Efficacy of vitamin D supplementation in the treatment of patients with COVID-19: a systematic review and meta-analysis of randomized controlled trials.

Context: COVID-19 has substantial effects on respiratory health and overall well-being. Recent studies suggest vitamin D as a potential treatment, but the results are inconclusive. Objective: The authors conducted a systematic review of randomized controlled trials (RCTs) to examine the link between vitamin D and patients with COVID-19. Data sources: The authors searched electronic databases PubMed, Cochrane, CINAHL, EMBASE and Google Scholar from their inception till August 2023. Study selection: Inclusion criteria used in our systematic review include: (1) patients who tested positive for COVID-19, (2) intervention was vitamin D supplementation, (3) the comparator was either a placebo, standard care of treatment, or, no treatment, (4) at least one of the clinical outcomes of interest were investigated, (5) study design being RCTs. Data extraction: Two independent reviewers manually extracted information from selected articles, including study characteristics, patient characteristics, and the primary outcomes: all-cause mortality, ICU and hospital stay length and secondary outcomes: mechanical ventilation, supplemental oxygen, ICU admission, and adverse events. Risk ratios or mean differences and 95% CIs were calculated using a random-effects model. Data synthesis: The authors' analysis included 14 RCTs with 2165 patients. Vitamin D significantly reduced ICU admissions and lowered the need for mechanical ventilation compared to placebo. However, it did not significantly affect hospital stay length, ICU stay length, mechanical ventilation duration, mortality, or the need for supplemental oxygen. Conclusion: Vitamin D does not significantly improve certain clinical outcomes, such as hospital and ICU stay length, for patients with COVID-19. However, it still may be significantly beneficial in decreasing the burden on intensive care services.

Exploring the clinical effectiveness of glucagon-like peptide-1 receptor agonists in managing cardiovascular complications: an updated comprehensive review and future directives.

The possible cardiovascular advantages of glucagon-like peptide-1 receptor agonists (GLP-1RAs), a class of drugs predominantly used to treat type 2 diabetes (T2D), have garnered increasing attention in recent years. Clinical trials have looked into the possibility that GLP-1RAs have extra cardioprotective benefits in addition to their ability to manage T2D, demonstrating significant major adverse cardiovascular events (MACE) reduction and a favorable safety profile. GLP-1 RAs improve cardiovascular outcomes, especially in those with existing cardiovascular disease. MACE has been steadily declining with this class of drugs, which results in a noticeable rise in cardiovascular outcome trials (CVOTs). GLP-1 RAs have a variety of impacts on the cardiovascular system beyond their function in glycemic control. They offer direct cardioprotection, vasodilation, promotion of salt excretion, reduction of weight, improved lipid profile, and anti-inflammatory qualities through a variety of mechanisms. Thus, this review focuses on GLP-1RAs, its mechanism of action, its clinical effectiveness in CVOTs, the mechanism behind its cardiovascular benefits, its potential role in heart failure, cardiovascular outcomes, its underutilization, and future directives. In conclusion, GLP-1 RAs shows potential in controlling T2D while also lowering cardiovascular risk, but warrants further study into long-term results and real-world data to optimize treatment regimens, ultimately increasing patient outcomes and lowering the burden of cardiovascular disease in T2D populations.

eConsent administered by Community Health Workers in a study using the Trials within Cohorts (TwiCs) design-Experiences from the Community-Based chronic Care Lesotho (ComBaCaL) project.

Improving access to essential health services requires the development of innovative health service delivery models and their scientific assessment in often large-scale pragmatic trials. In many low- and middle-income countries, lay Community Health Workers (CHWs) play an important role in delivering essential health services. As trusted members of their communities with basic medical training, they may also contribute to health data collection. Digital clinical decision support applications may facilitate the involvement of CHWs in service delivery and data collection. Electronic consent (eConsent) can streamline the consent process that is required if the collected data is used for the scientific purposes. Here, we describe the experiences of using eConsent in the Community-Based chronic Care Lesotho (ComBaCaL) cohort study and multiple nested pragmatic cluster-randomized trials assessing CHW-led care delivery models for type 2 diabetes and arterial hypertension using the Trials within Cohorts (TwiCs) design. More than a hundred CHWs, acting both as service providers and data collectors in remote villages of Lesotho utilize an eConsent application that is linked to a tailored clinical decision support and data collection application. The eConsent application presents simplified consent information and generates personalized consent forms that are signed electronically on a tablet and then uploaded to the database of the clinical decision support application. This significantly streamlines the consent process and allows for quality consent documentation through timely central monitoring, facilitating the CHW-led management of a large-scale population-based cohort in a remote low-resource area with continuous enrollment-currently at more than 16,000 participants.

Sociodemographic predictors of successful screening and subsequent randomization in a digital health hypertension intervention.

Introduction: Clinical trials often enroll nonrepresentative participant samples, limiting generalizability of trial findings. The current analysis explores the influences of remote recruitment and screening protocols on participation in a digital health intervention (DHI) to promote the evidence-based Dietary Approaches to Stop Hypertension (DASH) eating pattern. Methods: Nourish was a 12-month randomized controlled trial comparing the effectiveness of a DHI to an attention control arm among US adults with hypertension. Participants were recruited using digital approaches; eligible individuals completed several screening steps. We examined associations between sociodemographics and mobile technology use and completion of each screening step and compared those characteristics between randomized and nonrandomized participants (those consented but were screened out before randomization). Results: A total of 678 adults consented to participate in Nourish; 44% of those consented were randomized (n = 301). Those randomized possessed a higher education level (p < 0.0001); were more likely to use health-related apps (p < 0.0001) and wearables (p < 0.0001); and were older (p = 0.01) than nonrandomized individuals. Randomized adults were more likely to use a desktop/laptop/tablet for Internet access (vs mobile phones) (p = 0.01). No significant association was observed existed between sex, race, ethnicity, income, or geographic density of residence and subsequent randomization. Conclusions: Participants with lower education levels or limited experience in using mobile technologies may require additional support to participate in DHIs. Future research is needed to evaluate remote clinical trial procedures and impacts on generalizability to achieve equitable clinical trial participation.

Evidence map of traditional Chinese exercises.

Objective: This study aimed to assess and visually depict the clinical evidence landscape of traditional Chinese exercises and identify any research gaps and future research needs. Methods: We comprehensively searched seven Chinese and English databases to identify randomized controlled trials (RCTs) and systematic reviews (SRs) evaluating the effects of traditional Chinese exercises from their inception until May 2023. The quality of evidence was assessed via the GRADE approach, and the research topics, intervention effects, and strength of evidence were graphically displayed. Results: This evidence map includes 2,017 studies, comprising 1,822 RCTs and 195 SRs. These studies were conducted globally in various countries. Among the traditional Chinese exercises, Tai Chi and Baduanjin have received the most research attention, with a growing number of publications. When traditional Chinese exercises were compared with the control groups, 88.2% of the included SRs reported significantly positive effects, 4.1% reported unclear effects, and 7.7% reported no significant differences. The findings suggested that traditional Chinese exercises could benefit patients with osteoarthritis, osteoporosis, hypertension, coronary heart disease, diabetes, chronic obstructive pulmonary disease, stroke, Parkinson's disease, anxiety, and depression. However, the overall quality of the evidence was suboptimal, with 11.3% rated as moderate, 45.6% as low, and 43.1% as critically low. Conclusion: This evidence map visually represents valuable information on traditional Chinese exercises. While most studies have reported significant benefits, the overall quality of evidence is low.

Development and Novel Therapeutics in Diabetic Retinopathy.

Diabetic retinopathy (DR) is a complication of diabetes mellitus which causes retinal damage which when left untreated will cause visual problems. As the prevalence of DR increases over the years, there is a need to optimise the currently available treatments as well as developing novel drugs to improve the therapy provided for the patients in the clinical practice. Several pharmacological therapies like, anti-vascular endothelial growth factor and anti-inflammatory therapies which include intravitreal, and implant of corticosteroids are significant in the management to decrease the risk of DR-related vision impairment. Clinical trials for novel drug therapies are still ongoing till this day to enhance the efficacy of DR treatment. Even though there are also modern treatments such as laser therapy for the patients, prevention should be done to lower the number of individuals affected by DR. Due to the complexity of DR, there are numerous obstacles to develop new medications for DR which include the increasing healthcare cost of DR treatment. New insights such as utilisation of artificial intelligence will be implemented into the management of DR as it has proved its potential in aiding the screening process. In parallel with the increase in DR prevalence and the number of treatments developed, extensive understanding of the mechanism of action of DR should be further improved to prevent more complications in the future. This review summarises the epidemiological trend, prevention strategies, challenges in treatment, current novel therapeutics (including drugs under clinical trials), future therapeutic trends and possibilities for implementing AI in the early diagnosis and management of DR.

Impact of DNA Repair Deficiency in the Evolving Treatment Landscape of Bladder Cancer.

PURPOSE OF REVIEW: This review explores the current landscape of treatments which target the DNA damage response (DDR) in metastatic and muscle-invasive bladder cancer. It emphasizes recent clinical trials which integrate DDR inhibitors with standard chemotherapy and immunotherapy. RECENT FINDINGS: Noteworthy findings include the ATLANTIS trial, which demonstrated prolonged progression-free survival (PFS) in DDR biomarker-selected patients using PARP inhibitors as maintenance after standard chemotherapy. Trials such as BAYOU, which combined immunotherapy with PARP inhibition, similarly suggested a potential therapeutic benefit in DDR biomarker-selected patients with bladder cancer. Efforts to develop bladder-sparing treatment regimens based on DDR-associated mutational profiles, such as the RETAIN and HCRN 16-257 trials, have had mixed outcomes to date. There are now ongoing efforts to combine DDR inhibitors with the newest bladder cancer therapies, such as antibody-drug conjugates. This review highlights the most recent advances in targeting DNA repair deficiency in the evolving treatment landscape of bladder cancer.

The efficacy of ciprofol versus propofol on anesthesia in patients undergoing endoscopy: a systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Ciprofol is a new intravenous anesthetic with a similar chemical structure to propofol. We aimed to compare the incidence of adverse actions like injection pain and time indexes of ciprofol versus propofol on anesthesia in patients undergoing endoscopy. We also compared anesthetists' satisfaction during the procedure. METHODS: Two independent researchers (Liu and Zeng) searched the Cochrane Library, Embase databases, and PubMed for controlled clinical trials. This meta-analysis of randomized controlled trials (RCTs) was performed with the Review Manager, Stata and the Cochrane Risk-of-Bias 2 tool to evaluate methodological quality. Relative risks with 95% confidence interval (CI) were calculated for outcomes. RESULTS: Ten trials, including 1545 patients, were examined in the current meta-analysis. During anesthesia in patients undergoing endoscopy, the incidence of injection pain was significantly reduced in the research group. Compared with propofol, the pooled risk difference (RD) with the use of ciprofol for injection pain for all the procedures was - 0.34 (95% confidence interval [CI], -0.48 to 0.19), and RR for hypotension was 0.73(95% CI:0.58 to 0.92). GRADE showed this meta-analysis has moderate or low confidence. Trial sequential analysis for mortality indicated insufficient sample size for a definitive judgment for lower incidence of hypotension. CONCLUSION: In painless endoscopy, compared with propofol, ciprofol exhibited non-inferiority anesthesia/sedation in patients, and had a good safety profile with a lower incidence of pain on injection and may reduce the chance of hypotension. Trial sequential analysis suggested the need for more cases, and GRADE highlighted moderate certainty, emphasizing the necessity for further targeted RCTs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42023433627.

Preparations, Applications, Patents, and Marketed Formulations of Nanoemulsions - A Comprehensive Review.

Nanoemulsions have emerged as versatile colloidal dispersions with promising applications in various fields, including pharmaceuticals, food, and cosmetics. These nano-sized emulsions, stabilized by surfactants, offer unique advantages such as enhanced ingredient penetration efficacy and versatile dosage forms. This article provides an extensive overview of nanoemulsions, covering their composition, methods of preparation, and applications in drug delivery, the food industry, and cosmetics. Various high-energy and low-energy methods for nanoemulsion preparation are discussed, along with their advantages and limitations. Additionally, the article highlights the potential of nanoemulsions in improving drug bioavailability, stability, and therapeutic efficacy, especially in oral, topical, parenteral, intranasal, ocular, and pulmonary drug delivery. Furthermore, nanoemulsions are explored as carriers for encapsulating flavoring agents, nutraceuticals, and natural preservatives in the food industry, as well as their use in cosmetic formulations. Current clinical trials involving nanoemulsions and recent patents in the field are also summarized, providing insights into ongoing research and development efforts. Lastly, a selection of marketed nanoemulsion formulations is presented, showcasing their practical applications and commercial availability. Overall, nanoemulsions hold great promise as effective delivery systems with broad applications across various industries.

Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial.

BACKGROUND: No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting. METHODS: In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha. RESULTS: Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; P=0.02 for noninferiority at a 0.025 significance level and P=0.55 for 2-sided superiority at a 0.05 significance level). CONCLUSIONS: Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912.

Treatment of the blood cancer polycythemia vera with ruxolitinib in the MAJIC-PV study: a plain language summary.

WHAT IS THIS SUMMARY ABOUT?: This is a summary of an article describing the main results of the MAJIC-PV study. This study looked at using the cancer drug ruxolitinib to treat a type of blood cancer called polycythemia vera. People with polycythemia vera make too many red blood cells in their body. This can make their blood thicker and can increase the chances of blood clots forming in their blood vessels.Researchers wanted to find out how well ruxolitinib worked compared with the best available therapy as a treatment for people with polycythemia vera who were at risk of developing blood clots that could lead to a heart attack or stroke. Specifically, the study looked at people who had already taken the chemotherapy hydroxycarbamide (also known as hydroxyurea) for their polycythemia vera, but it either didn't work for them or gave them side effects that they could not tolerate. WHAT WERE THE RESULTS?: In the study, researchers divided 180 adults with polycythemia vera who were at high risk of developing blood clots that could lead to a stroke into two groups: 93 people who took ruxolitinib twice a day, and 87 people who took the best available therapy. 43% of people who took ruxolitinib and 26% of people who had the best available therapy had normal blood counts and spleen size within 1 year of treatment. 84% of people who took ruxolitinib and 75% of people who had the best available therapy lived for at least 3 years without their polycythemia vera becoming a more advanced type of blood cancer. The most common side effects were disorders of the digestive system (stomach and gut), disorders of the blood vessels, and infections. This is similar to the side effects that doctors know about for ruxolitinib. WHAT DO THE RESULTS MEAN?: Compared with people who had the best available therapy for their polycythemia vera, people who took ruxolitinib were more likely to have normal blood counts and spleen size within 1 year of treatment, and were more likely to live longer without their polycythemia vera becoming a more advanced type of blood cancer.

Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials.

OBJECTIVE: To evaluate the additive effect of naldemedine tosylate (naldemedine) on opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment. METHODS: We combined two randomized, double-blind, placebo-controlled, phase IIb and III trials of naldemedine and conducted a post hoc subgroup analysis. We evaluated the effect and safety of naldemedine in 116 patients who received naldemedine in addition to magnesium oxide (naldemedine group) and 117 patients who received placebo in addition to magnesium oxide (placebo group). Both groups included patients insufficiently responding to magnesium oxide for opioid-induced constipation. Effect was assessed using spontaneous bowel movement responder rate, complete spontaneous bowel movement responder rate, changes in spontaneous bowel movements and complete spontaneous bowel movements. Safety was also assessed. RESULTS: During the 2-week treatment period, the responder rates for spontaneous bowel movement and complete spontaneous bowel movement were 73.3 and 43.1% in naldemedine group, respectively, which were significantly higher (P < 0.0001) than 41.9 and 14.5% in placebo group, respectively. Median time to first spontaneous bowel movement and first complete spontaneous bowel movement was significantly shorter (P < 0.0001) in the naldemedine group (4.0 and 21.3 h, respectively) than in the placebo group (27.7 and 211.7 h, respectively). The incidence of adverse events and diarrhoea was significantly higher (P < 0.05) in the naldemedine group than in the placebo group, while the incidence of serious adverse events and severe diarrhoea was not significantly different between the naldemedine and placebo groups. CONCLUSION: The study suggested the addition of naldemedine as an effective treatment option for opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

The association between thyroid disease and hearing loss: a meta-analysis.

BACKGROUND: It has been shown that there is a link between thyroid-related diseases and hearing loss. OBJECTIVES: The purpose of this study is to investigate the relationship between thyroid-related diseases and hearing loss by conducting a meta-analysis. MATERIAL AND METHODS: A thorough search was carried out in the following electronic databases: PubMed, Cochrane Library, Embase, Web of Science, Google Scholar, Semantic Scholar, and ResearchRabbit. The chi-square test and the I2 index examined the research's heterogeneity. A funnel plot and the Eger test were used to examine publication-biased effects. RESULTS: A total of 48,507 individuals (6482 hypothyroid patients, 4162 hearing loss patients, and 37863 controls) were included in this meta-analysis of 18 research. Individuals with hypothyroidism had a 1.69-fold increased risk of hearing loss compared to those without the condition (OR: 1.69; 95% CI: 1.11-2.57, p < 0.001). among hypothyroidism, the prevalence of hearing loss was 24% (EC: 0.24; 95% CI: 0.11-0.39, p = 0.00), while among hearing-impaired individuals, the prevalence of hypothyroidism was 7% (EC: 0.21; 95% CI: 0.07-0.40). CONCLUSION: This study demonstrated how thyroid dysfunction can raise the chance of hearing loss. To completely comprehend the underlying mechanisms and create efficient treatments for this illness, more study is required.

Glucagon-like peptide-1 receptor agonists and kidney outcomes.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have gained increasing attention for their potential benefits in people with type 2 diabetes mellitus (T2DM) with chronic kidney disease (CKD). Most supportive evidence of a kidney-protective effect of the GLP-1RA class of medications has been derived from kidney-related outcomes reported from cardiovascular outcome trials (CVOTs). GLP-1RAs have been shown to reduce albuminuria, mitigate cardiovascular risk, and possibly attenuate estimated glomerular filtration rate (eGFR) decline. The kidney-protective effects of GLP-1RAs are thought to be attributed to their anti-inflammatory, antioxidant, and vasodilatory properties. Despite these promising findings, the use of GLP-RAs has yet to be definitively shown to slow progression to chronic kidney failure in people with T2DM. The Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW trial) is the first major trial assessing the potential of a GLP-1RA to slow progression of kidney disease in people with established CKD to clinically important kidney end points. On March 5, 2024, the top line result from FLOW was announced with semaglutide 1.0 mg being reported to reduce the primary end point of the trial by a significant 24% compared with placebo. Here, we summarize the kidney outcomes reported from CVOTs for the GLP-1RA class of medication and briefly describe kidney outcomes from other major GLP-1RAs trials. We also discuss a potential role of the dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, as a kidney-protective agent.

Comprehensive review on ethnomedicinal, phytochemistry and pharmacological profile of.

Ficus religiosa L. (F. religiosa) or sacred fig is a large perennial tree belonging to the family Moraceae or mulberry family. Though the tree has pan-tropical distribution but originally it is indigenous to the Indian subcontinent and Indochina region. Popularly the tree is named "Pepal or bodhi tree". Traditionally, it is practiced for the treatment of asthma, nose bleeding, heart disorders, diabetes, wound healing, ear problems, constipation, hyperlipidemia, gonorrhea, ulcers and infectious disorders. Chemical analysis demonstrated the presence of numerous bioactives including tannins, phenols, saponins, sugars, alkaloids, methionine, terpenoids, flavonoids, glycosides, proteins, separated amino acids, essential and volatile oils and steroids etc., which are probably responsible for its diverse pharmacological actions. The present work is an attempt to compile up-to-date comprehensive information on F. religiosa that covers its taxonomy, ethnomedicinal importance, phytochemistry, pharmacological attributes and clinical trials. Keeping in mind the various health attributes of F. religiosa, future research can be aimed at in-depth elucidation of the structure-function relationship and multifactorial signalings pathways.

The I2 Test for Selection Bias Risk Assessment in Single Trials: Recommended Simulated Comparator Trial (SCT) Settings.

Selection bias in clinical trials is a form of systematic error and may be detected using the I² test with a 0/>0% threshold (bias: I² > 0%, no bias: I² = 0%). The test operates on the premise that effective randomisation eliminates in-between study heterogeneity beyond the play of chance in a baseline variable meta-analysis of all the trial's baseline variables. Since the I² statistic was originally designed to measure in-between study heterogeneity in meta-analyses, the test requires the generation of at least two simulated comparator trials (SCTs). During this process, three parameters are set: SCT sample size (NSCT), the minimum-maximum range of random values (RSCT), and the number of generated SCTs to be used (SCTN). Each of these parameters influences the 0/>0% threshold of the resulting I² point estimate, thereby affecting the test's sensitivity in indicating a positive result. The purpose of this technical report is to highlight the effect that SCT parameters have on the test's accuracy and to recommend appropriate parameter settings.

Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial.

Background: Mental health problems in patients with chronic obstructive pulmonary disease (COPD) are common and frequently neglected. Digital psychological interventions may reduce mental health problems, but their effectiveness has not been evaluated in the Chinese COPD population. In this study, we will develop an integrated digital psychological intervention (EmoEase) and evaluate its effectiveness and cost-effectiveness in enhancing the mental wellbeing of patients with COPD in China. Methods: This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 patients with COPD with age over 35 years. Participants will be assigned to receive either usual care (control group) or usual care + EmoEase (intervention group). Assessments will take place at baseline (T0) and 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and physical measurements. The primary outcome measure will assess mental wellbeing using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socioeconomic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat approach. Discussion: This is the first RCT to examine the value of EmoEase, a novel digital psychological intervention for patients with COPD. If this intervention is effective and cost-effective, it could be rapidly scaled up to provide mental healthcare for patients with COPD in China. Trial registration: ClinicalTrials.gov Identifier: NCT06026709. Date of first submission: 30 August 2023. https://clinicaltrials.gov/study/NCT06026709.

Next-gen spinal cord injury clinical trials: lessons learned and opportunities for future success.

Despite promising basic science discoveries and a surge in clinical trials, the quest for effective treatments that restore neurological function after spinal cord injury lags on. While "failed" in a conventional sense, emerging solutions to longstanding challenges represent promising steps towards a future with effective interventions. In this personal view, we highlight clinical trials implementing new solutions and their impact on the field. Our perspective is that, ultimately, the integration of shared knowledge, adaptive designs, and a deeper understanding of the intricacies of spinal cord injury holds promise of unlocking of major breakthroughs, leading to improved outcomes for people with spinal cord injury.

The Impact of the American Association of Thoracic Surgery on Clinical Trial Development by Cardiothoracic Surgeons.

OBJECTIVE: Clinical trials play a critical role in the rapidly evolving field of cardiothoracic surgery and the American Association of Thoracic Surgery (AATS) Clinical Trials Methods Course has provided a biannual symposium led by preeminent surgeons with vast experience in planning, conducting and analyzing surgical clinical trials. This study hypothesizes that participation in the course is associated with future success in clinical trial leadership. METHODS: A list of course attendees (2014-2022) was queried in "ClinicalTrials.gov", a database of clinical trials funded by the United States Health and Human Services and the National Institutes of Health. The type of clinical trial and publications from the trial were collected. Demographic information about the participants were collected from faculty pages. RESULTS: A total of 107 participants from various professional backgrounds attended the AATS Clinical Trials course and led 91 clinical trials. The average time to starting a clinical trial after attending the workshop was 3.04 years for participants who had not already been involved with a trial. Of the 107 participants, 36 (36/107; 33.6%) were either the principal investigator or a sub-investigator for 91 clinical trials. CONCLUSIONS: The AATS Clinical Trials course provides participants the tools for successfully leading surgical clinical trials. Although participation has been limited, those who attend the course and lead a clinical trial do so within approximately 3 years. The Clinical Trials course provides an excellent return on investment and the AATS should continue sponsorship of this program as it supports the develop of future leaders in cardiothoracic surgery.