Appropriate supplementation of vitamin D can affect infections, allergy, and mental and behavioral development. This study aimed to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants. 109 preterm infants (24 0/7–32 6/7 weeks of gestation) were randomized to receive 500 IU vitamin D standard therapy (n=55; approximately 800-1000 IU from combined sources) or monitored therapy (n=54; with an option of dose modification). 25(OH)D concentrations were measured at birth, 4 weeks of age, and 35, 40, and 52±2 weeks of post-conceptional age (PCA). Vitamin D supplementation was discontinued in 23% of infants subjected to standard treatment due to increased potentially toxic 25(OH)D concentrations (>90 ng/mL) at 40 weeks of PCA. A significantly higher infants’ percentage in the monitored group had safe vitamin D levels (20–80 ng/mL) at 52 weeks of PCA (p=0.017). We observed increased vitamin D levels and abnormal ultrasound findings in five infants. Biochemical markers of vitamin D toxicity were observed in two patients at 52 weeks of PCA in the control group. Inadequate and excessive amounts of vitamin D can lead to serious health problems. Supplementation with 800–1000 IU of vitamin D prevents deficiency and should be monitored to avoid overdose.

The present study explored the effects of a Second-generation mindfulness-based intervention known as Flow Meditation (Meditación-Fluir) in the improvement of life habits. A sample of university students (n = 51) in Spain were randomly assigned to a seven-week mindfulness treatment or a waiting list control group. Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures, including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by emotional states negative, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol and cannabis consumption, and resting habits. There were differences between males and females in some of these variables and a better effect of the treatment was evident in the females of the experimental group as compared to males. The Flow Meditation program shows promise for fostering healthy life habits, thus decreasing behaviors related to maladaptive eating, tobacco, alcohol and drug consumption, as well as negative resting habits, in university students. This mindfulness program can significantly contribute in the treatment of eating disorders and addictions, wherein negative emotional states and impulsivity are central features of the condition.

As the world’s population age, Cognitive Frailty (CF) is becoming one of the most serious health problems and elucidating its biological mechanisms along with prevention and treatments becomes increasingly important also considering the associated health costs. This pilot study aims to investigate the potential cognitive and neuropsychological effects of a 5-week treatment with a therapy based on the regenerative properties of ozone (O3) in a cohort of patients stratified according to CF. We also study the potential effects of O3 on blood-based biomarkers indicative of specific biological systems that may be altered in CF. Seventy-five older persons have been recruited and randomly assigned to receive the active treatment (150cc of oxygen-O2-O3 mixture at the concentration of 30ug of O3 per cc of O2) or O2, or the placebo (air) for 5 weeks. The primary endpoint is a change in the scores of clinical scales from baseline (T0) to weeks 3 (T3), 9 (T9), 15 (T15) after treatment. The secondary endpoint is a change in biomarkers levels resulting from transcriptomics, proteomics and metabolomic patterns at the same times. This study will evaluate whether an intervention with the O2-O3 therapy could have potential cognitive, neuropsychological and biological effects on CF.

Background and Objectives: In this current state, Type 2 Diabetes Mellitus (T2DM) is more prevalent in the population, and metformin is used as a first-line medication for treating it. There was up surge in the utilization of alternative therapies in the management of diabetes. Especially in diabetes, Herbal medicines are considered safe and reliable by majority of the population. Aim: The purpose of this research is aimed to estimate the safety and efficacy of Polyherbal Metabolite Compounds (PHMC) capsules in adults with T2DM. Materials and Methods: In this study, 60 T2DM patients aged 18-60 years were randomly assigned to Groups A (30) receiving Metformin 500 mg twice a day after food and Group B (30) receiving PHMC capsule 500 mg twice a day after food in a prospective, randomized and open-label clinical study. The in-silico simulation study was performed to selected plants major compounds on target protein Insulin-like Growth Factor-1 (1K3A). Result: The PHMC is found to be safe and effective in the management of T2DM. The FBS, PPBS and HbA1c were significantly lowered (p

This multi-center, single-blinded, randomized controlled study assessed the efficacy of phased exercise rehabilitation programs in patients who underwent a total knee arthroplasty (TKA) and investigated suitable exercise types, intensities, and frequencies for patients undergoing postoperative rehabilitation. Between January and March 2018, 494 patients who had undergone TKA were treated at two medical centers. Patients were randomized and allocated to the rehabilitation group (n=330) or the control group (n=164; treated with postoperative care). The 100-mm Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), range of motion, and Short-Form 36 (SF-36) scores were assessed and compared between the two groups. The average WOMAC score was 84.40±15.20 in the rehabilitation group and 108.30±3.90 in the control group (p=0.009). The mean VAS score was 2.54±0.16 in the rehabilitation group and 2.87±0.31 in the control group (p=0.024). Furthermore, the range of motion was 125.02±6.20 in the rehabilitation group and 116.40±1.40 in the control group (p=0.017). The mean SF-36 score was 105.40±21.50 in the rehabilitation group and 83.70±5.01 in the control group (p=0.043). This study suggests that the phase rehabilitation program could be more effective at improving pain, knee function, and quality of life than condition postoperative care after TKA.

Despite the expansion of financial institutions and proliferation of mobile financial services, reaching the unbanked and bringing them under formal financial services has become a policy concern in many developing countries. Due to the lack of financial accounts, unbanked people prefer informal, risky, and inconvenient mechanisms for receiving, sending and transferring money. Previous studies rely much on common intervention like no account maintenance and opening fees, easy documentation processes and money subsidies for opening financial accounts. This study aims to examine the impact of the motivational workshop on opening savings accounts through causality among the unbanked people in a setting where the respondents are unbanked despite having all the requirements and many institutional offers for opening savings accounts. We encouraged the unbanked people through a one-hour-long motivational workshop to open saving account. Based on our cross-sectional data and randomized controlled trial experiment among 505 unbanked Village Defense Party (VDP) members at Dhubil Union under Sirajganj in Bangladesh, we have the evidence that motivational workshop positively impacts opening ac-counts by 32.33 percent. However, the account opening rate differs in terms of respondent’s pref-erence for financial institutions. Our study also finds that unbanked people have the highest pref-erence for mobile financial services for opening accounts resulting in 15.33 percent. The result of the study has some policy implications for adopting effective strategies of financial access in many developing countries.

Mediterranean diet, featuring sourdough bread, shows promise in managing metabolic syndrome. This study explored the effects of two sourdough breads with differing fermentation times but similar nutritional profiles on inflammation, satiety, and gut microbiota composition in adults with metabolic syndrome. The double-blind clinical trial randomized participants to consume over two-months Elias Boulanger® long fermentation (48h) sourdough bread (EBLong) or Elias Boulanger® short fermentation (2h) sourdough bread (EBShort). We assessed clinical parameters, inflammatory- and satiety-related biomarkers; and richness and abundance of gut microbiota at baseline and follow-up. 31 individuals (mean age: 67, 55.7% female) participated. EBShort was associated with reduced soluble intercellular adhesion molecule (sICAM) levels, and irrespective of the adjudicated intervention, all participants had a decrease in sICAM and diastolic pressure relative to baseline (p<0.017). At follow-up, plasminogen activator inhibitor-1 (PAI-1) levels were lower in EBShort (-744 pg/mL; 95%CI: -282 to -1210 pg/mL) compared to EBLong. High-quality sourdough bread may offer mild benefits in blood pressure and inflammation for those with metabolic syndrome, however, only EBLong was associated to reduced Enterobacteriaceae abundance. Further research is needed to understand potential benefits and mechanisms of sourdough bread in managing metabolic syndrome and improving cardiovascular health.

Depression and anxiety in cardiovascular disease worsen the prognosis of patients. Treatments for these disorders often provide limited improvement. The present study aimed to test, for the first time, the impact of educational technology on anxiety and depressive symptoms in patients participating in a cardiac rehabilitation program. A 12-month randomized controlled trial was conducted, in which 207 patients were randomly assigned to either the experimental (n=76) or control (n=69) groups. The intervention involved a structured patient education program provided by medical students who had undergone specially designed training in cardiac rehabilitation. The primary outcomes were death, hospitalization, heart failure, and recurrent myocardial infarction. The study also assessed anxiety and depression. A year later, the experimental group showed a statistically significant decrease in anxiety and depression on the HADS scale, with reductions of 2.0 and 1.9 points respectively (p<0.05). The control group showed reductions of 1.5 and 1.2 points (p<0.05). The difference in depression (HRDS) between the groups at 12 months was -1.29 in favor of the main group (95% CI, -0.7 to -1.88), and the standardized effect size (SMD) was 0.36 (95% CI, 0.03 to 0.69). No treatment-related adverse events were observed. The results suggest that educational interventions can have a positive impact on mental health. The study's strengths include a structured intervention, randomization, and long-term follow-up. Limitations include the lack of blinding of study participants and a relatively small sample size.

This study aimed to investigate the efficacy of manual therapy and exercise versus synchronized telerehabilitation with self-manual therapy and exercise in treating Subacromial Pain Syndrome (SAPS). Sixty individuals diagnosed with SPS, aged 18-50 years, were randomly assigned to home exercise (HE), manual therapy (MT), and telerehabilitation (TR) groups. Treatment protocols were administered over 8 weeks and included specific exercises and therapy interventions. Out-come measures included Visual Pain Scale (VAS), shoulder range of motion (ROM) via gonio-metric measurements, Quick Disability Arm-Shoulder-Hand Problems Survey (Q-DASH), and patient satisfaction. Results revealed that both MT and TR groups exhibited reduced pain, in-creased ROM, lower Q-DASH scores, and higher patient satisfaction compared to the HE group. However, no significant differences were found between MT and TR groups in pain levels, ROM, Q-DASH scores, or patient satisfaction. The study concludes that both telerehabilitation and manual therapy effectively alleviate pain and are well-received by patients with SPS. Addition-ally, manual therapy demonstrates superiority in enhancing functional levels compared to exer-cise-based interventions. (Registration: NCT05200130)

Executive functioning is a key component involved in many of the processes necessary for effective weight management behavior change (e.g., setting goals). Cognitive behavioral therapy (CBT) and third-wave CBT (e.g., mindfulness) are considered first-line treatments for obesity, but it is unknown to what extent they can improve or sustain executive functioning. This pilot randomized controlled trial examined if a CBT-based generalized weight management intervention would affect executive functioning and executive function-related brain activity in individuals with obesity or overweight. Participants were randomized to an intervention condition (N=24) that received the Noom Weight program or to a control group (N=26) receiving weekly educational newsletters. EEG measurements were taken during Flanker, Stroop, and N-back tasks at baseline and months 1 through 4. After 4 months, the intervention condition evidenced greater accuracy over time and, to some extent, neural markers of executive function (error-related negativity and beta and gamma band powers) compared to the control group on the Flanker and Stroop tasks. The intervention condition also lost more weight than controls (-7.1 pounds vs. +1.0 pounds). Given mixed evidence on whether CBT-based interventions can change markers of executive function, this study contributes preliminary evidence that a multicomponent CBT-based weight management intervention (i.e., that provide both support for weight management and is based on CBT) can help individuals sustain executive function compared to controls.

Severe postoperative pain affects most patients after thoracotomy and is a risk factor for post-thoracotomy pain syndrome (PTPS). This randomized controlled trial compared preemptively administered ketamine versus paravertebral block (PVB) versus control in patients undergoing posterolateral thoracotomy. The primary outcome was acute pain intensity on the visual analog scale (VAS) on the first postoperative day. Secondary outcomes included morphine consumption, patient satisfaction, and PTPS assessment with Neuropathic Pain Syndrome Inventory (NPSI). Acute pain intensity was significantly lower with PVB compared to other groups at four out of six time points. Patients in the PVB group used significantly less morphine via a patient-controlled analgesia pump than participants in other groups. Moreover, patients were more satisfied with postoperative pain management after PVB. PVB, but not ketamine, decreased PTPS intensity at 1, 3, and 6 months after posterolateral thoracotomy. Acute pain intensity at hour 8 and PTPS intensity at month 3 correlated positively with PTPS at month 6. Bodyweight was negatively associated with chronic pain at month 6. Thus, PVB but not preemptively administered ketamine decreases both acute and chronic pain intensity following posterolateral thoracotomies. The trial was prospectively registered at the Australian New Zealand Clinical Trial Registry (https://www.anzctr.org.au/; ACTRN12616000900415; 07 July 2016).

Background: this RCT assesses the 18 months clinical outcomes after regenerative therapy of periimplantitis lesions using either an electrolytic method (EC) to remove biofilms or a combination of powder spray and electrolytic method (PEC). Materials and Methods: Twenty-four patients (24 implants) suffering from periimplantitis were randomly treated by EC or PEC followed by augmentation and submerged healing. Probing pocket depth (PPD), Bleeding on Probing (BoP), suppuration and standardized radiographs were assessed before surgery (T0), 6 months after augmentation (T1), 6 (T2) and 12 (T3) months after replacement of the restoration. Results: Mean of PPD changed from 5.8 ± 1.6 mm (T0) to 3.1 ± 1.4 mm (T3). While BoP and suppuration at T0 was 100 % BoP decreased at T2 to 36.8 % and at T3 to 35.3 %. Suppuration could be found 10.6% at T2 and 11.8% at T3. Radiologic bone level measured from the implant shoulder to the first visible bone to implant contact was 4.9 ± 1.9 mm at me-sial and 4.4 ± 2.2 mm at distal sites (T0) and 1.7 ± 1.7 mm and 1.5 ± 17 mm at T3. Conclusions: Significant radiographic bone fill and improvement of clinical parameters were demonstrated 18 months after therapy.

To compare surgical and refractive outcomes between phacotrabeculectomy (P-Trab) and phaco with Ex-PRESS (P-Ex-PRESS) for glaucoma at 6-month follow-up. This prospective randomized controlled trial included 81 eyes; 43 (53%) and 38 (47%) were assigned to the P-Ex-PRESS and P-Trab groups, respectively. Refraction, intraocular pressure (IOP), and best-corrected visual acuity were measured. Refractive change was described by analyzing the magnitude of the cylinder, and polar analysis assessed the change in trend of astigmatism [with-the-rule, against-the-rule (ATR), oblique] evaluating mean astigmatism in centroid form. All patients showed statistically significant postsurgical decrease in IOP (P<0.05). There were no differences neither between the groups for postoperative IOP or visual outcomes, nor in astigmatism before or after surgery (P=0.61, P=0.74). In both groups, the mean pre- and postoperative astigmatism was ATR and OBL, respectively. Pre- and postoperative centroids in the P-Ex-PRESS group were 0.44±1.32 D at 177˚ and 0.35±1 D at 8˚, respectively, (P=0.5) and in the P-Trab group, 0.16±1.5 D at 141˚ and 0.39±1.38 D at 29˚, respectively (P=0.38). Both P-Ex-PRESS and P-Trab showed comparable antihypertensive efficacy in treating open-angle glaucoma in a 6-month period. Pre- and postoperative astigmatism did not differ between groups. The groups showed comparable results for final visual acuity.

This article describes rationales and limitations for making inferences based on data from randomized controlled trials (RCTs). We argue that obtaining a representative random sample from a patient population is impossible for a clinical trial because patients are accrued sequentially over time and thus comprise a convenience sample, subject only to protocol entry criteria. Consequently, the trial’s sample is unlikely to represent a definable patient population. We use causal diagrams to illustrate the difference between random allocation of interventions within a clinical trial sample and true simple or stratified random sampling, as done in surveys. We argue that group-specific statistics, such as a median survival time estimate for a treatment arm in an RCT, have limited meaning as estimates of larger patient population parameters. In contrast, random allocation between interventions facilitates comparative causal inferences about between-treatment effects, such as hazard ratios or differences between probabilities of response. Comparative inferences also require the assumption of transportability from a clinical trial’s convenience sample to a targeted patient population. We focus on the consequences and limitations of randomization procedures in order to clarify the distinctions between pairs of complementary concepts of fundamental importance to data science and RCT interpretation. These include internal and external validity, generalizability and transportability, uncertainty and variability, representativeness and inclusiveness, blocking and stratification, relevance and robustness, forward and reverse causal inference, intention to treat and per protocol analyses, and potential outcomes and counterfactuals.

Several studies have shown that tapering or stopping disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients in sustained remission is feasible. However, tapering/stopping bears the risk of decline in physical function as some patients may relapse and face increased disease activity. Here we analysed the impact of tapering or stopping DMARD treatment on the physical function of RA patients. The study was a posthoc analysis of physical functional worsening for 282 patients with RA in sustained remission tapering and stopping DMARD treatment in the prospective randomized RETRO study. HAQ and DAS-28 scores were determined in baseline samples of patients continuing DMARD (arm 1), tapering their dose by 50% (arm 2), or stopping after tapering (arm 3). Patients were followed over 1 year, and HAQ and DAS-28 scores were evaluated every 3 months. The effect of treatment reduction strategy on functional worsening was assessed in a recurrent-event Cox regression model with a study-group (control, taper, taper/stop) as the predictor. 282 patients were analysed. In 58 patients, functional worsening was observed. The incidences suggest a higher probability of functional worsening in patients tapering and/or stopping DMARDs, which is likely due to higher relapse rates in these individuals. At the end of the study, however, functional worsening was similar among the groups. Point estimates and survival curves show that functional decline after tapering or stopping DMARDs in RA patients with stable remission is small and related to relapses but to on overall functional decline.

Objective: The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults. Methods: Subjects (3x10³ ≤ peripheral blood leukocyte levels < 8x10³ cells/μl) who met the inclusion criteria were recruited for this study. Enrolled subjects (n=120) were randomly assigned to either the PTE group (n=60) who were given 2.5 g/day of PTE (as Porphyra tenera extract) in capsule form or the placebo group (n=60) who were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed by measuring natural killer cell (NK-cell) activity, cytokines, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks. Results: Compared to baseline, NK cell activity (%) increased for all effector cell to target cell ratios in the PTE group after 8 weeks, but there were no changes in the placebo group (p<0.1). Subgroup analysis of 101 subjects without an URI revealed that NK-cell activity in the PTE group tended to be increased for all E:T ratios (E:T=12.5:1 p=0.068; E:T=25:1 p=0.036; E:T=50:1 p=0.081) compared to the placebo group. There was a significant difference between these two groups for the E:T=25:1 ratio, which increased from 20.3±12.0% at baseline to 23.2±12.4% after 8 weeks in the PTE group (p=0.036). There was no significant difference in levels of cytokines between these two groups. Conclusions: PTE supplementation appears to enhance immune function by improving NK-cell activity without adverse effects in healthy adults.

Background: This study explored maternal gut, breast milk and infant gut microbiomes as possi-ble mediators of the observed effects of a relaxation intervention which reduced maternal stress and promoted infant weight gain. Methods: A randomized controlled trial was conducted in healthy Chinese primiparous mother-infant pairs. Mothers were randomly assigned to interven-tion group (IG, listening to relaxation meditation) or control group (CG). Outcomes were differ-ences in microbiome composition and diversity in maternal gut, breast milk and infant gut at 1- and 8-weeks between IG and CG, assessed by 16S rRNA gene amplicon sequencing of fecal and breastmilk samples. Results: 38 mother-infant pairs were included in this analysis (IG=19, CG=19). Overall microbiome community structure in the maternal gut was significantly different between IG and CG at 1-week and the difference was more significant at 8 weeks (Bray-Curtis distance R2=0.04 vs. R2=0.13). Post-intervention, the α-diversity was significantly lower in IG breast milk (observed features: CG=295 vs. IG=255, p=0.032); the Bifidobacterium genera presented higher relative abundance. In parallel, significantly higher α-diversity was observed in IG infant gut (observed features: CG=73 vs. IG=113, p

In this pilot study, 84 subjects with a history of poor oral hygiene were enrolled in an interventional, randomized, prospective, open-label controlled trial. The aim was to provide preliminary clinical data on the products, the recruitment monthly rate, and patient satisfaction to estimate resources for the main study, as well as descriptive data on oral microbiota rebalancing. The population was divided into five groups: 20 participants received delicate mint toothpaste, 12 mint toothpaste, 20 mint mouthwash, and 20 delicate mint toothpaste and mint mouthwash using a specifically custom-designed toothbrush. The 12 subjects in the control group continued to use their oral care products without changing their normal routine. The study duration was 28 days.All subjects tolerated the products well, and there were no adverse events. Recruitment capability and procedures allowed a realistic estimation for the future main trial. The products did not cause any changes in tooth color. The participants who completed the treatment consisting of delicate mint toothpaste, mint mouthwash, and the specifically custom-designed toothbrush showed the gingival sensitivity best results (p≤0.000). The products induced a statistically significant decrease in plaque in all treated groups (p≤0.000) and an improvement of gingival sensitivity (delicate mint toothpaste, p≤0.005; mint toothpaste, p≤0.015; and mint mouthwash, p≤0.015). All the products were effective in stabilizing the oral microbiota.The tested products showed an optimal safety profile. They also stabilized the biodiversity of the oral microbiota, making it less susceptible to microbial fluctuations than the control group.

Background: This study aimed to develop and evaluate a dietary self-care promotion program for hemodialysis patients based on Hurley's self-efficacy model. Methods: The needs of hemodialysis patients were identified, and an online community-based dietary self-care promotion program was developed with expert evaluations. 44 hemodialysis patients were randomly assigned to an experimental group (n=22) and a control group (n=22). The program was applied to the experimental group for four weeks. Before and after the intervention, as well as four weeks after the intervention, dietary self-efficacy, dietary self-care behavior, interdialytic weight gain, serum phosphorus, and serum potassium were assessed in both groups. Results: Significant differences over time and between groups were observed in dietary self-efficacy, interdialytic weight gain, serum phosphorus, and serum potassium. The interaction between time and group was also significant. While no significant differences were found over time in dietary self-care behavior, significant group differences and interaction effects between time and group were identified. Conclusions: The results indicate that the dietary self-care promotion program using an online community for hemodialysis patients is more effective in enhancing dietary self-efficacy and dietary self-care behavior compared to conventional treatment. This suggests the clinical applicability of the proposed dietary self-care promotion program.

Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double-blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and acceptability of the intervention in preparation for a future 8-week RCT which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed (n=10) and non-depressed (n=6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to diet allocation and study hypotheses. Health questionnaires were completed before and after the intervention, and, throughout the study, questionnaires assessed ratings of liking and sensory properties of the meals, adherence, and open-ended feedback. In the ND group, 75% of participants consumed no non-study foods, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.

The purpose of this study is to explore the effects of dual-task training, including cognitive tasks, on cognitive and bodily functioning and β-amyloid levels in Alzheimer's dementia patients. The subjects were 34 inpatients diagnosed with Alzheimer's dementia at a nursing hospital located in Gyeongsansi, South Korea. The patients were randomly divided into a dual-task group (n = 16) and a single-task group (n = 18). The dual-task group performed cognitive tasks at the same time as exercising tasks, while the single-task group performed only exercise tasks. Each group was trained for 30 minutes three times a week for eight weeks. The Mini-Mental State Examination was used to measure the patients’ cognitive function. Static and dynamic balance were measured to evaluate bodily functioning. Static balance was measured using Biorescue, while dynamic balance was measured using the Berg Balance Scale. Blood analysis was performed to measure levels of β-amyloid, which is known to cause Alzheimer's dementia. Both groups exhibited statistically significant improvements in gait function after the training (p < .05). The dual-task group exhibited statistically significant differences in cognitive function, static and dynamic balance function, and β-amyloid levels after training (p < .05). A significant difference was observed between the two groups (p < .05). Dual-task activities were found to be effective in improving cognitive and bodily functioning and reducing β-amyloid levels in Alzheimer's dementia patients. Therefore, dual-task training is thought to be an effective method of treating and preventing Alzheimer's dementia.

To assess the clinical efficacy of a novel organic olive oil-based denture adhesive and its effect on Candida Albicans growth in maxillary edentulous individuals wearing complete dentures. Individuals were selected from two Dental Schools in Portugal and Spain. Twenty-eight complete dentures were relined, following a standardized protocol. The novel product (Test) was compared with a commercialized adhesive (Control) and Vaseline (Placebo) randomly assigned in a cross-study design. The retention resistance was measured with a Gnathometer and a dynamometer, the patient related outcome evaluations with a 5-points questionnaire and the Candida albicans growth in a Sabouraud dextrose agar (SDA) medium in order to evaluate differences between the placebo and experimental product. Twenty-three participants were included. Dynamometer evaluation showed significant differences between not using a denture adhesive and using either (experimental, p = .03; control, p = .04), no significant differences between the two adhesives (p &gt; .05). In the subjective analysis, the experimental adhesive showed a significantly longer effectiveness (p = .001); the control reported better results at taste (p = .03) in chewing (p = .001). The test adhesive showed better (p &lt; .001) Candida albicans growth inhibition. The experimental adhesive showed longer effectiveness than the control and placebo with a better inhibition capacity for the growth of Candida albicans, patients reported better abilities for speech, chewing, taste and retirement in the control adhesive.

In schizophrenia, cognition is closely linked to social competence and influences long-term prognosis. Thus, treatment should target cognitive improvement to enhance the patients’ 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 group and treatment usual care (TAU) and 15 to the TAU alone groups. Over 12 weeks, patients received CR twice weekly, including two computer sessions and one verbal session. 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 Scale for the Assessment of Negative Symptoms, and functional level using modified Global Assessment of Functioning scale for Functioning. The CR + TAU group demonstrated considerable improvements in cognition, intrinsic motivation, negative symptoms, and functional level compared to the TAU-alone group. These findings indicate that the CR using RehaCom® enhances cognition and other outcomes in schizophrenia.

(1) Background: Ferric carboxymaltose (FCM) is an intravenous (IV) high-dose iron that is effective in the treatment of iron deficiency anemia. This study was to determine if preoperative IV FCM administration could improve recovery from postoperative anemia in patients undergoing revision total joint arthroplasty. (2) Methods: This prospective randomized controlled study analyzed 82 patients undergoing revision total joint arthroplasty during a single hospitalization. Patients in the iron group (n = 41) were administered 1000 mg of IV FCM two weeks preoperatively, while those in the control group (n = 41) were not. Moreover, patients with anemia defined as a preoperative suboptimal Hb concentration &lt;13.0 g/dl were compared according to IV FCM administration. The absolute Hb levels and changes in Hb levels, iron profiles, transfusion rate, and EuroQOL 5-dimension (EQ-5D) scores were compared. (3) Results: There were no significant differences in recovery of Hb levels at each timepoint between the two groups; however, the changes in Hb levels from baseline to four weeks postoperatively showed marginally significant differences favoring the iron group (p = 0.052). However, for preoperatively anemic patients, the change in hemoglobin (Hb) levels between baseline and four weeks postoperatively was significantly better in the iron group than in the control group (iron group [n = 26], −0.3 ± 0.7 g/dL vs. control group [n = 27], −0.9 ± 0.8 g/dL; p = 0.040), although the absolute Hb levels, transfusion rates, and patient quality of life were comparable (all p &gt; 0.05). The iron group showed improved iron metabolite levels including serum ferritin and transferrin saturation four weeks postoperatively, and no adverse events associated with IV FCM administration occurred in either group. (4) Conclusions: Preoperative IV FCM in anemic individuals undergoing revision joint arthroplasty was effective in accelerating recovery from surgery-related anemia by improving Hb levels without any adverse events, despite similar actual Hb levels between the groups. Our findings are clinically relevant and can facilitate determination of the suitability of IV FCM as a safe and reliable protocol for iron supplementation for anemia correction.

This study tests the utilization of Bluetooth noise-canceling headphones in improving the quality of eye exams in patients with hearing loss. University of Texas Medical Branch patients above 55 years of age were screened for hearing loss using SoundCheck audiometry. All 29 subjects (18 red-zone and 11 yellow-zone) answered pre-recorded Amsler grid and patient education questions that solicited precise responses. As controls, subjects were randomly administered half of the questions via headphones and half via a smartphone at normal speech volume (60 decibels). Points were awarded for responses demonstrating comprehension, and a post-exam survey was collected. Collectively, the mean score was 1.79 with headphones versus 0.96 with control on the Amsler grid segment and 1.90 with headphones versus 0.97 with control on education questions (p=0.001). Between the red and yellow zone hearing loss patients, the red-zone group answered significantly better in both Amsler (1.78 versus 0.50; p=0.0003) and education questions (1.88 versus 0.44; p&lt;0.0001) with headphones. The yellow zone group answered better with headphones overall but failed to reach significance. Post-exam survey indicated that 28 of 29 patients (97%) preferred the headphones during ophthalmic exams. Patients with severe hearing loss demonstrated better comprehension with the noise-canceling headphones; thus these devices show great promise in improving effective, compassionate communication between providers and hearing-loss patients.

Background and aim. The study aimed to assess the efficacy of the treatment of Kan Jang®, a fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and Eleutherococcus senticosus (Rupr. & Maxim.) Maxim in patients with mild symptoms of COVID-19. Methods. One hundred forty patients received six capsules of Kan Jang® (n = 68, daily dose of andrographolides – 90 mg) or placebo (n=72) and supportive treatment (paracetamol) for 14 consecutive days in a randomized, quadruple-blinded, placebo-controlled, two-parallel-group design. The efficacy outcomes were the rate of cases turning to severe, the detection rate of SARS-CoV-2 virus over the time of treatment, the duration and the severity of symptoms (sore throat, runny nose, cough, headache, fatigue, loss of smell, taste, pain in muscles) in the acute phase of the disease. Other efficacy measures included improving cognitive and physical performance, quality of life, and the levels of inflammatory blood markers - IL-6, c-reactive protein, and D-dimer. Results. Kan Jang® significantly (p < 0.05) reduced the rate of cases turning to severe (5.36%) compared to placebo (17.86%) and decreased the detection rate of SARS-CoV-2 virus over the time of treatment. The statistical difference in the rates of patients with clinical deterioration in the Kan Jang treatment and placebo control groups was significant (p = 0.0176) both in 112 patients included per protocol (IPP) analysis and in 140 patients included per intention to treat (ITT) analysis (p = 0.0236); the absolute risk reduction of cases by Kan Jang treatment was 12.5%, and the number Needed to Treat by Kan Jang was 8. The patient's recovery time (Number of sick days at the home/clinic) was shorter in the Kan Jang group compared with the placebo group. The rate of resolution of inflammatory symptoms in the Kan Jang® group was significantly higher compared with the placebo group, and relief of the severity of cough, sore throat/pain, runny nose, and muscle soreness. Kan Jang® significantly decreased the Wisconsin Upper Respiratory Symptoms scores compared to placebo in the sample size of 140 patients. However, the relief of fatigue and headache and the decrease of IL-6 in the blood was observed only in a subset of the 86 patients infected during the second three waves of the pandemic. Kan Jang® significantly increased physical activity and workout; however, it did not affect cognitive functions (attention and memory), Quality of life Score, inflammatory markers D-dimer, and c-reactive protein compared with the placebo group. Conclusions. Overall, the results of this study suggest that Kan Jang® is effective in treating mild and moderate COVID-19 irrespective of SARS-Cov-2 variants infection.

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

Exercise training influences the risk of vascular thrombosis in patients with peripheral arterial disease (PAD). Mitochondrial functionalities in platelets involve the cellular bioenergetics and thrombogenesis. This study aimed to elucidate the effect of cycling exercise training (CET) on platelet mitochondrial bioenergetics in PAD patients. Forty randomly selected patients with PAD engaged in general rehabilitation (GR) with CET (i.e., cycling exercise at ventilation threshold for 30 min/day, 3 days/week) (GR+CET, n=20) or to a control group that only received GR course (n=20) for 12 weeks. Systemic aerobic capacity and platelet mitochondrial bioenergetics that included oxidative phosphorylation (OXPHOS) and electron transport system (ETS) were measured using automatic gas analysis and high-resolution respirometry, respectively. The experimental results demonstrated that GR+CET for 12 weeks significantly (i) elevated VO2peak and lowered VE-VCO2 slope, (ii) raised resting ankle-brachial index and enhanced cardiac output response to exercise, (iii) increased the distance in 6-minute walk test and raised the Short Form-36 physical/mental component scores, and (iv) enhanced capacities of mitochondrial OXPHOS and ETS in platelets by activating FADH2 (Complex II)-dependent pathway. Moreover, changes in VO2peak levels were positively associated with changes in platelet OXPHOS and ETS capacities. However, no significant changes in systemic aerobic capacity, platelet mitochondrial bioenergetics, and health-related quality of life (HRQoL) occurred following GR alone. Hence, we conclude that CET effectively increases the capacities of platelet mitochondrial bioenergetics by enhancing Complex II activity in patients with PAD. Moreover, the exercise regimen also enhanced functional exercise capacity, consequently improving HRQoL in PAD patients.

High fructose and sugar-sweetened soft drink (SSSD) intakes are associated with elevated blood uric acid concentrations and increased risk of gout and cardiovascular disease. Fruits are naturally high in fructose but their effect on cardiometabolic risk is unknown. We examined the effect on serum uric acid and cardiometabolic risk factors of consuming fructose from either fruit or SSSD in overweight adults. 48 healthy, overweight (BMI≥ 28 kg/m²) men (n=21) and women (n=20) were randomised to either a fruit (n = 19) or SSSSD (n = 22) intervention for 4 weeks. The fruit group received 6 items of fresh and dried fruit per day and the SSSD group received 955ml of SSSD per day with treatments matched for energy and fructose content. Serum uric acid concentrations were significantly reduced in men in the fruit group compared to the SSSD group (difference 57.2 μmol/L [95% CI: 16.4, 98.0], p= 0.008) but there was no difference amongst women (1.3 μmol/L [95%CI: -9.5, 6.9], p= 0.295). There differences in weight change or other cardiometabolic risk factors. These findings suggest no need to restrict fruit intake in individuals with elevated serum uric acid concentrations, such as those with gout.

The study's objective was to assess the impact of Mediterranean diet/lifestyle interventions for weight loss on Positive airway pressure (PAP) adherence, Body mass index (ΒΜΙ), sleepiness, and blood pressure measurements (BP) in patients with obstructive sleep apnea (OSA). We designed a randomized, controlled trial, including overweight and obese patients with moderate-to-severe OSA, randomized to standard care (SCG, n=37) and Mediterranean diet group (MDG, n=37). SCG received healthy lifestyle advice, while MDG underwent a 6-month behavioral intervention aiming to enhance weight loss and adherence to Mediterranean diet. PAP adherence, BMI, Epworth Sleepiness Scale (ESS) and BP measurements were evaluated pre- and post-intervention. Post-intervention PAP use was higher in MDG compared to SCG (6.1 vs 5.4, p=0.02). Diet/lifestyle intervention was one of the most significant predictive factors for PAP adherence (OR = 5.458, 95% CI = 1.144-26.036, p=0.03). The SCG demonstrated a rise in BMI, while the MDG displayed a decline (0.41 vs -0.75, p=0.02). The MDG also demonstrated a substantial reduction in adjusted SBP (-5.5 vs 2.8, p=0.014) and DBP (-4.0 vs 2.5, p=0.01). Ultimately, incorporating a dietary/lifestyle intervention with standard care yields superior PAP adherence, BMI, and BP measurements in contrast to standard care alone, underscoring the potential benefits of allocating increased time and support within the MDG group. Trial registry: ClinicalTrials.gov; No.: NCT05881824; URL: www.clinicaltrials.gov.

Background: Evidence supports a causal relationship between circadian disturbance and impaired glucose homeostasis. Method: To determine the effect of a nursing educational intervention on improving healthy sleep, a parallel, open-label clinical trial in subjects with Impaired Fasting Glucose (IFG) or Type 2 Diabetes Mellitus (T2DM) and 18 and older was performed. Study variables were sex, age, fasting glucose, glycated hemoglobin A1c (HbA1c), Pittsburgh Sleep Quality Index (PSQI), sleep duration and efficiency, BMI, antidiabetic treatment and diet and physical exercise. An individual informative educational intervention was carried out following a bidirectional feedback method. It was intended to develop skills to improve sleep through 9 simple tips. An analysis of covariance was performed on all the mean centered outcome variables controlling for the respective baseline scores. Results: After the intervention, in the experimental group, PSQI dropped, the duration and quality of sleep increased. Further, a decrease in fasting glucose and in HbA1c levels was observed. Conclusion: The proposed intervention has proven to be effective to improve sleep quality, time, and efficiency and in only 3 months, to achieve a decrease in fasting glucose and HbA1c levels. These findings support the importance of sleep and circadian rhythms education focused on improving in T2DM or IFG.

To resolve problems in the dietary life of university athletes, education is essential for enabling athletes to change their own dietary behavior. The purpose of this research, it was decided to verify the effectiveness of sports nutrition education based on self-determination theory (SDT). Methods, the subjects were thirty-six male university rowers. A stratified randomized comparison test was conducted by student year (SDT group and control group). Sports nutrition education was held three times, via an Internet conferencing system. Furthermore, group work over social media was used for the SDT group. Four evaluations were carried out based on anthropometric measurements, brief-type self-administered diet history questionnaire (BDHQ),sports nutrition knowledge (SNK), and treatment self-regulation questionnaire (TSRQ). Results, for the intra-group factor "Protein," a significant difference was evident in the self-determination theory group (50.0±28.5, 78.6±28.1, 81.0±21.5, p<0.000, units: %), and there were significant differences between after and before, and between three months after and before (p=0.002, p=0.002). For BDHQ, significant differences were evident for green/yellow vegetables, fruits, and dairy between after and before for the self-determination theory group (159.1±74.2-126.7±70.6, p=0.009, 306.0±196.2-195.2±146.1, p=0.020, 257.0±147.0-183.3±167.9, p=0.040, units: g). In conclusion, sports nutrition education based on SDT improved dietary knowledge and increased dietary intake.

Attention deficit hyperactivity disorder (ADHD) results in various functioning impairments in children’s lives and families. Parents of children with ADHD report high levels of parenting stress, low levels of parental self-efficacy and use of more authoritarian and/or permissive parenting practices than parents of typically developing children. Intervention programs need to address both children’s and parents’ needs and multimodal intervention programs could cover this demand. The aim of this study was to examine the efficacy of “Child ViReal Support Program” - a multi-level evidence-based comprehensive program - on parenting stress, parental self-efficacy, parenting practices, and the core symptoms of children’s ADHD. Families with a child diagnosed with ADHD (n = 16) were randomly allocated to two groups (PC and CP; P = parent training, C = child training) and a cross-over design was utilized. Participating parents completed, in four different times during the study, the Parenting Stress Index-Short Form, the Parenting Sense of Competence Scale, the Parenting Styles and Dimensions Questionnaire-Short Version and the parent form of the ADHD Rating Scale-IV. Parents from both groups, after their participation in the parent training, demonstrated reduced parenting stress, enhanced parental self-efficacy and increased the employ of democratic parenting practices. More than that, they reported decreased levels of inattention and impulsivity/hyperactivity for their children. Evidence-based multi-level intervention programs could produce positive effects in parents and children by incorporating effective methods and tools in accordance with the needs and the demands of the family context.

Prevalence of malnutrition among children under five is alarmingly high in Pakistan. However, there are ready-to-use therapeutic foods (RUTF) available which may be used to treat children with severe acute malnutrition (SAM). This study aims to assess the efficacy of prebiotics as a synergistic additive to RUTF to enhance blood parameters and anthropometric measurements in children with uncomplicated SAM living in Southern Punjab, Pakistan. A double-blind parallel treatment randomized controlled trial was conducted on 204 children aged between 6-59 months. Participants were randomized and allocated to the placebo (n=102) and experimental arms (n=102) at a 1:1 ratio. One group of children were provided RUTF and 4 g prebiotics, while the other group were given RUTF and starch as a placebo. Participants recruited for both arms were given treatment for eight weeks, and then their biochemical and anthropometric outcomes were evaluated. A substantial difference between the mean weight, mid upper arm circumference, haemoglobin, haematocrit, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, and albumin was revealed. Conclusively, supplementation with RUTF and prebiotics has proven to be an efficient, effective and safe therapy for children suffering from SAM to improve their growth and development indicators and reduce the dangers of malnutrition in comparison to RUTF alone.

Background: Angelica gigas Nakai, Korean dang-gui, has long been widely used in traditional treatment methods. There have been a number of studies of the health effects of A. gigas and related compounds, but studies addressing effects on blood triglycerides (TG) are lacking. To investigate the effects of A. gigas Nakai extract (AGNE) on TG in Korean subjects, we carried out a 12-week, randomized, double-blind, placebo-controlled clinical trial. Methods: Subjects who met the inclusion criterion (130 mg/dL ≤ fasting blood TG ≤ 200 mg/dL) were recruited for this study. One hundred subjects were assigned to the AGNE group (n=50) or the placebo group (n=50), who were given 1g/day of AGNE (as a gigas Nakai extract 200mg/d) in capsules, and the control group for 12 weeks. Outcomes were efficacy TG, lipid profiles, atherogenic index, and safety parameters were assessed initially for a baseline measurement and after 12 weeks. Results: After 12 weeks of supplementation, TG and very low-density lipoprotein cholesterol (VLDL-C) concentration and TG/HDL-C ratio in the AGNE group were significantly reduced compared to the placebo group (p <0.05). No significant changes in any safety parameter were observed. Conclusions: These results suggest that ingestion of AGNE may improve TG and be useful to manage or prevent hypertriglyceridemia.

Objective: To assess the effects of chronic walnut consumption on body weight and adiposity in elderly individuals. Methods: The Walnuts And Healthy Aging study is a dual-center (Barcelona, Spain and Loma Linda University [LLU]), 2-year randomized parallel trial. This report concerns only the LLU cohort. Healthy elders (mean age 69 y, 67% women) were randomly assigned to walnut (n = 183) or control diets (n = 173). Subjects in the walnut group received packaged walnuts (28–56 g/d), equivalent to ≈15% of daily energy requirements, to incorporate into their habitual diet, while those in the control group abstained from walnuts. Adiposity was measured periodically, and data were adjusted for in-trial changes in self-reported physical activity. Results: After 2 years, body weight significantly decreased (P = 0.031), while body fat significantly increased (P = 0.0001). However, no significant differences were observed between the control and walnut groups regarding body weight (−0.6 kg and −0.4 kg, respectively, P = 0.67) or body fat (+0.9% and +1.3%, respectively, P = 0.53). Lean body mass, waist circumference and waist-to-hip ratio remained essentially unchanged. Sensitivity analyses were consistent with the findings of primary analysis. Conclusion: Our findings indicate that walnuts can be incorporated into the daily diet of healthy elders without concern for adverse effects on body weight or body composition.

This pilot randomized controlled trial (RCT) aimed to explore whether depression and anxiety could be reduced by psychiatric home healthcare supporters offering brief cognitive behavioral therapy for psychosis (CBTp) at home using a workbook for patients with schizophrenia. Eighteen patients with schizophrenia treated in a psychiatric home nursing service were randomly assigned to two groups: one group received CBTp in addition to usual care (CBTp + TAU group; n=8) and the other received only usual care (TAU group; n=8); 2 patients were excluded due to hospitalization or withdrawal of consent. Eight weekly CBTp sessions were conducted; anxiety/depression, quality of life, self-esteem, and overall functioning were assessed at baseline, week 9, and week 13. There was no significant difference in the primary evaluation; however, a significant improvement (p=0.014) was observed in the secondary evaluation of quality of life. The effect size was 0.95 for primary evaluation and 1.33 for the secondary evaluation, indicating a large effect. This study showed that nurses and occupational therapists can provide CBTp in psychiatric home care for patients with schizophrenia to potentially alleviate anxiety and depression compared to standard psychiatric home care alone. Therefore, larger RCTs with larger sample sizes are recommended.

The increasing number of caesarean section (CS) is a major challenge in modern obstetrics. This rise is not supported by better neonatal and maternal outcomes. The prevention of unnecessary primary CS is a global priority. This study focuses on effectiveness and safety of yoga practice during pregnancy and it’s connection to perinatal outcome. We conducted a single-blinded, randomized controlled clinical trial, with healthy singleton primiparas, randomized at first trimester of pregnancy. A total of 214 participants were randomized, 106 in yoga and 108 in controls. The study group performed yoga exercise while the controls received standard antenatal care. The yoga exercises were performed once a week, lasted 90 minutes, under the supervision of a certified yoga teacher. All pregnant women from study group completed 12 yoga exercises. The results showed that the yoga group had a lower rate of urgent intrapartum CS (p-0.004) and more frequent spontaneous vaginal delivery (p-0.009), while the control group had a higher rate of induced labour (p-0.032). Conclusion: Yoga practice in pregnancy is a promising intervention that has a potential to decrease intrapartum urgent CS rates and assures natural and spontaneous vaginal birth; it’s highly recommendable to healthy pregnant women.

Prolonged fatigue is associated with non-pathological causes, and lacks an established therapeutic approach. The current study is aimed at assessing the efficacy of a new food supplement (Improve® Response) based on a chemically characterized pomegranate extract and hydro-soluble vitamins (B complex and C). UHPLC-HRMS analysis of pomegranate extract showed the presence of 59 compounds, with gallotannins and ellagitannins being the most abundant phytochemicals. For the clinical study, 58 subjects were randomized into two groups, 1 and 2 (n = 29, each), which received either the food supplement or placebo. The effects of the food supplement against fatigue were assessed via validated questionnaires, recorded at time intervals t0 (at baseline), t1 (after 28 days), t2 (56 days), and t3 (after follow-up) in combination with the analysis of biochemical markers at t0 and t2. Fatigue Severity Scale (FSS) questionnaire scores were significantly decreased at the t2 and t3 time intervals in subjects treated with the food supplements, while the effect of the food supplement on a 12-Item Short Form Survey (SF-12) was not considerable. Moreover, the food supplement did not significantly affect biochemical parameters associated with fatigue and stressed conditions. This study shows that the food supplement tested reduces prolonged fatigue following two months supplementation in healthy subjects with mild prolonged fatigue.

Here we investigated the acute effects of an exhaustive intermittent exercise session on immunological parameters of the elderly and the subsequent incidence of upper respiratory tract infections and compare with the moderate-intensity. To do so, ixty-three old subjects were divided into three groups HIIT (n=21) submitted at one High-intensity interval training, SCG (n=21) kept in a sedentary state, and MICT (n=21) submitted at moderate intensity walking. Blood were collected at 5 time points, before, immediately after, 2h, 24h, and 48h after the intervention. In result the IL-6 and TNF-α were overexpressed immediately after the IL-10 stood overexpressed and correlated with IL-17, denoting an inflammatory process, and evidencing an immunologic competence without enhancement of the prevalence of upper respiratory infection tract (URTIs). So a modulation in the balance of Th1/Th2/Th17 cytokines and leukocytes, these modifications did not cause the effect characterized as an immunological window. Perhaps, the typical inflammation process, with IL-10 and IL-17 participation could also produce benefits to combat infections, a pertinent discussion during a post-pandemic time; we consider it a safe exercise program for older adults.

To demonstrate if botulinum toxin type A (BoNT-A) improves mandibular range of motion and muscle sensibility to palpation in refractory myofascial pain (MFP) patients. METHODS: Eighty consecutive female subjects with refractory MFP, were randomly divided into four equal groups (n=20): BoNT-A low (BoNTA-L/10 U in each temporalis and 30 U in each masseter), BoNT-A medium (BoNTA-M/20 U in each temporalis and 50 U in each masseter), BoNT-A high (BoNTA-H/25 U in each temporalis and 75 U in each masseter) and saline solution 0.9% (SS, placebo control group/0.4 mL in each temporalis and 0.6 mL in each masseter). Clinical measurements of the mandibular movements included: pain-free opening, maximum unassisted and assisted opening, and right and left lateral movements. Palpation tests were performed bilaterally in masseter and temporalis muscle. Results were expressed as median, minimum, maximum, and means ± standard deviation (SD). Chi-Square Test was used to compare differences among groups. A 5% probability level was considered significant in all tests RESULTS: Regardless of dose, all parameters of mandibular range of motion significantly improve after 180 days in BoNT- A groups, when compared to the control group. Pain to palpation on muscles, significantly reduced in all BoNT- A groups regardless of dose, when compared to the control group, after 28 and 180 days of treatment. CONCLUSIONS: Independent of doses, BoNT-A improved mandibular range of motion and muscle sensibility to palpation in refractory MFP patients when compared to SS injections.

The aim of this study is to evaluate the efficacy of taking a daily supplement based on active compounds (AUDISTIM® Day Night: A D/N) in alleviating tinnitus-related disability, as suggested by previous real-life studies. This double-blind randomized placebo-controlled study was conducted in adult with mild to severe tinnitus receiving a 3 month-supplementation. Tinnitus-related handicap (THI), psychological stress (MSP-9) and sleep quality (PSQI) were assessed at baseline and during intervention, perceived impression of tinnitus improvement at the end of the follow-up. The full set analysis included 114 patients (59 A D/N, 55 placebo) aged 53.8±11.4 years, 58% women, with fluctuating (45%) or permanent (55%) tinnitus from 9.3±9.4 years. A D/N supplementation led to greater changes in THI (-13.2±16.0 vs -6.2±14.4, p=0.0158, Cohen’s d=0.44) at 3 months, especially with continuous tinnitus (-15.0±16.3 vs -4.6±12.8, p=0.0065), and, to a lesser extent, at 1 month (-9.8±13.1 for A vs -4.3±12.1, p=0.0213). PSQI significantly improved over time in both groups, MSP-9 only with A D/N. In lines with previous observational studies, both clinical (THI score &gt; 7 pts) and statistical (vs. placebo) improvement, more pronounced in permanent tinnitus, demonstrate the effectiveness of the combination of active compounds and support its use in the management of mild to severe tinnitus.

Proprioceptive deficits accompanied with motor paresis after stroke, namely sensory ataxic motor paresis has a poorer prognosis of recovery than pure motor deficit. We aimed to investigate the effects of repetitive peripheral magnetic stimulation (rPMS) on sensory ataxic upper extremity (UE) paresis at acute stroke. Eighteen stroke participants with sensory ataxic UE paresis were randomized. rPMS group received five sessions of intervention per week, where 20 minutes of rPMS prior to 20 minutes of physical therapy (PT) every other day, alternating with 40 minutes of PT. The control group received five sessions of 40 minutes of PT/week. Outcome measures were Wolf motor function test (WMFT), UE motor section of Fugl-Meyer Motor Assessment Scale (FMA-UE), and Thumb localizing test (TLT). All assessments were compared before and after intervention. rPMS group received mean 6.5 sessions and the control group received 12.8 sessions, showing significantly imbalanced intervention due to different timing of hospital discharge. The imbalance was corrected by calculating gains of motor scores divided by sessions as Progress Rate (PR). Corrected gains (PR) of rPMS group was more significantly enhanced in WMFT and FMA-UE than control groups. rPMS group tended to improve TLT more than control one. rPMS might improve sensory ataxic UE paresis after stroke and proprioceptive deficit.

Cancer-related fatigue is a common, burdensome symptom of cancer and side-effect of chemotherapy. While a Mediterranean Diet (MedDiet) promotes energy metabolism and overall health, its effects on cancer-related fatigue remain unknown. In a randomized controlled trial, we evaluated a rigorous MedDiet intervention for feasibility and safety as well as preliminary effects on cancer-related fatigue and metabolism compared to usual care. Participants had stage I-III cancer and at least 6 weeks of chemotherapy scheduled. After baseline assessments, randomization occurred 2:1, MedDiet:usual care. Measures were collected at baseline, week 4, and week 8 including MedDiet adherence, dietary intake, and blood-based metabolic measures. Mitochondrial respiration from freshly isolated T cells was measured at baseline and 4 weeks. Participants (n=33) were 51.0±14.6 years old, 94% were female, and 91% were being treated for breast cancer. The study was feasible, with 100% completing the study and >70% increasing their MedDiet adherence at 4 and 8 weeks compared to baseline. Overall, the MedDiet intervention vs. usual care had a small-moderate effect on change in fatigue at weeks 4 and 8. For those with a baseline MedDiet score<5 (n=21), the MedDiet intervention had a moderate-large effect of 0.67 and 0.48 at weeks 4 and 8, respectively. The MedDiet did not affect blood-based lipids, though it had a beneficial effect on fructosamine (ES= -0.55). Fatigue was associated with mitochondrial dysfunction including lower basal respiration, maximal respiration, and spare capacity (p<0.05 for FACIT-F fatigue subscale and BFI, usual fatigue). In conclusion, the MedDiet was feasible and attenuated cancer-related fatigue among patients undergoing chemotherapy, especially those with lower MedDiet scores at baseline.

The purpose of this study was to assess if self-regulation of intensity based on rating of perceived exertion (RPE) is a reliable method to control the intensity of metabolic conditioning of functional-fitness session. In addition, the relationship between RPE and changes in heart rate and lactate responses was also analyzed. Eight male participants (age 28.1 ± 5.4 years; body mass 77.2 ± 4.4kg; VO₂max: 52.6 ± 4.6 mL·(kg·min)⁻¹) completed three randomly sessions (5 to 7 days apart) under different conditions: (1) all-out (ALL); (2) self-regulation of intensity based on a RPE of 6 (hard) on the Borg CR-10 scale (RPE6); and (3) a control session. Rate of perceived exertion, LAC and HR response were measured pre, during and immediately after the sessions. The RPE and LAC during the ALL-OUT sessions were higher (p ≤ 0.05) than the RPE6 and control sessions for all the analyzed time points during the sessions. Regarding HR, the 22 min area under the curve of HR during ALL-OUT and RPE6 sessions were significantly higher (p ≤ 0.05) than the control session. The average number of repetitions was lower (p ≤ 0.05) for the RPE6 session (190.5 ± 12.5 repetitions) when compared to the ALL session (214.4 ± 18.6 repetitions). There was a significant correlation between RPE and LAC (p = 0.001; r = 0.76; very large) and number of repetitions during the session (p = 0.026; r = 0.55; large). No correlation was observed between RPE and HR (p = 0.147; r = 0.380). These results indicate that self-regulation of intensity of effort based on RPE may be a useful tool to control exercise intensity during a metabolic conditioning session of functional-fitness.

Older adults with obesity have an increased risk for cognitive decline and subsequent Alzheimer’s disease. Previous research has focused on the impact of individual nutrients and overall dietary patterns to improve cognitive function. The Brain and Body Health (BB-Health) study aims to demonstrate the feasibility of a multicomponent nutritional supplement (MCNS) and weight loss (WL) intervention for individuals with overweight and obesity who are not consuming a healthy diet. BB-Health is a parallel-group randomized placebo-controlled 2x2 factorial pilot trial comparing the MCNS, WL, and MCNS+WL with a Control group. Eligible participants are 55 to 85 years of age with a body mass index 27.0 to 39.9 kg/m2. Major exclusion criteria include type 2 diabetes, moderate or severe cognitive impairment, and self-reported healthy dietary pattern. The BB-Health feasibility trial is registered as NCT05542199 at clinicaltrials.gov. The BB-Health objectives are to report: 1) recruitment and enrollment, including pace and descriptive statistics of the study sample; 2) adherence to the administered interventions; 3) successful data collection and performance of outcome assessments, including evaluation of change in key outcomes over time that are powered for this pilot study; and 4) summary statistics on outcomes for use in planning a subsequent, larger trial. The outcomes of interest are age-sensitive cognitive assessments, cerebral hemodynamics, and related health parameters. All measurements are collected at baseline, 3-, 6-, and 12-month visits. If the BB-Health protocol demonstrates feasibility, the novel MCNS with and without a parallel WL intervention has potential to be administered in a confirmatory randomized trial to evaluate ability to prevent age-related cognitive decline and improve brain health. The BB-Health Feasibility Study could significantly contribute to our understanding of the influence of diet and weight management on cognitive health

The prevalence of stunting in young Indonesian children is the highest among Southeast Asian Nations, and is associated with poor growth during the prenatal and early postnatal periods. A maternal mentoring program was developed for Indonesian women to improve birth outcomes. A cluster randomized control trial (CRCT) was conducted in three sub-districts of the Special Re-gion of Yogyakarta, Indonesia. A total of 384 eligible participants were randomly allocated to either intervention (received maternal mentoring program and standard care; n=189) or control (received standard care only; n=195). The maternal mentoring program provided preconception health education; health monitoring; and text message reminders for preconception women. Fetal growth was measured between gestational weeks 27-30 using estimated fetal weight generated from ultrasonographic measurement. Birth weight was measured within 24 hours of birth. A structured questionnaire captured women’s’ demographics, pregnancy readiness, and body mass index (BMI. After adjustment, fetal weight was 14% (95% CI: 5.1-23.0) higher in the intervention group than in the control group, and the average weight-for-length Z-score at birth was 0.16 (95% CI: 004-0.30) higher in the intervention group than in the control group. A maternal mentoring program was associated with improved fetal growth and birth weight in this population.

A randomized control trial (clinicaltrial.gov identification NCT04521504) was conducted to test if the combination of a rehabilitative protocol with a kinematic visual biofeedback tool could improve the functional level of patients arthroscopically treated for rotator cuff tear, both in the short- and medium-term assessments. Forty patients (aged between 35 and 65 y.o., employed at the time of the enrollment) were randomly assigned to two groups: Control group (C, n°21 patients) and Biofeedback group (B, n°19 patients). The primary outcome used for the assessment of shoulder functional performances was the Scapula-Weighted Constant-Murley Score. Patients were assessed longitudinally: before surgery, 45 days after surgery, at time of return-to-work, and at a final follow-up between 6 and 12 months. Results showed no biases for the two groups before the administration of the experimental protocol; significantly higher scores for B compared to C were found only at time of return-to-work. Based on results, we could conclude that the biofeedback training allowed patients to return to work in a better functional condition. This trial was funded by the National Institute for Insurance against Accidents at Work (INAIL).

To cope the high glycemic variability (GV) is crucial in the management of multiple daily insulin (MDI) in diabetes. We compared the effect of low dose metformin 750mg/d adding vildagliptin 100mg/d (DPP4+LMET) or the high dose metformin 1500mg/d (HMET), in type 2 diabetes (T2D) with MDI, evaluating GV by continuous glucose monitoring (CGM). Single center, open-label, 12 weeks - 2 period crossover design. Twenty T2D with inadequately controlled (7.0% <HbA1c ≦9.0%) with MDI + LMET were enrolled. Primary endpoints were GV and hypoglycemia derived from CGM performed after each 12 weeks treatment periods. There was no significant difference in HbA1c, body weight changes, total daily dose of insulin. DPP4+LMET compared to the HMET, significantly reduced the calculated GV value, mean (7.15±1.3 vs 7.82±1.6, p<0.05), standard deviation (1.78±0.55 vs 2.27±1.11, p=0.03), continuous overlapping net glycemic action (6.44±1.28 vs 7.12±1.69, p<0.05), J-Index (26.7±11.0 vs 34.9±19.8, p<0.05), high blood glucose index (3.01±1.96 vs. 6.73±4.85, p=0.02), and mean amplitude of glycemic excursions (4.53±1.35 vs 5.50±2.34, p=0.03). The GV metrics with hypoglycemia and nocturnal hypoglycemia were not significantly different. DPP4+LMET decreased GV associated with hyperglycemia. Adding DPP4 inhibitor to the lower dose of metformin is an alternative approach to the stable GV in MDI.

Background: One challenge in implant dentistry is to reduce marginal bone resorption to avoid long-term esthetic and biological complications. Sub-gingival implant placement has been suggested as a suitable strategy. Methods: 38 healthy patients were enrolled to receive bone level (BL – Control group) or 2 mm sub-crestal (SC - Test group) conical connection, platform-switched implants. An immediate tissue level abutment was used in the Test group by following a One Time Abutment (OTA) restorative procedure. Marginal Bone Modification (MBM) was calcu-latied on standardized radiographs at surgery (T0), loading (T1), and 6 months (T2) and 12 months after loading (T3), and cathegorised in Bone Loss (BL) if the resorption occurred below the implant neck and Bone Remodeling (BR) if above. Pocket probing depth (PPD), Bleeding on probing (BoP) and Plaque Index (PI) were also collected. Results: The mean MBM in the test group after 12 months was 0.61mm, compared to 0.52mm in the control group. However, no BL was observed in the test group, as the MBM completely occurred above the implant neck as BR, whilst in the control group MBM corresponded in total to BL. The average PPD was 2.38mm in the test group and 3.04mm in the control group after 12 months, BoP 50% and 43%, PI 33% and 19.44% respectively. Conclusions: Sub-crestal conical connection, platform-switched implants could be a suitable clinical choice to avoid BL with exposure of the treated implants surfaces.

Background: Inflammatory bowel diseases (IBD) present chronic inflammatory challenges marked by increased oxidative stress. This study assessed the collective impact of Curcumin plus piperine on oxidative stress and inflammation biomarkers in mild to moderate IBD patients. Methods Patients diagnosed with CD or UC, aged ≥18 years with preserved kidney and liver functions, were randomized into three groups: placebo, Curcumin (1000 mg/day), and Curcumin plus piperine (1000 mg + 10 mg/day) for 12 weeks. Blood and fecal samples were collected to analyze oxidative stress and inflammatory markers, before and after the intervention period. Results: Curcumin plus piperine group had significantly higher serum SOD compared to the placebo group, after adjusting for sex, age, and type of IBD (4346.9 ± 879.0 vs 3614.5 ± 731.5; p=0.041). There were no significant differences in the other oxidative stress or inflammatory markers between groups. Conclusions: This study suggests that 12 weeks of Curcumin plus piperine supplementation effectively enhances the enzymatic antioxidant defense, particularly SOD, in IBD patients. These findings hold promise for managing redox imbalance in individuals with IBD, highlighting potential therapeutic benefits.

This study evaluated the impact of didactic videos and service user testimonial videos on mental illness stigma among medical students. Two randomized controlled trials were conducted in Nepal. Study 1 examined stigma reduction for depression. Study 2 examined depression and psychosis. Participants were Nepali medical students (Study 1:n=94, Study 2:¬n=213) randomized to three conditions: a didactic video based on the mental health Gap Action Programme (mhGAP), a service user video about living with mental illness, or a control condition with no videos. In Study 1, videos only addressed depression. In Study 2, videos addressed depression and psychosis. In Study 1, both didactic and service user videos reduced stigma compared to the control (F2,91=6.37, p=0.003). In Study 2 (depression and psychosis), there were no differences among the three arms (F2,210=2.07, p=0.13). When comparing Study 1 and 2, there was greater stigma reduction in the service user video arm with only depression versus service user videos with depression and psychosis (t(31)=-3.04, p=0.005). In summary, didactic and service user videos were associated with decreased stigma when content addressed only depression. However, no stigma reduction was seen when including depression and psychosis. This calls for different strategies based on types of mental illnesses. ClinicalTrials.gov identifier: NCT03231761

Background: We aimed to evaluate the impact of two different phytotherapeutic agents on the decision making regarding prostate biopsy in patients with higher-than-normal prostate-specific antigen (PSA) levels. Methods: From June 2022 to May 2023, all patients attending two urological institutions due to higher-than-normal PSA levels were randomized to receive either oral capsules of Curcuma Longa, Boswellia, Pinus pinaster and Urtica dioica (Group A) or Serenoa Repens 320 mg (Group B), for 3 months. At the follow-up visit after 3 months all patients underwent PSA test and multiparametric magnetic resonance imaging (mpMRI). Results: In the per-protocol analysis, data from 66 patients in Group A and 76 in Group B were analyzed. Fifty patients in Group A (75.7%) showed a significant reduction of total PSA compared to 49 in Group B (64.4%) (p<0.001). Twenty-eight patients had PI-RADS III or higher at mpMRI: 12 in Group A and 14 in Group B. Twenty-three patients (34.8%) in Group A underwent prostate biopsy based on mpMRI findings and PSA values and 59 (77.6%) in Group B (p<0.001). Three patients in Group A showed a significant reduction of total PSA value while having positive findings at mpMRI (6%) compared with 9 in Group B (19.5%) (p<0.001). On the contrary, 7 patients in Group A did not show a significant reduction of total PSA value and had negative findings at mpMRI (43%) compared to 22 in Group B (81.4%) (p&lt;0.001). Conclusions: In conclusion, a three-month course of a combination of Curcuma Longa, Boswellia, Pinus pinaster, and Urtica dioica seems an interesting tool to avoid unnecessary prostate biopsies in men with higher-than-normal PSA levels.

The purpose of the study was to investigate the bacterial viability of the initial biofilm on the surface of experimental modified dental resin composites. Twenty-five healthy individuals with good oral hygiene were included in this study. In a split-mouth design, they received acrylic splints with five experimental composite resin specimens. Four of them were modified with either a novel polymeric hollow beads delivery system or methacrylated polymerizable Irgasan (Antibacterial B), while one specimen served as unmodified control (ST). The delivery system based on Poly-Pore® was loaded with one of the active agents Tego® Protect 5000 (Antiadhesive A), Dimethicone (Antiadhesive B) or Irgasan (Antibacterial A). All study subjects refrained from toothbrushing during the study period. Specimens were detached from the splints after 8h and given a live/dead staining before fluorescence microscopy. Friedman test and post-hoc Nemenyi test were applied with significance level at p &lt; 0.05. In summary all materials but Antibacterial B showed a significant antibacterial effect compared to ST. In conclusion dental resin composites with Poly-Pore loaded active agents show antibacterial effectiveness in situ.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem, and profoundly debilitating condition, probably of multifactorial etiology. No effective approved drugs are currently available for its treatment. Several studies have proposed symptomatic treatment with melatonin and zinc supplementation in chronic illnesses; however, little is known about the synergistic effect of this treatment on fatigue-related symptoms in ME/CFS. The primary endpoint of the study was to assess the effect of oral melatonin plus zinc supplementation on fatigue in ME/CFS. Secondary measures included participants’ sleep disturbances, anxiety/depression, and health-related quality of life. A proof-of-concept, 16-week, randomized, placebo-controlled, double-blind trial was conducted in 50 ME/CFS patients assigned to receive either oral melatonin (1 mg) plus zinc (10 mg) supplementation (n = 24) or matching placebo (n = 26) once daily. Endpoint outcomes were evaluated at baseline and then reassessed at 8 and 16 weeks of treatment and 4 weeks after treatment cessation, using self-reported outcome measures. Treatment was safe and well-tolerated. The most relevant results were the significant reduction in the perception of physical fatigue in the active group at the final follow-up versus placebo (p < 0.05), and the significant improvement in the physical component summary at all follow-up visits in the experimental group. Our findings suggest that oral melatonin plus zinc supplementation for 16 weeks is safe and potentially effective in reducing fatigue and improving the quality of life in ME/CFS. This clinical study was registered on ClinicalTrials.gov (NCT03000777).

Casein hydrolysate improves arterial stiffness, as estimated by brachial ankle pulse wave velocity (baPWV), in untreated hypertensive subjects. Facial pigmentation is a useful biomarker for arterial stiffness. This trial evaluated whether casein hydrolysate improves facial pigmentation in association with changes in arterial stiffness. A randomized, double-blind, placebo-controlled trial was conducted in 80 non-hypertensive Japanese participants randomly assigned to receive either active tablets containing casein hydrolysate or placebo for 48 weeks. Facial pigmentation and baPWV were measured at baseline and at the end of the intervention. Other biochemical atherosclerosis-related parameters were also measured, including advanced glycation end products (AGEs). Changes in facial pigmentation showed a significant difference between the groups. Change in baPWV was significantly better in the active than in the placebo group. In contrast, no significant association was seen between changes in facial pigmentation and those in baPWV. Among other atherosclerosis-related factors, changes in advanced glycation products (AGEs) were significantly decreased in the active compared to the placebo group. Further, changes in facial pigmentation were positively correlated with those in AGEs. Changes in AGEs were independently associated with changes in facial pigmentation. Casein hydrolysate improves facial pigmentation in non-hypertensive participants. Casein hydrolysate may have beneficial effects on glycation stress.

Background: Vitamin D was studied in regards to its possible impact on body mass reduction and metabolic changes in adults and children with obesity yet there were no studies assessing the impact of vitamin D supplementation during a weight management programme in children and adolescence. The aim of our study was to assess the influence of 26 weeks of vitamin D supplementation in overweight and obese children undergoing an integrated 12-months’ long weight loss programme on body mass reduction, body composition and bone mineral density. Methods: A double-blind randomized placebo-controlled trial. Vitamin D deficient patients ( <30 ng/ml level of vitamin D) aged 6-14, participating in multidisciplinary weight management programme were randomly allocated to receiving vitamin D (1200 IU) or placebo for the first 26 weeks of the intervention. Results: Out of the 152 qualified patients, 109 (72%) completed a full cycle of four visits scheduled in the programme. There were no difference in the level of BMI change. Although the reduction was greater in the vitamin D vs. placebo group (-4.28 ± 8.43 vs. -2.53 ±6.10) the difference was not statistically significant (p=0.319). Similarly the reduction in fat mass – assessed both using bioimpedance and DEXa was achieved, yet the differences between the groups were not statistically significant. Conclusions: Our study ads substantial results to support the thesis on no effect of vitamin D supplementation on body weight reduction in children and adolescents with vitamin D insufficiency undergoing a weight management programme. Trial registration no: NCT 02828228; trial registration date: 8 June 2016 registered in: ClinicalTrials.gov.

Regular exercise can reduce depression. However, the uptake of exercise is limited in patients with end-stage renal disease undergoing hemodialysis. To address the gap, we designed a gamified non-weight-bearing exercise program (Exergame), which can be executed during hemodialysis treatment. The Exergame is virtually supervised based on its interactive feedback via wearable sensors attached on lower extremities. We examined the effectiveness of this program to reduce depression symptom compared to supervised exercise in 73 hemodialysis patients (age=64.5±8.7years, BMI=31.6±7.6kg/m2). Participants were randomized into an Exergame group (EG) or a Supervised-exercise group (SG). Both groups received similar exercise tasks for 4-week, 3-session per week, 30-min per session, during hemodialysis treatment. Depression symptom was assessed at baseline and 4-week using Center for Epidemiologic Studies Depression (CES-D). Both groups showed significant reduction in depression score (37%, p<0.001, Cohen’s effect size d=0.69 in EG vs. 41%, p<0.001, d=0.65 in SG) with no between-group difference for the observed effect (p>0.050). The EG expressed a positive exercise experience including fun, safety, and helpfulness of sensor-feedback. Together, results suggested that the virtually-supervised low-intensity Exergame is feasible during routine hemodialysis treatment. It is as effective as supervised-exercise to reduce depression symptom, while reducing burden of administrating exercise in dialysis clinics.

The potential impact of a specific physical activity program on biomechanical gait parameters and neuromuscular strategies around the ankle joint in older adults with sarcopenic obesity (SO) remains largely unexplored. The objective of this study was to investigate the effectiveness of a 24-week Posture, Strengthening, and Motricity (PSM) program in improving neuromuscular strategies and biomechanical gait parameters in older adults with SO. 40 Participants were randomly assigned to either the trained group (TG) and the control group (CG). Only the TG received the PSM program. Standardized evaluations were performed before and after the intervention, including walking tests on an instrumented gait analysis treadmill to evaluate biomechanical gait parameters and EMG activity of ankle muscles. After the PSM program, TG exhibited an increase in comfortable walking speed (+80%, p<0.001) and step length (+38%, p<0.05). Moreover, TG demonstrated a reduction in CoP velocity (-26%, p<0.01). These gait modifications were associated with a decreased muscle activity during the different gait phases (p<0.05). The PSM program effectively improved gait, and neuromuscular capacities in older adults with SO. Notably, Results sheds light on the remarkable trainability of neuromuscular capacities in older adults with SO, despite the adverse effects of aging and obesity.

Background: This study explored the effects of a virtual reality exercise program on overweight middle-aged women. Methods: This randomized controlled trial included women 4065 years of age with a body mass index (BMI) of 23 kg/m2 or more living in D city. The virtual reality environment was set up by attaching an IoT sensor to an indoor bicycle and linking it with a smartphone, enabling exercise in an immersive virtual reality through a head-mounted display. Results: In the virtual reality exercise group, the BMI was significantly decreased after the 8-week intervention compared with the baseline value (F=100.806, p<.001). The depression scores were significantly different among the three groups, with the intervention effect being more significant in the virtual reality exercise group than in the indoor bicycle exercise and con-trol groups (F=3.462, p<.001). Furthermore, the levels of exercise fun (F=12.373, p<.001) and exer-cise immersion (F=14.629, p<.001) were significantly higher in the virtual reality exercise group than in the indoor bicycle exercise and control groups. Conclusions: The virtual reality exercise program positively affected the BMI and the levels of depression, exercise fun, and exercise im-mersion in overweight middle-aged women. It is an effective home exercise program for obesity management in this population.

Objective: The purpose of this study is to compare the effects of stretching methods for flexibility, muscle activation, and pressure pain threshold in ballet dancers, and to suggest an effective stretching method. Methods: Thirty-three ballet dancers were randomized to a static stretching group (n=11), muscle energy technique stretching group (n=11), and vibration-assisted stretching group (n=11). The angle of hip joint extension in arabesque, the activation of rectus femoris in Devéloppé, and the pressure pain threshold on rectus femoris in sitting position were measured to compare the effects of different stretching methods. Results: Hip joint extension angles increased in all stretching methods (p<0.05), however, vibration-assisted stretching and muscle energy technique stretching were more effective than static stretching (p<0.05). The activation of the rectus femoris decreased in all groups (p<0.05), but the muscle energy technique stretching group and the vibration-assisted stretching group showed a significant decrease compared to the static stretching group (p<0.05). The pressure pain threshold showed significant improvement only in the static stretching group (p<0.05), and the vibration-assisted stretching group (p<0.05). Conclusion: Vibration-assisted stretching compared to static stretching and muscle energy technique stretching is a beneficial method for flexibility, muscle activation, and pressure pain threshold in ballet dancers.

Variable during practice is widely accepted to be advantageous for motor learning and therefor a valuable strategy to effectively reduce high-risk landing mechanics and prevent primary anterior cruciate ligament (ACL) injury. Few attempts have examined the specific effects of variable train-ing in athletes who have undergone ACL reconstruction. Thereby it is still unclear to what extent the variations in different sensor areas lead to different effects. Accordingly, we compared the effects of versatile movement variations (DL) with variations of movements with emphasis on disrupting visual information (VMT) in athletes who had undergone ACL reconstruction. For-ty-five interceptive sports athletes after ACL reconstruction were randomly allocated to a DL group (n= 15), VT group (n= 15) or control group (n= 15). The primary outcome was functional performance (Triple Hop Test). The secondary outcomes included dynamic balance (Star Excur-sion Balance Test (SEBT)), biomechanics during single-leg drop-landing task hip flexion (HF), knee flexion (KF), ankle dorsiflexion (AD), knee valgus (KV), and vertical ground reaction force (VGRF), and kinesiophobia (Tampa Scale of Kinesiophobia (TSK)) assessed before and after the 8-weeks of interventions. Data were analyzed be means of 3×2 repeated measures ANOVA fol-lowed by post hoc comparison (Bonferroni) at the significance level of p≤0.05. Significant group × time interaction effects, main effect of time and main effect of group were found for triple hop test, all eight directions of SEBT, HF, KF, AD, KV, VGRF and TSK. There was no significant main ef-fect of group in HF and triple hop test. Also, significant differences in triple hop test, seven direc-tions of SEBT, HF, KF, KV, VGRF and TSK were found between control group with the DL and VMT groups. Between group differences in AD and medial direction of SEBT were not signifi-cant. Also, there was no significant differences between VMT and control groups in triple hop test and HF variables. Both motor learning (DL and VMT) programs improved outcomes in patients after ACL reconstruction. Findings suggest that DL and VMT training programs lead to compa-rable improvements in rehabilitation.

Background: New regional techniques can improve pain management after nephrectomy. Methods: This study was a randomized controlled trial conducted at two teaching hospitals. Patients undergoing elective open and laparoscopic nephrectomy were eligible to participate in the trial. A total of 100 patients were divided into a quadratus lumborum block (QLB) group and a control (CON) group. At the end of surgery, but while still under general anesthesia, unilateral QLB with ropivacaine was performed on the side of nephrectomy for patients in the QLB group. The main measured outcome of this study was oxycodone consumption via a patient-controlled anesthesia (PCA) pump during the first 24 hours following surgery; other measured outcomes included postoperative pain intensity assessment, patient satisfaction with pain management, and persistent pain evaluation. Results: Patients undergoing QLB needed less oxycodone than those in the CON group (34.5 mg [interquartile range 23–40 mg] vs. 47.5 mg [35–50 mg]; p<0.001). No difference between the groups was seen in postoperative pain intensity measured on the visual analog scale, except for the evaluation at hour 2, which was in favor of the QLB group (p=0.03). Patients who received QLB were more satisfied with postoperative pain management than the CON group. Persistent postoperative pain was assessed with the Neuropathic Pain Symptom Inventory (NPSI) at months 1, 3, and 6 and was found to be significantly lower in the QLB group at each evaluation (p<0.001). We also analyzed the impact of the surgery type on persistent pain severity, which was significantly lower after laparoscopic procedures than open procedures at months 1, 3, and 6. Conclusions: QLB reduces oxycodone consumption in patients undergoing open and laparoscopic nephrectomy and decreases persistent pain severity months after hospital discharge.

Premenstrual syndrome (PMS) continues to impact the health outcomes and emotional well-being of reproductive-age women, globally. Several studies have provided conflicting evidence concerning the role of dietary approaches in improving PMS symptoms. Accordingly, this study aimed to evaluate the possible influence of a healthy diet and motivational strategies on PMS symptoms and health-related quality of life among Omani adolescents. This open-label, randomized, prospective controlled trial was conducted in two randomly selected secondary schools, in Al Seeb Willayah, in Muscat region. Adolescents with PMS symptoms, who were at grade 10 or 11, aged 16 years or above, had regular menstrual cycles and not known to have psychiatric disorder, were included in this study. Participants in the intervention group received an individual face-to-face dietary consultation and motivational phone consultation. The health outcomes, including the PMS symptoms in both groups, and quality of life, were recorded via a daily record of severity of problems questionnaire (DRSP) and the 14-item Self-Reporting-Based Perceived Stress Scale tools, respectively. The primary outcome was the differences in the mean premenstrual symptom scores between the two groups. Secondary outcomes included the quality of life and stress levels of participants. The study period was from 1 February and ended 30 June 2021. SPSS was used to analyze the data and intention-to-treat analysis was utilized.A total of 72 adolescents with PMS were randomized to the intervention and control groups (n=36 each). Both groups were similar at baseline (P-value&gt;0.05). No significant association was found between healthy-diet and PMS symptoms (P-value&gt;0.05). In addition, no significant association was found between healthy-diet and quality of life at follow-up (P-value=0.216). The outcomes of this study refuted any possible relationships between healthy diet and PMS symptoms. Accordingly, dietary consultations may not facilitate the clinical management of PMS symptoms in adolescent females.

Obesity is a troubling public health problem worldwide as it increases risks of respiratory complications, systemic arterial hypertension, type 2 diabetes mellitus, sleep disorders, cardiovascular diseases, and metabolic syndrome (MetS). As a measure to counteract comorbidities associated with severe obesity, bariatric surgery stands out. This study aimed to investigate the adiponectin/leptin ratio in women with severe obesity with and without MetS undergone Roux-en-Y Gastric Bypass (RYGB) and to characterize the biochemical, glucose, and inflammatory parameters of blood in women with severe obesity before and after RYGB. Were enrolled female with severe obesity undergoing RYGP with MetS (n=11) and without (n=39). Anthropometric data and blood samples were obtained before and 6 months after RYGB to analyze total cholesterol, low-density lipoprotein (LDL), high- density lipoprotein (HDL), non-HDL total cholesterol, and glucose; and circulating levels of adiponectin and leptin. Significant reductions in weight, body mass index, and glucose, total cholesterol, LDL, and leptin were observed after surgery, with higher levels of HDL, adiponectin, and adiponectin/leptin ratio observed after surgery compared to preoperative values. This study demonstrated that weight loss induced by RYGB in patients with severe obesity with or without MetS improved biochemical and systemic inflammatory parameters, particularly the adiponectin/leptin ratio.

Background: Clean cookstove interventions can theoretically reduce exposure to household air pollution and benefit health, but this requires near-exclusive use of the stoves, with simultaneous disuse of traditional stoves. Previous cookstove trials have reported low adoption of new stoves and/or extensive continued traditional stove use. Methods: The Household Air Pollution Intervention Network (HAPIN) trial randomized 3195 pregnant women in Guatemala, India, Peru, and Rwanda either to a liquefied petroleum gas (LPG) stove and fuel intervention (n = 1590) or to control (n = 1605). The intervention consisted of an LPG stove and two initial cylinders of LPG, free fuel refills delivered to the home, and regular behavioral messaging. We assessed intervention fidelity (delivery of the intervention as intended) and adherence (intervention use) through the end of gestation, as relevant to the first primary health outcome of the trial: infant birth weight. Fidelity and adherence were evaluated using stove and fuel delivery records, questionnaires, visual observations, and temperature-logging stove use monitors (SUMs). Results: 1585 women received the intervention, at a median (interquartile range) of 8.0 (5.0–15.0) days post-randomization and gestational age of 17.9 (15.4–20.6) weeks. Over 96% reported cooking exclusively with LPG at two follow-up visits during pregnancy. Less than 4% reported ever running out of LPG. Complete abandonment of traditional stove cooking was observed in over 67% of intervention households. 31.4% removed their traditional stoves upon receipt of the intervention, and among those who retained traditional stoves, the majority did not use them: traditional stove use was detected via SUMs on a median (interquartile range) of 0.0% (0.0%, 1.6%) of follow-up days (median follow-up = 134 days). Conclusions: Fidelity of the HAPIN intervention, as measured by stove installation, timely ongoing fuel deliveries, and behavioral reinforcement as needed, was high. Exclusive use of the intervention during pregnancy was also high.

Chronic diseases are still known as incurable diseases, and we suspect that the medical research model is unfit for characterizing chronic diseases. In this study, we examined accuracy and reliability required for characterizing chronic diseases, reviewed implied presumptions in clinical trials and assumptions used in statistical analysis, examined sources of variances normally encountered in clinical trials, and conducted numeric simulations by using hypothetical data for several theoretical and hypothetical models. We found that the sources of variances attributable to personal differences in clinical trials can distort hypothesis test outcomes, that clinical trials introduce too many errors and too much inaccuracies that tend to hide weak and slow effects of treatments, and that the means of treatments used in statistical analysis have little or no relevance to specific patients. We further found that a large number of uncontrolled co-causal or interfering factors normally seen in human subjects can greatly enlarge the means and the variances of the experimental errors, and the use of high rejection criteria (e.g., low p values) further raises the chances of failing to find treatment effects. As a whole, we concluded that the research model using clinical trials is wrong on multiple grounds, under any of our realistic theoretical and hypothetical models, and that misuse of statistical analysis is most probably responsible for failure to identify treatment effects for chronic diseases and to detect harmful effects of toxic substances in the environment. We proposed alternative experimental models involving the use of single-person or mini optimization trials for studying low-risk weak treatments.

Due to the retrognathic mandible, an orthodontist frequently observes skeletal class II malocclusion in growing patients. The preferred technique for analyzing and monitoring the temporomandibular joint alterations caused by the functional device is magnetic resonance imaging [MRI]. The study aimed to assess and compare changes in the articular disc's dimension and location before and following the use of various class II correctors to correct the class II molar relation using MRI technology. Methods: 39 adolescent patients aged 15-23 years old [24 girls and 15 boys] who were diagnosed with skeletal Class II division 1 malocclusion based on clearly defined criteria underwent treatment with either the power scope II [PS], Sabbagh Advanced Repositioning Appliance [SARA] and or Dynaflex [DF] with fixed appliances. For fixed functional treatment, the average length of treatment was 5-7 months. The changes in the articular disc dimension and position and condylar position were assessed. The study was done at the Department of Orthodontics at the College of Dentistry, Hawler Medical University in Erbil City. Results: Group DF has a significant effect on the condylar position index and posterior joint space on the closed mouth and disc length on both open and close mouth techniques, and in the group SARA, disc position, and condylar position index on closed mouth technique have shown that significant differences were observed. Conclusion: Class II malocclusions can be effectively corrected by fixed functional appliances. The statistical significance forward movement of the condyle in the glenoid fossa and the posterior movement of the articular disc concerning the condylar head was observed. The mechanism of action of functional appliances appears to include the forward migration of the C-GF complex.

Objectives: To assess the short-term impact of a single global stretching session on plantar pressures and lumbar range of motion (RoM) over one week in sedentary university students. Design: A randomised controlled trial with two parallel groups. Participants: Sixty-four university students were randomly assigned to a stretching group or control group. The stretching group received a single session of global stretching and the control group remained seated for the same length of time as the stretching session. Main outcome measures: Lumbar RoM and plantar pressures were assessed before, immediately after, 48 hours after, and 7 days after intervention. Results: Group-by-time interaction was significant for lumbar lateral flexion (p = 0.044), right maximal pressure (p = 0.003), left maximal pressure (p = 0.008), right mean pressure (p = 0.025), left mean pressure (p = 0.002), and maximal pressure minus mean pressure in right foot (p = 0.007). The model with plantar pressures showed a significant difference for group-by-time interaction (p = 0.010).Conclusion: Global stretching seems to counteract the ill-effects of prolonged sitting up to seven days with respect to plantar pressure in standing without improving lumbar ROM

Stroke causes disability and significantly affects patient quality of life. Post-stroke rehabilitation of upper limb function is crucial, as it affects daily activities and individual autonomy. Traditional rehabilitation methods often require frequent visits to specialized centers, which can be costly and challenging. This study investigated the effectiveness of a home-based self-training device, "Kenko Yusuri," in improving upper limb function in patients with chronic stroke. This multicenter prospective intervention study used a quasi-randomized controlled trial design. Ninety-three outpatients from five hospitals in Japan were enrolled and assigned to either the intervention group who used the "Kenko Yusuri" device or the control group who underwent conventional rehabilitation. All patients received botulinum toxin type A (BoNT-A) injections to treat upper limb spasticity. The primary outcome measure was the Fugl-Meyer Assessment (FMA) of upper-extremity motor function. Secondary outcomes included the modified Ashworth scale (MAS) score, range of motion (ROM), and chronic pain assessments. The intervention group demonstrated significantly greater improvements in FMA total scores than the control group. Patients with moderate paralysis experienced the greatest benefits from the intervention. There were no significant between-group differences in MAS scores or ROM measurements. Pain and wrist ROM showed improvement in the intervention group. Home-based training with a shaking device significantly improved upper limb function in patients with moderate chronic post-stroke paralysis. This approach aligns with the principles of use-dependent plasticity and offers a feasible and cost-effective alternative to traditional rehabilitation methods.

It is estimated that about 50% of geriatric rehabilitation patients suffer from sarcopenia. Thereby, malnutrition is frequently associated with sarcopenia and dietary intake is the main modifiable risk factor. During hospitalization, older adults are recommended to consume more dietary protein than the current recommended dietary allowance of 0.8 g/kg body weight per day to optimize the recovery of muscular strength and physical function. This prospective study examined the effect of a short-term protein supplementation with protein-enriched foods and drinks on hand-grip strength, nutritional status and physical function in older patients at risk of malnutrition during a three week inpatient orthopedic rehabilitation stay. The Mini Nutritional Assessment (MNA) was used to assess malnutrition. Patients with a MNA score ≤ 23.5 points were randomly assigned to an intervention group (goal: to consume 1.2–1.5 g protein/kg body weight per day) or a control group (standard care). Both groups carried out the same rehabilitation program. Physical recovery parameters were determined at admission and discharge. There was a trend for participants in the intervention group to consume more protein than the control group (P = 0.058): 95.3 (SD 13.2) g/day as compared to 77.2 (SD 24.2) g/day, which corresponds to a mean protein intake of 1.6 (SD 0.3) g/kg/day vs. 1.3 (SD 0.5) g/kg/day. Dietary protein supplementation increased body weight by an average of 0.9 (SD 1.1) kg and fat mass by an average of 0.9 (SD 1.2) kg as compared with baseline (P = 0.039 and P = 0.050, respectively). There was no significant change in hand-grip strength, body composition and physical function. In conclusion, a short-term intervention with protein-enriched foods and drinks enabled older patients at risk of malnutrition to increase their protein intake to levels that are higher than their required intake. In these older individuals with appropriate protein intake, dietary protein supplementation did not result in a greater improvement in physical recovery outcomes during short-term inpatient rehabilitation. The intervention improved dietary protein intake, but further research (e.g., a full-scale randomized controlled trial with sufficient power) is required to determine the effects on physical function outcomes.

Background: Strengthening adherence to self-care behaviors in patients with periodontal disease (PD) and reducing plaque index is crucial for improving PD treatment. We evaluated the effectiveness of a theory of planned behavior (TPB)-based health education intervention involving planning strategy on self-care behaviors in patients with PD. Methods: A randomized controlled trial was conducted; 158 and 139 patients comprised the experimental group (EG) and control group (CG), respectively. Both groups received a leaflet, and the EG also received a planning intervention, which was a brief one-on-one counseling session with a planning sheet. Data were collected using a self-administered questionnaire. Results: Between-group comparisons of TPB measures revealed significant differences in all domains when controlling for baseline covariates. The EG exhibited significantly higher levels of action and coping planning than the CG at 2-week follow-up (effect size (ES) = 5.54 and 5.57, respectively) and 6-week follow-up (ES = 5.66 and 5.66, respectively). Between-group differences in changes of brushing behaviors increased significantly. More frequent use of dental floss was observed in the EG than in the CG at 2-week and 6-week follow-ups (24.7% and 22.8%, respectively). Conclusions: The intervention involving planning strategy effectively promoted adherence to self-care behaviors in patients with PD.

This study investigated the impact of seven-strain probiotic supplementation on the frequency of T helper 17 (Th17) cells, regulatory T (T-reg) cells, Treg/Th17 ratio, and their gene expression in individuals with severe traumatic brain injury (STBI). Probiotics can influence the gut microbiota, modulate the immune response, and prevent or alleviate certain immune diseases. However, it is necessary to clarify whether probiotics can effectively impact Th cells in STBI patient. Despite the great attention to improving the immune system in most diseases, there is currently no accurate mechanism for the use of probiotics in diseases with damage to the head injury, which can be a basis for the use of probiotics. The primary objective of this study is to address this research gap. The present study was a randomized, double-blind, placebo-controlled trial that enrolled 48 STBI patients. They were treated with probiotics or placebo: 4 capsule/day for 14 days. The pre- and post-study evaluation included examining the frequency of Treg, Th17 cells, as well as the expression of associated immunological parameters (Foxp3 and RORγt) and Treg/Th17 ratio in both groups. No significant differences were found between the two groups in terms of subject characteristics (P>0.05). GCS scores at 14 days were significantly higher in the probiotic compared to the placebo group. The probiotic group showed a significant decrease in Th17 cell and RORγt gene expression (P = 0.022 and P< 0.001, respectively), a notable increase in T-reg and FoxP3 gene expression (P= 0.025 and P< 0.001, respectively), and a higher Treg/Th17 ratio compared to the placebo group. Our study provides promising evidence of the beneficial effects of seven-strain probiotic supplementation on Th cells in individuals with STBI.

The global prevalence of type 2 diabetes mellitus (T2DM) has surged in recent decades and the identification of differential glycemic responders can aid tailored treatment for prevention of pre-diabetes and T2DM. A mixed meal tolerance test (MMTT) based on regular foods offers potential to uncover differential responders in dynamical postprandial events. We aimed to fit a simple mathematical model on dynamic postprandial glucose data from repeated MMTTs among partic-ipants with elevated T2DM risk, to identify response clusters and investigate their association with T2DM risk factors and gut microbiota. Data were used from a 12-week multi-center dietary inter-vention trial involving high-risk T2DM adults, comparing high- versus low-glycemic index foods within a Mediterranean diet context (MEDGICarb). Model-based analysis of MMTTs from 155 participants (81 females, 74 males) revealed two distinct plasma glucose response clusters that were associated with baseline gut microbiota. Cluster A, inversely associated with HbA1c and waist circumference and directly with insulin sensitivity, exhibited a contrasting profile to cluster B. Findings imply that a standardized breakfast MMTT using regular foods could effectively distin-guish non-diabetic individuals at varying risk levels for T2DM using a simple mechanistic model.

Background: Spine shape parameters, such as leg length, kyphotic or lordotic angle, are influenced by low back pain. There is also evidence that the thoracolumbar fascia plays a role in such pa-thologies. This study examined the immediate effects of a myofascial release technique (MFR) on the thoracolumbar fascia and of an osteopathic treatment (OMT) on postural parameters in pa-tients with acute low back pain (aLBP). Methods: This study was a single-blind randomized pla-cebo-controlled trial. Seventy-one subjects (43.8 ± 10.5 years) suffering from aLBP were randomly and blinded assigned to three groups to be treated with MFR, OMT or a placebo intervention. Spinal shape parameters (functional leg length discrepancy (fLLD), kyphotic angle, lordotic an-gle) were measured before and after the intervention using video raster stereography. Results: Within the MFR group, fLLD reduced by 5.2 mm, p < 0.001 and kyphotic angle by 8.2 degrees, p < 0.001. Within the OMT group, fLLD reduced by 4.5 mm, p < 0.001 and kyphotic angle by 8.4 °, p = 0.007. Conclusion: MFR and OMT have an influence on fLLD and the kyphotic angle in aLBP patients. The interventions could have a regulating effect on the impaired neuromotor control of the lumbar muscles.

To our best knowledge this is the first study to assess and compare lower limb biomechanics and gait pattern between patients undergoing total knee arthroplasty with use of fixed-bearing medial-pivot and multi-radius design implants. Results of this study show that there were no statistical differences between both types of implants and even though there was significant improvement in patient-reported outcome and gait pattern, those parameters still differ significantly in comparison to healthy volunteers. The problem with dissatisfaction after operative treatment may not lay in the procedure itself, but many different factors may contribute to it. Next studies comparing other designs of implants, as well as proper rehabilitation protocol should be performed

The increasing prevalence of obesity and sedentary lifestyles has led to an increased incidence of metabolic syndrome (MetS) worldwide. In Taiwan, middle-aged women are at a greater risk of MetS, type 2 diabetes, and cardiovascular disease than men are because they have more subcutaneous fat and larger waist circumferences compared to men with equal visceral fat levels. This study investigated the effects of calorie restriction supplemented with fish oil (CRF) in middle-aged women with MetS. For 12 weeks, 75 eligible participants were randomly assigned either calorie restriction (CR) or CRF. Both dietary intervention groups were further divided into two age groups: ≤45 and >45 years. The changes in MetS severity, inflammatory status, iron status, and red blood cell fatty acid profile were evaluated. Seventy-one participants completed the trial. Both dietary interventions significantly ameliorated MetS and improved the participants’ inflammatory status. CR significantly increased total iron binding capacity, whereas CRF increased hepcidin levels. Furthermore, CRF significantly increased the n-6/n-3 and arachidonic acid/docosahexaenoic acid ratios. In conclusion, CR and CRF improved the anthropometric and MetS characteristics of early-middle aged women, including body weight, blood glucose levels, triglyceride levels, as well as the scores for the homeostasis model assessment of insulin resistance and quantitative insulin sensitivity cheque index. Dietary intervention was more effective in >45-year-old women than ≤45-year-old women.

Background: Overweight and obese adults seek effective exercise interventions to reduce accumulated fat, but the effectiveness of these interventions vary across studies. The purpose of this meta-analysis was to investigate the effectiveness of exercise interventions in overweight and obese adults based on measurement of accumulated fat distributions. (2) Methods: Databases were used to select eligible studies for this meta-analysis. Randomized controlled trials with a control and experimental group were included. Degrees of effectiveness of exercise interventions were computed to assess the benefits on reducing weight and subcutaneous, visceral, and ectopic fat accumulation. (3) Results: A total of twenty-one studies were included in this meta-analysis. Participation in exercise interventions showed beneficial effects in reducing weight and subcutaneous and visceral fat. The effectiveness of exercise interventions on ectopic fat accumulation could not be assessed due to the limited number of studies measuring ectopic fat. Additionally, effectiveness of exercise interventions that depended on measurements of accumulated fat varied. The average exercise intervention for overweight and obese individuals was moderate to vigorous intensity, 4 times per week, 50 minutes per session, and 22 weeks duration. (4) Conclusions: Participating in exercise interventions has favorable effects on reducing weight and accumulation of subcutaneous and visceral fat.

Hospital readmission within 30 days of discharge (30-day readmission) is a high-priority quality measure and cost target. The purpose of this study was to explore the feasibility and efficacy of the Diabetes Transition of Hospital Care (DiaTOHC) Program on readmission risk in high-risk adults with diabetes. This was a non-blinded pilot randomized controlled trial (RCT) that compared usual care (UC) to DiaTOHC at a safety-net hospital. The primary outcome was all-cause 30-day readmission. Between 10/16/2017 and 05/30/2019, 115 patients were randomized. In the intention-to-treat (ITT) population, 14 (31.1%) of 45 DiaTOHC subjects and 15 (32.6%) of 46 UC subjects had a 30-day readmission (p=0.88) while 35.6% DiaTOHC and 39.1% UC subjects had a 30-day readmission or ED visit (p=0.72). The Intervention:UC cost ratio was 0.33 (0.13-0.79)95%CI (p<0.01). Among the 69 subjects with baseline HbA1c >7.0% (53 mmol/mol), 30-day readmission rates were 23.5% (DiaTOHC) and 31.4% (UC, p=0.46) and composite 30-day readmission or ED visit rates were 26.5% (DiaTOHC) and 40.0% (UC, p=0.23). In this subgroup, the Intervention:UC cost ratio was 0.21 (0.08-0.58)95%CI (p=0.002). The DiaTOHC Program is feasible and may decrease combined 30-day readmission/ED visit risk as well as healthcare costs among patients with higher HbA1c levels.

Background/Objectives: This study looks at how a kinematic chain exercise regimen that targets the lower, core, and upper body affects university shot put participants' shoulder muscle strength and throwing efficiency. This study fills an apparent research void on shot put training approaches by presenting a comprehensive kinematic chain workout program. It was anticipated that this method would improve performance the most, considering the complex biomechanical require-ments of the sport. Methodology: Athletes, seventy in age (19.87 ± 1.31 years), were assigned into two groups at random: experimental (n = 35) and control (n = 35). While the control group carried on with their usual training, the experimental group participated in an 8-week kinematic chain training program, pre- and post-training evaluations were carried out to evaluate shot put throwing ability, shoulder muscle strength, and participant satisfaction with the exercise regimen. Results: demonstrated that, when compared to the control group, the athletes in the kinematic chain program had a significantly improved throwing distance (p = 0.01) and shoulder muscle strength (p = 0.01). Furthermore, there was a significant difference (p = 0.005) in the athletes' satisfaction levels with the workout program among those in the experimental group. This implies that a kinematic chain-focused strategy improves performance and emphasizes the significance this type of training is for shot put athlete performance. Conclusion: As an improvement forward in sports science, the study's finding promotes the inclusion of kinematic chain workouts in shot put training programs and calls for more research on kinematic chain-based approaches in a variety of sports.

Despite limited research on the effects of a combined physical exercises on static and proactive postural control and neuromuscular functions in older adults with sarcopenic obesity (SO), this study addresses the gap by examining the efficacy of a 4-month Total Mobility Plus (TMP) regimen. The study enrolled 40 older adults with SO, split into an intervention group (n=25, mean age = 76.1 ± 3.5 years; mean BMI = 34.4 ± 4.0 kg/m²) and a control group (n=25, mean age = 75.9 ± 5.4 years; mean BMI = 32.9 ± 2.3 kg/m²). Participants in the IG engaged in 60-minute TMP sessions three times a week for four months, while the CG maintained their typical daily activities. Standardized evaluations were performed before and after the intervention, including the Romberg and Timed Up and Go (TUG) tests, Center of pressure (CoP) parameters during different conditions, muscle activation and strength of plantar and dorsal flexors. Post-intervention results revealed significant reduction of the standing time measured in the Romberg (-15.6%, p<0.05), and TUG (-34.6%, p<0.05) tests. Additionally, CoP area and velocity, were notably reduced in various conditions (p<0.05). Postural control improvements were associated with an increase of strength and decrease of ankle muscle activation. These findings validate the TMP program as a safe and effective method for enhancing static and proactive postural control and neuromuscular capabilities in older adults with SO.

A 24 week-controlled trial was conducted in menopausal women (mean age:61.5) to assess serum 25-hydroyvitaminD (s25OHD) evolution in relation to three interdependent determinants: doses of supplemented (Suppl.) vitamin D₃ (VitD₃); baseline status; seasonality. Participants were randomized into 3 groups (Gr): Gr.Suppl.0, time-controls maintaining dietary habits; Gr.Suppl.5 and Gr.Suppl.10 consuming one and two 125 g servings of VitD₃-fortified yogurts with 5 and 10 µg daily doses, respectively. The 16 intervention-weeks lasted from early-January to mid-August, the 8 follow-up-weeks from late-August to mid-October. Before enrollment, subjects were randomized into two s25OHD strata: “Low stratum (LoStr)“: 25-50 nmol/L; “High stratum (HiStr)“: >50-75 nmol/L. All enrolled participants remained compliant until study end: Gr.Suppl.0 (n=45), Gr.Suppl.5 (n=44) Gr.Suppl.10 (n=44). Over the 16 intervention and 8 follow-up weeks, s25OHD increased in both supplemented groups, more in Gr.Suppl.10 than Gr.Suppl.5. The constant rate of s25OHD per supplemental VitD₃ microgram was greater in LoStr than HiStr. s25OHD increase was greater with late (mid-March) than early (mid-January) inclusion. In conclusion, this randomized trial demonstrates: -a dose-dependent s25OHD improvement related to fortified yogurt consumption; -an inversely baseline-dependent increase in s25OHD; -a seasonal effect that highlights the importance of vitamin D₃ supplementation during winter, even at 5µg/d, in healthy menopausal women.

BACKGROUND: Probiotics may prevent the allergic response’s development due to their anti-inflammatory and immunomodulatory effects. The aim of this study is to determine if the prophylactic treatment with a mixture of Bifidobacterium animalis subsp. Lactis BB12 and Enterococcus faecium L3, would reduce symptoms and need for drug use in children with allergic rhinitis (AR). METHODS: The study included 250 children aged from 6 to 17 years, affected by AR. Patients were randomly assigned to the intervention group (117) or to the placebo group (86). Patients of the intervention group, in addition to conventional therapy (local corticosteroids and/or antihistamines), were treated, in the 3 months preceding the development of AR symptoms, with a daily oral administration of a probiotic mixture containing the Bifidobacterium animalis subsp Lactis BB12 DSM 15954 and the Enterococcus faecium L3 LMG P-27496 strain. Nasal Symptoms Score(NSS) was used to evaluate AR severity before and after the treatment with probiotics or placebo. RESULTS: 96% of the patients in the intervention group showed a significant decrease in their NSS after the probiotic treatment as well as a decrease in the intake of pharmacological therapy. GPower software was used to calculate the test power. Given the probability of error α = 0.05, the total sample size n = 117 and the effect size ρ = 2.0651316, the power of the test is 1 - β = 1. CONCLUSIONS: When administered as a prophylactic treatment the mixture of BB12 and L3 statistically decrease signs and symptoms of AR and reduces significantly the need of drugs.

Background: Areca nut and betel quid (ANBQ) chewing is a widespread carcinogenic habit. The BENIT (ClinicalTrials.gov - NCT02942745) is the first known randomized trial designed for ANBQ chewers. Methods: We compared intensive behavioral treatment intervention condition (IC) with control condition (CC) in the BENIT and included a 5-stage early stopping rule. We report the primary analysis at stage 3. English literate adults in Guam and Saipan who self-identified as ANBQ chewers with tobacco were enrolled between August 2016 and August 2020. IC participants (n=88) received five in-person sessions over 22 days and a brochure containing quitting advice. CC participants (n=88) received only the brochure. Participants were assessed at baseline and day-22 follow-up. Self-reported chewing status at day-22 was determined by a composite of two survey items with disparate wording and response options for cross-verification. Results: Cessation rates were 38.6% (IC) and 9.1% (CC). Proportional hazards regression revealed a p=0.0058, which met the Stage 3 criteria for significance and an estimated reduction in ANBQ chewing for IC compared to the CC of 71% (95% CI: 41%-88%). Conclusion: Robust self-reported intervention effects at day-22 suggests that intensive cessation programs such as BENIT should be further developed and implemented on a larger scale.

Microarray patches (MAPs) have the potential to be a safer, more acceptable, easier to use, and more cost-effective means for the administration of vaccines than injection by needle and syringe. Here, we report findings from a randomized, partially double-blind, placebo-controlled Phase I trial using the Vaxxas high-density MAP (HD-MAP) to deliver a measles rubella (MR) vaccine. Healthy adults (N = 63, age 18–50 years) were randomly assigned 1:1:1:1 to four groups: uncoated (placebo) HD-MAPs, low-dose MR HD-MAPs (~3,100 median cell-culture infectious dose [CCID50] measles, ~4,300 CCID50 rubella); high dose MR-HD-MAPs (~9,300 CCID50 measles, ~12,900 CCID50 rubella); or a sub-cutaneous (SC) injection of an approved MR vaccine, MR-Vac (≥1,000 CCID50 per virus). The MR vaccines were stable and remained viable on HD-MAPs when stored at 2–8°C for at least 24 months. When MR HD-MAPs stored at 2–8°C for 24 months were transferred to 40°C for 3 days in a controlled temperature excursion, loss of potency was minimal, and MR HD-MAPs still met World Health Organisation (WHO) specifications. MR HD-MAP vaccination was safe and well-tolerated; any systemic or local adverse events (AEs) were mild or moderate. Similar levels of binding and neutralizing antibodies to measles and rubella were induced by low-dose and high-dose MR HD-MAPs and MR-Vac. The neutralizing antibody seroconversion rates at day 28 after vaccination for the low-dose HD-MAP, high-dose HD-MAP and MR-Vac groups were 37.5%, 18.8% and 35.7% respectively for measles and 37.5%, 25.0% and 35.7% respectively for rubella. Most participants were seropositive for measles and rubella antibodies at baseline, which appeared to negatively impact the number of participants that seroconverted to vaccines delivered by either route. The data reported here suggest HD-MAPs could be a valuable means for delivering MR-vaccine to hard-to-reach populations and support further development. Clinical trial registry number: ACTRN12621000820808.

: Background: Overweight and obesity are major risk factors for many chronic diseases, and weight-loss interventions often include systematic exercising and nutritional supplements. The purpose of this study was to determine the independent/synergistic effects of Spirulina maxima supplementation (6-week, 4.5 g/day) and a systematic physical exercise program (6 weeks/ 2 times) on body composition and cardiorespiratory fitness of overweight and obese subjects. Methods: 27 overweight and 25 obese sedentary male subjects were assigned to four interventions through a randomized double-blind, crossover controlled trial: Physical exercise program with (SE) or without (Ex) Spirulina maxima or no-exercise program with (Sm) and without (C) Spirulina maxima. Body composition and cardiorespiratory fitness parameters were taken during a maximal intensity test. Results: As compared to C group, SE, Sm and Ex groups reduced (p < 0.05) their body fat percentage while improving their maximal oxygen uptake (VO₂max; r = −0.40), being obese subjects more benefited. Weight loss, time to reach fatigue and onset of blood lactate accumulation were improved in both Spirulina maxima supplemented groups, regardless the subjects’ body composition. Conclusions: Spirulina maxima supplementation synergistically improves the effects of systematic exercise in body composition and cardiorespiratory fitness parameters in overweight but mostly in obese adults.

Long-lasting insecticidal nets (LLINs) have been the main contributor to the reduction of malaria in the past two decades in sub-Saharan Africa. Development of pyrethroid insecticide resistance threatens the effectiveness of these LLINs, especially when nets become holed and the insecticide decays. Three classes of dual active ingredient (AI) LLINs, have been assessed for their physical durability as follows: 1) Royal Guard®, combining pyriproxyfen, which is known to disrupt female reproduction and fertility of eggs, and a pyrethroid alpha-cypermethrin; 2) Interceptor® G2, two adulticides with differing modes of action; chlorfenapyr and alpha-cypermethrin; 3) OlysetTM Plus incorporates permethrin (pyrethroid) and a synergist, piperonyl butoxide, to enhance the potency of pyrethroid insecticides; all nets were compared to standard pyrethroid only net (Interceptor®). About 40,000 nets of each type were distributed in February 2019 to different villages in Misungwi. A total of 3072 LLINs were followed at 6, 12, 24, 30 and 36 months to assess survivorship and fabric integrity in a community setting. The median functional survival were less than three years with Interceptor®, Interceptor® G2 and Royal Guard® having 1.9 year each and 0.9 years for OlysetTM Plus . After 36 months, 90% of OlysetTM Plus and Royal Guard® and 87% of Interceptor® G2 were no longer present (thrown away) in the households due to wear and tear, compared to 79% for standard Interceptor®. Short life spans of all assessed LLINs were driven by material of the net, rather than social economic status and housing material. All dual AI LLINs have a poor textile durability with OlysetTM Plus being the worst of the three.

Background: The management of erectile dysfunction (ED) shows several grey zones and new treatments for reduce the percentage of patients who discontinued the treatment are required. Here, we aim to evaluate the role of a natural mixture of named Icarifil (L-Citrulline, L-Carnitine, Eruca vesicaria, Panax ginseng, Tribulus terrestris, Turnera diffusa, Taurine, Vitamin E, Zinc) in the management of patients with ED. Methods: From September 2022 to March 2023, all patients attending 3 urological institutions due to ED were randomized to receive: Icarifil 1 sachet every 24 h (Group 1) or Icarifil 1 sachet + tadalafil 5 mg 1 tablet every 24 h (Group 2) or tadalafil 5 mg 1 tablet daily (Group 3), for 3 months. All patients underwent urologic visit and dedicated questionnaires (IIEF-5, SEP-2, SEP-3) at the enrollment and at the follow-up evaluation (3 months). Patient Reported Outcomes (PROs) at the follow-up evaluation were used. Primary endpoint was the difference in the questionnaires at the follow-up visit when compared with enrollment among the study groups. Results: In the per-protocol analysis, 52 patients in the Group 1, 55 in the Group 2 and 57 in Group 3 have been analyzed. At the follow-up evaluation, IIEF-5 have been improved in all the 3 Groups between enrollment and follow-up evaluation, but a statistically significant difference has been reported between Group 2 (+7.4) versus Group 1 (+4.1) or 3 (+5.1), (p&lt;0.001; p&lt;0.001). Moreover, 47 patients (94.0%) in the Group 2 showed an improvement in the SEP questionnaires, when compared with the baseline, while 29 in the Group 1 (56.9%) and 42 in the Group 3 (82.3%) with a statistically significant difference (p=0.004; p=0.003) among the Groups. The PROs analysis reported a better efficacy and patients’ satisfaction in Group 2 when compared with Group 1 or 3. Conclusions: In conclusion, Icarifil is able to improve penile erectile function in mild–moderate ED and it is able to significantly improve the clinical efficacy of tadalafil 5 mg daily use. Icarifil could be represent an interesting alternative treatment in patients experiencing adverse effects or with contraindications for chronic treatment with PDE5-is.

This study aims to explore the effect of real-time visual feedback (VF) information of the pres-sure of center (COP) provided by intelligent insoles on balance training in a one leg stance (OLS) and tandem stance (TS) posture. Thirty healthy female college students were randomly assigned to the visual feedback balance training group (VFT), non-visual feedback balance training group (NVFT), and control group (CG). The balance training includes: OLS, tandem Stance (dominant leg behind, TSDL), tandem stance (non-dominant leg behind, TSNDL). The training lasted 4 weeks, the training lasts 30 minutes at an interval of 1 days. There was a sig-nificant difference in the interaction effect between Groups*Times of the COP parameters (p<0.05) for OLS. There was no significant difference in the interaction effect between Groups*Times of the COP parameters (p>0.05) for TS. The main effect of the COP parameters was a significant difference in Times (p<0.05). The COP displacement, velocity, radius, and area in VFT significantly decreased after training (p < 0.05). Therefore, the visual feedback technology of intelligent auxiliary equipment during balance training can enhance the benefit of training. The use of smart wearable devices in OLS balance training may improve the visual and physical balance integration ability.

A drug repositioning effort supported the possible use of the anti-HIV drug etravirine as a treatment for Friedreich Ataxia (FRDA). Etravirine increases frataxin protein and corrects the biochemical defects in cells derived from FRDA patients. Because of these findings, and since etravirine displays a favorable safety profile, we conducted this pilot open-label phase 2 clinical trial assessing the safety and potential efficacy of etravirine in FRDA patients. Thirty-five patients were stratified into 3 severity groups and randomized to etravirine 200 mg/day or 400 mg/day. They were treated for 4 months. Efficacy endpoints were represented by changes in peak oxygen uptake and workload as measured by incremental exercise test, SARA score, cardiac measures, measures of QoL and disability. Data were collected 4 months before the start of the treatment (T-4), at the start (T0), at the end (T4) and 4 months after the termination of the treatment (T+4). Etravirine was well tolerated. Etravirine completely stopped the progression of the SARA score during the 4-months treatment period, compared to the 4 months pre and post treatment. It increased peak workload, while the improvement of peak oxygen uptake was not statistically significant. No changes in the cardiac measures were observed. Health and QoL measures showed a worsening at the suspension of the drug. In this open trial etravirine significantly improved neurological function and was generally safe and reasonably tolerated. This suggests that etravirine represents a potential therapeutic agent in FRDA deserving testing in a randomized placebo controlled clinical trial.

Our objective was to evaluate whether pregnancy is prolonged by use of a proteomics-based maternal serum screening test followed by treatment interventions. This is a secondary analysis of the PREVENT-PTB randomized trial comparing screening with the PreTRM test versus no screening. The primary trial analysis found no significant between-group difference in preterm birth rate. Rather than considering a dichotomous outcome (preterm vs term), we treated gestational age at birth as a continuous variable using survival analysis. We also evaluated between-group difference in NICU length of stay and duration of respiratory support. Results indicated that pregnancy was significantly prolonged in subjects screened with PreTRM test compared to controls (adjusted hazard ratio 0.53, 95% confidence interval 0.36-0.78, P &lt;0.01). Newborns of screened subjects had significantly shorter NICU stay but no significant decrease in duration of respiratory support. In the PreTRM screen-positive group, interventions that were associated with pregnancy prolongation included care management and low-dose aspirin but not 17-hydroxyprogesterone caproate. We concluded that screening with the PreTRM test followed by interventions for screen-positive pregnancies can prolong pregnancy and reduce NICU-LOS.

Shoulder tendinopathies produce pain and reduce functionality. The aim of this randomized clinical trial was to analyze the effects of Percutaneous electrolysis (PE), Percutaneous peripheral Nerve Stimulation (PNS) and eccentric exercise (EE), on pain (NPRS), strength, electromyographic activity, ultrasound characteristics of the tendon (echogenicity, thickness and hypervascularization) and functionality (DASH and SPADI) on individuals with supraspinatus tendinopathy. Participants (n=50) were divided into two groups, they received 4 treatment sessions, one per week, of PE and PNS (n=25) or 10 treatment sessions of TENS and US (n=25). Both groups performed EE program consisted of 3 sets of 10 repetitions of each of the 3 exercises, twice a day, during the 4 weeks. Follow-up was carried out at 4, 12 and 24 weeks after the start of the intervention. There are statistically significant differences in the analysis between groups (p&lt;0.001) in the post-treatment and follow-up measurements favorable to the PE+PNS+EE treatment on pain (NPRS), strength, supraspinatus electromyographic amplitude, ultrasound characteristics of the tendon (echogenicity, thickness and hypervascularization) and DASH and SPADI questionnaires. The combined treatment PE, PNS and EE is an effective option in the clinical management of tendinopathies, with positive results in the short and long term on the variables studied.

Increasing HIV drug resistance (DR) among children with HIV (CHIV) on antiretroviral treatment (ART) is concerning. CHIV ages 1-14 years enrolled March 2019 to December 2020 from five facilities in Kisumu County, Kenya were included. Children were randomized 1:1 to control (standard-of-care) or intervention (point-of-care viral load (POC VL) testing every three months with targeted genotypic drug resistance testing (DRT) for VF (&gt; 1000 copies/ml)). A multidisciplinary committee reviewed CHIV with DRT results and offered treatment recommendations. We describe DR mutations and present logistic regression models to identify factors associated with clinically significant DR. We enrolled 704 children in the study; median age was 9 years (interquartile range (IQR) 7,12), 344 (49%) were female and median time on ART was 5 years (IQR 3, 8). During the study period, 106 (15%) children had DRT results (84 intervention and 22 control). DRT detected mutations associate with DR in all participants tested, with 93 (88%) having major mutations, including 51 (54%) with dual class resistance. A history of VF in prior 2 years (adjusted odds ratio (aOR) 11.1; 95% confidence interval (CI) 6.3, 20.0) and less than 2 years on ART at enrollment (aOR 2.2; 95% CI 1.1, 4.4) were associated with increased odds of major DR. DR is highly prevalent among CHIV on ART with VF in Kenya. Factors associated with drug resistance may be used to determine which children should be prioritized for DRT.

Introduction: Emotional intelligence plays a critical role in nursing leadership, influencing organizational dynamics and patient care. However, there is limited understanding of the impact of Emotional Intelligence on leadership in Primary Health Care in the Greek context. Methods: A longitudinal experimental design assessed the effects of an educational intervention on EI and leadership among Greek Primary Health Care nurses. Questionnaires, including the Wong and Law Emotional Intelligence Scale (WLEIS) and Multifactor Leadership Questionnaire - form 5x (MLQ), were administered pre- and post-intervention. Results: The intervention group exhibited significant improvements in Emotional Intelligence and adoption of transformational leadership styles compared to the control group. Tables highlighted nuanced changes in leadership dynamics post-intervention. Conclusions: Educational interventions effectively enhance nurses' Emotional Intelligence and influence leadership styles, emphasizing the need for tailored professional development programs in nursing education.

This study aimed to evaluate the safety and tolerability of STP1, a combination of ibudilast and bumetanide, tailored for the treatment of a specific subgroup of patients with Autism Spectrum Disorder (ASD), namely ASD Phenotype 1 (ASD-Phen1). We conducted a randomized, double-blind, placebo-controlled, parallel-group phase 1b study with two 14-day treatment phases (registered at clinicaltrials.gov as NCT04644003). Nine ASD-Phen1 patients were administered STP1, while three received a placebo. We assessed safety and tolerability, along with electrophysiological markers, such as EEG, Auditory Habituation, and Auditory Chirp Synchronization, to better understand STP1's mechanism of action. Additionally, we used several clinical scales to measure treatment outcomes. The results showed that STP1 was safe and well-tolerated, with electrophysiological markers indicating a significant and dose-related reduction of gamma power in the whole brain and in brain areas associated with executive function and memory. Treatment with STP1 also increased alpha 2 power in frontal and occipital regions and improved habituation and neural synchronization to auditory chirps. Although numerical improvements were observed in several clinical scales, they did not reach statistical significance. Overall, this study suggests that STP1 is safe and well-tolerated in ASD-Phen1 patients and shows indirect target engagement in ASD brain regions of interest.

AbstractIntroduction: Increasing knowledge of obstetric danger signs (ODS) and encouraging birth preparedness and complication readiness (BPCR) practices are strategies to increase skilled maternal health service utilization in low-income countries. One of the methods to increase mothers' knowledge about ODS and promote BPCR practice is through health education intervention (HEI). However, the effect of context-specific community-based health education led by women's groups on these outcomes has not been comprehensively studied, and the existing evidence is inconclusive. Thus, we aimed to evaluate the effect of a context-specific community-based HEI led by women's groups on mothers' knowledge regarding ODS and BPCR practices in southern Ethiopia.Methods: An open-label, two-arm parallel group cluster-randomized controlled trial was conducted from January to August 2023 on pregnant women from 24 clusters (kebeles) (12 interventions and 12 controls) in the northern zone of the Sidama region. The Open Data Kit smartphone application was utilized to collect data. The intention-to-treat analysis was used to compare outcomes between groups. We fitted multi-level mixed-effects modified Poisson regression with robust standard error to account for between and within cluster effects. Results: One thousand and seventy pregnant women (540 in the intervention and 530 in the control clusters) responded to this study, making the overall response rate 95.02%. Excessive vaginal bleeding (94.3% in the interventional group vs. 88.7% in the control group) was the commonest ODS mentioned during childbirth. Overall, 68.7% of women in the intervention group and 36.2% of mothers in the control group had good knowledge of ODS (P-value < 0.001). Saving money and materials (97.1% in the interventional group vs. 92.7% in the control group) was the most frequently practiced BPCR plan. Overall, 64.3% of women in the intervention group and 38.9% of mothers in the control group practiced BPCR (P-value < 0.001). HEI significantly increased overall knowledge of ODS (adjusted risk ratio [ARR]: 1.71; 99% CI: 1.14-2.57) and improved overall BPCR practice (ARR: 1.55; 99% CI: 1.02-2.39). Conclusions: A community-based HEI led by women's groups improved mothers' knowledge regarding ODS and BPCR practices in a rural setting in southern Ethiopia. Interventions designed to increase women's knowledge of ODS and improve BPCR practice must implement context-specific, community-based HEI that aligns with World Health Organization recommendations. Trial registration: NCT05865873

Background: Dietary quality and the consumption of antioxidant-rich foods has been shown to protect against memory decline. Therefore, this double-blind, randomized, placebo-controlled study aimed to investigate the effects of a nutritional supplement on changes in cognitive performance. Methods: In adults aged 40 to 70 years with subjective memory complaints, participants were randomly allocated to take a supplement containing vitamin E, astaxanthin, and grape juice extract daily for 12 weeks or a matching placebo. The primary outcomes comprised changes in cognitive tasks assessing episodic memory, working memory, and verbal memory. Secondary and exploratory measures included changes in the speed of information processing, attention, and self-report measures of memory, stress, and eye and skin health. Moreover, changes in plasma concentrations of brain-derived neurotrophic factor, malondialdehyde, tumor-necrosis factor-α, and interleukin-6 were measured, along with changes in skin carotenoid concentrations. Results: compared to the placebo, nutritional supplementation was associated with larger improvements in episodic memory, a self-report measure of everyday memory, increased plasma brain-derived neurotrophic factor, decreased plasma malondialdehyde, and increased skin carotenoid concentrations. However, there were no group differences in changes in the remaining outcome measures. Conclusions: Twelve weeks of supplementation with a nutritional supplement was associated with improvements in episodic memory and several biological markers associated with cognitive health. Future research will be essential to extend and validate the current findings.

Taste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment. This condition leads to reduced food consumption, increasing the risk of malnutrition. Malnutrition is associated not only with worse treatment efficacy and poor disease prognosis but also with reduced functional status and quality of life. The fruit of Synsepalum dulcificum (Daniell), commonly known as miracle berry or miracle fruit, contains miraculin, a taste-modifying protein with profound effects on taste perception. The CLINMIR Protocol is a triple-blind, randomized, placebo-controlled clinical trial designed to evaluate the regular consumption of a food supplement containing a miraculin-based novel food, dried miracle berry (DMB), on the taste perception (measured through electrogustometry) and nutritional status (evaluated through the GLIM Criteria) of malnourished cancer patients under active antineoplastic treatment. To this end, a pilot study was designed with 30 randomized patients divided into three study arms (150 mg DMB + 150 mg freeze-dried strawberries, 300 mg DMB or placebo) for three months. Throughout the five main visits, an exhaustive assessment of different affected parameters susceptible to improvement through regular consumption of the miraculin-based food supplement will be conducted, including electrical and chemical taste perception, smell perception, nutritional and morphofunctional assessment, diet, quality of life, fatty acid profile of erythrocytes, levels of inflammatory and cancer-associated cytokines, oxidative stress, antioxidant defense system, plasma metabolomics, and saliva and stool microbiota. The primary anticipated result is that malnourished cancer patients with taste distortion who consume the miraculin-based food supplement will report an improvement in food taste perception. This improvement translates into increased food intake, thereby ameliorating their nutritional status and mitigating associated risks. Additionally, the study aims to pinpoint the optimal dosage that provides maximal benefits. The protocol adheres to the SPIRIT 2013 Statement, which provides evidence-based recommendations and is widely endorsed as an international standard for trial protocols (https://www.spirit-statement.org/spirit-statement/). The clinical trial protocol has been registered at http://clinicaltrials.gov (NCT05486260).

Background: Effectiveness of Anastrozole and levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. Methods: Randomized clinical trial. Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and symptoms suggestive of endometriosis. Thirty-one women were randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration(TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months. CS or TUGPA one month after starting medical treatment. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole. For CA-125, the most significant decrease was observed without anastrozole. After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole, although anastrozole seems to delay recurrences. At 4,2±1,7 years, 88% of the patients who underwent CS were asymptomatic, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusion: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time.

Background: Schizophrenia is a mental disorder associated with inflammatory and oxidative stress markers such as lactate; in addition, the rate of physical inactivity in this population is very high, which leads to physical and metabolic alterations. Aims: This study measured the effect of assisted physical exercise over lactate levels in schizophrenia. Methods: Stable outpatients with schizophrenia and a group of Healthy controls received two different programs of Physical exercise (Aerobic and Functional) in a clinical trial. Results: Patients had higher lactate compared to healthy controls before and after intervention, and had higher rate of lactate increase after activity. The finding of increased lactate in schizophrenia detected before and after physical exercise deserve further attention in biomarker studies and in the development of physical rehabilitation in schizophrenia, suggesting different profile of oxidative metabolism after physical exercise. Basal increased lactate may reflect mitochondrial dysfunction or metabolic dysregulation, and the higher rate of increase may reflect a different metabolic and oxidative process. Conclusion: The finding is in line with recent studies as surrogate of mitochondrial dysfunction in schizophrenia and points to the need of additional studies on mitochondrial activity in schizophrenia, and to additional care in the design of physical interventions in schizophrenia.