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Background: The lower limb motor dysfunction caused by stroke is one of the main sequelae affecting patients' ability to live normally in the later period. Acupuncture treatment of limb movement dysfunction after stroke has been recommended by authoritative guidelines for reducing limb spasticity, enhancing limb strength and so on. However, the efficacy of different acupuncture methods in treating lower limb motor dysfunction after stroke remains controversial. Objective: In this paper, network meta-analysis (NMA) was used to prioritize various acupuncture intervention combinations commonly used in clinical practice, try to screen the acupuncture intervention scheme with the highest clinical efficacy and safety, and explore its rationality in guiding clinical practice. Methods: We searched a total of 4,312 studies from 8 databases and 2 clinical trial registries, and selected 43 articles for systematic review. We used pairwise meta-analysis and network meta-analysis to evaluate the efficacy and ranking of various acupuncture interventions. At the same time, the risk of bias, publication bias, and sensitivity of included randomized controlled trials were analyzed. The main outcome indicator was Fugl-Meyer assessment of lower extremity (FMA-LE), and the secondary outcome indicators were Modified Barthel Index (MBI), Berg balance scale (BBS) and Modified Ashworth scale (MAS). Results: A total of 4,134 patients in 43 studies were included. The intervention included 9 acupuncture-related treatments, of which 20.9% were classified as high-risk. Among the four outcome indicators in pairwise meta-analysis, the effect of body acupuncture combined with conventional rehabilitation has the highest comprehensive credibility in terms of efficacy and safety comparing with conventional rehabilitation [SMD= 1.14, 95%CI (0.81, 1.46)], [SMD= 1.35, 95%CI (0.97, 1.72)], [SMD= 1.22, 95%CI (0.39, 2.05)], [SMD= 1.21, 95%CI (0.74, 1.44)]. In addition, multiple intervention methods, for example, warm acupuncture plus rehabilitation treatment for MBI and electroacupuncture plus body acupuncture plus rehabilitation treatment for BBS, may increase certain additional effects on different outcome indicators. Conclusion: This study proves that body acupuncture combined with rehabilitation treatment is the most widely used intervention method with the highest evidence quality in the treatment of lower limb motor dysfunction after stroke. However, for some other acupuncture methods, large samples and high-quality clinical randomized controlled trials are still needed to be fully verified. [ABSTRACT FROM AUTHOR]

Objective: To systematically evaluate the risk factors for perimenopausal depression in Chinese women and to provide a basis for screening perimenopausal women at high-risk for depression. Methods: A computer search of seven databases, including SinoMed, PubMed, Web of Science, and so on, and two clinical trial registries on the risk factors for depression in Chinese women during perimenopause was conducted for metaanalysis. The search time limit was from the establishment of the database to December 2022. The included case-control and cross-sectional studies were evaluated using the Newcastle-Ottawa scale (NOS) and criteria developed by the Agency for Healthcare Research and Quality (AHRQ). Results: A total of 15 papers with 12,168 patients and 18 risk factors were included. Meta-analysis results showed that the risk factors for depression in perimenopausal women were relationship quality [OR = 1.23, 95% confidence intervals (1.03, 1.46)], marital status [OR = 2.49, 95% CI (1.77, 3.50)], family income [OR = 1.48 95% CI (1.10, 2.00)], comorbid chronic diseases [OR = 2.39, 95% CI (1.93, 2.95)], exercise status [OR = 1.63, 95% CI (1.26, 2.11)], perimenopausal syndrome [OR = 2.36, 95% CI (2.11, 2.63)], age [OR = 1.04, 95% CI (1.01, 1.07)], and stressful events [OR = 12.14, 95% CI (6.48, 22.72)], and social support was a protective factor [OR = 0.76, 95% CI (0.63, 0.91), p < 0.05]. Conclusion: Based on the exploration of risk factors for perimenopausal depression in Chinese women, we aimed to provide guidance for the screening of risk factors for depression in perimenopausal women and thereby reduce the incidence of depression. [ABSTRACT FROM AUTHOR]

Latest advances in non-small cell lung cancer (NSCLC) therapies have revolutionized the treatment regimens utilized for NSCLCs with or without a driver mutation. Molecular targeted treatments such as tyrosine kinase inhibitors (TKIs) are utilized to prevent tumor progression and improve survival. Despite the great benefit of immunotherapy in NSCLC tumors with no driver mutation, the use of immune checkpoint inhibitors (ICIs) in NSCLC tumors harboring a driver mutation has been under debate. Furthermore, several trials have been conducted investigating the use of these therapies with TKIs. A few trials were halted due to growing concerns of increased toxicity with the combination of TKI and immunotherapy. The adverse events ranged from low grade dermatologic complaints to fatal interstitial lung diseases. These toxicities occur with both concurrent and sequential administration of treatment. Thus, recommendations for the safest method of combination treatment have not yet been described. This review paper discusses recent views on combination treatment, previous clinical trials reporting grade 3-4 toxicities, and guidelines for a safe timeline of administration of treatment based on past evidence. [ABSTRACT FROM AUTHOR]

Introduction: Global inequality in clinical research capacity and service delivery can be indicated simply by the proportion of clinical trials that a country or region has registered in clinical trial registry databases. The proportion of clinical trials registered in Africa is very low at 0.02%, even though the region accounts for approximately 15% of the world's population. Despite the economic challenges in most African countries, they have shown potential for growth and change in recent years. Methods: We conducted desk reviews on the interventional clinical trials done in Kenya, Ethiopia, and Nigeria between 2015 to May 2023. The search was done in clinical trials repositories, and journal repositories. The search focused on intervention clinical trials. Data was extracted by screening through the publications and clinical trial platforms. The data extracted from the publications included the type of clinical trial, clinical trial phase, diseases, etc. The data extracted from the reports included: challenges in conducting clinical trials, capacity-building efforts, and the impact of the clinical trial. Results: The number of clinical trial studies identified in Kenya was 113 (28 were on infant clinical trials). The study identified 97 clinical trials in Nigeria, of which 11 studies were on infant clinical trials. In Ethiopia, there were 28 clinical trials and only five were on infant clinical trials. The landscape review also expanded to capacity and gaps in clinical trials in the three countries. The largest proportion of clinical trials carried out in Kenya was on injury, occupational disease, and poisoning, 30.5% (n = 18) and the smallest proportion was on kidney disease, neonatal disease, obstetrics, and gynecology. Most Infant clinical trials were carried out in the area of infections and infestations 33.3% (n=7). Most of the challenges faced by clinical trials in the three countries include a lack of infrastructure, a lack of human resources, and a lack of financial resources. Implications: There is a need to map clinical trials done by African researchers based in Africa to exclude the trials done by non-African researchers based in Africa. Opportunities for clinical trials should be supported and challenges addressed. [ABSTRACT FROM AUTHOR]

Background: Policymakers, health insurers, and health care providers are becoming increasingly interested in cost-effectiveness analyses (CEA's) when choosing between possible treatment alternatives, as costs for mental health care have been increasing in recent years. Objective: The current study compared the cost-effectiveness and cost-utility of a phased-based treatment approach that included a preparatory stabilization phase with direct trauma-focused treatment in patients with PTSD and a history of childhood abuse. Methods: A cost-effectiveness analysis was conducted based on data from a randomized controlled trial of 121 patients with PTSD due to childhood abuse. A phase-based treatment (Eye Movement Desensitization and Reprocessing [EMDR] therapy preceded by Skills Training in Affect and Interpersonal Regulation [STAIR]; n = 57) was compared with a direct trauma-focused treatment (EMDR therapy only; n = 64). The primary outcome of cost-effectiveness was the proportion of patients with remitted PTSD. Quality-adjusted life years (QALY) were used as the primary outcome measure for cost-utility analysis. Results: Although the results of the cost-effectiveness analyses yielded no statistically significant differences between the two groups, the mean societal costs per patient differed significantly between the STAIR-EMDR and EMDR therapy groups (€19.599 vs. €13.501; M cost differences = €6.098, CI (95%) = [€117; €12.644]). Conclusion: STAIR-EMDR is not cost-effective compared with EMDR-only therapy. Since trauma-focused treatment is less time-consuming, non-traumafocused phase-based, treatment does not seem to be a viable alternative for the treatment of PTSD due to adverse childhood events. Clinical trial registration: https://onderzoekmetmensen.nl/nl/trial/22074, identifier NL5836. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression are highly prevalent and often comorbid mental disorders that are encompassed within the broad category of emotional disorders. The frequent comorbidity of anxiety and depression can pose challenges for accurate diagnosis and treatment which, in turn, highlights the need for reliable measurements that are simultaneously responsive to change and prevent non-response bias. Brief measures of anxiety and depression can potentially increase response rates due to their brevity and ease of administration. This study evaluates the psychometric characteristics, discriminative accuracy, and sensitivity to change of the Generalized Anxiety Disorder 2-item scale (GAD-2) and the Patient Health Questionnaire 2-item scale (PHQ-2) within a clinical population. Method: The sample comprised treatment-seeking participants (n = 3,411), screened (n = 2,477) to receive an internet-based psychotherapeutic intervention (cognitive-behavioral, psychodynamic, or waitlist). Results: Brief measures can effectively detect individuals who may be eligible for a diagnosis of depression and anxiety, not only prior to but also during and following the completion of psychological treatment. The discriminative ability of the GAD-2 was significantly greater during active treatment and at post-assessment compared with pre-treatment screening, although no such differences were found for the PHQ-2. Finally, endorsing the most severe response option on the GAD-2 and PHQ-2 was associated with a high probability of presenting with clinically relevant anxiety and depressive symptoms. Conclusion: Brief measures of anxiety and depression are viable instruments to screen for and monitor anxiety and depressive symptoms. Clinical trial registration: ClinicalTrials.gov, identifier NCT05016843. [ABSTRACT FROM AUTHOR]

Background: Operational tolerance in liver transplantation (OT-LT), defined as the graft survival with normal function in absence of immunosuppression, has been a field of intense research since the 1980s. Thereafter, tens of clinical trials and hundreds of articles have been published, making it challenging for researchers to assimilate all the information, more so outside of their disciplines. The aimof the present study was to analyze the research in OT-LT through a new web tool (https://tolerance.imib.es). Methods: We have developed a web resource that allowed the identification of the present trends and potential research avenues in OL-LT, an overview biomedical terms that weremost often cited, including which journals published the most articles, and an advanced search engine that exploited all the information in these publications. Results: A total of 734 studies were analyzed until November 2023, with a mean of 15 articles published per year, a total sum of 3,751 impact factor points and a total of 26,542 citations. The analysis of citations allowed us to establish a ranking of the most prolific countries, authors, journals and institutions, in addition to themost influential publications in OT-LT. Likewise, keyword and co-occurrence analyses answered which themes involving OT-LT are themost popular, whereas cooperation analysis showed that principal authors in OT-LT form a network, although the lack of international cooperation, especially with regard to clinical trials, appears to be one of the main challenges. Conclusion: Despite its limitations, our web tool will allow both OT-LT expert and novel researchers to be able to draw a comprehensive picture of the past, present and future of OT-LT research. [ABSTRACT FROM AUTHOR]

Background: The CONSORT Extension for Chinese Herbal Medicine Formula 2017 (CONSORT-CHM Formula 2017) has established a reporting standard for randomized controlled trials (RCTs) of Chinese Herbal Medicine Formula (CHMF) interventions; however, its adherence and implications for the design and execution of study design remain ambiguous. It is necessary to evaluate the level of compliance with the CONSORT-CHM Formula 2017 in RCTs conducted over the past 5 years, and to determine the reporting quality of clinical trials in this field. Methods: First, a systematic search is conducted for RCTs on CHMF in EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid-MEDLINE(R), Wanfang data, China National Knowledge Infrastructure (CNKI), VIP Chinese Medical Journal Database (VIP) and Chinese Biomedical Literature (CBM) database, that encompassed CHMF interventional RCTs published from 1 January 2018 to 8 June 2022, with language restriction to English or Chinese. Second, a descriptive analysis will be performed regarding the study design and general characteristics of the included trials. Third, for the quality assessment, we have subdivided the CONSORT-CHM Formula 2017 checklist (consisting of 22 extended items) into a total of 42 sub-questions to facilitate scoring, with a specific focus on the description, quality control, and safety assessment of CHMF interventions. Professional training and a pilot test on 100 randomly selected articles will be provided for all reviewers. Throughout this process, a standard operating procedure (SOP) for quality assessment will be developed to ensure consistency. Each item will be assessed by two reviewers in a paired back-to-back manner, and the compliance rate will be calculated to assess interrater agreement. Discussion: This review will identify the current reporting characteristics and quality of CHMF interventional studies and further evaluate the impact of CONSORT-CHM Formula 2017. The results may provide suggestions for future application or promotion of the guideline. Registration: The study has been registered on Open Science Framework (https://osf.io/xpn7f). [ABSTRACT FROM AUTHOR]

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors. [ABSTRACT FROM AUTHOR]

Introduction: Clinical trials are the gold standard for testing new therapies. Databases like ClinicalTrials.gov provide access to trial information, mainly covering the US and Europe. In 2006, WHO introduced the global ICTRP, aggregating data from ClinicalTrials.gov and 17 other national registers, making it the largest clinical trial platform by June 2019. This study conducts a comprehensive global analysis of the ICTRP database and provides framework for large-scale data analysis, data preparation, curation, and filtering. Materials and methods: The trends in 689,793 records from the ICTRP database (covering trials registered from 1990 to 2020) were analyzed. Records were adjusted for duplicates and mapping of agents to drug classes was performed. Several databases, including DrugBank, MESH, and the NIH Drug Information Portal were used to investigate trends in agent classes. Results: Our novel approach unveiled that 0.5% of the trials we identified were hidden duplicates, primarily originating from the EUCTR database, which accounted for 82.9% of these duplicates. However, the overall number of hidden duplicates within the ICTRP seems to be decreasing. In total, 689 793 trials (478 345 interventional) were registered in the ICTRP between 1990 and 2020, surpassing the count of trials in ClinicalTrials.gov (362 500 trials by the end of 2020). We identified 4 865 unique agents in trials with DrugBank, whereas 2 633 agents were identified with NIH Drug Information Portal data. After the ClinicalTrials.gov, EUCTR had the most trials in the ICTRP, followed by CTRI, IRCT, CHiCTR, and ISRCTN. CHiCTR displayed a significant surge in trial registration around 2015, while CTRI experienced rapid growth starting in 2016. Conclusion: This study highlights both the strengths and weaknesses of using the ICTRP as a data source for analyzing trends in clinical trials, and emphasizes the value of utilizing multiple registries for a comprehensive analysis. [ABSTRACT FROM AUTHOR]

Introduction: The sequelae post-COVID can affect different systems. In this sense, considering the multi-factorial etiology of COVID-19, multi-professional interventions could be a relevant strategy for recovery health indicators. Objective: This study aimed to investigate the effects of multi-professional intervention on body composition, physical fitness, and biomarkers in overweight COVID-19 survivors with different symptomatology. Methodology: A non-randomized parallel group intervention included 69 volunteers (BMI ≥25 kg/m2 ), divided into three groups according to SARS CoV-2 symptomatology, but only 35 finished the longitudinal protocol [control group (n = 11); moderate group (n = 17) and severe group (n = 7)]. The groups were submitted to a multi-professional program (nutritional intervention, psychoeducation, and physical exercise intervention) for 8 weeks, and the volunteers underwent body composition assessments (primary outcome) and physical and biochemical tests (secondary outcome) in pre- and post-intervention. This study was registered on the Clinical Trials Registration Platform number: RBR-4mxg57b and with the local research ethics committee protocol under number: 4,546,726/2021. Results: After the 8-week multi-professional intervention, the following results were observed for the moderate COVID-19 group: improved dynamic strength of lower- and (p = 0.003), upper-limbs (p = 0.008), maximal isometric lumbar)traction strength (p = 0.04), flexibility (p = 0.0006), and albumin (p = 0.0005), as well as a reduction in the C reactive protein (CRP) (p = 0.003) and fasting glucose (p = 0.001); for the severe COVID-19 group: an improvement in dynamic lower-body strength (p = 0.001), higher values of albumin (p = 0.005) and HDL-c (p = 0.002), and lower values of CRP (p = 0.05), and for the control group: an improvement in sit-up repetitions (p = 0.008), and a reduction of CRP (p = 0.01), fasting glucose (p = 0.001) and total cholesterol (p = 0.04) were identified. All experimental groups reduced triglycerides after intervention (p < 0.05). Conclusion: Finally, 8 weeks of multiprofessional intervention can be an efficient tool for reversing the inflammatory process and promoting improvements in daily activities and quality of life, although it is believed that the severe COVID-19 group needs longer interventions to improve different health indicators. [ABSTRACT FROM AUTHOR]

Background: The optimal dose of tenecteplase vs. alteplase for acute ischemic stroke (AIS) has yet to be established. Therefore, we included the latest randomized controlled trials (RCT) to assess the efficacy and safety of different doses of tenecteplase vs. alteplase for AIS within 4.5 hours of symptom onset. Methods: Literature was searched in PubMed, Cochrane Library, Embase, Web of Science, and clinical trial registries until February 12, 2023. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using Bayesian network meta-analysis (NMA). Treatments were ranked based on efficacy and safety using the surface under the cumulative ranking curve (SUCRA). Results: Eleven RCTs with 5,475 patients were included. Tenecteplase 0.25 mg/kg and alteplase 0.9 mg/kg had signicantly higher rates of excellent functional outcome (tenecteplase: OR, 1.85; 95% CrI, 1.44--2.37; alteplase: OR, 1.60; 95% CrI, 1.29--1.97) and good functional outcome (tenecteplase: OR, 1.54; 95% CrI, 1.19-- 1.98; alteplase: OR, 1.40; 95% CrI, 1.14--1.74) than placebo, despite an increased risk of symptomatic intracranial hemorrhage. Furthermore, the NMA (OR, 1.16; 95% CrI, 1.01--1.33) and the pairwise meta-analysis (OR, 1.16; 95% CI, 1.02--1.33; P = 0.03) indicated that tenecteplase 0.25 mg/kg was superior to alteplase 0.9 mg/kg in excellent functional outcome. Alteplase 0.9 mg/kg (OR, 2.54; 95% CrI, 1.45-- 8.08) signicantly increased the risk of any intracranial hemorrhage compared with placebo. SUCRA results demonstrated that tenecteplase 0.25 mg/kg ranked rst and tenecteplase 0.4 mg/kg ranked last in efficacy outcomes. Conclusions: The NMA indicated that tenecteplase 0.25 mg/kg and alteplase 0.9 mg/kg are safe and signicantly improve clinical outcomes in patients with AIS within 4.5 h of symptom onset. Furthermore, tenecteplase 0.25 mg/kg provides more benet and has the potential to replace alteplase 0.9 mg/kg in AIS treatment. [ABSTRACT FROM AUTHOR]

Objectives: Traumatic brain injury (TBI) is one of the top causes of morbidity and mortality worldwide. The review aimed to discuss and summarize the current evidence on the effectiveness of adjuvant neuroprotective treatments in terms of their effect on brain injury biomarkers in TBI patients. Methods: To identify relevant studies, four scholarly databases, including PubMed, Cochrane, Scopus, and Google Scholar, were systematically searched using predefined search terms. English-language randomized controlled clinical trials reporting changes in brain injury biomarkers, namely, neuron-specific enolase (NSE), glial fibrillary acid protein (GFAP), ubiquitin carboxyl-terminal esterase L1 (UCHL1) and/or S100 beta (S100 ß), were included. The methodological quality of the included studies was assessed using the Cochrane risk-of-bias tool. Results: A total of eleven studies with eight different therapeutic options were investigated; of them, tetracyclines, metformin, and memantine were discovered to be promising choices that could improve neurological outcomes in TBI patients. The most utilized serum biomarkers were NSE and S100 ß followed by GFAP, while none of the included studies quantified UCHL1. The heterogeneity in injury severity categories and measurement timing may affect the overall evaluation of the clinical efficacy of potential therapies. Therefore, unified measurement protocols are highly warranted to inform clinical decisions. Conclusion: Few therapeutic options showed promising results as an adjuvant to standard care in patients with TBI. Several considerations for future work must be directed towards standardizing monitoring biomarkers. Investigating the pharmacotherapy effectiveness using a multimodal biomarker panel is needed. Finally, employing stratified randomization in future clinical trials concerning potential confounders, including age, trauma severity levels, and type, is crucial to inform clinical decisions. [ABSTRACT FROM AUTHOR]

Alzheimer's disease (AD) is the most common type of dementia in the elderly. Several hypotheses emerged from AD pathophysiological mechanisms. However, no neuronal protective or regenerative drug is available nowadays. Researchers still work in drug development and are finding new molecular targets to treat AD. Therefore, this study aimed to summarize main advances in AD pharmacological therapy. Clinical trials registered in the National Library of Medicine database were selected and analyzed accordingly to molecular targets, therapeutic effects, and safety profile. The most common outcome was the lack of efficacy. Only seven trials concluded that tested drugs were safe and induced any kind of therapeutic improvement. Three works showed therapeutic effects followed by toxicity. In addition to aducanumab recent FDA approval, antibodies against amyloid-β (Aβ) showed no noteworthy results. 5-HT6 antagonists, tau inhibitors and nicotinic agonists' data were discouraging. However, anti-Aβ vaccine, BACE inhibitor and anti-neuroinflammation drugs showed promising results. [ABSTRACT FROM AUTHOR]

Introduction: Dementia patients often experience behavioral and psychological symptoms (BPSD), which severely affect their quality of life and activities of daily living. Non-pharmacological interventions are effective in treating BPSD, according to multiple clinical trials and systematic reviews. However, the optimal non-pharmacological treatment remains controversial. Therefore, the study aims to evaluate and compare multiple non-pharmacological methods for treating BPSD in order to identify the optimal non-pharmacological intervention. Objective: This study aims to perform a systematic review and network metaanalysis of evidence on non-pharmacological interventions in the treatment of BPSD, which may potentially guide future research and clinical decisions. Methods: In order to select potentially relevant randomized controlled trials (RCTs), 10 academic databases and 3 clinical trial registries will be systematically searched from inception until the 1 October 2022. Two researchers will independently extract information from eligible articles. The primary outcome is the severity of BPSD. Herein, Pairwise and Bayesian network meta-analyses will be conducted utilizing STATA 15.0 and ADDIS 1.16.8. Evidence quality will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results: Results from this study will be published in peer-reviewed journals or conference reports. Discussion: In this study, we aim to comparatively assess the efficacy of various non-pharmacological treatments for BPSD. Findings from this review will help clinicians to make evidence-based treatment decisions. [ABSTRACT FROM AUTHOR]

Background and aims: There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP). Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization. Four EBGs and 39 CPRs provided the basis on which 22 treatment management indicators were identified (7 referring to the time of hospital admission, 15 to post-admission). Results: The 21 participating centres recruited 587 hospitalized patients with hypothyroidism, 421 of which were females (71.7%, mean age 74.1 + 14.4 yrs): 318 in phase 1 and 269 in phase 3. The cause of hypothyroidism was unknown in 282 patients (48%). Evaluation at the time of admission identified satisfactory adherence to CPRs (>50%) for 63.6% of the indicators. In the phase 3, TG centres showed significant improvement vs CG in 4 of the 15 post-admission indicators, while 1 out of 15 was significantly worse. Conclusions: The EP based on outreach visits significantly improved some indicators in the management of patients with hypothyroidism, with specific reference to appropriateness of TSH dosage and levothyroxine (LT4) treatment modality. Clinical Trial Registration: ClinicalTrials.gov , identifier NCT05314790. [ABSTRACT FROM AUTHOR]

Introduction: Adequate, transparent, and consistent reporting of adverse events (AEs) in exercise oncology trials is critical to assess the safety of exercise interventions for people following a cancer diagnosis. However, there is little understanding of how AEs are reported in exercise oncology trials. Thus, we propose to conduct a scoping review to summarise and evaluate current practice of reporting of AEs in published exercise oncology trials with further exploration of factors associated with inadequate reporting of AEs. The study findings will serve to inform the need for future research on standardisation of the definition, collection, and reporting of AEs for exercise oncology research. Materials and Methods: The ADVANCE (ADverse eVents reporting of clinicAl trials iN exerCise oncology rEsearch) study will be conducted and reported following the PRISMA extension for scoping reviews guideline. Any type of clinical trial involving an exercise intervention in people living with and beyond cancer with a full-text report in English will be included. Six electronic databases (Embase, PubMed, Google Scholar, Web of Science Core Collection, SPORTDiscus, and CINAHL Plus) will be searched for studies. Two independent review authors will assess eligibility of identified studies, chart data using pre-established extraction forms, and evaluate adequacy of reporting of AEs-related data against a 20-item scoring checklist derived from the CONSORT (Consolidated Standards of Reporting Trials) harms extension. We will summarise results using descriptive and inferential analysis methods. Ethics and Dissemination: No ethics approval will be required to conduct the ADVANCE study owing to inclusion of only published data. The study results will be disseminated via publications in peer-reviewed journals and presentations at national and internationa conferences. Systematic Review Registration: Open Science Framework: https://osf.io/NXEJD/ (doi:10.17605/OSF.IO/NXEJD). [ABSTRACT FROM AUTHOR]

Keywords: drug repurposing; oncology; clinical trials; bioinformatics; database EN drug repurposing oncology clinical trials bioinformatics database 1 6 6 11/12/21 20211110 NES 211110 Introduction Drug repurposing is a strategy that seeks new medical treatments from existing licensed medications rather than from I de novo i development of new molecules. The ReDO Trials DB is the first database of repurposing trials focused solely on interventional trials of non-cancer drugs as new cancer treatments. In terms of the patent status, the ReDO database shows 287 drugs (80.6%) are off-patent, which is similar to the ReDO trials database with 134 of the 164 (81.7%) trials investigating ReDO drugs being off-patent. [Extracted from the article]

Background: The combination of strengthening Qi and eliminating pathogens is an available therapeutic principle in traditional Chinese medicine (TCM) for primary liver cancer (PLC) at middle-advanced stage. However, there is a lack of reasonable evidence to support the proper application of this therapeutic principle. This meta-analysis aims to evaluate the efficacy and safety of Chinese medicinal formulas (CMFs), including two subgroup analyses of the principle of strengthening Qi and eliminating pathogens. Method: Clinical trials were obtained through searching of EMBASE, Web of Science, PubMed, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database, Chinese Biomedical Literature Database, and two clinical trial registries. The randomized controlled trials with the combination of CMFs and transcatheter arterial chemoembolization (TACE) in the experiment group were acceptable, in contrast to the TACE alone in the control group. The statistics analysis was performed on Review Manager 5.4. Results: A total of eligible 24 trials were accessed in this work. Overall, CMFs could improve the survival duration of 6 months, 1 year, and 2 years, Karnofsky Performance Status, tumor objective response rate (ORR), AFP, and symptom. In the subgroup analysis, trials complying with the principle of single strengthening Qi did not show any significant difference in increasing tumor ORR. Meanwhile, the principle of combined strengthening Qi and eliminating pathogens was uncertain in improving symptoms and 1-year and 2-year survival time. In addition, the outcome indexes of ALT and AST were heterogeneous. In last, the total occurrence of adverse events could not be reduced via using CMFs. Patients treated with CMFs exhibited liver injury, fever, and white blood cell decline, with mild events occurring more frequently and severe events occurring less. Conclusion: CMFs are an effective treatment method to cure PLC at the middle-advanced stage. Adopting the principle of single strengthening Qi presents better efficacy in the long term by prolonging the survival duration. Following the principle of combined strengthening Qi and eliminating pathogens could be more beneficial to patients in short term by lessening the tumor size. CMFs have the advantage of reducing certain serious adverse events. [ABSTRACT FROM AUTHOR]

Background and Aim: Immune checkpoint inhibitors (ICIs) have been widely used in hepatocellular carcinoma (HCC), while only a subset of patients experience clinical benefit. We aimed to investigate the effects of viral etiology on response to ICIs in HCC and depict the tumor immune microenvironment (TIME) of virally infected and uninfected HCC. Methods: A systematic search was conducted in PubMed, Web of Science, Embase, and the Cochrane central register of controlled trials up to August 2021. Clinical trials reporting the efficacy of ICIs in HCC were eligible. Baseline characteristics including first author, year of publication, National Clinical Trials (NCT) registry number, study region, sample sizes, interventions, line of treatment, and viral status were extracted. Meta-analysis was conducted to generate combined odds ratios (ORs) with 95% confidence intervals (CI) based on random or fixed effect model, depending on heterogeneity. Tumor immune microenvironment was depicted using ESTIMATE and CIBERSORT algorithm. Results: Eight studies involving 1,520 patients were included. Combined data suggested that there was no significant difference of objective response rate (ORR) between virally infected HCC and non-viral HCC patients [OR = 1.03 (95% CI, 0.77–1.37; I2 = 30.9%, pH = 0.152)]. Similarly, difference was not observed on ORR between HBV-HCC and HCV-HCC patients [OR = 0.74 (95% CI, 0.52–1.06; I2 = 7.4%, pH = 0.374)]. The infiltration of immune cells in the tumor microenvironment did not differ by etiology except for M0 macrophages, M2 macrophages, regulatory T cells, naive B cells, follicular helper T cells, activated dendritic cells, activated mast cells, and plasma cells. Despite differences in infiltration observed in specific cell types, the immune score and stromal score were generally comparable among etiology groups. Conclusion: Viral etiology may not be considered as the selection criteria for patients receiving ICIs in HCC, and viral status has little impact on TIME remodeling during HCC tumorigenesis. [ABSTRACT FROM AUTHOR]

Loneliness has become a global major public health concern, with detrimental effects to the young and old. ARTISAN (Aspiration and Resilience Through Intergenerational Storytelling and Art-based Narratives) is a 5-week, 15-h participatory art and group-based intervention that focuses on resilience building and loneliness alleviation among the young and old through a structured multimodal framework held at a museum space. Developed with a Participatory Action Research (PAR) approach, this intervention is evaluated using an open-label waitlist randomized controlled trial design (RCT) comprised of community-dwelling youth and older adults randomized into an intervention group (n = 35) or a waitlist-control group (n = 33). Participants were assessed on standardized self-reported psychometric measures including loneliness, resilience, quality of life, social support, life satisfaction and national identity at three time points. Qualitative data generated during each intervention session as well as acceptability focus groups were recorded and transcribed. Linear mixed modeling analyses revealed that participants in the intervention group experienced improvements in life satisfaction compared to participants in the waitlist-control group (95% CI: 0.22 to 0.77, p < 0.001, Cohen's d = 0.53) immediately after the completion of ARTISAN. Subgroup analyses for youth participants indicated improvements in quality of life (95% CI: 0.16 to 0.52, p < 0.001, d = 1.31) and national identity (95% CI: 0.18 to 0.80, p = 0.002, d = 0.43) in comparison to the waitlist-control group. At 5-weeks follow-up, the intervention group participants continued to experience high levels of life satisfaction (95% CI: 0.04 to 0.42, p = 0.017, d = 0.47), enhancements in resilience (95% CI: 0.07 to 0.55, p = 0.011, d = 0.46), as well as a significant reduction in loneliness (95% CI: −0.34 to −0.08, p = 0.001, d = 0.61) compared to baseline, reflecting the effectiveness and positive residual effects of the ARTISAN intervention. Similarly, the qualitative findings provided support for the intervention and additional insights to the quantitative findings. This holistic intervention framework that integrates stories, arts and heritage for bridging and empowering lives fills a critical gap in knowledge and practice between the arts, health and citizenship, paving the way for further research in creating a more caring and inclusive society with the arts. Clinical Trials Registration: www.ClinicalTrials.gov, identifier: NCT03048708. [ABSTRACT FROM AUTHOR]