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Background: Rotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear. Methods: This study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas. Discussion: This study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options. Trial registration: ClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1. [ABSTRACT FROM AUTHOR]

Background: In locally advanced rectal cancer (LARC), optimizing neoadjuvant strategies, including the addition of concurrent chemotherapy and dose escalation of radiotherapy, is essential to improve tumor regression and subsequent implementation of anal preservation strategies. Currently, dose escalation studies in rectal cancer have focused on the primary lesions. However, a common source of recurrence in LARC is the metastasis of cancer cells to the proximal lymph nodes. In our trial, we implement simultaneous integrated boost (SIB) to both primary lesions and positive lymph nodes in the experimental group based on magnetic resonance-guided adaptive radiotherapy (MRgART), which allows for more precise (and consequently intense) targeting while sparing neighboring healthy tissue. The objective of this study is to evaluate the efficacy and safety of MRgART dose escalation to both primary lesions and positive lymph nodes, in comparison with the conventional radiotherapy of long-course concurrent chemoradiotherapy (LCCRT) group, in the neoadjuvant treatment of LARC. Methods: This is a multi-center, randomized, controlled phase III trial (NCT06246344). 128 patients with LARC (cT3-4/N+) will be enrolled. During LCCRT, patients will be randomized to receive either MRgART with SIB (60–65 Gy in 25–28 fractions to primary lesions and positive lymph nodes; 50–50.4 Gy in 25–28 fractions to the pelvis) or intensity-modulated radiotherapy (50–50.4 Gy in 25–28 fractions). Both groups will receive concurrent chemotherapy with capecitabine and consolidation chemotherapy of either two cycles of CAPEOX or three cycles of FOLFOX between radiotherapy and surgery. The primary endpoints are pathological complete response (pCR) rate and surgical difficulty, while the secondary endpoints are clinical complete response (cCR) rate, 3-year and 5-year disease-free survival (DFS) and overall survival (OS) rates, acute and late toxicity and quality of life. Discussion: Since dose escalation of both primary lesions and positive nodes in LARC is rare, we propose conducting a phase III trial to evaluate the efficacy and safety of SIB for both primary lesions and positive nodes in LARC based on MRgART. Trial registration: The study was registered at ClinicalTrials.gov with the Identifier: NCT06246344 (Registered 7th Feb 2024). [ABSTRACT FROM AUTHOR]

Background: Individuals with spinal cord injury (SCI) often suffer from neuropathic pain which is often disabling and negatively affects function, participation, and quality of life (QoL). Pharmacological treatments lack efficacy in neuropathic pain reduction hence studying alternatives to drug treatment is necessary. Preclinical evidence of various aerobic exercises has shown positive effects on neuropathic pain but scientific studies investigating its effect in the SCI human population are limited. Methodology: This study is a double-blind, parallel, two-group, randomized controlled trial with an interventional study design that aims to evaluate the effectiveness of aerobic exercise program on neuropathic pain and quality of life (QoL) in individuals with chronic paraplegia. Thirty individuals with chronic paraplegia with the neurological level of injury from T2 to L2 will be recruited from the rehabilitation department at a super specialty hospital based on the inclusion criteria. Using a 1:1 allocation ratio, the participants will be randomly assigned to one of the two groups. The intervention group will perform high-intensity interval training (HIIT) aerobic exercise using an arm ergometer based on their peak heart rate, and the control group will perform free-hand arm aerobic exercise. In both groups, the intervention will be delivered as 30-min sessions, four times a week for 6 weeks. Outcome measures: International Spinal Cord Injury Pain Basic Data Set Version 3.0 will be used for diagnosing and assessing neuropathic pain and its interference with day-to-day activities, mood, and sleep. The International Spinal Cord Society (ISCoS) QoL basic data set will be used to assess QoL, and 6-min push test distance will be used to assess peak heart rate and aerobic capacity. Discussion: The effectiveness of the aerobic exercise program will be assessed based on the changes in neuropathic pain score and its interference with day-to-day activities, mood, sleep, QoL, and aerobic capacity after 3 weeks mid-intervention and after 6 weeks post-intervention. The trial will provide new knowledge about the effectiveness of the aerobic exercise program in improving neuropathic pain and QoL in individuals with chronic paraplegia. Trial registration: Clinical Trials Registry-India CTRI/2023/08/056257. Registered on 8 August 2023. [ABSTRACT FROM AUTHOR]

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

Background: Infertility is a prevalent global condition, and emerging reproductive technologies may enhance its evaluation and treatment. Understanding the current features of randomized clinical trials in infertility is crucial for improving study design and ensuring the translation of results for patient benefits. Objectives: To investigate the primary characteristics of randomized clinical trials related to infertility and areas where require improvement. Materials and methods: We conducted a search on the International Clinical Trials Registry platform for eligible infertility trials between 2003 and 2022. The distribution ratio of various characteristics uploaded by infertility‐related studies on the platform was analyzed and compared according to sex and registration year. Results: Out of the total trials, 85.3% (1,906) included only women, 8.6% (192) included only men, and 6.1% (136) included couples. The majority of retrieved trials followed a parallel arm design (91.0%) and were non‐industry‐funded (92.2%), with a median planned sample size of 131 patients (interquartile range 75–270). Among these trials, 54.5% (1,217) were conducted in Asia. The most common primary purpose of infertility‐related trials was treatment (88.8%), with over half of the investigated interventions focusing on medication (57.9%). Discussion: Asia is the leading region for research, and the drug therapy is still widely used and updated. However, support care for infertile couples has also received some preference. Areas that require improvement and promotion include addressing male infertility and focusing on underserved regions like Africa. The results also highlight deficiencies in trial registration and masking methods, emphasizing the need for better regulation and facilitation of infertility trials in the post‐COVID‐19 era. Conclusion: Based on the current status of infertility RCT studies, greater attention should be paid to infertile men and populations in underdeveloped regions like Africa in future studies, together with a standardized registration and implementation procedures. [ABSTRACT FROM AUTHOR]

To evaluate (1) the long-term efficacy of low-concentration atropine over 5 years, (2) the proportion of children requiring re-treatment and associated factors, and (3) the efficacy of pro re nata (PRN) re-treatment using 0.05% atropine from years 3 to 5. Randomized, double-masked extended trial. Children 4 to 12 years of age originally from the Low-Concentration Atropine for Myopia Progression (LAMP) study. Children 4 to 12 years of age originally from the LAMP study were followed up for 5 years. During the third year, children in each group originally receiving 0.05%, 0.025%, and 0.01% atropine were randomized to continued treatment and treatment cessation. During years 4 and 5, all continued treatment subgroups were switched to 0.05% atropine for continued treatment, whereas all treatment cessation subgroups followed a PRN re-treatment protocol to resume 0.05% atropine for children with myopic progressions of 0.5 diopter (D) or more over 1 year. Generalized estimating equations were used to compare the changes in spherical equivalent (SE) progression and axial length (AL) elongation among groups. (1) Changes in SE and AL in different groups over 5 years, (2) the proportion of children who needed re-treatment, and (3) changes in SE and AL in the continued treatment and PRN re-treatment groups from years 3 to 5. Two hundred seventy (82.8%) of 326 children (82.5%) from the third year completed 5 years of follow-up. Over 5 years, the cumulative mean SE progressions were –1.34 ± 1.40 D, –1.97 ± 1.03 D, and –2.34 ± 1.71 D for the continued treatment groups with initial 0.05%, 0.025%, and 0.01% atropine, respectively (P = 0.02). Similar trends were observed in AL elongation (P = 0.01). Among the PRN re-treatment group, 87.9% of children (94/107) needed re-treatment. The proportion of re-treatment across all studied concentrations was similar (P = 0.76). The SE progressions for continued treatment and PRN re-treatment groups from years 3 to 5 were –0.97 ± 0.82 D and –1.00 ± 0.74 D (P = 0.55) and the AL elongations were 0.51 ± 0.34 mm and 0.49 ± 0.32 mm (P = 0.84), respectively. Over 5 years, the continued 0.05% atropine treatment demonstrated good efficacy for myopia control. Most children needed to restart treatment after atropine cessation at year 3. Restarted treatment with 0.05% atropine achieved similar efficacy as continued treatment. Children should be considered for re-treatment if myopia progresses after treatment cessation. The author(s) have no proprietary or commercial interest in any materials discussed in this article. [ABSTRACT FROM AUTHOR]

Background: Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. Methods and analysis: This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). Discussion: This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial's rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. Trial registration: Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452. [ABSTRACT FROM AUTHOR]

Background: Post-Covid-19 syndrome is defined as non-self-sustaining signs and/or symptoms lasting more than 12 weeks, occurring during or after a Covid-19 infection. The primary outcome was the analysis of the respiratory muscle training (RMT) result in respiratory muscle strength, (maximum inspiratory pressure (MIP) e maximum expiratory pressure (MEP)); and the secondary results were the analysis of lung function, dyspnea, quality of life (QoL), fatigue and functional performance. Methods: The PICO description for this research was: P: patients diagnosed with post-Covid-19; I: RMT; C: Sham or simulated inspiratory or expiratory muscle training and usual care; O: MIP, MEP, Lung Function, level of dyspnea, QoL and functional performance. On January 15, 2024, the following databases were consulted: PubMed, Lilacs, Cochrane Library, PEDro and EMBASE. Randomized clinical trials were included without restrictions on year of publication or language. The data selection and extraction steps were carried out by two independent reviewers. Results: The search in the databases resulted in a total of 14,216 studies, and after the eligibility process, 7 studies were included with a sample of 527 patients. The MIP results suffered a statistically significant increase, that is, the RMT was favorable to improve the MIP (MD = 29.55cmH2O IC 95%: 7.56cmH2O to 51.54cmH2O, p = 0,00001). For the MEP outcome, the results were statistically significant in favor of RMT (MD = 10.93cmH2O CI 95%: 3.65cmH2O to 18.21cmH2O, p = 0.00001). We also noticed a significant improvement for the group that received the RMT in the distance covered in the 6-Minute Walk Test (6MWT) MD = 40.70 m CI 95%: 18.23 m to 65.17 m%, p = 0.01). Conclusion: We noticed that RMT is being used in patients with respiratory diseases, including post-Covid-19. Our systematic review observed that this training provides an increase in inspiratory and expiratory muscle strength, a reduction in dyspnea levels, and an increase in the distance covered in the 6MWT and improved QoL in post-covid patients after intervention. [ABSTRACT FROM AUTHOR]

Background Purpose Materials and Methods Results Conclusions Robot‐assisted implant surgery has emerged as a novel digital technology, and the accuracy need further assessment.This study aimed to compare the accuracy of single dental implant placement between a novel semi‐active robot‐assisted implant surgery (RAIS) method and the conventional free‐hand implant surgery (FHIS) method through a multicenter, randomized controlled clinical trial.Patients requiring single dental implant placement were recruited and randomized into RAIS and FHIS group. Deviations at the platform, apex, and angle between the planned and final implant positions were assessed in both groups. Additionally, the evaluation of instrument and surgical complications was examined.A total of 140 patients (median age: 35.35 ± 12.55 years; 43 males, 97 females) with 140 implants from four different research centers were included, with 70 patients (70 implants) in the RAIS group and 70 patients (70 implants) in the FHIS group. In the RAIS and FHIS groups, the median platform deviations were 0.76 ± 0.36 mm and 1.48 ± 0.93 mm, respectively (p < 0.001); median apex deviations were 0.85 ± 0.48 mm and 2.14 ± 1.25 mm, respectively (p < 0.001); and median angular deviations were 2.05 ± 1.33° and 7.36 ± 4.67°, respectively (p < 0.001). Similar significant difference also presented between RAIS and FHIS group in platform vertical/horizontal deviation, apex vertical/horizontal deviation. Additionally, implants with self‐tapping characteristics exhibited significantly larger deviations compared with those without self‐tapping characteristics in the RAIS group. Both RAIS and FHIS methods demonstrated comparable morbidity and safety pre‐ and post‐operation.The results indicated that the RAIS method demonstrated superior accuracy in single dental implant placement compared with the FHIS method. Specifically, RAIS exhibited significantly smaller deviations in platform, apex, and angular positions, as well as platform and apex vertical/horizontal deviations.This clinical trial was not registered prior to participant recruitment and randomization. https://www.chictr.org.cn/showproj.html?proj=195045. [ABSTRACT FROM AUTHOR]

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials. [ABSTRACT FROM AUTHOR]

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

Prevalence of Parkinson's disease (PD) increases with age. The purpose of this study was to evaluate the eligibility criteria in randomized clinical trials (RCTs) in PD, especially those limiting the enrollment of older adults. We examined RCTs of pharmacological and non-pharmacological anti-parkinsonian interventions registered with ClinicalTrials.gov and started from 2013 through 2022. Primary outcome was proportion of RCTs with an upper age limit of 85 years of age or less. Secondary outcome was proportion of RCTs with other exclusion criteria. Associations between trial characteristics and the presence of the age limits were determined using logistic regression. Our study included 420 RCTs. Two hundred thirty-nine (57%) of these had an upper age limit of 85 years of age or less. Proportion of these trials significantly increased over time. The odds of the presence of an upper age limit were significantly associated with the investigational site location, phase, and timeframe for the primary endpoint assessment. Three hundred fifty-six (85%) trials had other eligibility criteria limiting the enrollment of older patients; these often (n = 285; 68%) included cognitive impairment. Overall, 386 (92%) RCTs either explicitly excluded older adults or had criteria indirectly limiting their enrollment. Underrepresentation of older patients in clinical trials in PD considerably reduces the generalizability of their results. Some eligibility criteria should be modified to enable the investigators to assess the benefits and harms of new therapeutic interventions in older adults. This problem is important in view of rapidly growing number of older patients with PD. [ABSTRACT FROM AUTHOR]

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

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

Background and Aims Design Setting Participants Intervention and Comparator Measurements Findings Conclusions Tobacco smoking represents a major cause for preventable death and morbidity. Results from non‐randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy.Prospective parallel‐group open‐label randomized superiority trial, with assessments at baseline, 6 and 12 months.Recruitment throughout Germany via media advertisements.Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4.Residential 9‐day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3–7 weeks) provided in routine care courses close to the participants' places of residence, both including at least 9 h of behavioral therapy.Co‐primary outcomes were self‐reported continuous 6‐ and 12‐month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy‐uptake population including participants who started therapy with sensitivity analyses in the intention‐to‐treat population of all randomized participants.Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy‐uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39–4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14–3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22–4.51, P = 0.011). In the intention‐to‐treat population, self‐reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77–5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85–6.52, P = 0.0001), respectively.Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers. [ABSTRACT FROM AUTHOR]

Primary axillary hyperhidrosis is an idiopathic disorder that creates severe psycho-social burden due to excessive uncontrolled sweating. Various therapeutic agents have been described, but each has its own limitations. The use of fractional microneedling radiofrequency has emerged lately with promising results. This study aimed to determine the efficacy and safety of fractional microneedle radiofrequency in comparison to Botulinum toxin-A (BT-A) in patients with primary axillary hyperhidrosis. In this randomized controlled clinical trial, 20 patients (40 sides) were randomized to either fractional microneedle radiofrequency (4 sessions at 3-week intervals) or BT-A (single session), where each side received one of the treatment modalities. Efficacy was measured at 3, 6 and 12 months using Minor's starch iodine test, HDSS score, Hqol questionnaire, and patient satisfaction. Fractional microneedle radiofrequency, although showed moderate efficacy, is inferior to BT-A regarding longitudinal efficacy at 12 months, as well as patients' satisfaction. Both treatment modalities showed to be equally safe, but fractional microneedle radiofrequency procedure was substantially more painful. In conclusion, fractional microneedle radiofrequency does not offer a better substitute to BT-A in primary axillary hyperhidrosis. BT-A shows higher efficacy, is less painful, less expensive, and needs a smaller number of sessions. [ABSTRACT FROM AUTHOR]

Chronic nonspecific neck pain is a common disorder that causes disability and reduced quality of life. Effective conservative treatment options are needed to manage this condition. This randomized trial compared the efficacy of McKenzie exercises alone versus McKenzie plus cervical and scapulothoracic stabilization training for patients with chronic nonspecific neck pain. A randomized controlled trial was conducted in an outpatient physical therapy clinic. 76 patients with chronic (> 3 months) neck pain were randomized to 6 weeks of either McKenzie exercises alone (n= 38) or McKenzie plus stabilization exercise (n= 38). The McKenzie protocol included posture correction, range of motion exercises, and lateral neck stretches. The stabilization program added targeted exercises for the neck and scapula. The combination of McKenzie plus stabilization exercises resulted in significantly greater reduction in current neck pain intensity compared to McKenzie alone at 6 weeks (mean difference: -1.2 points on 0–10 scale, 95% CI -1.8 to -0.6; p< 0.001). Neck disability improved in both groups. Cervical range of motion also improved more with the addition of stabilization, except for extension. Adding specific cervical and scapulothoracic stabilization exercises to a standard McKenzie protocol led to clinically meaningful reductions in neck pain compared to McKenzie therapy alone in patients with chronic nonspecific neck pain. This combined approach can improve outcomes. [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease (PD) poses a significant social burden. Zhengan Xifeng Decoction has been widely used in the treatment of PD. Objective: The aim of this study was to evaluate the clinical efficacy and safety of Zhengan Xifeng Decoction combined with Western medicine in the treatment of PD. Methods: Five independent databases were searched for clinical randomized controlled trials on Zhengan Xifeng Decoction combined with Western medicine for the treatment of PD. The risk of bias and quality of the included studies were assessed, followed by a meta-analysis. Results: A total of 21 studies, including 1678 patients, were included in the meta-analysis. The results suggested that the combination of Zhengan Xifeng Decoction and Western medicine demonstrated clinical efficacy in the treatment of PD [OR = 6.36, 95% confidence interval [CI] (4.70, 8.60), Z = 11.99 (P < 0.00001)] and reduced Unified Parkinson's Disease Rating Scale (UPDRS) scores [mean difference (MD) = -5.50, 95% CI (-6.93, -4.08)]; UPDRS I, II, III scores [MD = -4.87, 95% CI (-7.27, -2.47)]; UPDRS II, III scores [MD = -7.18, 95% CI (-15.71, -1.35)]; UPDRS I scores [MD = -0.15, 95% CI (-0.27, -0.03)]; UPDRS II scores [MD = -1.62, 95% CI (-2.42, -0.82)]; UPDRS III scores [MD = -2.14, 95% CI (-3.91, 0.38)]; and UPDRS IV scores [MD = -0.40, 95% CI (-0.79, -0.01)]. The differences between the groups were statistically significant (P < 0.05). Conclusions: Zhengan Xifeng Decoction combined with Western medicine demonstrates improved clinical efficacy in the treatment of PD, and patients tolerate adverse events well. [ABSTRACT FROM AUTHOR]

Background: The DAWN antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment. Aim: To explore which factors contributed to the premature termination. Design & setting: General practice in Belgium. Method: Patients were randomised to camostat or placebo (patients and physicians blinded) between June 2021 and July 2022; a third arm evaluating molnupiravir (open label) was opened in March 2022. The outcome assessor was blinded for all comparisons except for the patient reported outcomes in case of molnupiravir. The authors analysed available trial data and evaluated trial context, implementation, and mechanisms of impact based on semi-structured interviews with trial stakeholders. Results: The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years), and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; and staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun. Conclusion: The DAWN antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as a small and inexperienced sponsor and clinical teams, delays in regulatory processes, and research capacity in routine settings could be overcome by established research infrastructure and standardisation of processes. [ABSTRACT FROM AUTHOR]

Objectives Materials and Methods Results Conclusion The aim of this study was to evaluate esthetic parameters in the anterior maxillary region by comparing single‐piece zirconia versus titanium narrow‐diameter implants. Additionally, clinical, radiological and patient‐reported outcome measures (PROMs) were analyzed.Thirty implants (tissue level implant) were placed in 30 patients in the maxillary esthetic sector. Depending on randomization, a zirconia (test) or titanium implant (control) was placed. Esthetic, clinical, and radiological parameters, including the implant crown esthetic index (ICAI), pink esthetic score (PES), probing pocket depth, bleeding on probing, plaque index, and marginal bone levels, were evaluated at 12, 36 and 60 months after loading.Sixty months after crown placement, no significant differences were found between groups. The ICAI values were 5.25 ± 4.21 and 4.50 ± 2.98 for the test and control groups, respectively. The corresponding PES values were 7.44 ± 1.93 and 7.43 ± 1.74 for the test and control groups, respectively. There were no significant intergroup differences for the rest of the parameters evaluated.It can be suggested that monotype zirconia implants may serve as a potential alternative to titanium implants in selected clinical scenarios. While the results demonstrated comparable esthetic, clinical, and radiological aspects for zirconia implants as compared to titanium implants after a 5‐year follow‐up period, further research with larger sample sizes and longer‐term follow‐up is recommended. [ABSTRACT FROM AUTHOR]

Objectives: The impact of the Standard Protocol Items: Recommendations for Interventional Trials of Traditional Chinese Medicine (SPIRIT-TCM) Extension 2018 statement on the reporting quality of randomized controlled trial (RCT) protocols in traditional Chinese medicine (TCM) is not clear. This review aimed to assess the reporting characteristics and quality of RCT protocols involving interventions such as Chinese herbal medicine formulas (CHMF), acupuncture, and moxibustion published in the last 3 years. Methods: We conducted an extensive search among multiple databases, including All EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid MEDLINE(R), PubMed, Web of Science, Google Scholar, and ClinicalTrials.gov for publications in English from 1 January 2020 to 10 August 2023. Two reviewers independently assessed the eligibility of the publications, extracted predetermined information, and evaluated the reporting based on the SPIRIT-TCM Extension 2018 checklist. Results: Of the 420 eligible protocols (comprising 163 studies on CHMF, 239 on acupuncture, and 18 on moxibustion), the average reporting compliance rate was only 35.4%. Approximately half of the assessed items fell into the category of poorly reported, demonstrating a compliance rate below 65%. Notably, reporting compliance in acupuncture and moxibustion interventional studies exhibited higher scores than compliance in CHMF studies. Conclusion: Continued, concerted, and coordinated efforts are required by journals, editors, reviewers, and investigators to improve the application and promotion of the SPIRIT-TCM Extension 2018 reporting guideline. [ABSTRACT FROM AUTHOR]

Introduction: In recent years, diverse initiatives have been carried out to control the COVID-19 pandemic, ranging from measures restricting social activities to analyzing drugs and vaccines. Studies on herbal medicines are also increasingly conducted in various countries as an adjuvant therapy or supplement. Therefore, this systematic review aimed to investigate the efficacy of herbal medicines analyzed from various countries through clinical trials with the randomized controlled trial method. The outcomes of Length of Stay (LOS), Negative Conversion Time (NCT), and Negative Conversion Rate (NCR) were the main focus. Methods: An extensive review of literature spanning from 2019 to 2023 was carried out using well-known databases including PubMed, Scopus, and Cochrane. The search included relevant keywords such as "randomized controlled trial," "COVID-19," and "herbal medicine." Results: A total of 8 articles were part of the inclusion criteria with outcomes of LOS, NCT, and NCR. In terms of LOS outcomes, all types of herbal medicines showed significant results, such as Persian Medicine Herbal (PM Herbal), Persian Barley Water (PBW), Jingyin Granules (JY granules), Reduning Injection, and Phyllanthus emblica (Amla). However, only JY granules showed significant results in NCR outcome, while JY granules and Reduning Injection showed significant results in reducing NCT. Conclusion: These findings enrich our understanding of the potential benefits of herbal medicines in influencing LOS, NCR and NCT parameters in COVID-19 patients. Herbal medicines worked to treat COVID-19 through antiviral, antiinflammatory, and immunomodulatory mechanisms. [ABSTRACT FROM AUTHOR]

Background: Learning of burn patient assessment is very important, but heart-breaking for nursing students. This study aimed to compare the effects of feedback lecture method with a serious game (BAM Game) on nursing students' knowledge and skills in the assessment of burn patients. Method: In this randomized controlled clinical trial, 42 nursing students in their 5th semester at Mashhad University of Medical Sciences School of Nursing and Midwifery, were randomly assigned to intervention (BAM game, available for two weeks) and control (feedback lecture method presented in two 90-minute sessions) groups. Two weeks after the intervention, all students were evaluated for their knowledge (using knowledge assessment test) and skills (using an Objective Structured Clinical Examination). Statistical analysis involved independent t-test, Fisher's exact test, analysis of covariance (ANCOVA), and univariable and multivariable ordinal logistic regression models. Results: Following the intervention, the skill scores were 16.4 (SD 2.2) for the intervention group and 11.8 (SD 3.8) for the control group. Similarly, the knowledge scores were 17.4 (SD 2.2) for the intervention group and 14.7 (SD 2.6) for the control group. Both differences were statistically significant (P <.001). These differences remained significant even after adjusting for various factors such as age, gender, marital status, residence, university entrance exam rank, and annual GPA (P <.05). Furthermore, the BAM game group showed significantly higher skills rank than the feedback lecture group across most stations (eight of ten) (P <.05) in the univariable analysis. Multivariable analysis also revealed a significantly higher skills score across most stations even after adjusting for the mentioned factors (P <.05). These results suggest that the BAM game group had higher skills scores over a range of 1.5 to 3.9 compared to the feedback lecture group. Conclusions: This study demonstrated that nursing students who participated in the BAM game group exhibited superior performance in knowledge acquisition and skill development, compared to those in the control group. These results underscore a significant enhancement in educational outcomes for students involved with the BAM game, confirming its utility as a potent and effective pedagogical instrument within the realm of nursing education. Trial registration: Iranian Registry of Clinical Trials: IRCT20220410054483N1, Registration date: 18/04/2022. [ABSTRACT FROM AUTHOR]

Aim: To investigate the efficacy and safety of pioglitazone compared to placebo when added to metformin plus dapagliflozin, a sodium‐glucose cotransporter‐2 (SGLT2) inhibitor, for patients with type 2 diabetes mellitus (T2DM). Materials and Methods: In a multicentre study, with a randomized, double‐blind, placebo‐controlled design, 249 Korean patients with T2DM suboptimally managed on metformin and dapagliflozin were assigned to receive either pioglitazone (15 mg daily) or placebo for 24 weeks, followed by a 24‐week pioglitazone extension. Primary outcomes included changes in glycated haemoglobin (HbA1c), with secondary outcomes assessing insulin resistance, adiponectin levels, lipid profiles, liver enzymes, body weight and waist circumference. Results: Pioglitazone administration resulted in a significant reduction in HbA1c levels (from 7.80% ± 0.72% to 7.27% ± 0.82%) compared with placebo (from 7.79% ± 0.76% to 7.69% ± 0.86%, corrected mean difference: −0.42% ± 0.08%; p < 0.01) at 24 weeks. Additional benefits from pioglitazone treatment included enhanced insulin sensitivity, increased adiponectin levels, raised high‐density lipoprotein cholesterol levels and reduced liver enzyme levels, resulting in improvement in nonalcoholic fatty liver disease liver fat score. Despite no serious adverse events in either group, pioglitazone therapy was modestly but significantly associated with weight gain and increased waist circumference. Conclusions: Adjunctive pioglitazone treatment in T2DM inadequately controlled with metformin and dapagliflozin demonstrates considerable glycaemic improvement, metabolic benefits, and a low risk of hypoglycaemia. These advantages must be weighed against the potential for weight gain and increased waist circumference. [ABSTRACT FROM AUTHOR]

Background: Increasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis (PwMS). Methods: Randomized trials assessing approved DMTs in PwMS with results for at least one outcome referred to as "quality of life" were searched in PubMed and ClinicalTrials.gov. Results: We identified 38 trials published between 1999 and 2023 with a median of 531 participants (interquartile range (IQR) 202 to 941; total 23,225). The evaluated DMTs were mostly interferon-beta (n = 10; 26%), fingolimod (n = 7; 18%), natalizumab (n = 5; 13%), and glatiramer acetate (n = 4; 11%). The 38 trials used 18 different QoL instruments, with up to 11 QoL subscale measures per trial (median 2; IQR 1–3). QoL was never the single primary outcome. We identified quantitative QoL results in 24 trials (63%), and narrative statements in 15 trials (39%). In 16 trials (42%), at least one of the multiple QoL results was statistically significant. The effect sizes of the significant quantitative QoL results were large (median Cohen's d 1.02; IQR 0.3–1.7; median Hedges' g 1.01; IQR 0.3–1.69) and ranged between d 0.14 and 2.91. Conclusions: Certain DMTs have the potential to positively impact QoL of PwMS, and the assessment and reporting of QoL is suboptimal with a multitude of diverse instruments being used. There is an urgent need that design and reporting of clinical trials reflect the critical importance of QoL for PwMS. [ABSTRACT FROM AUTHOR]

Background and Aims: The use of corticosteroids in chronic drug‐induced liver injury (DILI) is an important issue. Our previous randomized controlled trial showed that patients with chronic DILI benefited from a 48‐week steroid stepwise reduction (SSR) regimen. However, it remains unclear whether a shorter course of therapy can achieve similar efficacy. In this study, we aimed to assess whether a 36‐week SSR can achieve efficacy similar to that of 48‐week SSR. Methods: A randomized open‐label trial was performed. Eligible patients were randomly assigned to the 36‐ or 48‐week (1:1) SSR group. Liver biopsies were performed at baseline and at the end of treatment. The primary outcome was the proportion of patients with relapse rate (RR). The secondary outcomes were improvement in liver histology and safety. Results: Of the 90 participants enrolled, 84 (87.5%) completed the trial, and 62 patients (68.9%) were women. Hepatocellular damage was observed in 53.4% of the cohort. The RR was 7.1% in the 36‐week SSR group but 4.8% in the 48‐week SSR group, as determined by per‐protocol set analysis (p = 1.000). Significant histological improvements in histological activity (93.1% vs. 92.9%, p = 1.000) and fibrosis (41.4% vs. 46.4%, p =.701) were observed in both the groups. Biochemical normalization time did not differ between the two groups. No severe adverse events were observed. Conclusions: Both the 36‐ and 48‐week SSR regimens demonstrated similar biochemical response and histological improvements with good safety, supporting 36‐week SSR as a preferable therapeutic choice (ClinicalTrials.gov, NCT03266146). [ABSTRACT FROM AUTHOR]

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Background: The effectiveness and safety of moderately hypofractionated radiotherapy (HFRT) in patients undergoing breast-conserving surgery (BCS) has been demonstrated in several pivotal randomized trials. However, the feasibility of applying simultaneous integrated boost (SIB) to the tumor bed and regional node irradiation (RNI) using modern radiotherapy techniques with HFRT needs further evaluation. Methods: This prospective, multi-center, randomized controlled, non-inferiority phase III trial aims to determine the non-inferiority of HFRT combined with SIB (HFRTsib) compared with conventional fractionated radiotherapy with sequential boost (CFRTseq) in terms of five-year locoregional control rate in breast cancer patients undergoing upfront BCS. A total of 2904 participants will be recruited and randomized in a 1:1 ratio into the HFRTsib and CFRTseq groups. All patients will receive whole breast irradiation, and those with positive axillary nodes will receive additional RNI, including internal mammary irradiation. The prescribed dose for the HFRTsib group will be 40 Gy in 15 fractions, combined with a SIB of 48 Gy in 15 fractions to the tumor bed. The CFRTseq group will receive 50 Gy in 25 fractions, with a sequential boost of 10 Gy in 5 fractions to the tumor bed. Discussion: This trial intends to assess the effectiveness and safety of SIB combined with HFRT in early breast cancer patients following BCS. The primary endpoint is locoregional control, and the results of this trial are expected to offer crucial evidence for utilizing HFRT in breast cancer patients after BCS. Trial registration: This trial was registered at ClincalTrials.gov (NCT04025164) on July 18, 2019. [ABSTRACT FROM AUTHOR]

Purpose: Regarding the importance of obesity concerns and trying to help obese individuals, we planned to develop an effective probiotic formula for weight control. So, this double-blind randomized clinical trial study investigated the impact of probiotics supplementation on anthropometric and biochemical parameters in obese adults. Methods: In this study, 66 obese patients with BMI in the range of 30–40 kg/m2, were enrolled and randomly assigned to either the probiotic or placebo group. They all received advice to maintain a reduction in daily caloric intake and for 3 months received two unlabeled placebo or probiotic (Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei and Bifidobacterium langum) capsules per day. For each participant demographic and medical history questionnaire, semi-quantitative food frequency questionnaire (FFQ), and modifiable activity questionnaire (MAQ) were completed at the beginning of the study and anthropometric and biochemical measurements were done before and after intervention. Results: At the end of the trial 25 subjects in the probiotic group and 26 subjects in the placebo group were analyzed. After the intervention, in the probiotic group, the level of fasting insulin was reduced significantly (P < 0.05). Weight, body mass index, waist circumference, and hip circumference decreased within both groups. This reduction amount's mean was higher in the probiotic group. Also, total cholesterol, triglycerides, and LDL levels were decreased, but not statistically significant. Conclusion: This study may suggest the potential of this combined probiotic supplement for treating obesity and related metabolic disorders. However, further researches are warranted for a definitive determination of its properties. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to estimate minimal clinically important difference (MCID) values for the World Health Organization Quality of Life Brief version (WHOQOL-BREF) among adults with neurofibromatosis (NF). An MCID is needed to demonstrate clinical meaningfulness of interventions for NF. Methods: We estimated MCID for the WHOQOL-BREF: the quality of life (QoL) measure recommended by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration. We used data from 228 clinical trial participants with NF type 1, NF type 2-related schwannomatosis, or schwannomatosis (SCHWN) who completed 10 weeks of a virtual group mind–body program targeting resiliency or a time- and attention-matched control. Following established guidelines, we estimated MCIDs using both anchor-based and distribution-based methods for physical, psychological, social relationships, and environmental domains of the WHOQOL-BREF. Results: MCID results varied across method and QoL domain. Three anchor-based methods, average change (AC), change difference (CD), and regression (REG), yielded the most consistent and comparable MCID across QoL domains. Based on these methods, we recommend ranges for each QoL domain: Physical QoL (3.9–7.3), Psychological QoL (4.7–8.1), Social QoL (2.6–5.9), and Environmental QoL (4.1–6.6). Conclusion: Establishing a rigorous MCID for QoL in NF is a critical step toward evaluating meaningful change in response to psychosocial interventions. [ABSTRACT FROM AUTHOR]

Objective: According to the World Alzheimer's Disease Report in 2015, there were 9.9 million new cases of dementia in the world every year. At present, the number of patients suffering from dementia in China has exceeded 8 million, and it may exceed 26 million by 2040.Mild cognitive impairment (MCI) refers to the pathological state of pre-dementia with the manifestation of the progressive decline of memory or other cognitive functions but without decline of activities of daily life. It is particularly important to prevent or prolong the development of MCI into dementia. Research showing effects of rhythmic auditory stimulation based-movement training(RASMT) interventions on cognitive function is also emerging. Therefore, the present meta-analysis briefly summarize findings regarding the impacts of RASMT programs on cognitive impairment. Methods: Data from Pubmed, Embase, and Cochrane Library were utilized. The impact of RASMT on cognitive functions was evaluated using indicators such as overall cognitive status, memory, attention, and executive functions. The REVMAN5.3 software was employed to analyze bias risks integrated into the study and the meta-analysis results for each indicator. Results: A total of 1,596 studies were retrieved, of which 1,385 non-randomized controlled studies and 48 repetitive studies were excluded. After reviewing titles and abstracts of the remaining 163 articles, 133 irrelevant studies were excluded, 30 studies were downloaded and read the full text. Among 30 articles, 18 articles that did not meet the inclusion criteria were excluded, the other 12 studies were included in this meta-analysis. Utilizing the Cochrane Collaborative Network Bias Risk Assessment Scale, it was found that 11 studies explained the method of random sequence generation, nine studies did not describe allocation concealment, four were single-blinded to all researchers, and eight reported single-blinding in the evaluation of experimental results. In the meta-analysis, the main outcomes showed statistically significant differences in overall cognitive status [MD = 1.19, 95%CI (0.09, 2.29), (p < 0.05)], attention [MD = -1.86, 95%CI (-3.53, -0.19), (p < 0.05)], memory [MD = 0.71, 95%CI (0.33, 1.09), (p < 0.01)], and executive function [MD = -0.23, 95% CI (-0.44, -0.02), (p < 0.05)]. Secondary outcomes indicated no statistically significant differences in verbal fluency [MD = -0.51, 95%CI (-1.30, 0.27), (p = 0.20)], while depression [MD = -0.29, 95% CI (-0.42, -0.16), (p < 0.01)] and anxiety [MD = 0.19, 95% CI (0.06, 0.32), (p < 0.01)] exhibited statistically significant differences. The GRADEpro GDT online tool assessed the quality of evidence for the outcome measures, revealing one low-quality outcome, two moderate-quality outcomes, and one high-quality outcome in this review. Conclusion: This study shows that RASMT can improve the general cognitive status, memory, attention and executive function of patients with cognitive impairment. The quality of evidence revealed that MMSE was low, attention and memory were moderate, and executive function was high. The RAMST program (type of exercise: play percussion instruments; time of exercise: 30-60 min; frequency of exercise: 2-3 times/week; duration of exercise: more than 12 weeks) was proved to be more effective in improving cognitive function. However, the sample size is relatively insufficient, the future needs further study. [ABSTRACT FROM AUTHOR]

Objective: Diabetic peripheral neuropathy (DPN) stands as a crucial complication of diabetes, significantly affecting patients' quality of life. This study aims to elucidate the evidence distribution from clinical randomized controlled trials (RCTs) on DPN treatment with traditional Chinese medicine (TCM) through evidence mapping. Methods: A comprehensive search was conducted from January 2017 to October 2022 in databases such as Wanfang (China Online Journals), CNKI (China National Knowledge Infrastructure), VIP (China Science and Technology Journal Database), SinoMed (Chinese Biomedical Literature Database), PubMed, Web of Science, and Cochrane Library. Literature related to the treatment of DPN with TCM was selected. From the 1,229 RCTs identified over the past 6 years, relevant data were extracted. The evidence mapping approach was utilized, and trends in publications, study scales, intervention types, and evaluation indicators were analyzed using descriptive text combined with tables and bubble charts. Results: Research on the treatment of DPN with TCM is extensive. The publication trend remains relatively stable with predominantly smaller sample sizes. The main treatments encompass oral Chinese medicine and traditional external treatments. The most common evaluation indicators are neurophysiological, efficiency rate, symptom signs, neuropathy scores, and traditional Chinese symptoms, with less focus on psychological status and the ankle-brachial index (ABI). Conclusion: Shedding light on contemporary research, this study explores the current RCTs evaluating TCM's efficacy in treating DPN. The findings not only highlight the potential role of TCM in addressing diabetic complications but also underscore areas that could benefit from refined research approaches, expanded intervention methods, and broader assessment criteria. Our observations aim to inform and inspire future research directions and clinical practices concerning TCM's role in managing diabetes-associated complications. [ABSTRACT FROM AUTHOR]

BACKGROUND: The relationship between dietary modification and Multiple Sclerosis (MS)-related disability has been emphasized in several researches. AIMS: To determine whether a co-administration of anti-inflammatory-antioxidant rich diet and synbiotics might improve clinical manifestations in progressive MS patients. METHODS: The study involved 70 patients with progressive MS (primary-progressive, secondary-progressive, and progressive-relapsing) who were randomized to receive either intervention (synbiotics capsule plus an anti-inflammatory-antioxidant-rich diet) or placebo. Quality of Life (QOL), Expanded Disability Status Scale (EDSS), and depression-anxiety scores were evaluated before and after the follow-up. Analysis of covariance was performed for final analysis (SPSS v.14). RESULTS: Significant reductions were seen in EDSS (2.6±1.1 to 2.4±1.0, P < 0.001), State Anxiety Inventory (53.7±10.3 to 47.8±10.6, P < 0.001), and QOL scores after four months of intervention. No significant difference was seen across the depression severity (Δ for intervention = –2.2±5.5 vs. Δ for control = –0.6±5.7; P = 0.264). CONCLUSION: This study demonstrates that a combination of synbiotics and diet could be a promising strategy to improve severity and clinical manifestations of progressive MS. [ABSTRACT FROM AUTHOR]

Introduction: Treatment of pregnancy‐associated breast cancer is complex, as providers try to balance risks to the pregnant person and the developing fetus. Given increased case fatality and increasing incidence, there is a pressing need understand the efficacy and safety of different treatment regimens in this population; however, pregnant and lactating people have traditionally been excluded from participating in randomized controlled trials (RCTs). Given recent efforts to expand the inclusion criteria for oncology RCTs, this study aimed to review the inclusion/exclusion criteria of current breast cancer RCTs to assess what proportion of trials permitted enrollment of pregnant and lactating persons. Material and methods: We conducted a comprehensive search of ClinicalTrials.gov in January 2022 to identify interventional studies of breast cancer in adults that were actively recruiting. The primary outcomes were the exclusion of pregnant and lactating people. Results: The search identified 1706 studies, of which 1451 met eligibility criteria. Overall, 69.4% and 54.8% of studies excluded pregnant and lactating people, respectively. The exclusion of pregnant and lactating persons differed by study characteristics but extended across all trial designs, locations, phases and interventions. Exclusion of pregnant and lactating persons was most common in trials where the intervention was biological (86.3%), drug (83.5%) or radiation (81.5%). Conclusions: The exclusion of pregnant and lactating people from clinical trials contributes to evidence gaps in how to treat this population. A paradigm shift is needed that focuses on how research can be used to protect pregnant people from future harms, instead of protecting pregnant people from research‐related risks. [ABSTRACT FROM AUTHOR]

BackgroundPeople living with HIV (PLHIV) have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among PLHIV, the World Health Organization (WHO) recommends systematic TB screening followed by (1) confirmatory TB testing for all who screen positive and (2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative. Symptom-based screening remains the standard of care in most high TB burden settings, including Uganda. Despite having high sensitivity for active TB among antiretroviral-naïve PLHIV, symptom screening has poor specificity; as such, many high-risk PLHIV without active TB are not referred for TPT. C-reactive protein (CRP) is a promising alternative strategy for TB screening that has comparable sensitivity and higher specificity than symptom screening, and was endorsed by WHO in 2021. However, the impact of CRP-based TB screening on TB burden for PLHIV remains unclear.MethodsTB SCRIPT (TB Screening Improves Preventive Therapy Uptake) is a phase 3, multi-center, single-blinded, individual (1:1) randomized controlled trial evaluating the effectiveness of CRP-based TB screening on clinical outcomes of PLHIV. The trial aims to compare the effectiveness of a TB screening strategy based on CRP levels using a point-of-care (POC) assay on 2-year TB incidence and all-cause mortality (composite primary trial endpoint) and prevalent TB case detection and uptake of TPT (intermediate outcomes), relative to symptom-based TB screening (current practice).DiscussionThis study will be critical to improving selection of eligible PLHIV for TPT and helping guide the scale-up and integration of TB screening and TPT activities. This work will enable the field to improve TB screening by removing barriers to TPT initiation among eligible PLHIV, and provide randomized evidence to inform and strengthen WHO guidelines.Trial registrationClinicalTrials.gov NCT04557176. Registered on September 21, 2020.

OBJECTIVE: At present, there are various surgical repair strategies for the lateral stability of chronic ankle instability after the injury of the lateral collateral ligament of the ankle, but the specific repair strategy to maximize the recovery of lateral stability of the ankle still lacks of evidence-based medical evidence. Based on this, for the first time, this paper systematically evaluated the effects of four popular repair strategies to restore the lateral stability of chronic ankle instability using the network meta-analysis method. METHODS: Computer retrieval was conducted on CNKI, WanFang, VIP, PubMed, Embase, Web of Science and Cochrane Library. The retrieval time was from the establishment of each database to December 2022. The randomized controlled trials or clinical controlled trials on different repair strategies to recover chronic ankle instability after injury of the lateral ligament of the ankle were included. The literature was screened and extracted. The literature quality was evaluated and data were analyzed using RevMan 5.4, R4.2 and Stata 14.2 software. RESULTS: Twelve studies (including 10 randomized controlled trials and 2 cohort studies) were included. A total of 673 patients with chronic ankle instability were involved in 4 repair strategies. The observation indicators were: anterior talar translation distance and talar tilt angle of ankle joint stress X-ray film (hereinafter referred to as anterior talar translation distance and talar tilt angle). The results of network meta-analysis showed that: (1) In terms of anterior talar translation distance, the sequence of reticular meta-analysis results from inferior to superior was anatomical repair > anatomical repair + enhancement of inferior extensor retinaculum > internal brake anatomical reconstruction > autologous/allogeneic tendon anatomical reconstruction. (2) In terms of talar tilt angle, the sorting results of reticular meta-analysis from inferior to superior were as follows: anatomical repair > anatomical repair + inferior extensor retinaculum enhancement > internal brace anatomical reconstruction > autologous/allogeneic tendon anatomical reconstruction. CONCLUSION: Anatomical reconstruction strategy of autologous/allogeneic tendon is the first in improving anterior talar translation distance and talar tilt angle, suggesting that this strategy may have the best effect in restoring the stability of chronic joint instability after injury of the lateral ligament of ankle, but more large sample, multicenter, double-blind randomized controlled trials are still needed in the future to further confirm. [ABSTRACT FROM AUTHOR]

Objective: To systematically review the efficacy and safety of nonsteroidal mineralocorticoid receptor antagonists (MRAs) in chronic kidney disease (CKD). Methods: We systematically searched six databases to identify randomized controlled trials (RCTs) about nonsteroidal MRAs for CKD, from inception to 22 August 2023. Two reviewers independently screened the retrieved articles, extracted data, and assessed the risk of bias of included RCTs using the Cochrane risk of bias tool. We then conducted meta-analysis of the data using Stata 17.0 software. Results: 11 RCTs (n = 15,817) were included in this meta-analysis. Compared with placebo, nonsteroidal MRAs significantly reduced the proportion of patients with =40% decline in estimated glomerular filtration rate (eGFR) from baseline [RR = 0.85, 95% CI (0.78, 0.92), p < 0.001], although the magnitude of eGFR reduction was greater [WMD = -2.83, 95% CI (-3.95, -1.72), p < 0.001]. The experimental group also had lower incidence of composite renal outcome [RR = 0.86, 95% CI (0.79, 0.93), p < 0.001] and greater reduction in urine albumin-tocreatinine ratio (UACR) from baseline [WMD = -0.41, 95% CI (-0.49, -0.32), p < 0.001], as well as reduced cardiovascular events [RR = 0.88, 95% CI (0.80, 0.95), p = 0.003]. MRAs did not increase any adverse events compared to placebo [RR = 1.00, 95% CI (0.99, 1.01), p = 0.909], but had higher incidence of hyperkalemia [RR = 2.05, 95% CI (1.85, 2.280), p < 0.001]. Compared with eplerenone, there was no significant difference in the proportion of patients with ≥40% decline in eGFR [RR = 0.57, 95% CI (0.18, 1.79), p = 0.335] or hyperkalemia [RR = 0.95, 95%CI (0.48, 1.88), p = 0.875]. Conclusion: Nonsteroidal MRAs can reduce the incidence of end-stage renal disease and cardiovascular adverse events in patients. Although there was still a risk of hyperkalemia compared to placebo, there was no significant difference in any adverse events compared to either placebo or eplerenone. It has become a new option for drug treatment of CKD patients, but more clinical trials are still needed to verify its efficacy and safety. Especially further direct comparison of the nonsteroidal MRAs to eplerenone in view of the relatively small number of patients reviewed are needed. [ABSTRACT FROM AUTHOR]

Background: Fluoridation of public water systems is known as a safe and effective strategy for preventing dental caries based on evidence from non-randomized studies. Yet 110 million Americans do not have access to a fluoridated public water system and many others do not drink tap water. This article describes the study protocol for the first randomized controlled trial (RCT) of fluoridated water that assesses its potential dental caries preventive efficacy when delivered in bottles. Methods: waterBEST is a phase 2b proof-of-concept, randomized, quadruple-masked, placebo-controlled, parallel-group trial designed to estimate the potential efficacy of fluoridated versus non-fluoridated bottled water to prevent dental caries incidence in the first 4 years of life. Two hundred children living in eastern North Carolina, USA, and aged 2–6 months at screening are being allocated at random in a 1:1 ratio to receive fluoridated (0.7 mg/L F) or non-fluoridated bottled water sourced from two local public water systems. Throughout the 3.5-year intervention, study water is delivered monthly in 5-gallon bottles to each child's home with instructions to use it whenever the child consumes water as a beverage or in food preparation. Parents are interviewed quarterly to monitor children's water consumption and health. At annual visits, the presence of dental caries is evaluated with a dental screening examination. Clippings from fingernails and toenails are collected to quantify fluoride content as a biomarker of total fluoride intake. The primary endpoint is the number of primary tooth surfaces decayed, missing, or filled due to dental caries measured by the study dentist near the time of the child's fourth birthday. Tooth decay is assessed at the threshold of macroscopic enamel loss. For the primary aim, a least-squares, generalized linear model will estimate efficacy and its one-tailed, upper 80% confidence limit. Discussion: waterBEST is the first evaluation of a randomized intervention of fluoridated drinking water in bottles to prevent dental caries in the primary dentition. This innovative method of delivering fluoridated water has the potential to prevent early childhood caries in a large segment of the US population that currently does not benefit from fluoridated public water. Trial registration: ClinicalTrials.gov NCT04893681. Registered on March 2022. Last update posted on 10 October 2023. https://clinicaltrials.gov/study/NCT04893681?cond=Dental%20Caries%20in%20Children&term=fluoride&locStr=North%20Carolina,%20USA&country=United%20States&state=North%20Carolina&distance=50&rank=1 [ABSTRACT FROM AUTHOR]

Purpose: Virtual reality (VR) training effectiveness in improving hip arthroplasty surgical skills requires further evaluation. We hypothesised VR training could improve accuracy and the time taken by medical students compared to a control group with only video teaching. Methods: This single-centre randomized controlled clinical trial collected data from March to June 2023. Surgically naïve volunteer undergraduate medical students performed three sessions on a VR training platform, either cup (VR-Cup=Control-Stem) or stem (VR-Stem=Control-Cup) implantation. The primary outcome was the mean difference between predefined cup inclination (60°) and stem anteversion (20°) compared to the actual implanted values in sawbones between VR and control groups. Secondary outcomes were task completion time and mistake number between the groups. Results: A total of 101 students participated (VR-Cup 47, VR-Stem 54). Groups did not significantly differ concerning age (p = 0.879), gender (p = 0.408), study year (p = 0.938), previous VR use (p = 0.269) and baseline medical and procedural knowledge. The VR-Cup implanted the cup closer to the intended target (p < 0.001) and faster than the Control-Cup group (p = 0.113). The VR-Stem implanted the stem closer to the intended target (p = 0.008) but not faster than the Control-Cup group (p = 0.661). Stem retroversion was commoner in the Control-Stem than in the VR-Stem group (p = 0.016). Conclusions: VR training resulted in higher rates of accurate procedure completion, reduced time and fewer errors compared to video teaching. VR training is an effective method for improving skill acquisition in THA. Trial registration: ClinicalTrials.gov Identifier: NCT05807828 [ABSTRACT FROM AUTHOR]

Objective: Exogenous hydrogen sulfide (H2S) has a positive effect on respiratory diseases. Oleo-gum of Ferula assa-foetida contains this compound. This study assessed the effects of Ferula assa-foetida L. oleo gum resin and tragacanth (Phytopaj) on patients with COVID-19. Materials and Methods: A randomized, single-blinded, controlled trial (RCT) phase 2 was conducted in Mashhad on hospitalized COVID-19 patients. In this RCT, 122 patients were randomly assigned to either receive a 14-day oral phytopaj plus ordinary treatment or ordinary treatment only. Changes in peripheral blood lymphocyte count (LC) and blood oxygen saturation (PO2) were the endpoints. Results: Mean±SD of PO2 in Phytopaj comparison ordinary treatment before intervention was 91.86±4.62 and 91.41±9.18, after the intervention it was 93.22±4.26 and 91.91±5.92 mmHg; before intervention, mean±SD of peripheral blood lymphocyte count was 1015.90±500.55, and 1104.28±543.61, and after intervention, it was 1652.27±921.38 and 1326.12±719.28/μL respectively. Conclusion: Phyopaj is most useful in moderate stages of Covid19, and it is not recommended for elderly patients and patients with comorbidity until more insight is gained. [ABSTRACT FROM AUTHOR]

This study (ISRCTN17174559) aimed to explore the efficacy and safety of a kind of herbal porridge (Hou Gu Mi Xi) on the clinical symptoms of functional dyspepsia (FD). This was a single‐center, single‐dose, prospective, double‐blind, randomized controlled trial involving 64 participants with FD (35 cases and 29 controls) for 2 months of intervention and 1 month of follow‐up. The 7‐point Global Overall Symptom Scale (GOSS), 36‐Item Short Form Survey (SF‐36), and other indicators were assessed at baseline (day 0), at days 15, 30, and 60 of treatment, and at follow‐up 1 month after the end of the intervention. Many participants with FD achieved remission of their epigastric symptoms at follow‐up on the 90th day after treatment with herbal porridge compared to the placebo group (45.71% vs. 20.69%, p =.036). Furthermore, herbal porridge appeared to be effective in improving the quality of life of participants with FD, which was reflected in the rising SF‐36 scores for physical role, bodily pain, emotional role, and mental health. Although adverse events were reported, there was no overall difference in the number of adverse events between the two groups (p =.578). Herbal porridge is another effective and safe method for improving the symptoms and quality of life in patients with FD. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to test the hypothesis that use of NerveTrend™ mode of intermittent neuromonitoring (i‐IONM) during thyroidectomy may identify and prevent impending recurrent laryngeal nerve (RLN) injury. Methods: A randomized clinical trial. The primary outcome was prevalence of RLN injury on postoperative day 1. In NerveTrend™ group the i‐IONM stimulator was used for trending of amplitude and latency changes from initial vagal electromyographic baseline to tailor surgical strategy. Results: Some 264 patients were randomized into the intervention versus the control group, 132 patients each. RLN injury was found on postoperative day 1 in 5/264 (1.89%) nerves at risk (NAR) versus 12/258 (4.65%) NAR whereas staged thyroidectomy was used in 0/132 (0.00%) versus 6/132 (4.54%) patients (p = 0.067 and p = 0.029, respectively). Conclusion: The use of NerveTrend™ mode resulted in tendency towards reduced RLN injury on postoperative day 1 and significant decrease of need for a staged thyroidectomy. [ABSTRACT FROM AUTHOR]

Background Emotional symptoms are recognized as a key feature in individuals with major depressive disorder. Previously, emotional blunting has been described both as a side effect of antidepressant treatment and as a symptom of depression. Little is known about the change of emotional blunting during antidepressant treatment. Methods The PREDDICT trial is a randomized, placebo-controlled, 6-week trial on the augmentation of vortioxetine with the anti-inflammatory agent celecoxib or placebo. Presently we report on exploratory secondary outcomes of changes in emotional blunting in depression assessed with the Oxford Depression Questionnaire (ODQ) total score and subscores from baseline to 8-week, 3-month, and 6-month follow-up assessments. Results In the whole group, there was a significant improvement in the ODQ total score and all subscores after 8 weeks. After stratification of participants into the treatment groups, the ODQ total score as well as subscores related to emotional blunting as a symptom of depression (reduction in positive emotions, not caring) improved between baseline and all follow-up time points in both treatment groups. Changes in subscores considered as a side effect of antidepressants (general reduction in emotions, emotional detachment) were inconclusive in both treatment groups. Overall, the placebo-augmented group showed slightly better results in changes of emotional blunting scores than the celecoxib group as did those with elevated inflammation at screening, regardless of treatment group. Conclusions This analysis suggests favorable effects of vortioxetine on emotional blunting in both short- and long-term course. The beneficial impact of vortioxetine on emotional blunting was weaker in celecoxib-augmented patients compared with placebo, possibly due to pharmacokinetic interactions. Clinical Trials Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000527369p. Registered on 11 April 2017, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000527369p. [ABSTRACT FROM AUTHOR]

Background: Clinical trials assessing new treatment effects require a control group to compare the pure treatment effects. However, in clinical trials on regenerative medicine, rare diseases, and intractable diseases, it may be ethically difficult to assign participants to the control group. In recent years, the use of historical control data has attracted attention as a method for supplementing the number of participants in the control group. When combining historical control data with new randomized controlled trial (RCT) data, the assessment of heterogeneity using outcome data is not sufficient. Therefore, several statistical methods that consider participant outcomes and baseline characteristics, including the propensity score (PS) method have been proposed. Methods: We propose a new method considering "information on whether the data are RCT data or not" in the PS model when combining the RCT and historical control data. The performance of the proposed method in estimating the treatment effect is evaluated using simulation data. Results: When the distribution of covariates is similar between the RCT and historical control data, not much difference in performance is found between the proposed and conventional methods to estimate the treatment effect. On the other hand, when the distribution of covariates is not similar between the two kinds of data, the proposed method shows higher performance. Conclusions: Even when it is not known whether RCT and historical control data are similar, the proposed PS model is useful to estimate the treatment effect appropriately in RCTs using historical control data. [ABSTRACT FROM AUTHOR]

Background: Vancomycin is a commonly prescribed antibiotic to treat gram-positive infections. The efficacy of vancomycin is known to be directly related to the pharmacokinetic/pharmacodynamic (PK/PD) index of the area under the concentration-time curve (AUC) divided by the minimal inhibitory concentration (MIC) of the pathogen. However, in most countries, steady-state plasma concentrations are used as a surrogate parameter of target AUC/MIC, but this practice has some drawbacks. Hence, direct AUC-guided monitoring of vancomycin using model-informed precision dosing (MIPD) tools has been proposed for earlier attainment of target concentrations and reducing vancomycin-related nephrotoxicity. However, solid scientific evidence for these benefits in clinical practice is still lacking. This randomized controlled trial (RCT) aims to investigate the clinical utility of MIPD dosing of vancomycin administered via continuous infusion in hospitalized adults. Methods: Participants from 11 wards at two Belgian hospitals are randomly allocated to the intervention group or the standard-of-care comparator group. In the intervention group, clinical pharmacists perform dose calculations using CE-labeled MIPD software and target an AUC24h of 400 to 600 mg × h/L, whereas patients in the comparator group receive standard-of-care dosing and monitoring according to the institutional guidelines. The primary endpoint is the proportion of patients reaching the target AUC24h/MIC of 400–600 between 48 and 72 h after start of vancomycin treatment. Secondary endpoints are the proportion of patients with (worsening) acute kidney injury (AKI) during and until 48 h after stop of vancomycin treatment, the proportion of patients reaching target AUC24h/MIC of 400–600 between 72 and 96 h after start of vancomycin treatment, and the proportion of time within the target AUC24h/MIC of 400–600. Discussion: This trial will clarify the propagated benefits and provide new insights into how to optimally monitor vancomycin treatment. Trial registration: EudraCT number: 2021-003670-31. Registered June 28, 2021. ClinicalTrials.gov identifier: NCT05535075. Registered September 10, 2022. Protocol version 3, protocol date: April 21, 2023. [ABSTRACT FROM AUTHOR]

The purpose is to explore the analgesic effect of a single Nd:YAG laser dose after mandibular third molar extraction. This was a prospective randomized controlled clinical trial. Subjects were enrolled according to the inclusion and exclusion criteria and randomly divided into the experimental and control groups. In the experimental group, the wound was irradiated with the Nd:YAG laser (wavelength, 1064 nm; output power, 1.5 W; energy density, 45 J/cm2; and power density, 1.5/cm2, pulsed mode) immediately after mandibular third molar extraction for 120 s (30 s at each site). In the control group, the laser working tip was placed near the extraction site but not activated. The primary outcome was the visual analog scale (VAS) pain scores in both groups at 2, 4, 12, 24, 48, and 72 h and 7 days after surgery. Secondary outcomes included wound healing scores and adverse reactions. The VAS score was significantly lower in the experimental group than in the control group at 2 and 4 h after surgery, while there was no significant difference in the VAS score between the two groups at 12, 24, or 48 h or 7 days after surgery. There were no significant differences in the wound healing scores between the two groups on postoperative day 7. No adverse reactions were observed in any of the laser-irradiated areas. A single Nd:YAG laser dose was effective in reducing pain at 2 and 4 h after mandibular third molar extraction. China Clinical Trial Registry: ChiCTR2000033870 (Registration Date: 2020–6-15). [ABSTRACT FROM AUTHOR]

Background: Premature ejaculation is one of the most common male sexual dysfunction, affecting approximately 30% of men. The aim of this study is to evaluate the efficacy and at the same time the safety of the cranial electrotherapy stimulation (CES) device in treatment of premature ejaculation disorder. Methods: Based on a randomized clinical trial, two groups were included in the study, so that the first group was treated with sertraline along with an ATANG (AT-9 model) CES, and the second group with sertraline and inactive the CES device (as the placebo group). The state of premature ejaculation after treatment (using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) was evaluated and compared for both groups. Results: In the intervention and placebo groups, the average score of the PEDT questionnaire before the intervention did not differ significantly between the two groups (p-value equal to 0.93). However, the average score of the PEDT questionnaire after the intervention for CES group and placebo group was 10.28 ± 1.93 and 13.23 ± 3.05, respectively, which demonstrated a significant decrease in the intervention group (p-value equal to 0.01). Conclusion: The use of CES device as a complementary treatment along with routine drug treatment (sertraline) is associated with a significant improvement in the condition of premature ejaculation of patients. Trial registration: Name of the registry: IRCT Iranian Registry of Clinical Trials. Trial registration number: IRCT20210621051657N1. Date of registration: December 11, 2022. URL of trial registry record: https://en.irct.ir/trial/57201. [ABSTRACT FROM AUTHOR]

Background: The distal transradial access (dTRA) has become an attractive and alternative access to the conventional transradial access (TRA) for cardiovascular interventional diagnosis and/or treatment. There was a lack of randomized clinical trials to evaluate the effect of the dTRA on the long-term radial artery occlusion (RAO). Methods: This was a prospective, randomized controlled study. The primary endpoint was the incidence of long-term RAO at 3 months after discharge. The secondary endpoints included the successful puncture rate, puncture time, and other access-related complications. Results: The incidence of long-term RAO was 0.8% (3/361) for dTRA and 3.3% (12/365) for TRA (risk ratio = 0.25, 95% confidence interval = 0.07–0.88, P = 0.02). The incidence of RAO at 24 h was significantly lower in the dTRA group than in the TRA group (2.5% vs. 6.7%, P < 0.01). The puncture success rate (96.0% vs. 98.5%, P = 0.03) and single puncture attempt (70.9% vs. 83.9%, P < 0.01) were significantly lower in the dTRA group than in the TRA group. However, the number of puncture attempts and puncture time were higher in the dTRA group. The dTRA group had a lower incidence of bleeding than the TRA group (1.5% vs. 6.0%, P < 0.01). There was no difference in the success rate of the procedure, total fluoroscopy time, or incidence of other access-related complications between the two groups. In the per-protocol analysis, the incidence of mEASY type ≥ II haematoma was significantly lower in the dTRA group, which was consistent with that in the as-treated analysis. Conclusions: The dTRA significantly reduced the incidence of long-term RAO, bleeding or haematoma. Trial registration: ClinicalTrials.gov identifer: NCT05253820. [ABSTRACT FROM AUTHOR]

We examined whether a housing voucher intervention influenced adolescent risky sexual behavior (RSB) across 15 years in the Moving to Opportunity Study. Low-income families in public housing that resided in 5 cities were randomized to one of three treatment groups: a housing voucher to move to low-poverty neighborhoods (i.e., < 10% poverty rate), a Sect. 8 voucher but no housing relocation counseling, or a control group that could remain in public housing. Youth and their caregivers completed baseline surveys, as well as two uniform follow-ups: interim (2001–2002; 4–7 years after baseline) and final (2008–2010; 10–15 years after baseline). Approximately 4,600 adolescents (50.5% female) aged 13–20 years participated at the final timepoint. Adolescents reported on their RSB, including condom use, other contraceptive use, early sexual initiation (< 15 years old), and 2+ sexual partners in the past year. We modeled each indicator separately and as part of a composite index. We tested baseline health vulnerabilities as potential effect modifiers. The low-poverty voucher group and the Sect. 8 voucher group were combined due to homogeneity of their effects. Applying intent-to-treat (ITT) regression analyses, we found no significant main effects of voucher receipt (vs. control) on any RSB. However, we found protective effects of voucher receipt on RSB among youth with health problems that limited activity, and youth < 7 at baseline but adverse effects among females, youth > 7 at baseline, and youth who were suspended/expelled from school. Results highlight the importance of understanding how housing interventions differentially influence adolescent health and behaviors. [ABSTRACT FROM AUTHOR]

The severe coronavirus disease 2019 (COVID-19) is associated with increased levels of blood interleukin (IL)-6. Therefore, it is hypothesized that modulating the levels or effects of IL-6 could diminish airway inflammation and alter the course of COVID-19. We conducted a controlled, randomized, double-blind clinical trial on hospitalized patients with severe COVID-19 in Iran. The patients were randomly distributed by block randomization to take either standard-of-care (SOC) plus 1 or 2 doses of tocilizumab 8 mg/kg or SOC alone. The endpoint was defined by clinical improvement and discharge. We enrolled 40 patients (20 patients in each group) from 10 July to 10 December 2020. After randomization, 1 patient in the SOC arm and 3 patients in the tocilizumab arm refused to participate and were eliminated from the study. The mean age of participants was 59.62±15.80 in the tocilizumab group (8 women and 9 men) and 63.52±12.83 years old in the SOC group (9 women and 10 men) groups. The number of patients who recovered did not differ significantly between the tocilizumab and SOC groups (12 [70.6%][70.6%] vs. 15 [78.9%]), respectively). Hospitalization rates were also similar between the groups (Log-rank test, p=0.615; hazard ratio, 0.83; 95% CI [0.39–1.78]). The results show that tocilizumab could not be a beneficial agent for treating severe cases of COVID-19 patients and would not significantly improve clinical outcomes. [ABSTRACT FROM AUTHOR]