Safety profile

HEV Vaccine and Fetal Loss in Rural Bangladesh Practical Solutions and Value Vaccination is an important way to control hepatitis E virus (HEV), which is a significant cause of maternal and perinatal mortality worldwide. However, a study of pregnant women in Bangladesh receiving the HEV vaccine HEV239 showed a potential link to fetal losses. This analysis aims to provide a detailed understanding of this safety signal. In a trial, non-pregnant women aged 16-39 in 67 villages in Bangladesh were randomly assigned to receive either HEV239 or a hepatitis B vaccine (Hepa-B). The study implemented regular pregnancy surveillance and follow-up to… ➡️➡️➡️

Sequence of Morphological Changes Preceding Atrophy in Intermediate AMD Using Deep Learning ABSTRACT PURPOSE: Investigating the sequence of morphological changes preceding outer plexiform layer (OPL) subsidence, a marker preceding geographic atrophy, in intermediate AMD (iAMD) using high-precision artificial intelligence (AI) quantifications on optical coherence tomography imaging. METHODS: In this longitudinal observational study, individuals with bilateral iAMD participating in a multicenter clinical trial were screened for OPL subsidence and RPE and outer retinal atrophy. OPL subsidence was segmented on an A-scan basis in optical coherence tomography volumes, obtained 6-monthly with 36 months follow-up. AI-based quantification of photoreceptor (PR) and outer nuclear… ➡️➡️➡️

Targeted Vibratory Therapy for Chronic Low Back Pain in Older Patients Introduction As people age, their proprioceptive function declines, leading to issues such as falls, pain, and difficulty in daily activities. This clinical trial aimed to investigate the effectiveness of targeted vibratory therapy (TVT) in improving proprioceptive function and alleviating chronic low back pain (LBP) in older patients. Methods The trial involved older patients with non-specific chronic LBP. TVT consisted of applying vibratory stimulation matching the frequency of dysfunctional receptors for 1 minute daily over 14 days. Patients performed TVT three times daily at home. TVT was tailored to the… ➡️➡️➡️

Diagnosing Solid Lesions in the Pancreas With Multimodal Artificial Intelligence: A Randomized Crossover Trial Summary Artificial intelligence (AI) can help diagnose solid lesions in the pancreas from endoscopic ultrasonographic (EUS) images. This study developed a multimodal AI model integrating clinical information and EUS images to improve diagnosis. Key Findings The joint-AI model showed high performance in both internal and external test datasets, with the ability to enhance the diagnostic accuracy of novice endoscopists. Experienced endoscopists also benefited from supplementary interpretability information provided by the AI. Practical Solutions and Value The study suggests that the joint-AI model has the potential to… ➡️➡️➡️

Effects of Low-Dose Ketamine Infusion on Hopelessness and Suicidal Thoughts Background Low-dose ketamine infusion has been shown to reduce suicidal thoughts in patients with treatment-resistant depression (TRD) and strong suicidal ideation. However, its effects on hopelessness have been less studied. Methods 84 patients with TRD and strong suicidal ideation were randomly assigned to receive a single infusion of either 0.5 mg/kg ketamine or 0.045 mg/kg midazolam. Hopelessness and suicidal symptoms were assessed at various time points post-infusion using the Beck Hopelessness Scale (BHS) and Positive and Negative Suicide Ideation Inventory (PANSI). Results Analysis revealed that the ketamine group had significantly… ➡️➡️➡️

High Flow Nasal Cannula Oxygen Therapy vs Non-Invasive Ventilation for COPD Key Findings A clinical trial compared high-flow nasal cannula oxygen therapy (HFNC) with non-invasive ventilation (NIV) for COPD patients with acute-moderate hypercapnic respiratory failure. The trial found that HFNC was not shown to be non-inferior to NIV and resulted in a higher incidence of treatment failure than NIV when used as the initial respiratory support for these patients. Practical Solutions and Value This trial provides important insights into the initial treatment options for COPD patients with acute-moderate hypercapnic respiratory failure. Healthcare providers can use this information to make informed… ➡️➡️➡️

Effect of Music Therapy Combined with Aerobic Exercise on Sleep Quality among Breast Cancer Patients BMC Womens Health. 2024 Jul 18;24(1):408 Purpose: This study aimed to investigate the impact of music therapy combined with aerobic exercise on the sleep quality of breast cancer patients undergoing chemotherapy after a radical mastectomy. Methods: A randomized controlled trial was conducted at the Breast Disease Diagnosis and Treatment Center, Shaanxi Province Tumor Hospital, from July 2017 to June 2019. 110 female breast cancer patients who underwent a radical mastectomy were randomly assigned to either an intervention group or a control group. The intervention group… ➡️➡️➡️

Community Case Detection Tool for Mental Health Care in Ugandan Refugee Settlements: Clinical Trial Results Background Strategies to promote mental health care help-seeking among children are crucial, especially in low-income and complex settings. This trial aimed to compare a proactive case detection tool (CCDT) against standard awareness raising for promoting mental health help-seeking among children and adolescents. Methods The trial was conducted in Ugandan refugee settlements using a stepped wedge cluster randomised design. Community gatekeepers received training on using the CCDT to detect children with mental health concerns and encourage them to use mental health-care services. The primary outcome was… ➡️➡️➡️

Assessing the Clinical Effectiveness of Exergame-Based Exercise Training Program Using Ring Fit Adventure for Older Adults in Long-Term Care Facilities Background Frailty and sarcopenia are common among older adults in long-term care facilities (LTCFs) and can lead to health issues. Implementing exercise programs in LTCFs, especially in rural areas, can be challenging due to staff shortages. The Nintendo Switch Ring Fit Adventure (RFA) exergame offers a potential solution by providing a more engaging exercise experience and reducing staff intervention needs. Objective The study aimed to evaluate the effectiveness of an exergame-based exercise program using RFA in improving muscle mass and… ➡️➡️➡️

Ritlecitinib: A Breakthrough in Vitiligo Treatment Published in Arch Dermatol Res, a clinical trial showed that ritlecitinib, an oral JAK3/TEC family kinase inhibitor, significantly stabilized active lesions and repigmented stable lesions in patients with non-segmental vitiligo. Key Findings: Ritlecitinib 50 mg demonstrated significant stabilization of depigmentation extent in both active and stable lesions compared to placebo. Stable lesions showed greater repigmentation after 24 weeks of treatment with ritlecitinib 50 mg. Ritlecitinib 50 mg increased expression of melanocyte markers in stable lesions and decreased Th1/Th2-related and co-stimulatory molecules in both stable and active lesions. Data confirmed at transcription/protein levels indicate that… ➡️➡️➡️

Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT Practical Solutions and Value Highlights Atopic eczema is a common childhood skin problem connected with asthma and allergies, affecting quality of life. The study aimed to determine if advising parents to apply daily emollients in the first year can prevent eczema and other allergic conditions in high-risk children. A pragmatic clinical trial was conducted in the UK involving healthy infants at high risk of developing eczema. Infants were randomized to apply emollient daily or receive standard skincare advice only. The primary outcome found no evidence that daily… ➡️➡️➡️

The effects of regular home delivery of HIV self-testing and follow-up counselling on HIV testing and prevention outcomes in men who have sex with men who test infrequently in the United States: a pragmatic, virtual randomized controlled trial J Int AIDS Soc. 2024 Jul;27(7):e26318. doi: 10.1002/jia2.26318. INTRODUCTION: Research has shown that HIV self-testing (HIVST) can lead to increased testing and more HIV diagnoses compared to clinic testing. However, concerns in the United States about HIVST users being less likely to seek care have limited its use. METHODS: From January 2019 to April 2022, 811 men who have sex with men… ➡️➡️➡️

The Role of Vitamin D in Management of Oral Lichen Planus Background and Objectives Oral lichen planus (OLP) is an immune-mediated inflammatory disease affecting the oral mucosa. Vitamin D (VD) has been studied for its potential immune-modulatory and anti-inflammatory effects in managing OLP. This study aimed to investigate the role of VD in the management of VD-deficient OLP patients and its effect on IFN-γ levels. Methods 40 OLP patients were randomly assigned to receive systemic steroids with VD supplements or systemic steroids only. Blood samples were collected to measure VD levels and evaluate clinical symptoms. Salivary and tissue IFN-γ levels… ➡️➡️➡️

The Effect of USM-IAM-based Counselling vs Standard Counselling on Insulin Adherence, FBS, and HbA1c among Patients with Uncontrolled Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial Abstract Many patients with T2DM on insulin struggle with control despite standard counselling. To address poor insulin adherence, we developed and assessed a new counselling module, USM-IAM, for poorly controlled diabetes patients on insulin therapy. Methods Patient eligibility included T2DM diagnosis, age 18-65, HbA1c levels between 8-15%, and one year of insulin therapy. Patients were randomly assigned to receive either USM-IAM-based counselling or standard counselling at baseline and a follow-up visit. They were… ➡️➡️➡️

Effectiveness of Extracorporeal Shock Wave Therapy on Functional Ability in Grade IV Knee Osteoarthritis Summary Extracorporeal shockwave therapy (ESWT) is a non-invasive treatment for knee osteoarthritis (OA). This study aimed to assess the effects of ESWT on functional ability in grade IV KOA patients. The trial showed that adding ESWT to conventional physiotherapy (CPT) significantly improved lower extremity functional scale (LEFS) scores compared to CPT alone. Practical Solutions and Value Our trial results demonstrate that incorporating ESWT into CPT can effectively improve functional disability in grade IV primary KOA patients. This finding has the potential to enhance patient care and… ➡️➡️➡️

Reliability of Impedance Spectroscopy in Occlusal Caries Detection Key Findings: The study compared the performance of alternating current impedance spectroscopy (ACIST) with digital radiograph (DR) and ICDAS-II in detecting occlusal carious lesions. Results showed excellent agreement in the different groups, with ACIST proving to be a reliable tool for detecting occlusal caries in dentin. Visual-tactile examination was considered a feasible and valid technique for occlusal caries detection. DR was found to be superior to ACIST in diagnosing enamel caries, but it could underestimate the caries depth. ACIST had higher sensitivity for dentinal caries detection, while DR had higher specificity. Practical… ➡️➡️➡️

ObiVas Study Overview Introduction ANCA-associated vasculitis (AAV) is a condition where relapses can lead to severe organ damage, necessitating prolonged immunosuppressive therapy. Rituximab, the current standard of care, may not always be effective and is linked to a high relapse risk. Obinutuzumab is a potential alternative with the ability to achieve better tissue B cell depletion and reduce relapse risk in AAV. Methods and Analysis The ObiVas trial is a phase II, double-blind controlled study comparing the effects of rituximab and obinutuzumab in treating AAV patients. 26 patients will be recruited to receive either rituximab or obinutuzumab alongside a tapering… ➡️➡️➡️

Altered States of Consciousness Caused by Mindfulness-Based Programme: Results from a Randomised Controlled Trial Background Mindfulness-based programmes (MBPs) have shown positive effects on mental health. There is evidence that MBPs may also lead to significant changes in waking consciousness. This study aimed to explore the causal role of MBPs in different types of altered states of consciousness. Methods We conducted a pragmatic randomised controlled trial with University of Cambridge students. Participants were randomised to an 8-week MBP plus mental health support as usual (SAU), or to SAU alone. We used the Altered States of Consciousness Rating Scale (OAV) to assess… ➡️➡️➡️

Opioid-sparing Effect of Erector Spinae Plane Block and Intravenous Dexmedetomidine for Obese Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial Objective: This study aimed to evaluate the impact of erector spinae plane block (ESPB) and intravenous (IV) dexmedetomidine in reducing opioid consumption after bariatric surgery and their effects on post-operative recovery, pain relief, and lung functions. Design: A randomized controlled trial. Location: Tanta University Hospitals, Tanta, Gharboa, Egypt. Participants: Forty obese patients with obstructive sleep apnea syndrome (OSAS), aged 20-55 years, eligible for bariatric surgery. Interventions: Patients were assigned to group I (received general anesthesia with opioid, sham ESPB,… ➡️➡️➡️

Key Findings from Clinical Trial Practical Solutions for Chronic Low Back Pain Management Participants with opioid-treated chronic low back pain (CLBP) reported various pain management strategies as helpful. Medication, physical activity, and stretching remained stable over time. However, passive management strategies like body position and thermal application declined, while psychological strategies showed increased usage. Value of the Study The study highlights the importance of integrating active pain management strategies and psychological interventions for effective self-management of CLBP. Importance of Clinical Trials Clinical trials play a crucial role in developing safe and effective treatments. It’s essential to translate their findings into… ➡️➡️➡️