Clinical research

Web-Based Cognitive Behavioral Treatment for Bulimia Nervosa: A Randomized Clinical Trial Practical Solutions and Value Despite effective treatments for bulimia nervosa (BN), many individuals do not receive evidence-based therapies. Integrating digital interventions into routine care can reach more patients and reduce the clinical burden of BN. A web-based cognitive behavioral self-help intervention was evaluated for effectiveness in individuals with BN. The intervention included 12 weekly modules and was compared with a waiting-list control group with access to routine care. The results showed that participants receiving the web-based intervention demonstrated a significantly greater decrease in bulimic episodes compared with the control… ➡️➡️➡️

Prediction of Long-Term Treatment Outcomes for Diabetic Macular Edema Using a Generative Adversarial Network ABSTRACT The study aimed to use generative adversarial networks (GANs) to analyze optical coherence tomography (OCT) images for predicting diabetic macular edema outcomes after long-term treatment. METHODS Diabetic macular edema (DME) eyes (n = 327) from a randomized controlled trial underwent anti-vascular endothelial growth factor (VEGF) treatments every 4 weeks for 52 weeks. GAN models were trained to generate probable OCT images after treatment using various combinations of input images. RESULTS Various GAN models showed positive predictive value, sensitivity, specificity, and kappa for residual fluid and… ➡️➡️➡️

Can Biomarkers Predict Ventilator-associated Pneumonia in Patients After Cardiac Arrest? Summary Ventilator-associated pneumonia (VAP) is a common complication after cardiac arrest, but diagnosing it accurately remains a challenge. This study aimed to evaluate the usefulness of biomarkers in diagnosing VAP in post-cardiac arrest patients. Study Design This study was part of the ANTHARTIC trial, a multicenter, double-blind placebo-controlled trial focusing on antibiotic prophylaxis to prevent VAP in out-of-hospital cardiac arrest patients treated with therapeutic hypothermia. Findings Among the patients included in the study, those who developed VAP showed distinct clinical characteristics and higher levels of certain biomarkers, including CRP, interleukin… ➡️➡️➡️

Impact of Coenzyme Q10 as Adjuvant Therapy to Letrozole Spermiogram Results and Sex Hormone Levels in Iraqi Men with Infertility Background: Infertility affects about 15% of reproductive-age couples globally. The clinical trial aimed to assess the effects of adding Coenzyme Q10 (CoQ10) to letrozole on the spermiogram and sex hormone levels in men with idiopathic oligoasthenoteratozoospermia (iOAT) syndrome. Methods: The study involved 67 adult male patients diagnosed with iOAT syndrome. Patients were divided into two groups: Group A received letrozole alone, and Group B received a combination of letrozole and CoQ10. Both groups completed a three-month treatment regimen. Results: Both… ➡️➡️➡️

Peer2Me: A Peer-Supported Program for AYA Cancer Patients Study Protocol of a Randomised Trial Using a Comprehensive Cohort Design Background: Young adult cancer patients often experience psychological distress and unmet support needs. The Peer2Me intervention aims to provide peer support to AYA cancer patients to enhance self-efficacy and coping with the disease. Methods: The study will enroll 180 AYA patients in active cancer treatment, randomized to receive the Peer2Me intervention or a single AYA-specific consultation. Mentees and mentors are matched based on diagnosis, age, and gender. The primary outcome is self-efficacy, with secondary outcomes including anxiety, depression, health literacy, life… ➡️➡️➡️

Effect of Cuff Inflation with Lidocaine, Saline, and Air on Tracheal Tube Cuff Pressure during Laparoscopic Resection of Colorectal Neoplasms: A Randomized Clinical Trial BMC Anesthesiol. 2024 Jul 1;24(1):216. doi: 10.1186/s12871-024-02606-6. Background: This trial aimed to determine if inflating tracheal tube cuffs with normal saline or lidocaine can prevent an increase in cuff pressure and tracheal mucosal damage during laparoscopic surgeries with general anesthesia. Additionally, the study sought to assess the predictive value of changes in tracheal tube cuff transverse diameter for changes in cuff pressure. Methods: Ninety patients undergoing laparoscopic resection of colorectal neoplasms were randomly assigned to groups… ➡️➡️➡️

Evaluating Subthreshold Micropulse Laser Combined with Ranibizumab for Diabetic Macular Edema Study Overview A study was conducted to assess the effectiveness and safety of using subthreshold micropulse laser (SMPL) in combination with ranibizumab for treating diabetic macular edema (DME). Patients were randomly assigned to receive either ranibizumab monotherapy or the combination therapy. Key Findings Both treatment groups showed significant improvement in visual acuity and reduction in central macular thickness at 6 and 12 months. No statistically significant difference was observed between groups for these measures. Combination therapy led to a significant increase in vessel density of the deep capillary plexus… ➡️➡️➡️

Feasibility of Cardiac Brief Intervention for ST-elevation Myocardial Infarction Patients Key Points: Patients often experience emotional distress and misconceptions after a heart attack. This study aims to assess the feasibility of providing a nurse-led, 20-minute emotional and educational support discussion, along with a memory-aid leaflet, to patients before discharge from the hospital. Participants will be recruited from two hospital centers in Northern Ireland, with half receiving the intervention and the other half receiving standard care information. Data will be collected at various time points to evaluate the intervention’s impact and feasibility. The study aims to address the educational and emotional… ➡️➡️➡️

Efficacy, Safety, Satisfaction, Adherence to Treatment With Nano-Formulated Cysteamine Tranexamic Acid Cream to Treat Melasma Key Findings An innovative cream combining cysteamine and tranexamic acid (TXA) showed significant improvement in treating subjects with epidermal melasma. Results Continuous improvement in melasma was observed, with modified Melasma Area and Severity Index (mMASI) scores improving by 40%, 57%, and 63% at 30, 60, and 90 days, respectively. 91% of participants experienced melasma improvement. Conclusion Nano-formulated cysteamine and TXA combination cream demonstrated significant efficacy in decreasing mMASI score while maintaining a strong safety profile and high patient satisfaction. Practical Solutions and Value Clinical trials… ➡️➡️➡️

Textured Insoles Feasibility Trial for Children with Motor Coordination Issues Summary Textured insoles may improve balance measures in children with motor coordination issues, but do not show significant impact on endurance measures. The trial aimed to assess the feasibility of conducting a randomised controlled trial for children with motor coordination issues and to evaluate the limited efficacy of textured insoles on gross motor assessment balance domains and endurance. Practical Solutions and Value The trial found that using a larger multi-disciplinary organization for recruitment, providing velcro shoe fixtures, and using a shorter timed walk test can improve the feasibility of the… ➡️➡️➡️

Re-evaluating Insomnia Severity Index in Clinical Trials Key Findings and Practical Solutions Background: The Insomnia Severity Index (ISI) is commonly used to assess insomnia severity, but different research findings have led to variations in defining meaningful within-individual change (MWIC) for treatment response. Methods: We analyzed data from two large clinical trials of lemborexant to improve the validation of ISI. By using a two-factor solution based on 6 items, we determined the MWIC through different methods, including anchor-based, distribution-based, and ROC curve approaches. Results: The 6-item two-factor scale demonstrated better psychometric properties than the 7-item scale, and a 5-point reduction in… ➡️➡️➡️

Comparing Performance of Primary Care Clinicians in the Interpretation of SPIROmetry with or without Artificial Intelligence Decision Support Software (SPIRO-AID): A Protocol for a Randomised Controlled Trial ABSTRACT Spirometry, a lung function test, is crucial for diagnosing and monitoring chronic lung disease. However, its interpretation in primary care varies in quality and accuracy. This study aims to assess whether artificial intelligence (AI) decision support software can enhance primary care clinicians’ performance in interpreting spirometry. METHODS AND ANALYSIS A randomised controlled trial will involve primary care clinicians in the UK, assessing their interpretation of fifty de-identified patient spirometry sessions with or… ➡️➡️➡️

Predictors of long-term progression-free survival in ovarian cancer patients treated with niraparib Key Findings In a study on advanced ovarian cancer patients receiving niraparib maintenance therapy, certain factors were found to be associated with long-term progression-free survival (≥2 years). Practical Implications The study identified that patients with BRCA1/2 mutation/homologous recombination-deficiency status, FIGO stage III, and fewer baseline non-target lesions were more likely to achieve long-term progression-free survival. Value in Clinical Practice Understanding these predictors can help clinicians in making treatment decisions and providing personalized care to patients with advanced ovarian cancer. About the Study This post hoc analysis of the… ➡️➡️➡️

Exploring Relations Between Unique Patient Characteristics and Virtual Reality Immersion Level on Anxiety and Pain in Patients Undergoing Venipuncture: Secondary Analysis of a Randomized Control Trial ABSTRACT Virtual reality (VR) has been widely studied as a digital tool for managing acute pain and anxiety in pediatric patients during medical procedures. This study investigates how specific patient characteristics and the level of immersion in VR impact anxiety and pain levels during venipuncture procedures. OBJECTIVE The study aims to determine how patient characteristics and VR immersion level affect anxiety and pain levels in pediatric patients undergoing venipuncture. METHODS The study is a… ➡️➡️➡️

Exercise-Induced Oxygen Desaturation and Arterial Stiffness in COPD Patients Study Overview This study aimed to investigate the impact of exercise-induced oxygen desaturation (EID) on arterial stiffness in individuals with COPD. Patients underwent the 6-minute walk test (6-MWT) with continuous monitoring of blood oxygen saturation (SpO2) to assess the acute effects of exercise on arterial stiffness. Key Findings The study classified patients into three groups based on EID severity: non-EID, mild-EID, and severe-EID. The results showed that severe-EID was associated with a significant increase in arterial stiffness during exercise, compared to non-EID and mild-EID groups. Multivariable analysis confirmed severe-EID as an… ➡️➡️➡️

Study Title: Calcium Dibutyryl Adenosine Cyclophosphate Enhances the Effect of Metoprolol in Treating Older Adults With Heart Failure Combined With Arrhythmia Objective: To investigate the effectiveness and safety of combining calcium dibutyryl adenosine cyclophosphate (dbcAMP-Ca) with metoprolol in treating older adults with heart failure and arrhythmia. Methods: – 102 elderly patients were enrolled and randomly assigned to a control group (n=51) and an experimental group (n=51). – The control group received metoprolol, while the experimental group received dbcAMP-Ca in addition to metoprolol. – Both groups were treated for 4 weeks, and various clinical parameters were measured. Results: – The experimental… ➡️➡️➡️

Low Pressure versus Standard Pressure Pneumoperitoneum in Laparoscopic Appendectomy: A Randomized Controlled Trial Key Findings The use of low pressure pneumoperitoneum did not reduce the incidence of abdominal pain in patients who had laparoscopic appendectomy. Patients with acute appendicitis can be treated with either low or normal pressure pneumoperitoneum depending on the experience of the surgeon. Practical Solutions Clinical trials are crucial for safe and effective treatments. Our AI-driven platform, DocSym, consolidates ICD-11 standards, clinical protocols, and research into a single, easily accessible knowledge base for clinicians, extending the benefits of clinical trials into everyday medical practice. Value in Healthcare… ➡️➡️➡️

Efficacy and Safety of Combination Therapy for Schistosomiasis in Kenyan Children Introduction Reliance on praziquantel for treating schistosomiasis may lead to drug resistance. We evaluated the efficacy and safety of combining praziquantel with artesunate plus sulfalene-pyrimethamine in Kenyan children with schistosomiasis. Methods 426 children aged 7-15 were randomly assigned to receive praziquantel alone, artesunate plus sulfalene-pyrimethamine alone, or a combination of both. Cure and egg reduction rates were assessed 6 weeks post-treatment, and adverse events were monitored. Results The combination therapy showed promising results, with higher cure rates for S. haematobium-infected children compared to the individual treatments. Adverse events were… ➡️➡️➡️

Empagliflozin Reduces Ventricular Arrhythmias in Type 2 Diabetes Patients Study Overview Sodium-glucose cotransporter 2 (SGLT2) inhibitors like empagliflozin have shown benefits in reducing heart failure and cardiovascular death in type 2 diabetes patients. This study aimed to investigate the effects of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes who were treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator (ICD/CRT-D). Results Patients treated with empagliflozin showed a decrease in the number of ventricular arrhythmias recorded by ICD/CRT-D during treatment compared to before treatment, while the placebo group showed an increase. The change in the number of… ➡️➡️➡️

Exploring the Impact of Link Workers on Multimorbidity in Deprived Communities Overview An exploratory trial was conducted to assess the feasibility, impact, and cost effectiveness of using link workers to connect individuals with multiple health conditions to non-clinical supports in deprived urban communities. The study aimed to evaluate the benefits of this approach on health outcomes and cost effectiveness, particularly during the COVID-19 pandemic. Key Findings 251 patients from 13 general practices participated in the trial, with an 80% retention rate at the one-month mark. Although no significant differences were found in health-related quality of life and mental health outcomes,… ➡️➡️➡️