Safety profile

The Impact of Curcumin on Inflammation in Lupus Patients Study Overview This study focused on how curcumin, a compound from turmeric, affects inflammation in patients with systemic lupus erythematosus (SLE), a chronic autoimmune disease. Study Design Seventy SLE patients aged 18-60 participated in this randomized, triple-blinded, placebo-controlled trial. Out of these, 62 completed the study. The curcumin group took 1000 mg of curcumin daily, while the placebo group took inactive capsules for 10 weeks. Key inflammatory markers were measured before and after the treatment. Key Findings Curcumin significantly reduced two important inflammatory markers: Anti-double stranded DNA (anti-ds DNA): Decreased from… ➡️➡️➡️

Impact of L-carnitine Supplementation on Children on a Ketogenic Diet Study Overview The ketogenic diet (KD) is high in fat, moderate in protein, and low in carbohydrates. This diet can affect how the stomach empties and how quickly food moves through the intestines. Purpose of the Trial The main goal of this clinical trial was to see how L-carnitine supplementation affects stomach emptying in children with drug-resistant epilepsy (DRE) who are on a KD. A secondary goal was to evaluate how L-carnitine impacts bowel function and habits. Participants Thirty children aged 12 months to 18 years, who were newly diagnosed… ➡️➡️➡️

Multicentre Randomised Controlled Trial on Shoulder Instability (STABLE): Study Overview Introduction Recurrent shoulder dislocations can damage the labrum and lead to bone loss in the shoulder. There are two main treatment options: soft tissue repair and bone augmentation. However, the best treatment for patients with some bone loss is still unclear, and current practices vary widely. Methods and Analysis The STABLE trial is an ongoing study involving 114 patients with recurrent shoulder instability and minor bone loss (10%-20%). Participants will be randomly assigned to one of two treatments: Arthroscopic Capsuloligamentous Repair: Bankart repair combined with remplissage. Latarjet Procedure: Open or… ➡️➡️➡️

Cost-Effectiveness of Computer-Assisted Cognitive Behavioral Therapy for Depression Background About 1 in 5 adults experience depression, but less than half get help. Those with lower income and education face bigger challenges in accessing treatment. Computer-assisted cognitive behavioral therapy (CCBT) is a helpful and convenient method for treating depression, but we need to understand its cost-effectiveness for diverse populations. Study Objective We aimed to compare the cost-effectiveness of clinician-supported CCBT with standard treatment in a primary care setting, focusing on patients with low income and limited internet access. Study Design This analysis was part of a randomized clinical trial conducted at… ➡️➡️➡️

Clinical Efficacy of Combined Treatments for Diabetic Foot Ulcers Objective This study investigates how autologous platelet-rich gel (APG) combined with continuous vacuum-sealed drainage (CVSD) and recombinant human acidic fibroblast growth factor (rh-aFGF) can help heal diabetic foot ulcers (DFU). The goal is to understand the healing process better and find new treatment options. Methods Ninety patients with DFU were divided into three groups: Group A: Received CVSD after wound cleaning. Group B: Received CVSD and negative pressure wound therapy, with rh-aFGF added to saline for washing. Group C: Received APG along with the treatments from Group B. The effectiveness of… ➡️➡️➡️

Conventional Colonoscopy vs. Cap-Assisted Colonoscopy Introduction Colonoscopy is the main method for diagnosing colorectal cancer. However, the results for detecting polyps and adenomas have varied with different devices. Objectives This study aims to see if there are differences in the diagnostic performance of conventional colonoscopy (CC) versus cap-assisted colonoscopy (CAC) for adenoma detection. Materials and Methods We conducted a prospective randomized clinical trial comparing CC and CAC in a public reference hospital. Results We assigned 131 patients to either CC (64 patients) or CAC (67 patients). Key findings include: Shorter Cecal Intubation Time: CAC had a shorter average time (6… ➡️➡️➡️

Visual Performance of School-age Children Wearing Dual-Focus Soft Contact Lenses Background This study explores how dual-focus soft contact lenses (DFSCL) affect the vision of school-age children. Study Details We conducted a clinical trial with 64 children aged 8 to 12 years who needed vision correction. These children were divided into two groups: one group wore regular glasses (single vision spectacles or SVS), while the other group wore MiSight dual-focus soft contact lenses. Key Findings No major differences in corrected visual acuity between the two groups. Contrast sensitivity was similar for both groups. Children wearing glasses reported more eye discomfort (score… ➡️➡️➡️

Study Overview: SIMUL-CHD Trial Purpose Effective communication between doctors and patients is essential, especially when discussing serious conditions like congenital heart diseases. To address communication challenges faced by medical professionals, we are introducing a simulation-based training program for pediatric cardiology trainees. This study will work with associations that support families of children with congenital heart disease, showing how targeted training can improve compassionate care in healthcare settings. Methodology This study is a multicenter, open-label randomized controlled trial taking place in pediatric cardiac units and simulation centers across 10 universities in France. It will involve pediatric cardiology trainees, including fellows and… ➡️➡️➡️

Impact of Platelet-Rich Fibrin on Patient Recovery After Gum Surgery Study Overview This study looked at how platelet-rich fibrin (PRF) can help patients heal better after free gingival graft (FGG) surgery. PRF is a material that helps with tissue healing and can improve patient comfort and quality of life. What We Did We involved 39 participants who underwent FGG to improve gum health. They were divided into three groups: one using L-PRF, another using A-PRF, and a control group. Participants rated their pain, medication use, dietary changes, discomfort, and bleeding at different times during their recovery. We also assessed their… ➡️➡️➡️

Respiratory Complications in Children Under Anesthesia Study Overview This study looked at how different anesthesia methods affect respiratory issues in young children during fiberoptic bronchoscopy (FOB). Objective The goal was to compare the effects of propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years. Methods A total of 120 children were randomly assigned to one of three anesthesia groups: sevoflurane inhalation, 1 mg/kg propofol, or 1 μg/kg dexmedetomidine. We monitored their heart rate, blood pressure, sedation levels, and any respiratory complications during and after the procedure. Key Findings Heart Rate and Blood Pressure: The… ➡️➡️➡️

Randomized Trial of Very Early Medication Abortion Background Medication abortion using mifepristone and misoprostol is proven to be safe and effective. However, there is limited data on its effectiveness when the pregnancy is very early and not visible through ultrasound. Methods We conducted a multicenter trial involving women seeking medication abortion within 42 days of gestation, where the pregnancy was not confirmed by ultrasound. Participants were divided into two groups: one receiving immediate treatment (early-start group) and the other receiving standard care after pregnancy confirmation (standard group). The main goal was to see if complete abortion was achieved. Results A… ➡️➡️➡️

Significant Improvements in Atopic Dermatitis with Rocatinlimab Study Overview In a recent clinical trial, adult patients with moderate-to-severe atopic dermatitis (AD) were treated with rocatinlimab. This treatment showed **significant clinical improvements** compared to a placebo, particularly in the overall Eczema Area and Severity Index (EASI) score. Focus on Head and Neck Region AD often affects various body areas, and the **head and neck** is particularly challenging and can greatly impact quality of life. Our analysis looked into how effective rocatinlimab was in these sensitive areas. Key Findings – At **Week 16**, patients receiving rocatinlimab had a greater reduction in EASI… ➡️➡️➡️

The Effectiveness of a Problem-Solving Intervention in the Workplace Study Overview This study examines a problem-solving intervention with workplace involvement (PSI-WPI) aimed at reducing sick leave and improving work ability among employees. It focuses on individuals experiencing mild to moderate mental health issues after a sick leave episode. Key Findings Participants: 199 individuals were invited, with 81 receiving the intervention and 104 in the control group. Outcomes Measured: Self-reported sick leave, psychological symptoms, work ability, work performance, and health. Results: No significant differences were found between the intervention and control groups, except for a notable difference in self-rated health favoring… ➡️➡️➡️

Comparison of Teneligliptin and Luseogliflozin on Pancreatic β-cell Function Study Overview This study aims to compare the effects of two medications, SGLT2 inhibitors (luseogliflozin) and DPP-4 inhibitors (teneligliptin), on pancreatic β-cell function in patients with type 2 diabetes. Study Details We conducted a 26-week study with 103 patients who had type 2 diabetes. Participants were randomly assigned to take either luseogliflozin or teneligliptin. The main goal was to measure changes in β-cell function using an oral glucose tolerance test. Key Findings Improvement in β-cell Function: Both medications showed improvements in β-cell function, but luseogliflozin had a more significant effect on… ➡️➡️➡️

Long-Term Effects of Antenatal Betamethasone: Key Findings Study Overview This study looked at the health and social outcomes of individuals who were exposed to antenatal betamethasone 50 years ago. Antenatal corticosteroids are given to pregnant women at risk of preterm birth to help reduce complications for newborns. Methodology We followed 424 adults whose mothers participated in a major clinical trial. Mothers received either betamethasone or a placebo, and we evaluated various health and social outcomes through questionnaires and administrative data. Main Findings Overall, there were no significant differences in mental health, general health, or social outcomes between those who received… ➡️➡️➡️

Study on Pain Management for Chronic Low Back Pain Objective Chronic low back pain (CLBP) is a common health issue. This study aims to see if combining Pain Neuroscience Education (PNE) with neuromuscular exercises (NMS) can improve pain and overall well-being more than using NMS alone. Methods We will conduct a trial with 60 participants aged 30-60 with CLBP. They will be split into two groups: Group 1: 30 participants will receive 24 sessions of PNE plus NMS over 8 weeks. Group 2: 30 participants will receive 24 sessions of NMS only over 8 weeks. We will assess outcomes like… ➡️➡️➡️

National Liver Cancer Screening Trial (TRACER) Study Overview Background HCC Screening Recommendations: Guidelines suggest screening for liver cancer (HCC) in high-risk patients using ultrasound every six months, sometimes combined with a blood test for alpha-fetoprotein (AFP). However, this method often lacks effectiveness due to low patient adherence and sensitivity. Potential Solution: Blood-based biomarker panels, like GALAD—which includes sex, age, and three specific blood markers (AFP, AFP-L3, and des-carboxy prothrombin)—may improve screening effectiveness. Previous studies have shown that GALAD has a high rate of accuracy, but it needs further testing in a large trial. Methods Trial Design: The TRACER study is… ➡️➡️➡️

Understanding the Impact of Acupuncture on Generalized Anxiety Disorder Introduction: Generalized Anxiety Disorder (GAD) is a common mental health issue that often starts in adolescence or early adulthood. It results in persistent anxiety and can be worsened by Partial Sleep Deprivation (PSD), which is a significant risk factor for developing GAD. This condition can affect cognitive abilities, such as attention and control. Although acupuncture has shown promise in treating GAD and sleep issues, we need to better understand how it works, especially for those experiencing both GAD and PSD. Study Design: In this clinical trial, we will enroll 56 participants… ➡️➡️➡️

Whole-Volume Histogram Analysis of Spectral-Computed Tomography Iodine Maps in Gastric Cancer Background Surgery is the main treatment for gastric cancer (GC), but finding effective alternatives for patients who cannot have surgery is important. About 15%-20% of advanced GC cases show HER2 overexpression, which influences treatment choices. Spectral-computed tomography (sCT) helps measure material compositions, and its iodine concentration parameters can aid in diagnosing GC and predicting its depth of invasion, blood vessel growth, and response to chemotherapy. However, predicting HER2 status in GC using sCT iodine maps has not been reported before. Aim The goal of this study was to see… ➡️➡️➡️

Biomarkers of Glucose-Insulin Homeostasis and Their Impact on Type 2 Diabetes and Cardiovascular Disease Study Overview This study investigates how certain biomarkers related to glucose and insulin levels can predict the risk of developing type 2 diabetes (T2D) and cardiovascular disease (CVD). It also explores whether vitamin D and omega-3 fatty acids can influence these risks. Key Findings Study Design: The VITamin D and OmegA-3 TriaL (NCT01169259) was a randomized clinical trial lasting about 5.3 years. Participants: The study included 218 pairs of individuals with T2D and 715 pairs with CVD. Biomarkers Assessed: Insulin, C-peptide, HbA1c, and a new insulin… ➡️➡️➡️