Safety profile

Adoption of Cardiopulmonary Exercise Testing in Rehabilitation of Coronary Artery Disease Patients BMC Cardiovasc Disord. 2024 Jun 21;24(1):313 Summary: This study explored the use of cardiopulmonary exercise testing in patients with coronary artery disease (CAD) and its impact on exercise ability and cardiopulmonary function. Significant improvements in health outcomes and quality of life were observed. Key Findings: RT training led to decreased postoperative blood lipid levels and improved quantitative load levels in CAD patients, contributing to enhanced cardiopulmonary function. Improvements were observed in cardiac function, cardiopulmonary fitness, exercise ability, and quality of life in patients who underwent RT training. Significant… ➡️➡️➡️

Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes-Randomized Controlled Trial (PRISM-RCT) Highlights of the Study We designed a patient-centered care model to evaluate its impact on clinical outcomes in young-onset type 2 diabetes patients. Research Design and Methods The trial evaluates a multicomponent care model using technology, biogenetic markers, and patient-reported outcomes in patients diagnosed with type 2 diabetes at a young age. Results 884 patients were assigned to receive specialist-led team-based management or usual care. The study identified various health profiles and comorbidities among the patients, highlighting the complexity of young-onset diabetes. Conclusions The study shows that young-onset… ➡️➡️➡️

miR-221-3p: A Potential Biomarker for Chronic Periodontitis Overview Researchers investigated the role of miR-221-3p in chronic periodontitis (CP) development and management. They aimed to uncover its diagnostic potential and therapeutic implications. Key Findings miR-221-3p levels were lower in CP patients compared to healthy individuals. miR-221-3p demonstrated high diagnostic accuracy for CP, showing potential as a biological marker. It was negatively correlated with periodontal indicators and inflammatory factors. Overexpression of miR-221-3p reduced the production of inflammatory factors in lab-induced cells. Clinical Relevance The expression of miR-221-3p holds promise as a diagnostic bioindicator for chronic periodontitis. This research opens up new possibilities… ➡️➡️➡️

The Effect of Tub Bathing on Newborns Undergoing Phototherapy: A Clinical Trial Objective To study the impact of tub bathing on the skin and bilirubin levels of newborns undergoing tunnel and light-emitting diode phototherapy. Methods Newborns with hyperbilirubinemia receiving tunnel or light-emitting diode phototherapy were randomly assigned to either a bath or no bath group. Skin condition and bilirubin levels were assessed at 6, 12, and 24 hours after phototherapy. Results Babies in the bath group showed a significant decrease in total serum bilirubin levels compared to the control group. The skin integrity-moisture balance was also higher in the bath… ➡️➡️➡️

Randomised, Split-Face Study of Dermocosmetic Cream for Rosacea Published in Skin Research and Technology, June 2024 Objective: To assess the benefit of a dermocosmetic cream (DC cream) containing Sphingobioma xenophaga extract and soothing agent in adult females with rosacea-associated erythema and sensitive skin. Methods: The study involved a 28-day phase where DC was applied twice daily on one half of the face and compared to usual-skincare (USC), followed by a 56-day phase of applying DC on the full face. Clinical, instrumental, and skin sensitivity assessments were performed at all visits. Results: At day 28, DC showed significant benefits over USC… ➡️➡️➡️

The effect of educational intervention based on health belief model on colorectal cancer screening behaviors BMC Public Health. 2024 Jun 19;24(1):1640. doi: 10.1186/s12889-024-19180-8. Summary: This study aimed to assess the impact of an educational intervention based on the health belief model (HBM) on colorectal cancer screening behaviors in individuals aged 50 and above. Methods: 134 participants from Fasa City Health Service Center were divided equally into an experimental group and a control group. A questionnaire covering demographic information, knowledge, and HBM constructs was used for data collection. Both groups completed the questionnaire before and after the intervention. SPSS 22 and… ➡️➡️➡️

Web-Based, Human-Guided, or Computer-Guided Transdiagnostic Cognitive Behavioral Therapy in University Students With Anxiety and Depression: Randomized Controlled Trial Key Findings: Web-based interventions were marginally more effective than usual care over 6 months. All groups showed significant improvement in depression and anxiety symptoms over time. Participants in the human-guided condition attended more sessions than those in the computer-guided condition. Practical Solutions and Value: The transdiagnostic iCBT program provides a practical, feasible, and effective alternative to usual care for addressing mental health problems in a large university setting. There is no indication that human guidance is superior to technological guidance, but the… ➡️➡️➡️

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Effect of a Dietary Supplement Containing Dry Artichoke and Bergamot Extracts on Metabolic and Vascular Risk Factors in Individuals with Suboptimal Cholesterol Levels Key Findings The study found that a dietary supplement containing dry extracts of bergamot and artichoke significantly improved serum lipid concentration and insulin sensitivity, reduced high-sensitivity C-reactive protein (hs-CRP), and positively impacted non-alcoholic fatty liver disease (NAFLD) in individuals with suboptimal cholesterol levels. Practical Solutions and Value These findings support the use of the tested dietary supplement as a safe and effective approach for the prevention and management of… ➡️➡️➡️

Efficacy and Mechanisms of TCPS Qigong for Insomnia in College Students Protocol for a Double-Blind, Randomized Controlled Trial Background: Insomnia in college students is often overlooked despite its impact on health and wellbeing. Improving sleep quality through targeted interventions can reduce the risk of related health issues. Qigong exercises, specifically Three-circle Post Standing (TCPS), have shown promise in enhancing sleep quality and relieving insomnia by integrating body, breath, and mind. Objectives: This clinical trial aims to evaluate the feasibility, safety, and therapeutic efficacy of TCPS in improving sleep quality and quality of life in college students with insomnia. Additionally, it… ➡️➡️➡️

Efficacy and Safety of Eliapixant in Endometriosis-Associated Pelvic Pain: The SCHUMANN Study Published in BMC Women’s Health, June 19, 2024 Background: The SCHUMANN study assessed the effectiveness and safety of eliapixant in treating endometriosis-associated pelvic pain (EAPP). Methods: This was a phase 2b study involving women with surgically diagnosed endometriosis and EAPP. Participants were randomly assigned to receive eliapixant at different doses or a placebo for 12 weeks. The primary goal was to measure the change in worst EAPP from baseline to the end of the study. Results: The study was terminated early due to safety concerns, with fewer participants… ➡️➡️➡️

Functioning and Quality of Life Among Adults with Psychotic Disorders in Tanzania: KUPAA Clinical Trial Key Findings and Implications Understanding the functioning and quality of life of individuals with psychotic disorders is essential for informing policies and programs in low-resource settings like urban Tanzania. Results from the KUPAA clinical trial revealed that higher disability was associated with factors such as food insecurity, symptom severity, self-stigma, and low levels of support and hope. On the other hand, higher quality of life was linked to factors including self-efficacy, hopefulness, support, reduced self-stigma, and better family functioning. Identifying these factors can help clinicians… ➡️➡️➡️

Microvascular Recovery with Ultrasound in Myocardial Infarction Post-PCI Trial Abstract Purpose: This study aimed to assess the effectiveness of post-PCI sonothrombolysis in patients with acute anterior wall STEMI. Methods: A randomized controlled trial was conducted on 50 patients who underwent continuous microbubble infusion following successful PCI. Sonothrombolysis was applied in the treatment group. MRI was used to evaluate differences in infarct size, LVEF, and MVO. Results: Sonothrombolysis did not significantly reduce infarct size or MVO at 48 hours post-PCI. However, LVEF improvement was observed in the sonothrombolysis group at 6-8 weeks follow-up. Conclusion: Post-PCI sonothrombolysis had minimal effect on reducing… ➡️➡️➡️

Efficacy and Neural Mechanisms of Mindfulness Meditation Among Adults With Internet Gaming Disorder: A Randomized Clinical Trial Overview The study aimed to assess the effectiveness of mindfulness meditation (MM) in treating internet gaming disorder (IGD) and to identify the neural mechanisms behind MM treatment. Key Findings MM was more effective than progressive muscle relaxation (PMR) in reducing addiction severity and gaming cravings. MM was associated with decreased brain activation in specific areas and altered frontopallidal pathways. Practical Solutions and Value These findings suggest that MM may be a promising treatment for IGD and may work by modifying specific brain pathways.… ➡️➡️➡️

Comparative Effectiveness of Personal Sound Amplification Products Versus Hearing Aids for Unilateral Hearing Loss: A Prospective Randomized Crossover Trial ABSTRACT This study compared the effectiveness of personal sound amplification products (PSAPs) and hearing aids (HAs) for individuals with moderate to moderately severe unilateral hearing loss. Thirty-nine participants were randomly assigned to use either a basic or premium type HA, or a basic or high-end type PSAP for 8 weeks each. They underwent various examinations to assess hearing outcomes. Results showed that HAs provided significantly higher functional gain across all frequencies. HAs also outperformed PSAPs in improving word recognition score, speech… ➡️➡️➡️

Cost-effectiveness of Talazoparib for Advanced Breast Cancer Key Findings: Talazoparib, a targeted PARP inhibitor, has shown significant extension in progression-free survival and improved response markers for patients with germline BRCA1/2 mutated HER2-negative advanced breast cancer, compared to conventional therapies. Practical Solutions: Our analysis aims to assess the cost-effectiveness of talazoparib in treating advanced breast cancer with germline BRCA1/2 mutations and HER2 negativity. The results provide valuable insights for rational drug utilization and enhancing medical resource efficiency. Value: Our study developed a Markov model based on the EMBRACA clinical trial to simulate the survival events of breast cancer patients in the… ➡️➡️➡️

Lateral Episiotomy in Vacuum Assisted Delivery for First-Time Mothers Objective To compare the effect of lateral episiotomy versus no episiotomy on obstetric anal sphincter injury in first-time mothers requiring vacuum extraction. Study Design A multicentre, open label, randomised controlled trial conducted in eight hospitals in Sweden from 2017 to 2023. Participants 717 first-time mothers with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction. Intervention First-time mothers were randomly assigned to receive either a lateral episiotomy or no episiotomy during vacuum extraction. Main Outcome Measures The primary outcome was obstetric anal sphincter injury diagnosed by combined… ➡️➡️➡️

Assessing the Impact of Jail-Initiated Medication for Opioid Use Disorder: A Multisite Analysis of the SOMATICS Collaborative Objective The objective of this study was to assess the effects of jail-initiated medication for opioid use disorder (MOUD) and patient navigation (PN) on opioid use disorder (OUD) at 6 months post-release. Study Details Three randomized trials (combined N = 330) were conducted to evaluate whether MOUD initiated prior to release from jail, with or without PN, would reduce the likelihood of an OUD diagnosis 6 months post-release compared to enhanced treatment-as-usual (ETAU). Findings Results showed that MOUD initiation compared to ETAU was… ➡️➡️➡️

Cost-Effectiveness Analysis of Bevacizumab Combined with Lomustine in the Treatment of Progressive Glioblastoma Key Findings Compared to Lomustine alone, the combination of Bevacizumab and Lomustine increased the total treatment cost from $2,646.70 to $23,650.98. The health-adjusted life years (QALYs) for the combination therapy increased from 0.26 QALYs to 0.51 QALYs, representing an increment of 0.25 QALYs. The incremental cost-effectiveness ratio (ICER) was $84,071.12. Conclusion From the perspective of payers in China, Bevacizumab and Lomustine combination therapy as a first-line treatment for GBM is not a cost-effective option. However, considering the survival advantages this regimen may offer for this rare disease,… ➡️➡️➡️

Characterization of Anti-Drug Antibody Responses to Cibisatamab Practical Solutions and Value An appropriately designed pharmacokinetic (PK) assay sensitive for anti-drug antibody (ADA) impact on exposure is an alternative strategy to understand the neutralizing potential of ADAs. The PK assay of cibisatamab, a T-cell-engaging bispecific antibody, was developed based on its mechanism of action (MoA). Using critical monoclonal anti-idiotypic (anti-ID) antibody positive controls as ADA surrogates, the impact on exposure was evaluated pre-clinically. In a phase I clinical trial (NCT02324257), initial data suggest that the combination of ADA and PK assays can correlate the ADA response with cibisatamab exposure. Advanced ADA… ➡️➡️➡️

Short-term effects of gastric bypass versus sleeve gastrectomy on high LDL cholesterol: The BASALTO randomized clinical trial ABSTRACT There has been a substantial increase in the use of laparoscopic sleeve gastrectomy (SG) to treat morbid obesity despite observational evidence demonstrating the superiority of Roux-en-Y gastric bypass (RYGB) for reducing low-density lipoprotein (LDL) cholesterol. The main aim was to ascertain whether high LDL cholesterol levels should be considered when selecting the most appropriate surgical procedure for each patient (RYGB or SG). In this single-center, randomized clinical trial using intention-to-treat analysis, 38 patients with severe obesity and elevated levels of LDL cholesterol… ➡️➡️➡️