Safety profile

Study Title A study on the effectiveness of low-dose olanzapine in preventing nausea and vomiting during chemotherapy Objective To evaluate the effectiveness of 5 mg olanzapine in preventing chemotherapy-induced nausea and vomiting (CINV) in female patients with gastrointestinal tract tumors undergoing moderately emetogenic chemotherapy (MEC). Methods Patients received either 5 mg olanzapine with palonosetron and dexamethasone or a standard two-drug combination of dexamethasone and palonosetron. The study assessed total protection rates, total control rates, complete remission rates, and quality of life, as well as collected adverse events data. Results 1) The olanzapine group showed higher total protection rates compared to… ➡️➡️➡️

GLORIA Trial: Combining CXCL12 Inhibition and Radiotherapy in Glioblastoma Key Findings: The GLORIA trial combined radiotherapy with the CXCL12-neutralizing aptamer olaptesed pegol (NOX-A12) in patients with newly-diagnosed glioblastoma. The study found that the treatment was safe and well-tolerated, with no dose-limiting toxicities or treatment-related deaths. Increasing the NOX-A12 dose levels led to higher NOX-A12 plasma levels, and a significant proportion of patients showed radiographic responses, with some reaching partial remission. The median progression-free survival (PFS) was 174 days, and the median overall survival (OS) was 389 days. Notably, higher frequency of CXCL12+ endothelial and glioma cells was associated with longer… ➡️➡️➡️

ASSIST Trial: Impact of Strength Exercise Volume on Insulin Sensitivity in Obese Adults Overview The ASSIST trial aims to investigate the effects of high- and low-volume strength exercise sessions on insulin sensitivity in obese adults, providing valuable insights for personalized exercise prescription. Background Type 2 diabetes mellitus is characterized by impaired insulin action, and acute strength exercise has been shown to improve insulin sensitivity. However, the impact of variations in exercise volume on insulin sensitivity remains unclear. This study seeks to address this gap by comparing high-volume (21 total sets) and low-volume (7 total sets) strength exercise sessions, as well… ➡️➡️➡️

Progesterone for Neurodevelopment in Fetuses With Congenital Heart Defects: A Randomized Clinical Trial ABSTRACT Importance: Children with congenital heart defects (CHD) have seen minimal improvement in neurodevelopmental outcomes over the past 20 years. Objectives: Evaluate the feasibility and tolerability of maternal progesterone therapy and its impact on neurodevelopment in fetuses with CHD. Design, Setting, and Participants: A double-blinded clinical trial was conducted at a children’s hospital from July 2014 to November 2021, involving maternal-fetal dyads carrying fetuses with CHD identified before 28 weeks’ gestational age. Exclusion criteria included major genetic anomalies and known contraindications to progesterone. Intervention: Participants were randomized… ➡️➡️➡️

Phase 1 Study of CK0801 in Treatment of Bone Marrow Failure Syndromes Background An inflammatory bone marrow microenvironment contributes to acquired bone marrow failure syndromes. CK0801, an allogeneic T regulatory (Treg) cell therapy product, can potentially interrupt this continuous loop of inflammation and restore hematopoiesis. Methods In this phase 1 dose-escalation study of CK0801 Treg cells, we enrolled patients with bone marrow failure syndromes with suboptimal response to their prior therapy to determine the safety and efficacy of this treatment for bone marrow failure syndromes. Results We enrolled nine patients with a median age of 57 years with an underlying… ➡️➡️➡️

Long-Term Changes of Urinary Exosomal Peptide Levels After Thyroidectomy in Patients with Thyroid Cancer: A Prospective Observational Study ABSTRACT The study aimed to investigate the potential of urine exosomal peptide levels to predict the risk of thyroid cancer recurrence after thyroidectomy. METHODS Patients newly diagnosed with papillary thyroid cancer and who had undergone thyroidectomy were included. Urine samples were collected at 12 months and 24 months after enrollment, and urine exosomes containing different peptides were analyzed. RESULTS 70 patients were enrolled, categorized by the time interval between surgery and enrollment. No recurrences were observed during the 2-year follow-up. No significant… ➡️➡️➡️

Phase 1 Study of MK-5475 for Pulmonary Hypertension in COPD Patients Key Findings: This study assessed the safety and effectiveness of MK-5475 in COPD patients with pulmonary hypertension. The results showed a favorable safety profile and numerical reductions in pulmonary vascular resistance, supporting further development of MK-5475 for PH-COPD treatment. Practical Solutions and Value: Clinical trials are essential for developing safe and effective treatments. Our AI-driven platform, DocSym, consolidates standards, protocols, and research into an easily accessible knowledge base for clinicians, helping to extend the benefits of clinical trials into everyday medical practice. In today’s healthcare environment, streamlining operations is… ➡️➡️➡️

Association between insulin sensitivity and lean mass loss during weight loss Objective The study aimed to assess the relationship between insulin sensitivity and changes in total lean mass (LM) and appendicular LM (ALM) during weight loss. Methods Individuals were randomly assigned to either a standard or a moderately reduced carbohydrate diet for 16 weeks. Body composition was assessed using dual-energy x-ray absorptiometry and insulin sensitivity index (SI) using an intravenous glucose tolerance test. Multiple linear regression was used to determine whether baseline SI was predictive of changes in total LM and ALM. Results Participants (n = 57; baseline BMI 32.1… ➡️➡️➡️

Comparison of Feedback-Based Learning and Traditional-Based Training for Operating Room Technology Students Background Effective feedback is crucial in clinical education to identify weaknesses and intervene at the right times. This study compared the effects of apprenticeship training using sandwich feedback and traditional methods on the perioperative competence and performance of Operating Room (OR) technology students. Methods Thirty final-semester OR technology students were randomly assigned to either Feedback-Based Learning (FBL) using a sandwich model or Traditional-Based Training (TBT) for three consecutive weeks. The students completed the Perceived Perioperative Competence Scale-Revised (PPCS-R) and were evaluated via Direct Observation of Procedural Skills (DOPS).… ➡️➡️➡️

Comparison of Vitality Test with Sensitivity Tests in Mature and Immature Teeth: Clinical Trial Abstract One of the crucial steps in deciding on tooth treatment is determining the vitality and health status of the pulp. This study compares pulse oximetry (PO), electric pulp test (EPT), and cold test in both mature and immature permanent teeth. Methods 20 immature and 20 mature permanent incisors of 6-12-year-old ASA1 children were included. Pulp vitality was determined using EPT, cold test, and PO. The study used a PO device (CMS60D, Contec Medical Systems Co. Ltd, China) to measure the SpO2 of the teeth. Statistical… ➡️➡️➡️

Internet of Things-Based Home Respiratory Muscle Training for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial Abstract Purpose: This study aims to assess the effectiveness of Internet of Things (IoT)-based home respiratory muscle training (RMT) for patients with chronic obstructive pulmonary disease (COPD). Patients and Methods: Seventy-eight patients with COPD were randomly divided into two groups. The intervention group received IoT-based home RMT twice daily for 12 weeks, while the control group received routine health education. Assessments were conducted pre-intervention and 12 weeks post-intervention. Results: The intervention group showed improvements in lung function, respiratory muscle strength, dyspnea scale,… ➡️➡️➡️

Effectiveness of a Self-Help Guide for Alcohol Abstinence Key Findings The study aimed to assess the impact of a self-help guide on successful completion of a temporary alcohol abstinence challenge and changes in drinking refusal self-efficacy, behavioral automaticity, craving, and alcohol consumption. After 8 months, all participants experienced a significant decrease in behavioral automaticity, craving, and alcohol consumption, regardless of group assignment. No significant changes were observed in drinking refusal self-efficacy. The self-help guide did not add value to the temporary abstinence challenge. Conclusion Future research should focus on more personalized support for participants during temporary abstinence challenges. Clinical Trials… ➡️➡️➡️

Laser Hemorrhoidoplasty vs. Rubber Band Ligation: A Comparison Study Purpose Investigating the clinical efficacy of Laser Hemorrhoidoplasty (LHP) for grade II hemorrhoids as a minimally invasive procedure. Methods 70 patients with grade II hemorrhoids were randomly assigned to receive LHP or Rubber Band Ligation (RBL). Postoperative pain, bleeding, feeling of anal distension, and recurrence rate were compared between the two groups. Results LHP group showed significantly improved postoperative pain, bleeding, and feeling of anal distension within 2 weeks after surgery compared to RBL group (P < 0.01). Both methods effectively relieved grade II hemorrhoid symptoms. No difference in recurrence rate… ➡️➡️➡️

Protocol for CHAMPION study Practical Solutions and Value The CHAMPION study aims to assess the effectiveness of a multi-modal treatment approach for newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) patients with a limited number of distant metastatic sites. The study focuses on the use of PSMA PET/CT-guided cytoreduction in combination with apalutamide and androgen deprivation therapy (ADT) to improve patient prognosis. Study Details CHAMPION (NCT05717582) is an open-label, single-arm, phase II trial enrolling mHSPC cases with ≤ 10 distant metastatic sites. Patients will receive 6 cycles of apalutamide plus ADT. Those with oligometastatic disease at PSMA PET/CT after 3 treatment… ➡️➡️➡️

Comparing the Efficacy of Digital and In-Person Weight Loss Interventions for Patients with Obesity and Glycemic Disorders: Evidence from a Randomized Non-Inferiority Trial Abstract Digital weight loss interventions offer a cost-effective alternative to traditional therapy. This trial aimed to compare the effects of an intensive in-person weight loss intervention program with Vitadio digital therapy for patients with obesity and glycemic disorders. The study demonstrated comparable effectiveness of both treatments for weight reduction. The positive effects of Vitadio were further evidenced by favorable changes in body composition and lipid metabolism, as well as improved glycemic control. Clinical Trials and Practical Solutions… ➡️➡️➡️

Bioavailability of Lutein from Marigold Flowers (Free vs. Ester Forms): A Randomised Cross-Over Study to Assess Serum Response and Visual Contrast Threshold in Adults Published in Nutrients. 2024 May 8;16(10):1415. doi: 10.3390/nu16101415. Lutein (Lut) and zeaxanthin (Zeax) are important for eye health and are found in the blood and retina. They are present in the diet as free forms and esterified with fatty acids. A high intake is linked to lower risk of eye diseases. Marigold flowers are a major source of Lut, mainly as lutein esters. As the bioavailability of Lut from free or ester forms is debated, this… ➡️➡️➡️

Mindfulness in Pregnancy and Postpartum: Virtually Delivered MBCT Pilot Trial Background During pregnancy and postpartum, vulnerable individuals are at risk for psychological distress. Accessible mental health interventions are needed. Research suggests that Mindfulness-Based Cognitive Therapy (MBCT) can help, but few studies have evaluated it in the perinatal period. We are conducting a pilot trial of virtually delivered MBCT to assess its feasibility and effectiveness. Methods Eligible participants are pregnant individuals between 12 and 30 weeks of gestation. They complete diagnostic interviews, self-report symptom ratings, and cognitive assessments at baseline. They are then randomized to either MBCT or care as usual.… ➡️➡️➡️

Effects of FACAM Intervention on Child Development and Parent-Child Interaction Study Overview Published in the International Journal of Environmental Research and Public Health, this study evaluated the impact of the FACAM intervention on vulnerable pregnant women and their children up to two years old. The FACAM intervention provides the services of a health nurse or family therapist from pregnancy until the child starts school. Findings The primary outcome measured was maternal sensitivity, with secondary outcomes including the parent-child relationship, child social-emotional development, child developmental progress, parent-child interaction, and child development. The study found that while care-as-usual children showed greater involvement… ➡️➡️➡️

Efficacy of Integrated Risk Score Using Omics-Based Biomarkers for the Prediction of Acute Rejection in Kidney Transplantation: A Randomized Prospective Pilot Study Abstract This study aimed to evaluate the efficacy of integrated risk scoring using omics-based biomarkers in predicting acute rejection in kidney transplant recipients. The study enrolled 40 high-immunologic-risk kidney transplant patients, measuring five omics biomarkers at specific intervals. An integrated risk score was generated, and the biomarker group used this information to adjust immunosuppression. The study found that the proportion of graft biopsies was significantly lower in the biomarker group, and the biomarker monitoring enabled tailored immunosuppression, potentially… ➡️➡️➡️

Effects of Esketamine on Postoperative Fatigue Syndrome in Patients after Laparoscopic Resection of Gastric Carcinoma: A Randomized Controlled Trial Background Despite various postoperative management strategies, postoperative fatigue syndrome (POFS) remains common in patients undergoing laparoscopic radical gastrectomy. Esketamine, an N-methyl-D-aspartic acid receptor antagonist, has shown effectiveness in improving sleep quality and reducing postoperative pain. However, its impact on POFS is uncertain. Methods A total of 133 gastric cancer patients were randomly assigned to two groups: the control group (Group C) and the esketamine group (Group E). Group C received standard anesthesia, while Group E received esketamine in addition to standard… ➡️➡️➡️