Tranexamic acid is an antifibrinolytic agent widely used in several surgical procedures to reduce intraoperative bleeding. Intraoperative bleeding is a crucial problem for the ear surgeon, as it prevents good visualization of the surgical field. The aim of this work was to analyze the relevant literature about the use of tranexamic acid in ear surgery. A literature search was conducted in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement, across 3 databases (Medline, Cochrane, and Google Scholar), with the terms \"tranexamic acid,\" and \"ear,\" and \"surgery.\" Three prospective, randomized, and double-blind clinical trials met the inclusion criteria. Studies were not able to be pooled because of heterogeneity in material, methods of delivery and evaluation, and procedures used. Despite these limitations, all 3 papers found a significant reduction in intraoperative bleeding, allowing a better visualization of the operating field. Despite the scarcity of published trials, tranexamic acid is safe and seems to be useful in reducing intraoperative bleeding in ear surgery, thus improving operative field visualization.

The risks and benefits of bedaquiline (BDQ) for treatment of drug-resistant tuberculosis (DR-TB) have not been firmly established. We aimed to assess the safety and efficacy of BDQ-containing regimens for the treatment of DR-TB as evidenced in available randomized controlled trials (RCTs). In this systematic review and meta-analysis, five databases (i.e., ClinicalTrials.gov, Cochrane CENTRAL, PubMed, ScienceDirect, and SinoMed) were searched. RCTs among DR-TB patients that had a control arm were eligible. The safety endpoints were all-cause mortality and serious adverse effects (SAEs). Efficacy outcomes were sputum culture conversion rate at 8-12 weeks and 24-26 weeks, treatment success, and time to culture conversion. A total of 476 records were screened; 18 met the eligibility criteria. The pooled analysis included 2520 participants (55.8% received BDQ-containing regimens, n = 1408). Pooled safety outcomes showed no significant reduction in all-cause mortality (relative risk [RR] [95%confidence interval (CI)] = 0.94 [0.41-2.20]) or SAEs (RR [95%CI] = 0.91 [0.67-1.23]) in the BDQ-regimen group. Pooled efficacy outcomes showed significantly superior culture conversion rates at 8-12 weeks (RR [95%CI] = 1.35 [1.10-1.65]) and 24-26 weeks (RR [95%CI] = 1.25 [1.15-1.36]), more treatment success (RR [95%CI] = 1.30 [1.17-1.44]), and a 17-day reduction in the time to culture conversion (standardized mean difference [SMD] [95%CI] = -17.46 [-34.82 to -0.11]) in the BDQ-regimen group (reference: non-BDQ regimen). Overall, BDQ regimens showed significant treatment effect against DR-TB but did not reduce mortality or SAEs.

BACKGROUND: There is an emerging need to systematically investigate the causes for the increased cesarean section rates in Greece and undertake interventions so as to substantially reduce its rates. To this end, the ability of the participating Greek obstetricians to follow evidence-based guidelines and respond to other educational and behavioral interventions while managing labor will be explored, along with barriers and enablers. Herein discussed is the protocol of a stepped-wedge designed intervention trial in Greek maternity units with the aforementioned goals in mind, named ENGAGE (ENhancinG vAGinal dElivery in Greece).
METHODS: Twenty-two selected maternity units in Greece will participate in a multicenter stepped-wedge randomized prospective trial involving 20,000 to 25,000 births, with two of them entering the intervention period of the study each month (stepped randomization). The maternity care units entering the study will apply the suggested interventions for a period of 8-18 months depending on the time they enter the intervention stage of the study. There will also be an initial phase of the study lasting from 8 to 18 months including observation and recording of the routine practice (cesarean section, vaginal birth, and maternal and perinatal morbidity and mortality) in the participating units. The second phase, the intervention period, will include such interventions as the application of the HSOG (the Hellenic Society of Obstetrics and Gynecology) Guidelines on labor management, training on the correct interpretation of cardiotocography, and dealing with emergencies in vaginal deliveries, while the steering committee members will be available to discuss and implement organizational and behavioral changes, answer questions, clarify relevant issues, and provide practical instructions to the participating healthcare professionals during regular visits or video conferences. Furthermore, during the study, the results will be available for the participating units in order for them to monitor their own performance while also receiving feedback regarding their rates. Τhe final 2-month phase of the study will be devoted to completing follow-up questionnaires with data concerning maternal and neonatal morbidities that occurred after the completion of the intervention period. The total duration of the study is estimated at 28 months. The primary outcome assessed will be the cesarean section rate change and the secondary outcomes will be maternal and neonatal morbidity and mortality.
CONCLUSIONS: The study is expected to yield new information on the effects, advantages, possibilities, and challenges of consistent clinical engagement and implementation of behavioral, educational, and organizational interventions described in detail in the protocol on cesarean section practice in Greece. The results may lead to new insights into means of improving the quality of maternal and neonatal care, particularly since this represents a shared effort to reduce the high cesarean section rates in Greece and, moreover, points the way to their reduction in other countries.
BACKGROUND: NCT04504500 (ClinicalTrials.gov). The trial was prospectively registered. Ethics Reference No: 320/23.6.2020, Bioethics and Conduct Committee, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.

BACKGROUND: The association between opioid use and the risk of ventricular arrhythmias (VA) is poorly understood.
OBJECTIVE: The objective of this study was to synthesize the evidence on the risk of VA associated with opioid use.
METHODS: We systematically searched the Cochrane Library, Embase, MEDLINE, and CINAHL databases in July 2022. Risk of bias was assessed using the Cochrane risk for bias tool for randomized controlled trials (RCTs) and ROBINS-I for observational studies. Certainty of evidence was assessed using GRADE.
RESULTS: We included 15 studies (12 observational, 2 post hoc analyses of RCTs, 1 RCT). Most studies focused on opioid use for maintenance therapy (n = 9), comparing methadone to buprenorphine (n = 13), and reported QTc prolongation (n = 13). Six observational studies had a critical risk of bias, and one RCT was at high risk of bias. Two studies could not be included in the meta-analysis as they reported a different outcome and studied an opioid antagonist. Meta-analysis of 13 studies indicated that the use of methadone was associated with an increased risk of VA compared to the use of buprenorphine, morphine, placebo, or levacetylmethadol (risk ratio [RR], 2.39; 95% CI, 1.31-4.35; I2 = 60%). The pooled estimate varied greatly between observational studies (RR, 2.12; 95% CI, 1.15-3.91; I2 = 62%) and RCTs (RR, 14.09; 95% CI, 1.52-130.61; I2 = 0%), but both indicated an increased risk.
CONCLUSIONS: In this systematic review and meta-analysis, we found that methadone use is associated with more than twice the risk of VA compared to comparators. However, our findings should be interpreted cautiously given the limited quality of the available evidence.

Despite recent advancements in psoriasis treatment, challenges in management persist. Recently, there has been a rising interest amongst patients in complementary and alternative medicines (CAM), driven by the desire for more natural, holistic approaches and dissatisfaction with conventional treatments. Up to 41% of patients with psoriasis reported using alternative therapies and 39.5% use complementary therapies (Murphy EC, Nussbaum D, Prussick R, Friedman AJ (2019) Use of complementary and alternative medicine by patients with psoriasis. J Am Acad Dermatol 81:280-283). Despite their rapidly growing prevalence, literature on CAM therapies for psoriasis is lacking, making their recommendation difficult. Since the last systematic review on this topic published in 2018, evidence for new alternative therapies has emerged, promoting a further investigation of their efficacy (Gamret AC, Price A, Fertig RM, Lev-Tov H, Nichols AJ (2018) Complementary and Alternative Medicine Therapies for Psoriasis: A Systematic Review. JAMA Dermatol 154:1330-1337). This systematic review aims to compile recent literature on the most studied alternative therapies for psoriasis and further discuss their effectiveness in order to counsel clinicians in guiding patients on the use of these non-standard approaches. A literature search was conducted in the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov databases for randomized controlled trials (RCT) on complementary and alternative therapies in psoriasis from March 2018 through April 2024, resulting in 12 studies being included in this review. The preliminary results for many treatments such as curcumin, dietary modification and additions, indigo naturalis, meditation, acupuncture, and balneotherapy showed positive clinical effects. However, additional well-designed randomized trials are needed to confirm the potential beneficial effects and to establish safety of use.

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BACKGROUND: Haemodialysis (HD) patients usually engage in a low level of physical activities, which could impact the prognosis and mortality of this group. Fitness Qigong Baduanjin, a physical exercise from traditional Chinese Medicine, is known to have benefit in chronic heart failure patients and peritoneal dialysis patients. However, researches about Baduanjin in HD patients are currently limited. So, the aim of the study is to investigate the current exercise intensity of HD patients and its influencing factors, and to explore the effects of Baduanjin on HD patients.
METHODS: This prospective, non-blinded, randomised controlled trial will enrol patients with end-stage kidney disease who were stable on HD for more than 3 months. All eligible participants will be randomly divided into the intervention group undergoing Baduanjin and the control group without Baduanjin in a 1:1 ratio. The intervention group is required to perform Baduanjin two times per day, starting 30 min after breakfast and dinner, 45 min per session for a total of a 6 month, starting from 10 June 2024. Information such as laboratory biochemical examination indicators, radiological examination results and related scales and questionnaires will be collected at baseline, 1 month follow-up, 3 month follow-up and 6 month follow-up. All statistical tests are conducted through the two-tailed test, and a p-value≤0.05 will be considered statistically significant for the difference being tested. The description of quantitative indicators will be used in calculating the number of cases, mean, SD, median and IQR method. The classification indicators will be used to describe the number of cases and percentages (frequency and frequency rate).
BACKGROUND: The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (V20230521). The results will be reported in a peer-reviewed journal and a relevant academic conference.
BACKGROUND: ChiCTR2300074659.

BACKGROUND: Adolescent e-cigarette use, globally and within Australia, has increased in recent years. In response, public health agencies have called for the development of education and communication programmes targeting adolescents. Despite such recommendations, few rigorous evaluations of such interventions currently exist. The main objective of this study is to examine the potential effect of a text message intervention targeting parents and adolescents on adolescent susceptibility to e-cigarette use (eg, intentions towards using e-cigarettes). Secondary objectives are to (1): examine the effect of the intervention on adolescent e-cigarette and combustible tobacco use and (2) examine the acceptability of the intervention.
METHODS: A randomised controlled trial employing a 2×2 factorial design will be conducted with parent-adolescent dyads (aged 12-15 years). Dyads will be randomly allocated to one of four arms: arm 1-a text message intervention delivered to adolescents only; arm 2-a text message intervention delivered to the parents of adolescents only; arm 3-a text message intervention delivered to both the parents and adolescents; and arm 4-an information only control, consisting of an e-cigarette factsheet provided to parents only. Participant recruitment commenced in March 2023 with the aim to recruit 120 parent-adolescent dyads. Data collection to assess study outcomes will occur at baseline, 6, 12 and 24 months post the commencement of the intervention. The primary endpoint will be 6-month follow-up. The primary outcome will be adolescent susceptibility to e-cigarette use, assessed using validated items. Analyses of trial outcomes will be undertaken under an intention-to-treat framework, with all participants included in the analysis in the group they were allocated.
BACKGROUND: Ethics approval has been obtained from the human research ethics committee of the University of Newcastle (H-2022-0340). Findings will be disseminated in peer-reviewed journals and at conferences.
BACKGROUND: The trial was registered prospectively with Australian New Zealand Clinical Trials Registry (ACTRN12623000079640).

BACKGROUND: Multiple sclerosis (MS) causes a broad range of symptoms, with physical function being one of the most disabling consequences according to patients themselves. Exercise effectively improves lower extremity physical function. Nonetheless, it is unknown which exercise modality is most effective and it remains challenging to keep persons with MS adhering to exercise over a longer period. Therefore, the present study aims to investigate how exercise booster sessions (EBS) influence the sustainability of exercise-induced effects on physical function, and furthermore, to investigate which exercise modality (aerobic training or resistance training) is most effective in terms of improving physical function.
METHODS: This study is a multi-arm, parallel-group, open-label multicentre randomised controlled trial investigating the effects of EBS. Participants (n=150) are initially randomised to 12 weeks of either resistance training+usual care, aerobic training+usual care or usual care. After 12 weeks of intervention, participants in the exercise groups will again be randomised to either EBS+usual care or usual care during a 40-week follow-up period. The primary outcome is physical function (composite score based on 6-min walk test and five-time sit to stand), and the secondary outcomes are fatigue, cognition, physical activity, symptoms of depression and quality of life.
BACKGROUND: The study is approved by the Central Denmark Region Committees on Health Research Ethics (1-10-72-237-21) and is registered at the Danish Data Protection Agency (2016-051-000001) and at Clinicaltrials.gov (NCT04913012). All study findings will be published in scientific peer-reviewed journals and presented at scientific conferences.
BACKGROUND: NCT04913012.