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Low back pain (LBP) and neck pain predominate as the primary causes of disability. Cell‐ and platelet‐rich plasma (PRP) products are potential therapies with clinical trials and reviews promoting their efficacy. Nonetheless, they frequently disregard the clinical significance of reported improvements. In this systematic review, the effectuated improvements in pain, disability, quality of life (QoL), and radiographic images are comprehensively described and scored on their clinical significance. An electronic database literature search was conducted on July 2023 for in‐human assessment of cell or PRP products to alleviate discogenic pain. Papers were screened on quantitative pain, disability, QoL, radiographic improvements, and safety outcomes. Risk of bias was assessed through MINORS and Cochrane Source of Bias tools. Reported outcomes were obtained, calculated, and assessed to meet minimal clinically important difference (MCID) standards. From 7623 screened papers, a total of 80 articles met the eligibility criteria, presenting 68 specific studies. These presented at least 1974 treated patients. Overall, cell/PRP injections could alleviate pain and disability, resulting in MCID for pain and disability in up to a 2‐year follow‐up, similar to those observed in patients undergoing spinal fusion. Included trials predominantly presented high levels of bias, involved heterogeneous study designs, and only a minimal number of randomized controlled trials. Nonetheless, a clear clinically significant impact was observed for cell‐ and PRP‐treated cohorts with overall good safety profiles. These results highlight a strong therapeutic potential but also underline the need for future cost‐effectiveness assessments to determine the benefits of cell/PRP treatments. [ABSTRACT FROM AUTHOR]

Total knee arthroplasty (TKA) is a common surgery for osteoarthritis, with increasing prevalence expected in the near future. This systematic review and meta‐analysis compared the effectiveness of computerized TKA versus traditional TKA, focusing on postoperative outcomes measured by the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and the Knee Society score (KSS). A search on PubMed and Cochrane databases on November 14, 2023 for retrospective randomized controlled trials (RCTs) yielded data on WOMAC and KSS. The search strategy was predefined, and methodological quality of studies was critically appraised. Two researchers extracted data. Unpaired t‐testing assessed the mean monthly changes in KSS and WOMAC for computer‐aided versus traditional TKA. Review Manager 5.3 was used for data synthesis and analysis. Out of 729 records, five RCTs enrolling 339 patients were eligible and analyzed using a random effects meta‐analysis. The mean monthly ΔKSS score differed significantly between the traditional and computerized groups (11.47 ± 8.76 vs. 9.26 ± 6.05, respectively; p < 0.01). However, the pooled mean difference estimate showed no significant differences (D = 0.20, 95% CI = −0.53 to 0.93, p = 0.59), with high heterogeneity (I2 = 85%, p < 0.001). The mean monthly ΔWOMAC score also differed significantly (−14.18 ± 21.54 vs. −18.43 ± 20.65, respectively; p < 0.05), but again, no significant differences were found in the pooled estimate (D = 0.17, 95% CI = −0.46 to 0.79, p = 0.60), with moderate heterogeneity (I2 = 28%, p = 0.24).There is no significant difference in KSS or WOMAC outcomes between traditional and computerized TKA. The study suggests the need for further research with longer follow‐up periods, more timepoints, and a broader range of patient outcome measures to fully evaluate the advantages and disadvantages of each method. [ABSTRACT FROM AUTHOR]

This paper studies inference in randomized controlled trials with multiple treatments, where treatment status is determined according to a "matched tuples" design. If there are |D| possible treatments, then by a matched tuples design, we mean an experimental design where units are sampled i.i.d. from the population of interest, grouped into "homogeneous" blocks of size |D|, and finally, within each block, exactly one individual is randomly assigned to each of the |D| treatments. We first study estimation and inference for matched tuples designs in the general setting where the parameter of interest is a vector of linear contrasts over the collection of average potential outcomes for each treatment. Parameters of this form include standard average treatment effects used to compare one treatment relative to another, but also include parameters that may be of interest in the analysis of factorial designs. We first establish conditions under which a sample analog estimator is asymptotically normal and construct a consistent estimator of its corresponding asymptotic variance. Combining these results establish the asymptotic exactness of tests based on these estimators. In contrast, we show that, for two common testing procedures based on t‐tests constructed from linear regressions, one test is generally conservative while the other is generally invalid. We go on to apply our results to study the asymptotic properties of what we call "fully‐blocked" 2K factorial designs, which are simply matched tuples designs applied to a full factorial experiment. Leveraging our previous results, we establish that our estimator achieves a lower asymptotic variance under the fully‐blocked design than that under any stratified factorial design, which stratifies the experimental sample into a finite number of "large" strata. A simulation study and empirical application illustrate the practical relevance of our results. [ABSTRACT FROM AUTHOR]

An important cause of stunting is limited consumption of complementary foods, in terms of both quantities and nutrients. Although existing studies show a positive association between fathers' engagement and children's diet, programmes designed to improve complementary feeding practices often only target mothers. In response to this, maternal behaviour change communication (BCC), paternal BCC and food voucher programmes were designed and implemented in Ethiopia using a clustered randomized controlled trial design. The paternal BCC programme included gender‐equal messages to increase fathers' participation in childcare, household labour and decision making. The research reported in this paper is an examination of the BCC programmes, characterizing the behavioural, normative and control beliefs of both mothers and fathers in BCC households compared to those in control households. In this study, a total of 40 participants were included, with 13 mother–father pairs in the BCC + food voucher group, and seven pairs in the control group. Each participant was interviewed separately. We found that BCC mothers showed more gender‐equal tendencies than the control mothers despite being more rural in location. By contrast, the beliefs of BCC and control fathers were similar overall, suggesting men are more resistant to gender‐equal BCC. More work is needed to develop and test effective methods for changing fathers' beliefs and practices. Key messages: Mothers in behaviour change communication (BCC) group mothers held more gender‐equal beliefs than control mothers, while BCC and control fathers shared similar views, suggesting a male resistance to gender equality.Mothers found fathers' involvement in childcare socially acceptable but often perceived them as inexperienced, which limited their participation.Control mothers' traditional view on household chores maintained the conventional labour division, influencing fathers' involvement.Fathers typically resisted maternal control of resources; however, they agreed that the more knowledgeable should lead decision‐making. BCC mothers showed greater confidence in making household decisions as effectively as fathers. [ABSTRACT FROM AUTHOR]

Financial education represents a powerful tool for improving economic literacy of citizens. This paper presents results from an experiment providing a group of 136 workers in an Italian university (administrative staff) an online, synchronous course. Classes were organized in 5 sessions of 2h each and covered basic topics about personal finance. The effectiveness of the course is assessed through a rigorous randomized controlled trial (RCT). In addition to the analysis of improvements in financial knowledge, financial self‐efficacy and the role of prior attitudes and behaviors were explored. Participants obtained post‐test scores statistically higher than individuals in the control group, with an average effect size of 0.55 SD. The effect is particularly relevant for participants starting with low levels of financial knowledge. Moreover, two novel findings emerge: financial self‐efficacy increases (0.51 SD) after the course, and pre‐treatment individuals' financial attitudes and behaviors shed further light on the financial learning process. [ABSTRACT FROM AUTHOR]

Aim: To compare the effect of iMOVE (Intensive Mobility training with Variability and Error) therapy with dose‐matched conventional therapy on gross motor development and secondary outcomes in young children with cerebral palsy. Method: This single‐blind, randomized controlled trial included repeated assessments of gross motor function (using the Gross Motor Function Measure) and secondary outcomes during a 12‐ to 24‐week intervention phase and at three follow‐up points after treatment. Treatment was delivered three times per week in both groups. Forty‐two children aged 12 to 36 months were stratified by age and motor function to ensure equivalence between groups at baseline. Results: Thirty‐six children completed treatment and follow‐up phases. Treatment fidelity was high and adherence was equivalent between groups (77.3% conventional therapy, 76.2% iMOVE). There were no group differences on the primary (gross motor function after 12 weeks p = 0.18; after 24 weeks p = 0.94) or any secondary (postural control p = 0.88, caregiver satisfaction p = 0.52, child engagement p = 0.98) measure after treatment or at the follow‐up points. However, one‐third of total participants exceeded predicted change after 12 weeks and 77% exceeded predicted change after 24 weeks of treatment. Interpretation: Our observations indicate a potential dose–response effect of rehabilitation therapy. We further demonstrated that individual therapeutic ingredients can be manipulated. When delivered consistently, both iMOVE and conventional therapy interventions might both be more effective than standard care. What this paper adds: Those receiving iMOVE therapy demonstrated more independent practice time, error, and child‐initiation than those receiving the dose‐matched control.iMOVE therapy was not superior to the control (conventional physical) therapy.Most participants exceeded predicted change after 24 weeks of treatment. [ABSTRACT FROM AUTHOR]

Responsive feeding serves as an important protective factor for infant growth and overall health development. This study based on self‐determination theory (SDT) aimed to assess the effects of a responsive breastfeeding (RBF) intervention programme on maternal breastfeeding and infant growth and development. A total of 110 mother–infant pairs were recruited and randomly divided into an intervention group (n = 55) and a control group (n = 55). The primary outcomes were breastfeeding motivation score, breastfeeding self‐efficacy (BSE) and exclusive breastfeeding rate; the secondary outcomes were infant physical development at 6 weeks and 3 months. A repeated measures ANOVA indicated that the intervention group had significantly higher Enjoyment scores compared to the control group at three time points: at discharge (MD: 5.28; 95% CI: 3.68 to 6.89; p < 0.001), 6 weeks post‐partum (MD: 5.06; 95% CI: 3.80 to 6.31; p < 0.001) and 3 months post‐partum (MD: 5.24; 95% CI: 4.12 to 6.35; p < 0.001). Similarly, the intervention group reported significantly higher connection and mother's self‐perception scores at discharge (MD: 4.31; 95% CI: 3.07 to 5.56; p < 0.001), 6 weeks post‐partum (MD: 4.69; 95% CI: 3.71 to 5.68; p < 0.001) and 3 months post‐partum (MD: 4.93; 95% CI: 4.14 to 5.72; p < 0.001), compared to the control group. In contrast, the pressure from significant others scores were higher in the control group relative to the intervention group at discharge (MD: −2.09; 95% CI: −2.88 to −1.31; p < 0.001), 6 weeks post‐partum (MD: −4.35; 95% CI: −5.20 to −3.49; p < 0.001) and 3 months (MD: −4.89; 95% CI: −5.70 to −4.08; p < 0.001). Finally, the intervention group also reported higher Instrumental Needs scores at all three time points: at discharge (MD: 1.96; 95% CI: 1.35 to 2.58; p < 0.001), 6 weeks post‐partum (MD: 3.58; 95% CI: 3.05 to 4.11; p < 0.001) and 3 months post‐partum (MD: 1.18; 95% CI: 0.68 to 1.69; p < 0.001). BSE scores were significantly higher in the intervention group compared to the control group at discharge (MD: 14.29; 95% CI: 10.38 to 18.21; p < 0.001), 6 weeks post‐partum (MD: 14.04; 95% CI: 11.05 to 17.02; p < 0.001) and 3 months post‐partum (MD: 6.80; 95% CI: 4.66 to 8.94; p < 0.001). The rates of exclusive breastfeeding were higher in the intervention group than in the control group at each stage of the intervention (p < 0.01). At 6 weeks post‐partum, the intervention group's infants showed slower weight (t = −0.90, p = 0.371) and length (t = −0.69, p = 0.495) growth compared to the control group, though not significantly. By 3 months post‐partum, there was a significant difference in both weight (t = −3.46, p = 0.001) and length (t = −2.95, p = 0.004) between the groups. The findings in this study suggest that the RBF intervention programme based on SDT may be effective in improving mothers' motivation to breastfeed, building breastfeeding self‐confidence and increasing the rate of exclusive breastfeeding. The effects of the intervention on infant physical development will need to be verified with longer follow‐up in future research. Key messages: This study validated the application of responsive breastfeeding (RBF) intervention during the exclusive breastfeeding phase of Chinese infants.The RBF intervention may help to increase mothers' level of autonomous motivation for breastfeeding, enhance breastfeeding self‐efficacy and increase exclusive breastfeedingrates. The intervention had no significant effect on the weight and length of 6 week old infants but significantly impacted 3monthold infants, with slower growth observed in the intervention group compared to the control group.Future intervention programmes shouldinclude extended follow‐up periods to investigate the long‐term effects of RBF on infant growth and development. [ABSTRACT FROM AUTHOR]

To investigate the effects of 8‐week hiking bench training on cardiorespiratory and muscular responses of highly trained sailors during hiking emulation. Twenty‐four sailors were assigned into two groups: the hiking bench training group (HTG, n = 12) and the control group (CG, n = 12). Both groups maintained their regular training with the HTG performed two additional hiking bench training sessions per week for 8 weeks, while the CG performed an equivalent duration of on‐water sailing training. Physiological responses were assessed by performing four successive 3‐min hiking bouts on a sailing emulation ergometer before and after the 8‐week training period. Comparing the pretest, both groups exhibited a significant decrease (p < 0.05) in the percentage of maximal oxygen uptake (%VO2max) and maximal heart rate (%HRmax); the HTG experienced a greater decrease in %VO2max in bouts 2 and 3. The root mean square (RMS) of rectus femoris (RF), vastus lateralis (VL), rectus abdominis (RA), and external oblique decreased significantly (p < 0.05), whereas the mean power frequency (MPF) of RF, VL, and RA exhibited an increasing trend. The RMS of RF and RA in HTG were lower than those in CG in the initial three bouts; VL and EA in HTG were lower than those in CG in bouts 1 and 2 (p < 0.05). The MPF of RA in HTG was significantly increased in bouts 2, 3, and 4 (p < 0.05). Eight‐week hiking bench training could improve hiking economy and the activation of lower limb and trunk muscles delaying the onset of fatigue in sailors. Highlights: Hiking is the most physically demanding task in dinghy sailing, eliciting highly specific cardiorespiratory, and muscular responses. Highly trained sailors attempt to improve the physiological response and performance of hiking through hiking bench training.Hiking bench training involves a series of movement exercises performed by sailors on sailing emulation ergometer that are tailored specific profiles with the objective of optimizing sailing performance.Hiking bench training can effectively enhance the economy of hiking among highly trained sailors, improve the activation of lower limb and trunk muscles, and delay the onset of fatigue in hiking. Hiking bench training can be used as an effective means of enhancing hiking performance for highly trained sailors. [ABSTRACT FROM AUTHOR]

Introduction: Panoramic radiography quality can be impaired by some errors such as positioning errors. Palatoglossal air space shadow error is one of the most common positioning errors and it is due to the tongue not sticking to the roof of the palate. Techniques used to deal with this error might help prevent unnecessary radiation to patients and save them time and money. The study aimed to investigate the effects of using celluloid matrix and edible tapes (fruit leather and chewing gum) on reducing the palatoglossal air space shadow error in panoramic imaging. Methods: In our study, 270 patients referred to the Department of Radiology were randomised into three groups: a control group, a celluloid matrix group and an edible tapes group. Before panoramic imaging, all patients were instructed to adhere their tongues to the roof of their mouths, with the distinction that for the celluloid matrix and edible tapes groups, patients were asked to place celluloid tapes, fruit leathers, or chewing gums on their tongues before doing so. The routine imaging process was then performed, and the results were compared across groups to evaluate the incidence of palatoglossal air space shadow error. Results: The number of error‐free images in each fruit leather, chewing gum and celluloid tape group were significantly higher than the control group (all cases P < 0.05). The chances of error‐free images in the fruit leather groups were the highest (9.57 times). The age (P = 0.136) and gender (P = 0.272) of patients had no significant effect on the results of interventions. Conclusion: The application of fruit leathers, chewing gums and celluloid tapes reduced the palatoglossal air space shadow error of panoramic imaging. [ABSTRACT FROM AUTHOR]

Objective: Self‐management interventions may enhance health‐related quality of life (HRQoL) in epilepsy. However, several barriers often impair their implementation in the real world. Digital interventions may help to overcome some of these barriers. Considering this, the Helpilepsy Plus Prototype was developed as a prototype smartphone‐delivered self‐care treatment program for adults with epilepsy. Methods: The 12‐week Helpilepsy Plus Prototype was evaluated through a randomized controlled feasibility trial with a waiting‐list control (WLC) group. Outcome measurement at baseline and at 12 weeks assessed adherence to the prototype intervention and changes in epilepsy‐related outcomes. The primary endpoint was patient autonomy measured with EASE, and secondary endpoints included HRQoL measured with QOLIE‐31, health literacy measured with HLQ, anxiety, and depression symptoms measured with HADS. Semi‐structured interviews were conducted with a heterogeneous sample of participants to assess user‐friendliness and usefulness. The prototype program was delivered through the Neuroventis Platform (Neuroventis, BV, Overijse, Belgium), a certified medical device (under EU/MDD Class I, and EU/MDR grace period). Results: Ninety‐two patients were included (46 in the intervention group, 46 in WLC). Most participants (63%, 58/92 women, median age 30 years) had pharmacoresistant epilepsy (61%, 56/92). Only 22% of participants (10/46) in the intervention group completed at least half of all intervention sessions. No significant differences between the intervention group and WLC were observed. Although there was a larger proportion of patients in the intervention group with meaningful improvements in HRQoL compared to WLC (19/46 versus 11/46), the difference was not significant (p = 0.119). Qualitative feedback showed that participants would appreciate more personalization, such as adaptation of the content to their current epilepsy knowledge level, a more interactive interface, shorter text sections, and interaction through reminders and notifications. Significance: Digital interventions should allow sufficient scope for personalization and interaction to increase patient engagement and enable benefits from self‐care apps. Feedback loops allow the participatory development of tailored interventions. Plain Language Summary: In this study, we investigated the effectiveness of an app‐based self‐help intervention. Study participants were either randomly assigned to a group that had access to the app or a group that received access to the app after the end of the study. Although a larger proportion of participants in the intervention group showed a relevant improvement in quality of life, the difference between the two groups was not statistically significant. Less than one‐fifth of participants in the intervention group attended at least half of all intervention sessions; patient feedback showed that patients required more personalization and interactive options. [ABSTRACT FROM AUTHOR]

This study aimed to examine the effect of acute exogenous melatonin administration on salivary cortisol and alpha‐amylase (sCort and sAA) as representatives of the HPA axis and the sympathetic nervous system, respectively. A single‐dose prolonged‐release melatonin (2 mg) or a placebo tablet was given to healthy volunteers (n = 64) at 20:00 h in a crossover design. The saliva was collected at six time points (20:00, 21:00, awakening, 30 min after awakening, 10:00, and 12:00 h) and was measured for sCort, sAA, and salivary melatonin (sMT) levels. Pulse rates and sleep parameters were also collected. Melatonin was effective in improving sleep onset latency by 7:04 min (p =.037) and increasing total sleep time by 24 min (p =.006). Participants with poor baseline sleep quality responded more strongly to melatonin than participants with normal baseline sleep quality as they reported more satisfaction in having adequate sleep (p =.017). Melatonin administration resulted in higher sCort levels at awakening time point (p =.023) and a tendency of lower sAA levels but these were not significant. Melatonin ingestion at 20:00 h resulted in a marked increase in sMT levels at 21:00 h and remained higher than baseline up to at least 10:00 h (p <.001). Melatonin increases sCort levels at certain time point with a tendency to lower sAA levels. These opposing effects of melatonin suggested a complex interplay between melatonin and these biomarkers. Also, the results confirmed the positive acute effect of a single‐dose melatonin on sleep quality. [ABSTRACT FROM AUTHOR]

Introduction: Vitiligo is a skin pigmentation disorder caused by the selective degradation of melanocytes. This study investigates the therapeutic effects of microneedling with and without N‐acetylcysteine (NAC) in patients with persistent and limited vitiligo. Method: This research employed a clinical trial design with double‐blind randomization. Individuals affected by vitiligo and seeking treatment at Rasool Akram Medical Complex were divided into two separate treatment groups. In the intervention group, 24 affected areas underwent meso‐microneedling using 5% NAC ampoules over six sessions, in addition to the application of 4.7% NAC cream once daily on the specified area. Conversely, the control group, consisting of 22 lesions, underwent microneedling using distilled water during six sessions. The severity of lesions and the extent of repigmentation were gauged using the Modified VETI Score. Assessment of treatment efficacy was determined through both physician evaluations and patient feedback. Results: Twenty patients with a mean age of 36.4 years were recruited. The mean percentage of lesions and their intensity were significantly improved 2 weeks after the third session and 1 month after the end of the treatment (p < 0.01). There was no statistically significant difference between the intervention and control groups. Gender, age, family history, duration of disease, duration of disease stability, and history of hypothyroidism had no statistically significant relationship with patients' treatment outcomes (p > 0.05). Conclusion: Microneedling with or without the application of NAC appears to be an effective treatment option for persistent vitiligo lesions. However, despite the higher improvement rate with the application of NAC, the difference was not significant. [ABSTRACT FROM AUTHOR]

Aim: To describe the protocol of a feasibility trial designed to test the preliminary effect of a 12‐week culturally appropriate physical activity programme on metabolic syndrome markers and quality of life in Ghanaian adults with type 2 diabetes (T2DM). Design: Feasibility randomised controlled trial. Methods: Through random allocation, 90 adults with T2DM will be allocated to either the control group (CG) (n = 45) or the intervention group (IG) (n = 45). The IG will receive the physical activity programme in addition to their usual diabetes care; those in the CG will receive their usual diabetes care. Measurements will be performed at baseline and 12‐week follow‐up. The primary outcome is a change in metabolic syndrome markers in the IG compared to the CG. Secondary outcomes are: (a) a change in quality of life in the IG compared to the CG, (b) the feasibility of implementation. Results: Findings will inform the design of a future large‐scale trial. Patient or Public Contribution: Patients with T2DM and their healthcare professionals contributed to this study protocol by participating in semi‐structured interviews towards the design of the physical activity programme. Clinical Trial Registration Number: The trial is registered in the Australian and New Zealand Clinical Trial Registry (registration number: ACTRN12622000323729p). [ABSTRACT FROM AUTHOR]

Background and Aims: Inflammatory bowel disease (IBD) is a chronic inflammatory gastrointestinal tract disease subdivided into Crohn's disease (CD) and ulcerative colitis (UC). There is currently no cure for IBD, and individuals with IBD frequently experience a lower health‐related quality of life (HRQOL) than the general population. Gamification has become an increasingly popular topic in recent years. Adapting game design concepts to nongaming contexts represents a novel and potential approach to changing user engagement. This study will be conducted with the aim of evaluating the effect of a gamified mobile‐based self‐management application on disease activity index, quality of life, and mental health in adults with IBD. Methods: A multicenter, parallel, two‐arm, exploratory randomized controlled trial with a 6‐month follow‐up per patient will be designed to compare the impact of the gamified mobile‐based tele‐management system on primary and secondary health outcomes and outpatient visits in 210 patients with all types of IBD which are divided equally into a control group with standard care and an intervention group which will use the developed mobile application named MY IBD BUDDY. All patients will attend study visits at baseline, 12 and 24 weeks, and routine IBD clinic visits or telephone consultations based on randomization group assignment. Disease activity or disease activity index, mental health (anxiety and depression) symptoms, quality of life, self‐efficacy, and IBD‐specific knowledge will be measured at baseline with two follow‐ups at 12 and 24 weeks. Conclusions: In sum, the outcomes of our trial will demonstrate the impact of the gamified mobile‐based self‐management system on disease activity, quality of life, and anxiety and depression by means of interactive care and patient empowerment. Trial Registration: IRCT: IRCT20200613047757N1. Registered November 16, 2021. Prospectively registered and visible at OSF (https://doi.org/10.17605/OSF.IO/AWFY9). [ABSTRACT FROM AUTHOR]

To compare the analgesic efficacy and adverse events of proximal versus distal ACB for adults undergoing knee arthroplasty, we searched PubMed, Cochrane, Web of Science, and Embase to identify all eligible randomized controlled trials (RCTs). The study quality of the RCTs was evaluated using the Cochrane risk of bias assessment tool. Heterogeneity among studies was examined by Cochrane Q test. Our primary outcomes were pain intensity at rest/during movement and morphine consumption. Statistical analyses were conducted by RevMan Software. Seven eligible studies involving 400 subjects were included in this meta‐analysis with 202 participants in the proximal ACB group and 198 participants in the distal ACB group. The results demonstrated that proximal ACB provided significantly better pain relief at rest at 2 h (SMD −0.27, 95% CI −0.54 to −0.01, four trials, 222 participants, I2 = 0, p = 0.04) and 24 h (SMD −0.28, 95% CI −0.48 to −0.08, seven trials, 400 participants, I2 = 0, p = 0.006) following the surgery. We found no evidence of a difference in postoperative pain intensity at other timepoints. Furthermore, we noted no evidence of a difference in cumulative morphine consumption and occurrence of adverse events. Proximal ACB provides better pain relief and comparable adverse effects profile compared with distal ACB. The analgesic benefit offered by proximal ACB, however, did not appear to extend beyond the first 24 h. The overall evidence level was mostly low or very low, which requires more well‐organized multicenter randomized trials in the future. [ABSTRACT FROM AUTHOR]

No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and primary end points (PEs) of phase II and III trials intended to modify the natural course of the disease in patients with RMS. The purpose of the study is to explore trends/topics and discussion points in clinical trial design and PE, comparing them to regulatory guidelines and expert recommendations. Three trial registration systems, ClinicalTrials.gov, the EU Clinical Trials Register, and the Japan Registry of Clinical Trials, were used and 60 trials were evaluated. The dominant clinical trial design was a randomized controlled parallel‐arms trial and other details were as follows: in adult phase III confirmatory trials (n = 32), active‐controlled double‐blind trial (DBT) (53%) and active‐controlled open‐label assessor‐masking trial (16%); in adult phase II dose‐finding trials (n = 9), placebo‐ and active‐controlled DBT (44%), placebo‐controlled DBT (22%), and placebo‐controlled add‐on DBT (22%); and in pediatric phase III confirmatory trials (n = 8), active‐controlled DBT (38%) and active‐controlled open‐label non‐masking trial (25%). The most common PEs were as follows: in adult confirmatory trials, annual relapse rate (ARR) (56%) and no evidence of disease activity‐3 (NEDA‐3) (13%); in adult dose‐finding trials, the cumulative number of T1 gadolinium‐enhancing lesions (56%), combined unique active lesions (22%), and overall disability response score (22%); and in pediatric confirmatory trials, ARR (38%) and time to first relapse (25%). It was suggested that some parts of the regulatory guidelines and expert recommendations need to be revised. [ABSTRACT FROM AUTHOR]

Cardiovascular (CV) disease accounts for one third of deaths in females, with hypertension (HTN) and type 2 diabetes mellitus (T2DM) risk factors for its development. Global longitudinal strain (GLS) is a strong prognostic indicator for future CV dysfunction and can be impaired in women with HTN and T2DM. This study aimed to determine if exercise impacts GLS in women with HTN or T2DM. A randomized crossover trial was conducted with 15 women (aged 64.1 ± 4.7) diagnosed with HTN (n = 12) or T2DM (n = 3). Participants completed an 8‐week exercise and 8‐week non‐exercising control period, separated by a 21.6 ± 14.2‐week washout period. Resting echocardiography and exercise testing were performed pre and post each arm to measure GLS and aerobic fitness (VO2peak). GLS (%) improved significantly following exercise (−16.8 ± 1.5 to −18.4 ± 1.8; p ≤ 0.001, d = 0.98), but not control (−17.2 ± 2.0 to −16.9 ± 1.4; p = 0.585, d = −0.14). Similarly, VO2peak (mL/kg/min) increased following exercise (18.0 ± 2.1 to 19.2 ± 2.6; p ≤ 0.001, d = 0.53), but not control (17.5 ± 2.7–17.2 ± 2.7; p = 0.269, d = −0.12). There were significant between‐group differences for GLS (p ≤ 0.001, d = 1.02) and VO2peak (p = 0.011, d = 0.63). Aerobic exercise positively impacts GLS and VO2peak in women with HTN and T2DM. GLS may inform exercise professionals regarding the early effectiveness of an aerobic exercise intervention and infer a reduction in CV disease risk. Highlights: The impact of aerobic exercise on global longitudinal strain (GLS), and other measures of cardiovascular (CV) function, was explored in women with hypertension and type 2 diabetes.Eight weeks of aerobic exercise significantly improved GLS (very large effect; d = 1.02) and aerobic capacity (moderate effect; d = 0.63) compared to control.Improvements observed in GLS and aerobic capacity were clinically meaningful. Significant reductions in systolic and diastolic blood pressure were also observed following exercise, but not control.GLS can measure the effectiveness of aerobic exercise on myocardial function in women at risk of developing CV disease. [ABSTRACT FROM AUTHOR]

Background: Comparative investigations evaluating the efficacy of pomalidomide‐based (Pom‐based) versus daratumumab‐based (Dara‐based) therapies in patients with relapsed/refractory multiple myeloma (RRMM) remain scarce, both in randomized controlled trials and real‐world studies. Methods: This retrospective cohort study included 140 RRMM patients treated with Pom‐based or Dara‐based or a combination of pomalidomide and daratumumab (DPd) regimens in a Chinese tertiary hospital between December 2018 and July 2023. Results: The overall response rates (ORR) for Pom‐based (n = 48), Dara‐based (n = 68), and DPd (n = 24) groups were 57.8%, 84.6%, and 75.0%, respectively (p = 0.007). At data cutoff on August 1, 2023, the median progression‐free survival (PFS) was 5.7 months (95% CI: 5.0–6.5) for the Pom‐based group, 10.5 months (5.2–15.8) for the Dara‐based group, and 6.7 months (4.0–9.3) for the DPd group (p = 0.056). Multivariate analysis identified treatment regimens (Dara‐based vs. Pom‐based, DPd vs. Pom‐based) and Eastern Cooperative Oncology Group performance status (ECOG PS) as independent prognostic factors for PFS. In the subgroups of patients aged >65 years, with ECOG PS ≥2, lines of therapy ≥2, extramedullary disease or double‐refractory disease (refractory to both lenalidomide and proteasome inhibitors), the superiority of Dara‐based regimens over Pom‐based regimens was not evident. A higher incidence of infections was observed in patients receiving Dara‐based and DPd regimens (Pom‐based 39.6% vs. Dara‐based 64.7% vs. DPd 70.8%, p = 0.009). Conclusions: In real‐world settings, Pom‐based, Dara‐based, and DPd therapies exhibited favorable efficacy in patients with RRMM. Dara‐based therapy yielded superior clinical response and PFS compared to Pom‐based therapy. [ABSTRACT FROM AUTHOR]

Aims: To investigate the effect of Self‐designed Metabolic Equivalent Exercises (SMEE) on cancer‐related fatigue in patients with gastric cancer. Methods: 130 patients with gastric cancer admitted to Department of Oncology of a tertiary hospital in Shanghai were enrolled and assessed for eligibility. After excluding 1 patient who declined to participate, 129 eligible patients were randomly assigned into SMEE (n = 65) and control (n = 64) groups. The Revised Piper Fatigue Scale (RPFS) and EORTC QLQ‐C30 Quality of Life Scale were used to measure cancer‐caused fatigue and quality of life, respectively, in both groups at the first admission and after 3 months. Results: After excluding patients who did not receive allocated intervention due to medical (n = 3) and personal (n = 2) reasons, those who were lost to follow‐up (n = 3), and those who had discontinued intervention (n = 2), 119 patients (64 in the SMEE group and 55 in the control group) were included for analysis. There were no statistically significant differences in the RPFS or QLQ‐C30 score between the two groups at baseline. After 3 months, the total RPFS score of the SMEE group was significantly lower than that of the control group (2.86 ± 1.75 vs. 4.65 ± 1.29, p = 0.009), with significant improvements in affective meaning (0.83 ± 0.92 vs. 1.13 ± 0.77, p = 0.044) and sensory (0.70 ± 0.71 vs. 1.00 ± 0.54, p < 0.001) subscales; in the SMEE group, QLQ‐C30 scores in somatic (2.00 ± 0.27 vs. 1.31 ± 0.26, p < 0.001), emotional (2.67 ± 0.58 vs. 2.07 ± 0.48, p < 0.001), and social (3.23 ± 0.58 vs. 1.64 ± 0.51, p < 0.001) functioning were significantly higher than those in the control group, with significant improvements in fatigue (p < 0.001), nausea/vomiting (p = 0.014), shortness of breath (p < 0.001), constipation (p < 0.001), and diarrhea (p = 0.001) dimensions. Conclusion: The self‐programmed metabolic equivalent manipulation as an exercise intervention could effectively reduce the degree of cancer‐caused fatigue and improve quality of life in patients with gastric cancer. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the use of after‐visit instructions (AVIs) in an academic rheumatology clinic and assess the impact of standardized AVIs (sAVIs) and teach‐back (TB) on comprehension of health information. Methods: A retrospective review of adult patients seen between October 1 and 8, 2021, at the rheumatology clinic collected data on patient demographics, clinical features, and the presence, content, and readability of AVIs. During a subsequent prospective proof‐of‐concept study, routinely scheduled patients seen at the rheumatology clinic were randomized into three groups: control (received standard of care), received sAVIs only, and received sAVIs plus TB. Patients completed a health literacy questionnaire, satisfaction survey, and a one‐ to two‐week postvisit telephone survey to assess AVI comprehension. Results: Out of 316 retrospective patient visits, 82 (25.9%) received AVIs. Among 210 of 316 patients (66.5%) with management changes, 76 (36.1%) received AVI, with 74.2% of the instructions considered concordant with the provider's note. Use of AVIs was higher with management changes, new patient visits, and medical trainee/teaching clinics. AVIs were written at a median 6.8 grade level. A total of 75 patients completed the prospective study: 31 (41.3%) were in the control group, 19 (25.3%) were in the group that received sAVIs only, and 25 (33.3%) were in the group that received AVIs with TB. There were no differences in overall postvisit survey comprehension/retention scores among the three patient groups evaluated. Conclusion: Although a lack of AVI use was identified, implementation of sAVIs did not appear to impact patient retention or comprehension of discharge health information. [ABSTRACT FROM AUTHOR]

Background and Aims: Osteoarthritis (OA) is one of the most common debilitating diseases among the aging population. Nigella sativa is one potential treatment for OA. Here, we sought to evaluate the efficacy and safety of Nigella sativa for treating patients with OA. Methods: PubMed, Scopus, Embase, and Web of Science were searched up to October 20, 2022. The primary outcome was changes in the pain score after receiving Nigella sativa or control agents based on the results of randomized controlled trials (RCTs). The secondary outcome was set as the frequency of adverse events reported during the follow‐up period. Results: Six RCTs involving a total of 370 patients with knee OA were included in the present systematic review. Among the four screened studies, the topical administration of Nigella sativa oil was found to be more effective than the placebo in relieving pain in three trials. Additionally, the oral use of Nigella sativa oil was assessed in two trials, and an improvement in pain score relative to placebo was documented in only one of the studies. Also, the trial that evaluated the effectiveness of Nigella sativa oral capsules did not demonstrate any difference in pain reduction between the intervention and placebo groups. Overall, either topical or oral administration of Nigella sativa was well tolerated, and no serious adverse events were reported. Conclusion: Nigella sativa is generally safe, but conflicting findings from low‐quality studies hinder the ability to make clinical recommendations for or against treating OA. Robust trials are needed for informed decisions. [ABSTRACT FROM AUTHOR]

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non‐healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs. [ABSTRACT FROM AUTHOR]

This study investigates the effects of comprehensive nursing interventions on wound pain in patients undergoing catheter insertion for peritoneal dialysis. Sixty patients who underwent catheter insertion for peritoneal dialysis from January 2021 to January 2023 at our hospital were selected as subjects and randomly divided into an experimental group and a control group using a random number table method. The control group received routine nursing care, while the experimental group was subjected to comprehensive nursing interventions. The study compared the impact of nursing measures on visual analogue scale (VAS), self‐rating anxiety scale (SAS), self‐rating depression scale (SDS) and nursing satisfaction between the two groups. The analysis revealed that on the third, fifth and seventh days post‐intervention, the experimental group's wound VAS scores were significantly lower than those of the control group (p < 0.001). Furthermore, levels of anxiety and depression were markedly lower in the experimental group compared with the control group (p < 0.001). In addition, the nursing satisfaction rate was significantly higher in the experimental group than in the control group (96.67% vs. 73.33%, p = 0.011). This study indicates that the application of comprehensive nursing interventions in patients undergoing catheter insertion for peritoneal dialysis is highly effective. It can alleviate wound pain and negative emotions to a certain extent, while also achieving high patient satisfaction, thus demonstrating significant clinical value. [ABSTRACT FROM AUTHOR]

Aims: The aim of the present study was to explore the effect of oropharyngeal mother's milk administration on oral microbial colonization in infants fed by gastric tube at different time points. Methods: Infants (n = 116) with birth weight <1500 g were randomly allocated into two groups which both received breast milk for enteral nutrition. The control group (n = 51) accepted oropharyngeal normal saline administration. The experimental group (n = 53) accepted oropharyngeal mother's milk administration before fed by gastric tube once every 3 h over 21 days after birth. We analyzed the oral microbiota at initiation and 7 and 14 and 21 days later using 16S DNA amplicon sequencing. Results: There were no difference in oral microbial diversity between the two groups at any time point, but diversity decreased significantly over time in both groups. On the first day of life, the oral microbiota of the infant in the experimental and control groups consisted mainly of Firmicutes (7.75%, 6.18%) and Proteobacteria (68.65%, 68.69%), respectively. As time increases to 21 days after birth, Firmicutes (77.67%, 77.66%) had replaced Proteobacteria (68.65%, 68.69%) as the predominant phylum. Discussion: From birth to 21 days after birth, oropharyngeal mother's milk administration did not change the diversity and structural composition of the oral microbiota. The oral microbial diversity of infants declined significantly over time. Firmicutes had replaced Proteobacteria as the predominant phylum. [ABSTRACT FROM AUTHOR]

Antigenic drift is a major driver of viral evolution and a primary reason why influenza vaccines must be reformulated annually. Mismatch between vaccine and circulating viral strains negatively affects vaccine effectiveness and often contributes to higher rates of influenza‐related hospitalizations and deaths, particularly in years dominated by A(H3N2). Several countries recommend enhanced influenza vaccines for older adults, who are at the highest risk of severe influenza complications and mortality. The immunogenicity of enhanced vaccines against heterologous A(H3N2) strains has been examined in nine studies to date. In six studies, an enhanced, licensed MF59‐adjuvanted trivalent inactivated influenza vaccine (aIIV3) consistently increased heterologous antibody titers relative to standard influenza vaccine, with evidence of a broad heterologous immune response across multiple genetic clades. In one study, licensed high‐dose trivalent inactivated influenza vaccine (HD‐IIV3) also induced higher heterologous antibody titers than standard influenza vaccine. In a study comparing a higher dose licensed quadrivalent recombinant influenza vaccine (RIV4) with HD‐IIV3 and aIIV3, no significant differences in antibody titers against a heterologous strain were observed, although seroconversion rates were higher with RIV4 versus comparators. With the unmet medical need for improved influenza vaccines, the paucity of studies especially with enhanced vaccines covering mismatched strains highlights a need for further investigation of cross‐protection in older adults. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess the clinical and radiographic outcomes of non‐instrumentation endodontic treatment (NIET) using a modified antibiotic mix of cefixime, ciprofloxacin and metronidazole with simvastatin (an anti‐inflammatory, bone regeneration drug) on necrotic primary molars compared to conventional pulpectomy to help preservation of necrotic primary teeth until its natural exfoliation. Materials and Methods: Forty mandibular primary second molars with necrotic pulp tissue from 38 healthy patients aged between 4 and 8 years were randomly assigned to two groups with a 1:1 allocation ratio. Group A teeth underwent conventional root canal treatment. The procedure involved a two‐visit approach, employing k‐files and h‐files during the initial visit, followed by the application of calcium hydroxide paste as canal dressing between visits, while Group B teeth were treated with 3Mixtatin. All teeth were clinically evaluated after 1, 3, 6, and 12 months, and radiographically at 3, 6, and 12 months. Two external examiners assessed the results. Data analysis was conducted using a chi‐square test at a 0.05 significance level. Results: At the end of the follow‐up interval, 90% of teeth in each group exhibited no clinical signs or symptoms. Additionally, inter‐radicular radiolucency healing occurred in 75% of cases in the NIET group and 89.5% in the conventional pulpectomy group. However, no statistically significant difference was found between the two groups. Conclusion: NIET using 3Mixtatin seems to be a good alternative choice to conventional pulpectomy, offering a less complex treatment approach that may help avoid the complications associated with traditional pulpectomy and could be suitable for teeth with shorter roots. [ABSTRACT FROM AUTHOR]

This study assessed the effect of a commercial carbohydrate menthol drink on cycling time trial (TT) performance in hot and humid conditions compared with a carbohydrate only drink. Ten participants (5 women; V̇O2max: 52.3 ± 8.6 mL kg−1 min−1, Peak Power Output: 286 ± 56 W) completed a 40‐min cycling preload (50% V̇O2max) followed by a 15‐min self‐paced TT in hot (∼35°C) and humid (∼54%) conditions on two occasions (double blind, crossover design). Every 10‐min, 85 mL of carbohydrate (CHO; SIS GO Energy, 60 g h−1) or carbohydrate and menthol (CHO + MEN; SIS Turbo+ 60 g h−1, 0.01% menthol) was swilled (∼10‐s) and ingested. Rectal temperature (Trec) and heart rate (HR) were recorded throughout. Thermal sensation (TS), thermal comfort (TC) and rating of perceived exertion (RPE) were recorded every 5‐min. Taste and aftertaste were rated from very pleasant (+5) to very unpleasant (−5). TT performance (total work; kJ) was similar between CHO (153 kJ [95% CI: 129–177 kJ]) and CHO + MEN (151 kJ [128–178 kJ]). During preload exercise, Trec increased by ∼0.9°C and was similar at the end of the TT (∼38.20°C). Mean preload HR was ∼140 b min−1 in each condition and reached ∼177 b min−1 at the end of the TT. TC was rated as 'much too warm' and TS rated as 'very hot' in both conditions. Both conditions were 'extremely hard' (end point RPE ∼19). All participants preferred the taste and aftertaste of the CHO drink. The commercial carbohydrate menthol drink offered no additional ergogenic benefit compared to a carbohydrate only drink during cycling exercise performed in hot and humid conditions. Highlights: The addition of menthol to a carbohydrate drink had no effect on 15‐min time trial performance.The addition of menthol to a carbohydrate drink had no effect on thermal perceptual measures or physiological measures.Taste and aftertaste perceptions were favourable towards the carbohydrate drink compared to the carbohydrate‐menthol drink. [ABSTRACT FROM AUTHOR]

This study aimed to comprehensively evaluate the effects of evidence‐based nursing (EBN) intervention on wound infection and postoperative complications in patients after appendectomy for acute appendicitis (AA), with the expectation of providing a theoretical basis for postoperative care in AA. Randomised controlled trials (RCTs) on the postoperative application of EBN in patients with AA were searched in PubMed, Web of Science, Cochrane Library, Embase, China Biomedical Literature Database, Wanfang and China National Knowledge Infrastructure from the inception of databases to October 2023. Two authors screened and evaluated the literature based on the inclusion and exclusion criteria, and data were extracted from the final included literature. Stata software (version 17.0) was employed for data analysis. In total, 29 RCTs involving 2848 patients with AA were included, with 1424 in the EBN group and 1424 in the conventional care group. The analyses revealed that patients with AA who experienced EBN were significantly less likely to develop postoperative wound infections (odds ratio [OR] = 0.23, 95% confidence intervals [CIs]: 0.14–0.38, p < 0.001) and postoperative complications (OR = 0.20, 95% CI: 0.15–0.26, p < 0.001) as opposed to conventional care. Available evidence suggests that EBN can effectively reduce the risk of wound infection and postoperative complications in patients undergoing appendectomy for AA, thereby improving patient prognosis. This finding is worth promoting in the clinical practice. [ABSTRACT FROM AUTHOR]

This was a non‐blinded, single‐centre, randomized, controlled clinical trial that compared the effectiveness of direct observation of procedural skills (DOPSs)with traditional assessment methods in pressure injury (PI) care skills. The study population included 82 nursing professionals randomly assigned to the study group (n = 41) and the control group (n = 41). Both groups of nurses underwent a 6‐month training in PI care skills and were subsequently evaluated. The main outcome variables were the PI skill operation scores and theoretical scores. Secondary outcome variables included satisfaction and critical thinking abilities. Independent sample t‐tests and chi‐square tests were used to assess differences between the two groups of nurses. The results showed no statistically significant difference in PI skill operation scores between the two groups of nurses (p > 0.05). When comparing the PI theoretical scores, the study group scored higher than the control group, and this difference was statistically significant (p < 0.05). In terms of satisfaction assessment, the study group and the control group showed differences in improving self‐directed learning, enhancing communication skills with patients, improving learning outcomes and increasing flexibility in clinical application (p < 0.05). When comparing critical thinking abilities between the two groups of nurses, there was no statistically significant difference at the beginning of the training, but after 3 months following the training, there was a statistically significant difference between the two groups (p < 0.01).The results indicated that the DOPS was effective in improving PI theoretical scores, increasing nurse satisfaction with the training and enhancing critical thinking abilities among nurses. [ABSTRACT FROM AUTHOR]

The efficacy of administering high doses of vitamin D to patients diagnosed with COVID‐19 remains uncertain. We conducted a comprehensive search across multiple databases (PubMed, EMBASE, Cochrane Library, and ISI Web of Science) from inception until August 2022, with no limitations on language, to locate randomized controlled trials (RCTs) that investigated the impact of high‐dose vitamin D supplementation (defined as a single dose of ≥100,000 IU or daily dose of ≥10,000 IU reaching a total dose of ≥100,000 IU) on COVID‐19 patients. Risk ratios (RR) with 95% confidence intervals (CI) and weighted mean differences (WMD) with 95% CI were calculated. Our meta‐analysis included 5 RCTs with a total of 834 patients. High‐dose vitamin D supplementation did not show any significant benefits for mortality (I2 = 0.0%, p =.670; RR 1.092, 95% CI 0.685–1.742, p =.711) or intensive care unit (ICU) admission (I2 = 0.0%, p =.519; RR 0.707, 95% CI 0.454–1.102, p =.126) in COVID‐19 patients compared to the control group. However, it was found to be safe and well‐tolerated (I2 = 0.0%, p =.887; RR 1.218, 95% CI 0.930–1.594, p =.151). Subgroup analysis also showed no benefits in overall mortality, including for patients with vitamin D deficiency (I2 = 0.0%, p =.452; RR 2.441, 95% CI 0.448–13.312, p =.303) or compared to the placebo (I2 = 0.0%, p =.673; RR 1.666, 95% CI 0.711–3.902, p =.240). Our research indicates that there is no evidence to support the efficacy of high‐dose vitamin D supplementation in improving clinical outcomes among individuals with COVID‐19, in line with previous studies focused on contexts including rickets. Considering the limitations of the study, additional research may be required. [ABSTRACT FROM AUTHOR]

Background: Topical minoxidil is the recommended first‐line pharmacologic treatment for male and female pattern hair loss. However, low‐dose oral minoxidil has been used off‐label with good clinical efficacy and safety. Aim: To compare the effectiveness and safety of topical minoxidil as a first‐choice treatment of androgenetic alopecia versus 1 mg daily oral minoxidil. Method: Sixty‐five AGA patients were randomly allocated to receive either 5% topical solution or 1 mg/day oral minoxidil for 6 months. Treatment efficacy was evaluated by measuring hair diameter, photographic assessment, and patient self‐assessment questionnaires. The safety of treatment was checked through history taking and physical examination. Results: Both topical and oral minoxidil groups showed significant improvement in hair diameter after 6 months of treatment (p < 0.001). However, there was no significant difference between the two groups. The photographic assessment demonstrated a significant improvement in hair density in the topical minoxidil group in all marked points located at 12 cm (p = 0.025), 16 cm (p = 0.034), and 24 cm (p = 0.014) distance from the glabella but not in the oral minoxidil group. Nevertheless, the difference between the two groups was not significant. In each group, over 60% of patients expressed satisfaction with their treatments, and no significant difference was detected between the two groups. Conclusion: Although topical minoxidil has a better overall therapeutic effect than 1 mg oral minoxidil, the difference between the two groups was not significant. Therefore, 1 mg oral minoxidil may be as effective and safe as standard topical minoxidil in female and male pattern hair loss. [ABSTRACT FROM AUTHOR]

Background: Numerous studies have characterized the gut microbiome (GM) in lung cancer (LC). Yet, the causality between GM and LC and its subtypes remain uncharacterized. Methods: Two‐sample Mendelian randomization (MR) was designed to investigate the causal relationship between the GM and LC and its subtypes, using publicly available summary data of genome‐wide association studies. The researchers ran two groups of MR analyses, including the genome‐wide statistical significance threshold (5 × 10−8) and the locus‐wide significance level (1 × 10−5). Results: Using MR analysis, we ascertained 42 groups of GM that are intimately linked to LC and its subtypes at the locus‐wide significance level. Of the 42 groups, 12 were in LC, nine in non‐small cell lung cancer (NSCLC), six in small cell lung cancer (SCLC), two in lung adenocarcinomas, and 13 in lung squamous carcinomas. After false discovery rate correction, we still found a remarkable causal interaction between the Eubacterium ruminantium group and SCLC. Moreover, five groups of GM closely linked to LC and its subtypes were recognised at the genome‐wide statistical significance threshold. This finding included one group each in LC, NSCLC and SCLC, two groups in lung adenocarcinoma and none in lung squamous carcinoma. None of the foregoing findings were heterogeneous or horizontal pleiotropy. Reverse MR revealed that genetic susceptibility to LC and its subtypes caused significant changes in three groups of GM. Conclusion: Our findings substantiate the causality between GM and LC and its subtypes. This study offers fresh insights into the function of GM in mediating the progression of LC. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the efficacy of acupuncture in the treatment of pressure ulcers. Randomized controlled trials evaluating the effects of acupuncture on pressure ulcers were identified through a comprehensive literature search on public database. The quality assessment of the included trials was performed based on the guidance of the Cochrane Reviewers' Handbook, and pooled analyses were performed by using the RevMan 5.4 software. The pooled results demonstrated that acupuncture in combination with standard wound care was significantly superior to standard wound care alone with regard to effective rate (RR 1.17, 95% CI [1.10, 1.24]), reduction in Wound Size (MD −2.78, 95% CI [−2.43, −1.44]), healing time (MD −6.24, 95% CI [−12.32, −0.17]) and the amount of 24‐h exudate (MD −0.86, 95% CI [−1.54, −0.18]). In conclusion, this study suggests that acupuncture can be used as an adjunctive therapy to promote healing of pressure ulcers. [ABSTRACT FROM AUTHOR]

In this study, we aimed to evaluate the effect of moxibustion on pressure ulcers. A thorough search was performed for articles published from database inception up to 14 December 2023. Randomized controlled trials, which evaluated the effects of moxibustion were included. Finally, 11 relevant trails that enrolled a total of 795 participants met inclusion criteria. The results of meta‐analysis suggested beneficial effects of moxibustion for pressure ulcer compared with control on the response rate (RR: 1.21; 95% CI: 1.13–1.29; p = 0.82; I2 = 0%), healing time (MD: −5.69; 95% CI: −9.58 to −1.80; p<0.05; I2 = 97%) and pressure ulcer scale for healing scores (MD: −1.13; 95% CI: −1.36 to −0.89; p = 0.79; I2 = 0%). The evidence suggests that moxibustion possesses satisfactory efficacy in promoting healing of pressure ulcers. However, due to the small number of trials included in this study, as well as the small sample size and high risk of bias, we were unable to draw firm conclusions about the effectiveness of moxibustion for pressure ulcers. [ABSTRACT FROM AUTHOR]

This study systematically evaluated the effect of hydrocolloid dressings on facial pressure ulcers in patients receiving non‐invasive positive pressure ventilation (NIPPV). The Embase, PubMed, Cochrane Library, CNKI, VIP, Chinese Biomedical Literature Database and Wanfang databases were searched for randomised controlled trials on the use of hydrocolloid dressings in patients receiving NIPPV published from the inception of each database to August 2023. The literature was independently screened, data were extracted by two authors based on the inclusion and exclusion criteria, and the quality of the included literature was assessed. The meta‐analysis was performed using Stata 17.0. Thirteen studies including 1248 patients were included, with 639 patients in the intervention group and 609 patients in the control group. Meta‐analysis showed that the hydrocolloid dressing significantly reduced the incidence of facial pressure ulcers in patients with NIPPV (odds ratio = 0.16, 95% confidence intervals: 0.11–0.24, p < 0.001). Hydrocolloid dressings are effective in reducing the incidence of facial pressure ulcers in patients receiving NIPPV. However, because of the small number of included studies, this conclusion needs to be confirmed with larger samples and high‐quality clinical studies. [ABSTRACT FROM AUTHOR]

Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions. [ABSTRACT FROM AUTHOR]

Backgroud: Discharge planning from the hospital of frail older patients is an important step to avoid inappropriate long‐stay hospitalizations and to prevent the risks related to the prolonged hospitalization. In this frame, we developed an experimental trial—'PRO‐HOME', a multicomponent programme of interventions for multimorbid and polytreated hospitalized older patients. Aim: The main aim of the study was to develop a protected discharge facility using a mini apartment equipped with advanced architectural and technological components to reduce the length of hospital stay of older participants (aged 65+ years old) admitted to the hospital for an acute event, deemed stable and dischargeable. Materials and Methods: This is a pilot randomized controlled study, comparing 30 hospitalized participants included in a multidimensional, transitional care programme based on information and communication technologies to 30 patients in standard usual care until hospital discharge. Results: We presented the study design of the PRO‐HOME programme, including architectural and technological components, the enrolment procedures, the components of the intervention that is physical activity, cognitive training and life‐style education and the evaluation method of the intervention based on the Comprehensive Geriatric Assessment to explore the changes in the individual domains that are target of the multicomponent intervention. Conclusions: The final results will suggest whether the PRO‐HOME programme represents a useful and feasible intervention to reduce the length of hospital stay of multimorbid and polytreated hospitalized older patients and improve their physical and cognitive performances and overall quality of life. Patient or Public Contribution: Due to the characteristics of the population of interest of the PRO‐HOME study, we involved in the study design and programme of the activities the participants enrolled in a previous smart home‐based project named MoDiPro carried‐out during a 3‐year period. The elderly participants from the local population involved were asked, by means of focus groups, for feedback on their experience in MoDiPro, and their suggestions were integrated into the design phase of the current PRO‐HOME project. The focus groups included open group interviews with a qualitative collection of the patients' feedback so that the participants could interact with each other. [ABSTRACT FROM AUTHOR]

Background: Frontal fibrosing alopecia (FFA) is a cicatricial alopecia with rapid epidemic growth. However, there is no agreement on the best therapeutic approach. Aims: To compare the therapeutic effects of finasteride as a first‐line systemic treatment of FFA versus hydroxychloroquine as a relatively safe and effective immunosuppressive drug. Methods: Thirty‐four female FFA patients were randomly assigned to receive either 400 mg/day of hydroxychloroquine or 2.5 mg/day of finasteride for 6 months. Topical treatments in both groups include pimecrolimus, mometasone, and minoxidil. Treatment efficacy was evaluated using the Frontal Fibrosing Alopecia Severity Score (FFASS), photography, and trichoscopy after 3 and 6 months. Results: Both the finasteride and hydroxychloroquine groups showed significant improvements in FFASS and trichoscopic scores (p < 0.01). However, there was no significant difference between the two groups during the study. Photographic assessment showed that more than 60% of patients in both groups had improved without statistically significant differences between the two groups. Conclusions: Both finasteride and hydroxychloroquine are equally effective, safe, and well‐tolerable for treating FFA patients. [ABSTRACT FROM AUTHOR]

Prenatal iron supplementation improves children's health and cognitive performance, but few studies explore behavioural development. This study assessed the effects of adjusting prenatal iron supplementation to maternal iron stores during early pregnancy on children's behavioural problems. Randomized controlled trial conducted in Tarragona (Spain) involving 230 nonanaemic pregnant women and their children after a 4‐year follow‐up. Based on haemoglobin (Hb) levels before gestational week (GW) 12, women receive different iron doses: those with Hb = 110–130 g/L were randomized to receive 80 or 40 mg/day and those with Hb > 130 g/L were randomized to receive 20 or 40 mg/day. Maternal iron stores at GW12 were classified using serum ferritin (SF) as low (SF < 15 µg/L), normal (SF = 15–65 µg/L), and normal‐high (SF > 65 µg/L). Children's behaviour was assessed by parents using the Child Behaviour Checklist for ages 1.5–5 years and the Behaviour Rating Inventory of Executive Function‐Preschool Version, and by teachers using the Teacher's Report Form for ages 1.5–5 years. Multivariable regression models were performed. Taking 80 mg/day of iron improved child behaviour when women had low iron stores but worsened it when mothers had normal–high iron stores, except for depressive and attention/hyperactivity problems. Taking 20 mg/day of iron improved behaviour only in those children whose mothers had SF > 65 µg/L in early pregnancy. Additionally, executive functioning improved at high doses of prenatal iron when maternal baseline SF < 15 µg/L. Adjusting prenatal iron supplementation to both maternal baseline Hb levels and iron stores reduces behavioural problems in 4‐year‐old children. Key messages: Prenatal iron supplementation succeeds in improving maternal haematological outcomes and cognitive performance of children, but few studies have focused on behavioural development.Prenatal iron supplementation adjusted to maternal iron stores reduces behavioural problems in 4‐year‐old children.Maternal iron stores early in pregnancy should be measured in addition to haemoglobin concentration.These findings contribute greatly to the advancement of public health by giving physicians the tools to prescribe the most appropriate dose of iron supplementation to contribute to better child development. [ABSTRACT FROM AUTHOR]

We evaluate the impacts of a $120 million project in Indonesia conducted between 2014 and 2018 that sought to reduce stunting through a combination of (1) community‐driven development grants targeted at health and education outcomes, (2) training for health providers on infant and young child feeding and growth monitoring and (3) training for sanitarians on a local variation of community‐led total sanitation. This cluster randomized controlled trial involved 95 treatment and 95 control subdistricts across South Sumatra, West Kalimantan, and Central Kalimantan provinces. Overall, we find no significant impacts on stunting, the study's primary outcome measure (0.5 pp; 95% confidence interval [CI]: −3.0 to 4.1 percentage points [pp]), or other longer‐term undernutrition outcomes about 1 year after the end of the project. The project had a modest impact on some secondary, more proximal outcomes related to maternal and child nutrition, including the percentage of mothers consuming the recommended number of iron‐folic acid pills during pregnancy (8.7 pp; 95% CI: 4.1–13.3 pp), 0–5‐month‐olds being exclusively breastfed (8.7 pp; 95% CI: 1.8–15.6 pp) and 6–23‐month‐olds receiving the number of recommended meals per day (8.5 pp; 95% CI: 3.8–13.2 pp). However, there were no significant impacts on other proximal outcomes like the number of pre‐natal and post‐natal checkups, child dietary diversity, child vitamin A receipt or the incidence of child diarrhoea. Our findings highlight that successfully implementing an integrated package of interventions to reduce child stunting may be challenging in practice. Project design needs to consider implementation reality along with best practice—for example, by piloting the synchronous implementation of multifaceted interventions or phasing them in more gradually over a longer timeframe. Key messages: A well‐resourced multifaceted project that sought to reduce stunting through (1) a health and education‐focused community‐driven development programme, (2) provider training on infant and young child feeding and growth monitoring, and (3) training on community‐led total sanitation had no impact on child stunting rates although it successfully improved aspects of maternal nutrition during pregnancy, exclusive breastfeeding, and complementary feeding.Successfully implementing an integrated package of interventions to reduce child stunting may be challenging in practice, especially in a typical programme timeframe.Piloting the synchronous implementation of multifaceted interventions or phasing them in more gradually are potential solutions but might require funders to commit to longer implementation timeframes. [ABSTRACT FROM AUTHOR]

Resistance exercise training is effective to counteract the adverse effects of androgen deprivation therapy (ADT) on body composition, muscle mass and leg strength in prostate cancer patients (PCa). However, it is unknown whether these effects can be autonomously maintained after cessation of the supervised program. Sixty‐eight PCa patients on ADT were included. The exercise intervention group (EX, n = 37) performed 20 weeks of supervised resistance exercise training. Thereafter, patients were advised to autonomously continue exercise training. The control group (CON, n = 31) only received usual care. Outcome measures were compared between baseline and after 1 year. Changes during the intervention (baseline vs. 20 weeks) and follow‐up period (20 weeks vs. 1 year) were descriptively explored. In EX, 83% reported to have continued exercise training themselves. After 1 year, fat mass gains were attenuated in EX compared to CON (1.2 ± 2.6 and 2.8 ± 1.9 kg, respectively; time × treatment effect p = 0.032). The fat percentage increased, and lean mass and quadriceps muscle cross‐sectional area decreased over time, with no differences between groups (overall 1.6 ± 2.1%, −0.7 ± 2.3 kg and −2.2 ± 2.9 cm2, respectively; time effects, all p < 0.05). For muscle strength, an increase of ∼5% in EX was observed, significantly different from the ∼10% decrease in CON (p < 0.001). Subsequent analyses showed that the initial exercise training‐obtained gains in lean mass, muscle mass and strength in EX compared to CON, declined during the follow‐up period. In conclusion, PCa patients on ADT are not capable to autonomously maintain the exercise‐obtained gains of a 20‐week supervised training program over a subsequent 1‐year period. Highlights: ADT for prostate cancer results in many side effects, including muscle mass lossA supervised resistance exercise training program can counteract many side effectsAfter cessation of the supervised program, exercise benefits are not effectively preservedMore focus on sustainability of exercise programs during ADT is required [ABSTRACT FROM AUTHOR]

Neuromuscular deficits at the proximal or distal to the knee may contribute to knee valgus and anterior cruciate ligament (ACL) injury. A valgus or abducted position of the knee greater than 12° for females is suggested to be an indicator of the risk of lower extremity injuries. However, there is a lack of examination regarding neuromuscular patterns in both proximal and distal kinetic chains. The purpose of this study was to investigate the effect of 8 weeks of neuromuscular training on knee valgus and co‐activation of the hip and ankle muscles during a countermovement jump in female athletes with a high risk of ACL injury. Twenty‐eight female athletes, with knee valgus greater than 12°, were randomly assigned into two groups: training (n = 14) and control (n = 14). The following measurements were taken before and after the intervention: co‐activation of Gluteus Maximus‐Tensor Fasciae Latae (GMax‐TFL), Gluteus Medius‐Adductor Longus (GMed‐AL), Tibialis Anterior‐Medial Gastrocnemius (TA‐MG), Tibialis Anterior‐Lateral Gastrocnemius (TA‐LG), Medial Gastrocnemius‐Lateral Gastrocnemius (MG‐LG) muscles, and DKV angle during single‐leg countermovement jump task. Following the intervention, the training group demonstrated increased co‐activation of muscles (except TA‐LG) (P < 0.05). The knee valgus angle in the training group decreased by 5.9° (P = 0.001). Our results demonstrated that neuromuscular training alters muscle activity patterns and the neuromuscular group demonstrated a clinically meaningful and statistical reduction in knee valgus. Highlights: Dynamic knee valgus (DKV) is a risk factor for identifying women with a risk of lower extremity injuries.Muscle activity patterns of the hip and ankle, such as DKV, may be modifiable through neuromuscular training.Neuromuscular training with feedback could reduce excessive DKV at a clinically meaningful level. [ABSTRACT FROM AUTHOR]

The barbell squat is a multijoint exercise often employed by athletes and fitness enthusiasts due to its beneficial effects on functional and morphological neuromuscular adaptations. This study compared the effects of squat variations on lower limb muscle strength and hypertrophy adaptations. Twenty‐four recreationally trained females were assigned to a 12‐week front squat (FS; n = 12) or back squat (BS; n = 12) resistance training protocol (twice per week). Maximum dynamic strength (1‐RM) on the 45° leg press, a nonspecific strength test, and muscle thickness of the proximal, middle, and distal portions of the lateral thigh were assessed at baseline and post‐training. A significant time versus group interaction was observed for 1‐RM values (F(1,22) = 10.53; p = 0.0004), indicating that BS training elicits greater improvements in muscle strength compared with FS training (p = 0.048). No time versus group interactions were found for muscle thickness (F(1,22) = 0.103; p = 0.752); however, there was a significant main effect of time for the proximal (F(1,22) = 7.794; p = 0.011), middle (F(1,22) = 7.091; p = 0.014), and distal portions (F(1,22) = 7.220; p = 0.013) of the lateral thigh. There were no between‐group differences for any muscle thickness portion (proximal: p = 0.971; middle: p = 0.844; and distal: p = 0.510). Our findings suggest that BS elicits greater improvements in lower limb muscle strength on the 45° leg press than FS, but hypertrophic adaptations are similar regardless of variations during the squat exercise. Highlights: Back squat training elicited greater strength‐related improvements in a nonspecific strength test than front squat training.Hypertrophic adaptations of the lateral thigh are similar between both squat variations.Both squat variations elicited similar growth at proximal, middle, and distal regions of the lateral thigh. [ABSTRACT FROM AUTHOR]

This meta‐analysis aimed to evaluate the effects of flaxseed supplementation on weight loss, lipid profiles, high‐sensitivity C‐reactive protein (hs‐CRP), and glucose levels in patients with coronary artery disease (CAD). A systematic search was performed using various online databases, including Scopus, PubMed, Web of Science, EMBASE, and Cochrane Library, to identify relevant randomized controlled trials (RCTs) until June 2023. To evaluate heterogeneity among the selected studies, the Q‐test and I2 statistics were employed. Data were combined using either a fixed‐ or random‐effects model and presented as a weighted mean difference (WMD) with a 95% confidence interval (CI). Of the 428 citations, six RCTs were included. The pooled results did not show significant changes in the WMD of lipid factors (high‐density lipoprotein cholesterol, triglycerides (TG), low‐density lipoprotein cholesterol, and total cholesterol) following flaxseed intake. However, after performing a sensitivity analysis to determine the source of heterogeneity, flaxseed supplementation resulted in a significant decrease in TG levels (WMD = −18.39 mg/dL; 95% CI: −35.02, −1.75). Moreover, no significant differences were observed in either weight or BMI following flaxseed intake. However, the circulating levels of fasting blood glucose (WMD = −8.35 mg/dL; 95% CI: −15.01, −1.69, p =.01) and hs‐CRP (WMD = −1.35 mg/L; 95% CI: −1.93, −0.77, p <.01) significantly decreased after the intervention. Flaxseed supplementation was associated with lowering FBS, hs‐CRP, and TG levels but did not affect weight loss parameters and other lipid markers in CAD. [ABSTRACT FROM AUTHOR]

Background: Tactile sensation plays a crucial role in object manipulation, communication, and even emotional well‐being. It has been reported that the deformability of skin (also described as skin compliance) that shows a large mechanical response to stimuli is associated with high tactile sensitivity. However, although the compliance of the stratum corneum, the outermost layer of skin, can change daily due to skin care and environmental factors, few studies have quantified the effect of the stratum corneum on tactile sensation. Aims: We investigated the changes in tactile sensitivity resulting from skin hydration and identified corresponding alterations in the compliance of the stratum corneum. Methods: A randomized controlled trial was conducted. Participants were randomly assigned to an intervention group (n = 20) that had a moisturizing cream applied to their cheeks or a control group (n = 19) that had Milli‐Q water applied to their cheeks. Tactile discrimination performance was assessed using psychophysical techniques before and after application. The water content, mechanical response characteristics, and penetration of PEG/PPG‐17/4 dimethyl ether from the cream in the stratum corneum were evaluated to identify hydration effects. Skin deformations occurring during tactile sensation were measured concurrently using a suction device employed for tactile stimulation. Results: Tactile sensitivity was increased in participants who had cream applied to the skin surface, while no significant change was observed in participants who received Milli‐Q water. The improved discrimination of tactile stimulus intensity was directly related to the magnitude of skin displacement. The higher water content of the stratum corneum due to cream application decreased the dynamic modulus of elasticity of the stratum corneum and increased the skin's extensibility in response to tactile stimuli. Conclusions: Hydrating the stratum corneum significantly enhances tactile sensitivity and is accompanied by an increase in skin extensibility, a factor in tactile intensity perception. The compliance of the thin stratum corneum layer plays a crucial role in tactile experiences that involve skin stretching. [ABSTRACT FROM AUTHOR]