consciousness, hallucinations, restlessness, and, sometimes, agitation, which fluctuate over time. This condition can be very distressing for the patient and their family. In this article, the authors reviewed different treatments for delirium in patients receiving palliative care. Previous studies have shown that certain medications, such as neuroleptics and benzodiazepines, may be helpful in controlling the terminal agitation associated with end-of-life delirium. However, further research is needed to confirm these findings and find new treatment options to address this challenging issue. End-of-life delirium affects a vast majority of patients before death. It is highly distressing and often associated with restlessness or agitation. Unlike delirium in other settings, it is considered irreversible, and non-pharmacologic measures may be less feasible. The objective of this review is to provide an in-depth discussion of the clinical trials on delirium in the palliative care setting, with a particular focus on studies investigating pharmacologic interventions for end-of-life delirium. To date, only six randomized trials have examined pharmacologic options in palliative care populations, and only two have focused on end-of-life delirium. These studies suggest that neuroleptics and benzodiazepines may be beneficial for the control of the terminal restlessness or agitation associated with end-of-life delirium. However, existing studies have significant methodologic limitations. Further studies are needed to confirm these findings and examine novel therapeutic options to manage this distressing syndrome. [ABSTRACT FROM AUTHOR]

Despite the rapidly emerging evidence on the contributions of physical activity to improving cancer-related health outcomes, adherence to physical activity among young adults with lymphoma remains suboptimal. Guided by self-determination theory (SDT), the Lymfit intervention (a 12-week individualized exercise program with bi-weekly kinesiologist support and an activity tracker) aimed to foster autonomous motivation toward physical activity. This pilot randomized controlled trial aimed to evaluate the feasibility, acceptability, and preliminary effects of Lymfit. Young adults (N = 26; mean age of 32.1 years) with lymphoma who were newly diagnosed and those up to six months after completing treatment were recruited and randomly assigned one-to-one to either the intervention group (n = 13) or a wait-list control group (n = 13). All a priori feasibility benchmarks were met, confirming the feasibility of the study in terms of recruitment uptake, retention, questionnaire completion, intervention fidelity, missing data, Fitbit wear adherence, and control group design. The intervention acceptability assessment showed high ratings, with eight out of ten items receiving >80% high ratings. At post-intervention, an analysis of covariance models showed a clinically significant increase in self-reported physical activity levels, psychological need satisfaction, and exercise motivation in the intervention group compared to controls. Lymfit also led to meaningful changes in six quality-of-life domains in the intervention group, including anxiety, depression, fatigue, sleep disturbance, social roles and activities, and pain interference. The findings support Lymfit as a promising means to meet psychological needs and increase the autonomous motivation for physical activity in this group. A fully powered efficacy trial is warranted to assess the validity of these findings. [ABSTRACT FROM AUTHOR]

Chrono-nutrition (meal timing) aligns food consumption with one's circadian rhythm. The first meal (e.g., breakfast) likely promotes synchronization of peripheral circadian clocks, thereby supporting metabolic health. Time-restricted feeding (TRF) has been shown to reduce body weight (BW) and/or improve cardiovascular biomarkers. In this explorative literature assessment, 13 TRF randomized controlled trials (RCTs) were selected from PubMed and Scopus to evaluate the effects of early (eTRF: first meal before 10:30 a.m.) and late TRF (lTRF: first meal after 11:30 a.m.) on parameters of metabolic health. Although distinct variations in study design were evident between reports, TRF consistently decreased energy intake (EI) and BW, and improved insulin resistance as well as systolic blood pressure. eTRF seemed to have a greater beneficial effect than lTRF on insulin resistance (HOMA-IR). Importantly, most studies did not appear to consider chronotype in their evaluation, which may have underestimated TRF effects. TRF intervention may be a promising approach for risk reduction of human metabolic diseases. To conclusively determine benefits of TRF and identify clear differences between eTRF and lTRF, future studies should be longer-term (≥8 weeks) with well-defined (differences in) feeding windows, include participants chronotypically matching the intervention, and compare outcomes to those of control groups without any dietary limitations. [ABSTRACT FROM AUTHOR]

Gut microbiome-modulating agents (MMAs), including probiotics, prebiotics, postbiotics, and synbiotics, are shown to ameliorate type 1 diabetes (T1D) by restoring the microbiome from dysbiosis. The objective of this systematic review and meta-analysis was to assess the impact of MMAs on hemoglobin A1c (HbA1c) and biomarkers associated with (T1D). A comprehensive search was conducted in PubMed, Web of Science, Embase, Cochrane Library, National Knowledge Infrastructure, WeiPu, and WanFang Data up to 30 November 2023. Ten randomized controlled trials (n = 630) were included, with study quality evaluated using the Cochrane risk-of-bias tool. Random-effect models with standardized mean differences (SMDs) were utilized. MMA supplementation was associated with improvements in HbA1c (SMD = −0.52, 95% CI [−0.83, −0.20]), daily insulin usage (SMD = −0.41, 95% confidence interval (CI) [−0.76, −0.07]), and fasting C-peptide (SMD = 0.99, 95% CI [0.17, 1.81]) but had no effects on FBG, CRP, TNF-α, IL-10, LDL, HDL, and the Shannon index. Subgroup analysis of HbA1c indicated that a long-term intervention (>3 months) might exert a more substantial effect. These findings suggest an association between MMAs and glycemic control in T1D. Further large-scale clinical trials are necessary to confirm these findings with investigations on inflammation and gut microbiota composition while adjusting confounding factors such as diet, physical activity, and the dose and form of MMA intervention. [ABSTRACT FROM AUTHOR]

Background and Objectives: The focus on mild cognitive dysfunction in adults is of great interest, given the risk of worsening and conversion to dementia. Cognitive dysfunctions are characterized by a decrease in the weight and volume of the brain, due to cortical atrophy, with a widening of the grooves and flattening of the convolutions. Brain atrophy that mainly involves the hippocampus is related to the progression of cognitive impairment and the conversion from mild cognitive dysfunction to dementia. Currently, there is no treatment for MCI. Results from a trial on Alzheimer's disease (ASCOMALVA trial) suggest that a sustained cholinergic challenge can slow the progression of brain atrophy typical of Alzheimer's disease associated with vascular damage. This study intends to evaluate the efficacy of choline alphoscerate in patients with mild cognitive impairment (MCI) and associated vascular damage, in stabilizing and/or slowing brain atrophy typical of adult-onset cognitive dysfunction, and in improving and/or slowing the progression of cognitive and behavioral symptoms associated with MCI. Materials and Methods: This randomized controlled trial will recruit 60 patients that will be evaluated and randomized in a 1:1 ratio to receive choline alphoscerate (1200 mg/day) or placebo, for 12 months. Analyses will be carried out using SPSS vesion No 26 the Statistician in charge of this study, with the statistical significance level chosen as 0.05. Discussion: This trial may provide evidence about the efficacy of treatment with the cholinergic precursor choline alphoscerate in patients with mild cognitive dysfunction. The results of this study will be published in peer-reviewed journals. Registration: EudraCT number: 2020-000576-38 [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigated whether using virtual reality (VR) could help reduce anxiety in women undergoing gynecological cancer surgery. Participants were split into two groups: one receiving VR therapy alongside usual care and the other receiving only usual care. Results showed that VR significantly decreased anxiety levels before surgery compared to the control group. This suggests that VR could be a valuable tool in preparing patients for surgery, potentially improving their experience and outcomes. Further research is needed to explore VR's benefits in other types of surgery and its long-term effects on patient recovery. Perioperative anxiety is common among patients undergoing surgery, potentially leading to negative outcomes. Immersive virtual reality (VR) has shown promise in reducing anxiety in various clinical settings. This study aimed to evaluate the effectiveness of VR in reducing perioperative anxiety in patients undergoing gynecological oncology surgery and was conducted as a single-center, double-arm, single-blinded randomized controlled trial at the Gold Coast University Hospital, Queensland, Australia. Participants were randomized into the VR intervention + care as usual (CAU) group (n = 39) and the CAU group (n = 41). Anxiety scores were assessed using a six-tier visual facial anxiety scale at baseline, after the intervention/CAU on the same day, and, several days up to weeks later, immediately before surgery. There was no significant difference in baseline anxiety scores, type of operation, or suspected cancer between the two groups. The VR intervention significantly reduced anxiety scores from baseline to preoperative assessment (p < 0.001). The median anxiety score in the VR intervention group decreased from 3 (interquartile range 2 to 5) at baseline to 2 (2 to 3) prior to surgery, while the control group's scores were 4 (2 to 5) and 4 (3 to 5), respectively. Multivariate analysis showed that group assignment was the sole outcome predictor, not age, type of procedure, or the time elapsed until surgery. Thus, VR exposure was effective in reducing perioperative anxiety in patients undergoing gynecological oncology surgery. The use of VR as a preparation tool may improve patient experience and contribute to better surgical outcomes, warranting further research into exploring the potential benefits of VR in other surgical specialties and its long-term impact on patient recovery. [ABSTRACT FROM AUTHOR]

Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1–2 to weeks 3–4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies. [ABSTRACT FROM AUTHOR]

This review aimed to synthesise existing literature on the efficacy of personalised or precision nutrition (PPN) interventions, including medical nutrition therapy (MNT), in improving outcomes related to glycaemic control (HbA1c, post-prandial glucose [PPG], and fasting blood glucose), anthropometry (weight, BMI, and waist circumference [WC]), blood lipids, blood pressure (BP), and dietary intake among adults with prediabetes or metabolic syndrome (MetS). Six databases were systematically searched (Scopus, Medline, Embase, CINAHL, PsycINFO, and Cochrane) for randomised controlled trials (RCTs) published from January 2000 to 16 April 2023. The Academy of Nutrition and Dietetics Quality Criteria were used to assess the risk of bias. Seven RCTs (n = 873), comprising five PPN and two MNT interventions, lasting 3–24 months were included. Consistent and significant improvements favouring PPN and MNT interventions were reported across studies that examined outcomes like HbA1c, PPG, and waist circumference. Results for other measures, including fasting blood glucose, HOMA-IR, blood lipids, BP, and diet, were inconsistent. Longer, more frequent interventions yielded greater improvements, especially for HbA1c and WC. However, more research in studies with larger sample sizes and standardised PPN definitions is needed. Future studies should also investigate combining MNT with contemporary PPN factors, including genetic, epigenetic, metabolomic, and metagenomic data. [ABSTRACT FROM AUTHOR]

Simple Summary: Head and neck cancer is associated with significant morbidity. Shoulder and neck dysfunction, weight loss, and declines in muscular strength and physical functioning are commonly seen following cancer therapies. This pragmatic randomized controlled trial involved sixty-one individuals with cancer in the head and neck region who had completed their cancer treatment. The primary aim was to assess the effectiveness of the addition of lower-body resistance exercise training to a physiotherapeutic shoulder and neck exercise protocol on fatigue-related quality of life. Findings support the benefit of the combined intervention for fatigue-related quality of life, six-minute walk test distance, upper- and lower-body muscular strength, and physical activity level. The continued improvement in treatment effect over the one-year follow-up period suggests promise from this interdisciplinary approach to bridge individuals with head and neck cancer from rehabilitation care to general exercise and physical activity. Background: Established barriers to general exercise and physical activity among individuals with head and neck cancer include dry mouth, difficulty eating, weight loss, fear of injury, comorbidities, and treatment-related symptoms of pain and fatigue. Methods/Design: A 12-week pragmatic randomized controlled trial was conducted followed by an optional supported exercise transition phase. Eligible participants were individuals with head and neck cancers who had undergone surgery and/or radiation therapy to lymph node regions in the neck. Participants were randomized to a comparison group involving a shoulder and neck physiotherapeutic exercise protocol, or to a combined experimental group comprising the shoulder and neck physiotherapeutic exercise protocol and lower-body resistance exercise training. The primary outcome of this study was fatigue-related quality of life. Results: Sixty-one participants enrolled, 59 (97%) completed the randomized trial phase, 55 (90%) completed the 24-week follow-up, and 52 (85%) completed the one-year follow-up. Statistically significant between-group differences were found in favor of the combined experimental group for the fatigue-related quality of life, fitness outcomes, and overall physical activity. Paired comparisons confirmed significant within-group improvements for both groups from baseline to one-year follow-up across most outcomes. Discussion: A group-based combined physiotherapeutic and lower-body resistance exercise program was feasible and effective. Findings are limited to individuals who had undergone a surgical neck dissection procedure. Given the complexity of head and neck cancer, further pragmatic interdisciplinary research is warranted. [ABSTRACT FROM AUTHOR]

This systematic review and meta-analysis aimed to compare the immunogenicity and safety of an additional heterologous (viral vector) versus homologous (mRNA) COVID-19 vaccine dose among non-seroconverted immunocompromised patients after a two-dose primary series of mRNA vaccine. We searched studies published up to 21 June 2023 in PubMed, Scopus, and Embase. The meta-analysis was conducted to compare the seropositivity rates based on anti-SARS-CoV-2 spike protein IgG (anti-S IgG) and SARS-CoV-2-specific T-cell immune response rates, assessed by interferon-γ release assay at 4 weeks, and the incidences of serious adverse events (SAEs) within 28 days between the two vaccine regimens. In four included randomized controlled trials (RCTs), there were no statistically significant differences in the seropositive rate of anti-S IgG (risk ratio [RR]: 0.79, 95% CI: 0.48–1.29) and the concentration of SARS-CoV-2 interferon-γ (RR: 1.19, 95% CI: 0.96–1.48) between heterologous and homologous regimens. The heterologous regimen exhibited a significantly lower incidence of injection pain (RR: 0.55, 95% CI: 0.45–0.69), but a higher incidence of headache (RR: 1.44, 95% CI: 1.02–2.02) compared with the homologous regimen. No vaccine-related SAEs were reported within 28 days following vaccination. An additional heterologous or homologous COVID-19 vaccine dose was well tolerated and demonstrated a comparable vaccine immunogenicity among non-seroconverted immunocompromised patients who were initially vaccinated with a two-dose COVID-19 mRNA vaccine. This finding supports the recommendations of an extended primary series of COVID-19 vaccination in immunocompromised persons. [ABSTRACT FROM AUTHOR]

Synbiotics modulate the gut microbiome and contribute to the prevention of liver diseases such as metabolic-dysfunction-associated fatty liver disease (MAFLD). This study aimed to evaluate the effect of a randomized, placebo-controlled, double-blinded seven-week intervention trial on the liver metabolism in 117 metabolically healthy male participants. Anthropometric data, blood parameters, and stool samples were analyzed using linear mixed models. After seven weeks of intervention, there was a significant reduction in alanine aminotransferase (ALT) in the synbiotic group compared to the placebo group (−14.92%, CI: −26.60–−3.23%, p = 0.013). A stratified analysis according to body fat percentage revealed a significant decrease in ALT (−20.70%, CI: −40.88–−0.53%, p = 0.045) in participants with an elevated body fat percentage. Further, a significant change in microbiome composition (1.16, CI: 0.06–2.25, p = 0.039) in this group was found, while the microbial composition remained stable upon intervention in the group with physiological body fat. The 7-week synbiotic intervention reduced ALT levels, especially in participants with an elevated body fat percentage, possibly due to modulation of the gut microbiome. Synbiotic intake may be helpful in delaying the progression of MAFLD and could be used in addition to the recommended lifestyle modification therapy. [ABSTRACT FROM AUTHOR]

Background and Objectives: Cellulite, or edemato-fibro-sclerotic panniculopathy (EFP), is characterized by dermal and hypodermal changes leading to adipose tissue accumulation and compromised venous circulation. This study investigates the efficacy of a hypertonic cream containing concentrated sodium chloride (Jovita Osmocell®) in addressing water retention and structural alterations in adipose tissue, aiming to interrupt the cellulite formation process. Materials and Methods: A 12-week, prospective, monocentric, double-blind, placebo-controlled study enrolled 30 female subjects with grade II or III cellulite. Patients were randomized to receive hypertonic cream or a placebo. Thigh circumference, ultrasound evaluations, and standardized photographs were collected at baseline, intermediate, and endpoint visits. Adverse events were monitored. Results: After 84 days, the hypertonic cream group exhibited a significant reduction in thigh circumference compared to the placebo group (p = 0.0037). B-mode ultrasound examinations revealed significant changes in the parameters studied, such as the thickness of the subcutaneous tissue. No statistically significant changes were noticed in the placebo group. Volunteers reported the investigational product's pleasantness and good anti-cellulite activity, with no reported adverse events. Conclusions: The hypertonic cream demonstrated efficacy in reducing thigh circumference, addressing water retention and structural alterations in adipose tissue. The proposed mechanism involves osmosis, releasing accumulated fluids between fat cells, supporting drainage, and reducing inflammation. This study supports the efficacy and safety of hypertonic sodium chloride emulsions in cellulite treatment and confirms safety and user satisfaction. [ABSTRACT FROM AUTHOR]

Background: A healthy, well-balanced diet plays an essential role in respiratory diseases. Since micronutrient deficiency is relatively common in patients with chronic obstructive pulmonary disease (COPD), micronutrient supplementation might have the beneficial health effects in those patients. This systematic review and meta-analysis aimed to demonstrate the impact of micronutrient supplementation on the lung function of patients with COPD. Methods: The PubMed, Cochrane Library, and Web of Science databases were searched from their corresponding creation until February 2024. Search terms included 'chronic obstructive pulmonary disease', 'COPD', 'micronutrients', 'dietary supplements', 'vitamins', 'minerals', and 'randomized controlled trials'. Meta-analysis was performed to evaluate the effects of micronutrient supplementation alone or complex on lung function in patients with COPD. Results: A total of 43 RCTs fulfilled the inclusion criteria of this study. Meta-analysis revealed that vitamin D supplementation could significantly improve FEV1% (WMDdifferences between baseline and post-intervention (de): 6.39, 95% CI: 4.59, 8.18, p < 0.01; WMDpost-intervention indicators (af): 7.55, 95% CI: 5.86, 9.24, p < 0.01) and FEV1/FVC% (WMDde: 6.88, 95%CI: 2.11, 11.65, WMDaf: 7.64, 95% CI: 3.18, 12.10, p < 0.001), decrease the odds of acute exacerbations, and improve the level of T-cell subsets, including CD3+%, CD4+%, CD8+%, and CD4+/CD8+% (all p < 0.01). The effects of compound nutrients intervention were effective in improving FEV1% (WMDde: 8.38, 95%CI: 1.89, 14.87, WMDaf: 7.07, 95%CI: −0.34, 14.48) and FEV1/FVC% (WMDde: 7.58, 95% CI: 4.86, 10.29, WMDaf: 6.00, 95% CI: 3.19, 8.81). However, vitamin C and vitamin E supplementation alone had no significant effects on lung function (p > 0.05). Conclusions: Micronutrient supplementation, such as vitamin D alone and compound nutrients, has improved effect on the lung function of patients with COPD. Therefore, proper supplementation with micronutrients would be beneficial to stabilize the condition and restore ventilation function for COPD patients. [ABSTRACT FROM AUTHOR]

There are numerous recognized benefits of breastfeeding; however, sociocultural, individual, and environmental factors influence its initiation and continuation, sometimes leading to breastfeeding rates that are lower than recommended by international guidelines. The aim of this study was to evaluate the effectiveness of a group intervention led by midwives supporting breastfeeding during the postpartum period in promoting exclusive breastfeeding, as well as to assess the impact of this intervention on perceived self-efficacy. This was a non-blind, multicentric, cluster-randomized controlled trial. Recruitment started October 2021, concluding May 2023. A total of 382 women from Andalusia (Spain) participated in the study. The results showed that at 4 months postpartum there was a higher prevalence of breastfeeding in the intervention group compared to formula feeding (p = 0.01), as well as a higher prevalence of exclusive breastfeeding (p = 0.03), and also at 6 months (p = 0.01). Perceived self-efficacy was similar in both groups for the first two months after delivery, which then remained stable until 4 months and decreased slightly at 6 months in both groups (p = 0.99). The intervention improved the average scores of perceived self-efficacy and indirectly caused higher rates of exclusive breastfeeding (p = 0.005). In conclusion, the midwife-led group intervention supporting breastfeeding proved to be effective at maintaining exclusive breastfeeding at 6 months postpartum and also at increasing perceived self-efficacy. [ABSTRACT FROM AUTHOR]

A randomized, double-blind, and placebo-controlled study was conducted to assess the effect of dietary supplementation with high-rich docosahexaenoic acid (DHA) (Tridocosahexanoin-AOX® 70%) at 50 mg/kg/day in pediatric patients with cystic fibrosis (CF) as compared with placebo. The duration of supplementation was 12 months. A total of 22 patients were included, with 11 in the DHA group and 11 in the placebo group. The mean age was 11.7 years. The outcome variables were pulmonary function, exacerbations, sputum cellularity, inflammatory biomarkers in sputum and peripheral blood, and anthropometric variables. In the DHA group, there was a significant increase in FVC (p = 0.004) and FVE1 expressed in liters (p = 0.044) as compared with placebo, and a lower median number of exacerbations (1 vs. 2). Differences in sputum cellularity (predominantly neutrophilic), neutrophilic elastase, and sputum and serum concentrations of resolvin D1 (RvD1), interleukin (IL)-8 (IL-8), and tumor necrosis factor alpha (TNF-α) between the study groups were not found. Significant increases in weight and height were also observed among DHA-supplemented patients. The administration of the study product was safe and well tolerated. In summary, the use of a highly concentrated DHA supplement for 1 year as compared with placebo improved pulmonary function and reduced exacerbations in pediatric CF. [ABSTRACT FROM AUTHOR]

Background: Water consumption is believed to be a key factor in weight management strategies, yet the existing literature on the subject yields inconsistent findings. To systematically assess the scientific evidence regarding the effect of water intake on adiposity, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) among overweight and obese populations. Methods: PubMed and Embase were searched for relevant articles published up to December 2023. The summary weighted mean difference (WMD) and 95% confidence interval (CI) were estimated using the DerSimonian–Laird random-effects model. Results: In this meta-analysis of eight RCTs, interventions to promote water intake or to substitute water for other beverages as compared to the control group resulted in a summary WMD of −0.33 kg (95% CI = −1.75–1.08, I2 = 78%) for body weight, −0.23 kg/m2 (95% CI = −0.55–0.09, I2 = 0%) for body mass index (BMI), and 0.05 cm (95% CI = −1.20–1.30, I2 = 40%) for waist circumference (WC). Among RCTs substituting water for artificially sweetened beverages, summary WMD was 1.82 kg (95% CI = 0.97–2.67, I2 = 0%) for body weight and 1.23 cm (95% CI = −0.03–2.48, I2 = 0%) for WC. Conversely, among RCTs substituting water for sugar-sweetened beverages, summary WMD was −0.81 kg (95% CI = −1.66–0.03, I2 = 2%) for body weight and −0.96 cm (95% CI = −2.06–0.13, I2 = 0%) for WC. Conclusions: In conclusion, water intake may not significantly impact adiposity among overweight and obese individuals. However, replacing sugar-sweetened beverages with water might offer a modest benefit in inducing weight loss. [ABSTRACT FROM AUTHOR]

Recent research exploring the relationship between the gut and the brain suggests that the condition of the gut microbiota can influence cognitive health. A well-balanced gut microbiota may help reduce inflammation, which is linked to neurodegenerative conditions. Prebiotics, probiotics, and symbiotics are nutritional supplements and functional food components associated with gastrointestinal well-being. The bidirectional communication of the gut–brain axis is essential for maintaining homeostasis, with pre-, pro-, and symbiotics potentially affecting various cognitive functions such as attention, perception, and memory. Numerous studies have consistently shown that incorporating pre-, pro-, and symbiotics into a healthy diet can lead to improvements in cognitive functions and mood. Maintaining a healthy gut microbiota can support optimal cognitive function, which is crucial for disease prevention in our fast-paced, Westernized society. Our results indicate cognitive benefits in healthy older individuals with probiotic supplementation but not in healthy older individuals who have good and adequate levels of physical activity. Additionally, it appears that there are cognitive benefits in patients with mild cognitive impairment and Alzheimer's disease, while mixed results seem to arise in younger and healthier individuals. However, it is important to acknowledge that individual responses may vary, and the use of these dietary supplements should be tailored to each individual's unique health circumstances and needs. [ABSTRACT FROM AUTHOR]

Stress urinary incontinence (SUI) affects around 20% of women. In addition to the established suburethral sling insertion, two less invasive approaches are of interest today: urethral bulking agents and vaginal laser therapy. This review discusses articles through December 2023 identified by a PubMed literature search using the keywords "incontinence" and "bulking" or "laser". Although the two approaches are less effective than sling insertions, there are specific conditions in which one or the other technique is more advantageous. Injecting bulking agents into the urethra only takes some minutes and works without general anesthesia. The method is particularly suited for elderly, frail, or obese patients with multiple comorbidities, but is also applicable for all patients and in combination with other therapies. Generally, the safety profile is good but differs between bulking materials. Two laser types—the Erbium:YAG laser with SMOOTH-mode and the fractional ablative CO2 laser—deliver heat into the tissue to induce tissue tightening and regeneration. Intravaginal laser therapy improves mild to moderate SUI, while studies describe how intraurethral laser therapy is also beneficial for severe SUI. Young women between childbirths, as well as postmenopausal women, may benefit from laser therapy. The method is safe, can be performed on an outpatient basis, and does not require any artificial material. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to compare the clinical effectiveness of robot-assisted therapy with that of conventional occupational therapy according to the onset and severity of stroke. Methods: In this multicenter randomized controlled trial, stroke patients were randomized (1:1) to receive robot-assisted therapy or conventional occupational therapy. The robot-assisted training group received 30 min of robot-assisted therapy twice and 30 min of conventional occupational therapy daily, while the conventional therapy group received 90 min of occupational therapy. Therapy was conducted 5 days/week for 4 weeks. The primary outcome was the Wolf Motor Function Test (WMFT) score after 4 and 8 weeks of therapy. Results: Overall, 113 and 115 patients received robot-assisted and conventional therapy, respectively. The WMFT score after robot-assisted therapy was not significantly better than that after conventional therapy, but there were significant improvements in the Motricity Index (trunk) and the Fugl–Meyer Assessment. After robot-assisted therapy, wrist strength significantly improved in the subacute or moderate-severity group of stroke patients. Conclusions: Robot-assisted therapy improved the upper-limb functions and activities of daily living (ADL) performance as much as conventional occupational therapy. In particular, it showed signs of more therapeutic effectiveness in the subacute stage or moderate-severity group. [ABSTRACT FROM AUTHOR]

This study aimed to compare the video laryngoscope views facilitated by curved blades 3 and 4 with an exploration of the relationship between these views and patient height. Conducted as a randomized controlled trial, this study enrolled adults scheduled for surgery under general anesthesia. Intubation procedures were recorded, and the percentage of glottic opening was measured before tube insertion. Multivariate analysis validated the impact of various factors, including blade size and patient height, on the percentage of glottic opening scores. A total of 192 patients were included. The median percentage of glottic opening scores for curved blades 3 and 4 were 100 and 83, respectively (p < 0.001). The unstandardized coefficient indicated a significant negative impact of blade 4 on the percentage of glottic opening scores (−13, p < 0.001). In the locally estimated scatterplot smoothing analysis, blade 3 exhibited a steady rise in glottic opening scores with increasing height, whereas blade 4 showed a peak followed by a decline around 185 cm. The unstandardized coefficient of height showed no significant association (0, p = 0.819). The study observed superior laryngoscopic views with blade 3 compared to blade 4. However, no significant association was found between laryngoscopic views and patient height. [ABSTRACT FROM AUTHOR]

Background: The social restriction measures during the COVID-19 pandemic resulted in decreasing physical activity levels. We aimed to evaluate whether the interventions reported in randomized controlled trials (RCTs) assessing the effects of physical activity during the COVID-19 lockdown on people with sedentary behavior were effective. Methods: We searched several databases from their inception until 1 April 2023, including RCTs evaluating the effects of any physical activity intervention in increasing the physical activity level in people with sedentary behavior during COVID-19 confinement, based on evidence derived from intervention studies with a control group. Studies were excluded if they (i) did not include humans; (ii) did not include sufficient information regarding the interventions or regarding the outcomes of interest; (iii) did not have a control group. We used the Rayyan systematic review platform for the selection of the studies to include based on the title/abstract information. Results: Starting with 2461 records from the original literature search, and after reviewing them according to the latest PRISMA recommendations, 11 RCTs including a total of 1770 participants were available and were included in the systematic review. We found that most of the studies examined (73%) reported the beneficial effects of the proposed interventions on improving the physical activity, reducing the sedentary time, and positively contributing to the psychological well-being of the participants. Conclusions: The results of the present systematic review on RCTs of interventions to increase physical activity in sedentary people during the COVID-19 lockdown show the beneficial effects of diverse online-delivered strategies, which can be applied even after the pandemic in conditions in which access to in-person activities is not possible. [ABSTRACT FROM AUTHOR]

Background and Objectives: The purpose of this study was to compare clinical outcomes and polyethylene (PE) insert thickness between total knee arthroplasty (TKA) systems providing 1 mm and 2 mm increments. Materials and Methods: In this randomized controlled trial, 50 patients (100 knees) undergoing same-day or staggered bilateral TKA were randomized to receive a TKA system providing 1 mm increments in one knee (1 mm group) and a TKA system providing 2 mm increments in the other knee (2 mm group). At 2 years postoperatively, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, Forgotten Joint Score (FJS), range of motion (ROM), and insert thicknesses were compared between the groups. Results: A total of 47 patients (94 knees) participated in follow-up analysis. In each group, patient-reported outcomes improved significantly after TKA (all, p < 0.05). There were no significant differences in patient-reported outcomes. The mean ROM was not significantly different between groups at preoperative and 2-year points. The rate of postoperative flexion contracture ≥ 5° was 2.1% and 4.3%, and the rate of postoperative recurvatum ≥ 5° was 4.3% and 2.1% in the 1 mm group and 2 mm, respectively (all, p = 1.000). Mean insert thickness was significantly thinner in the 1 mm group than the 2 mm group (p = 0.001). The usage rate of a thick insert (≥14 mm) was 12.7% and 38.3% in the 1 mm group and 2 mm group (p = 0.005). Conclusions: The use of a TKA system providing 1 mm PE insert thickness increments offered no clinical benefit in terms of patient reported outcomes over systems with 2 mm increments at 2 years of follow-up. However, the TKA system with 1 mm increments showed significantly thinner PE insert usage. As a theoretical advantage of 1 mm increments has yet to be proven, the mid- to long-term effects of thinner PE insert usage must be determined. [ABSTRACT FROM AUTHOR]