Safety profile

Anti-dsDNA IgE: a Potential Non-Invasive Test for Prediction of Lupus Nephritis Relapse RMD Open. 2024 Jun 28;10(2):e004255. doi: 10.1136/rmdopen-2024-004255. Objectives: The WIN-IgE study aims to assess the value of serum anti-dsDNA IgE autoantibodies as a biomarker for predicting relapse in severe lupus nephritis (LN) to guide the discontinuation or continuation of maintenance immunosuppressive therapy (MIST). Methods: WIN-IgE is an ancillary study of the WIN-Lupus trial, evaluating the discontinuation of MIST after 2-3 years in class III or IV±V LN with active lesions. Serum samples were collected at randomization for continuation or discontinuation of MIST, and anti-dsDNA antibodies, IgE, and IgG… ➡️➡️➡️

Hydromorphone combined with ropivacaine for erector spinae plane block in patients undergoing modified radical mastectomy: A prospective randomized controlled trial Medicine (Baltimore). 2024 Jun 28;103(26):e38758. doi: 10.1097/MD.0000000000038758. Background: Combining hydromorphone with ropivacaine in ultrasound-guided erector spinae plane blocks enhances postoperative pain relief and reduces interleukin-6 expression in breast surgery patients. Methods: Breast cancer patients undergoing modified radical mastectomy were divided into 3 groups for anesthesia: standard general (group C), Erector Spinae Plane Block (ESPB) with ropivacaine (group R), and ESPB with ropivacaine plus hydromorphone (group HR). The study compared pain levels, IL-6 expression, anesthetic doses, additional analgesia needs, and recovery… ➡️➡️➡️

Prospective, Randomised Clinical Trial on Silicone Intubarium Necessity in Endonasal-Endoscopic Dacryocystorhinostomy (EN-DCR) Background This study evaluates the impact of using a silicone stent tube (SST) on the success of EN-DCR for treating primary acquired nasolacrimal duct obstruction. Methods Patients were randomly assigned to receive EN-DCR with or without SST intubation. The surgery was performed using standardized techniques, and patients were assessed at three different timepoints over a 24-week period. Results After 24 weeks, no statistically significant differences in epiphora levels or patency were found between the groups. The study did not show any significant changes over time. Conclusions The study… ➡️➡️➡️

Clinical Trial: Efficacy of Sivelestat in Treating Sepsis Patients with ARDS and SCM Background Researchers assessed the effectiveness of sivelestat, a neutrophil elastase inhibitor, in treating sepsis-induced acute respiratory distress syndrome (ARDS) and septic cardiomyopathy (SCM). Methods A randomized trial was conducted on patients diagnosed with sepsis-induced ARDS and SCM at Wuhan Union Hospital. The patients were divided into Sivelestat and Control groups. Serum concentrations of certain inflammatory markers were measured at five time points from baseline to 72 hours after admission to the ICU. Cardiac function was also evaluated using sonography and heart rate variability monitoring. Results The study… ➡️➡️➡️

Developing a Fit-for-Purpose Composite Symptom Score for Malignant Pleural Mesothelioma Clinical Trials Key Practical Solutions and Value We developed a composite symptom score (CSS) to measure disease-related symptom burden in patients with malignant pleural mesothelioma (MPM). The CSS, derived from the MD Anderson Symptom Inventory for MPM, includes 5 symptoms: pain, fatigue, shortness of breath, muscle weakness, and coughing. It correlates strongly with the full symptom set and has good sensitivity to worsening disease and quality of life ratings. The MDASI-MPM CSS can be used in clinical trials to assess treatment outcomes and can be administered frequently, even electronically, to… ➡️➡️➡️

Clinical Trial Results: Afatinib in Metastatic Esophageal Squamous Cell Carcinoma Key Findings: Preclinical data demonstrated promising antitumor activity of afatinib in EGFR-overexpressing ESCC. Phase II trial showed a confirmed objective response rate (ORR) of 39% and a median overall survival of 7.8 months in pretreated metastatic ESCC patients with EGFR overexpression. Transcriptome analysis revealed a negative association between NTRK2 and afatinib sensitivity, suggesting its potential as a predictive biomarker. Knocking down or inhibiting NTRK2 sensitized ESCC cells to afatinib treatment. Practical Solutions and Value: These findings offer insights into molecular factors underlying afatinib resistance and highlight its potential as an… ➡️➡️➡️

Local Radiotherapy and Measurable Residual Disease-Driven Immunotherapy in Early-Stage Follicular Lymphoma (FIL MIRO) Trial: Final Results Practical Solutions and Value Highlights: Local radiotherapy and anti-CD20 monoclonal antibody (mAb) treatment were evaluated using a measurable residual disease (MRD)-driven approach. Patients with early-stage follicular lymphoma were initially treated with radiotherapy, and those still MRD-positive received anti-CD20 mAb ofatumumab. Of the patients MRD-positive after radiotherapy, 92% achieved MRD-negativity with ofatumumab, leading to a reduced incidence of relapse over time. AI-driven platform DocSym consolidates clinical standards, protocols, and research for easy access by clinicians, streamlining operations and enhancing patient care. Mobile apps support scheduling,… ➡️➡️➡️

Phase II Study of Ulixertinib in Children and Young Adults With Tumors Harboring Activating Mitogen-Activated Protein Kinase Pathway Alterations: APEC1621J of the National Cancer Institute-Children’s Oncology Group Pediatric MATCH Trial Summary The National Cancer Institute-Children’s Oncology Group (NCI-COG) Pediatric MATCH trial tested ulixertinib, a targeted therapy, in patients aged 1-21 with refractory malignancies harboring genetic alterations in the mitogen-activated protein kinase pathway. The study aimed to determine the recommended phase II dose (RP2D) and assess treatment response, safety, and progression-free survival. Key Findings – Ulixertinib was administered at 260 mg/m2/dose orally twice a day and was found to be the… ➡️➡️➡️

Effectiveness of Eccentric Load in Upper Limb Injury Rehabilitation Practical Solutions and Value The study aimed to assess the effectiveness of therapeutic exercises with eccentric muscle loads in rehabilitating patients with upper limb injuries. This is particularly relevant for athletes, elderly individuals, and those with an active lifestyle. Patients were divided into two groups: one receiving isolated therapeutic exercises with eccentric muscle loads and the other receiving traditional exercises. The study included clinical examination, functional tests, and assessment of rehabilitation effectiveness by comparing indicators before and after treatment. The results showed significant improvements in muscle strength, movement amplitude, and pain… ➡️➡️➡️

Efficacy and Viability of Subgingival Application of Probiotics as an Adjunct to Scaling and Root Planing in Periodontitis Summary This study compared the effectiveness of applying probiotics under the gums along with scaling and root planing (SRP) versus SRP alone in patients with periodontitis. Key Findings Patients who received probiotics in addition to SRP showed greater improvement in clinical parameters compared to those who only received SRP. The probiotic bacteria remained viable in the periodontal pocket for up to 8 days after placement, and stable improvements were seen in all clinical parameters even at 12 weeks, indicating its prolonged efficacy.… ➡️➡️➡️

Practicing Interoceptive Sensitivity as a Couple A Mixed-Methods Acceptance Analysis of a Dyadic vs. Single Pilot Randomized Controlled Trial Interoceptive sensitivity (IS) training is a step toward promoting intuitive eating (IE). A pilot randomized controlled trial was conducted among couples aged 50+ to increase IE. The trial involved three exercises: Body Scan (BS), hunger exercise (HU), and satiety exercise (SA). The study evaluated how couples accepted the training, comparing dyadic versus single approaches. The findings, from a survey of 68 couples and focus groups with 4 couples, revealed moderate general acceptance and a preference for the Body Scan exercise. Couples… ➡️➡️➡️

Silymarin Supplementation in Active Rheumatoid Arthritis: Pilot Study Results Background and Objectives Coadministration of silymarin, a natural supplement, with conventional antirheumatic drugs is of interest in treating active rheumatoid arthritis. This study aimed to evaluate the impact of silymarin supplementation on patients’ disease activity and overall condition. Materials and Methods 122 patients with active rheumatoid arthritis were randomly assigned to control or intervention groups. The intervention group received 300 mg/day of silymarin for 8 weeks. Disease activity, inflammatory markers, European League Against Rheumatism responses, fatigue, depression, and anxiety scores were assessed at baseline and week 8. Results Silymarin supplementation led… ➡️➡️➡️

Reframing Communication about Fall Prevention Programs to Increase Older Adults’ Intentions to Participate ABSTRACT Falls and fall-related injuries in community-dwelling older adults are a growing global health concern. Despite effective exercise-based fall prevention programs (FPPs), low enrollment rates persist due to negative connotations associated with falls and aging. This study aimed to investigate whether positive framing in communication leads to a higher intention to participate in an FPP among community-dwelling older adults. METHODS We conducted a two-sequence randomized crossover study. We designed two flyers, a standard flyer containing standard terminology regarding FPPs for older adults, and a reframed flyer highlighting… ➡️➡️➡️

Colchicine in Patients with Acute Ischaemic Stroke or Transient Ischaemic Attack (CHANCE-3) Key Findings The study aimed to determine the effectiveness and safety of colchicine in reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset. Study Design This was a multicentre, double blind, randomised, placebo controlled trial conducted in 244 hospitals in China between 11 August 2022 and 13 April 2023. Participants A total of 8343 patients aged 40 years or older with a minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity… ➡️➡️➡️

Digital Cognitive-Behavioural Therapy vs. Zolpidem for Insomnia Treatment BMJ Open. 2024 Jun 25;14(6):e081205 Introduction: Insomnia is a common health issue, and cognitive-behavioural therapy (CBT) is a recommended treatment. Due to a shortage of CBT-trained therapists, we developed a digital CBT application (IIIP MED: Sleepy Med) for insomnia. This study outlines an exploratory trial to assess the effectiveness and safety of our digital CBT compared to zolpidem tartrate for patients with insomnia disorder. Methods and Analysis: The multicentre exploratory trial will be conducted at Chiba University Hospital, Akita University Hospital, and Yoyogi Sleep Disorder Center, Japan. The study will include two… ➡️➡️➡️

Unified Protocol Versus Self-Acceptance Group Therapy for Emotional Disorders in People With Severe Shame ABSTRACT Severe shame is a distressing negative emotion linked to various psychological disorders. A study compared the effects of two treatments, the Unified Protocol (UP) and Self-Acceptance Group Therapy (SAGT), on shame dysregulation in individuals with emotional disorders, including borderline personality disorder (BPD). Individuals with high levels of shame were randomly assigned to either UP (N = 280) or SAGT (N = 282). Outcome measures included shame, loneliness, neuroticism, emotional dysregulation, and positive and negative affect measured pre-treatment, post-treatment, and at 3- and 6-month follow-ups. Results… ➡️➡️➡️

Effect of Individualized Ocular Refraction Customization Spectacle Lens Wear on Visual Performance in Myopic Chinese Children ABSTRACT PURPOSE: This study aimed to compare the visual performance of myopic children wearing individualized ocular refraction customization (IORC) lenses with different amounts of myopic defocus (MD) to determine whether higher MD resulted in greater visual compromise. METHODS: 184 myopic children aged eight to 12 years participated in the study, with 172 completing the trial. They were randomly assigned to wear IORC lenses with low (IORC-L, 2.50 D), medium (IORC-M, 3.50 D), or high (IORC-H, 4.50 D) MD, or single-vision spectacle lenses (SVL). Visual… ➡️➡️➡️

Efficacy of In-Office Treatments for Dentin Hypersensitivity Study Details This clinical trial evaluated in-office treatments for dentin hypersensitivity (DH) using different desensitizers: fluoride varnish (Duraphat), bioactive ceramic solution (Biosilicate), universal self-etching adhesive (Single Bond Universal), and bioactive photoactivated varnish (PRG filler). Findings The study found that all desensitizers tested were able to reduce initial sensitivity. The bioactive ceramic solution gradually reduced DH after 30 days using computerized analysis. Practical Solutions and Value Clinical trials like this one are essential for developing safe and effective treatments. Our AI-driven platform, DocSym, consolidates standards, protocols, and research into an easily accessible knowledge base… ➡️➡️➡️

Implementing Active Learning for Caries Detection: A Practical Economic Evaluation Key Findings: This trial-based economic evaluation aimed to estimate the incremental cost of implementing an active learning strategy (theoretical-practical workshop) to substitute the didactic lecture as the sole method for students training in caries detection. The incremental cost estimated for the workshop implementation would be $7.93 per student (interquartile range (IQR): $7.8-8.1), and the total cost of the teaching activity would be $684 (IQR:672-696). The laboratory training comprised more than 50% of the total amount spent, and a higher percentage of this value was related to human resources costs (72%).… ➡️➡️➡️

Long-term Impact of Weight-related Discussions on Children’s Well-being Study Overview Parents’ perspectives on discussing weight-related issues with children after obesity treatment were explored in a qualitative study as part of the More and Less study. This study is a 4-year follow-up of a randomized controlled trial evaluating the effectiveness of a parental support program in treating obesity in preschool-aged children in Stockholm, Sweden. Key Findings Parents emphasized the importance of discussing weight and health behaviors with their children, but found it challenging due to uncertainties about how to approach it safely and sensitively. They reported engaging in weight-related conversations with… ➡️➡️➡️