Safety profile

Serum β2-Microglobulin Predicts Time to Recovery of Delayed Graft Function in Kidney Transplant Recipients Background Delayed graft function (DGF) after kidney transplantation can lead to negative patient and allograft outcomes. Prolonged DGF is linked to worse graft outcomes. The relationship between posttransplant serum β2-microglobulin (B2M) and DGF recovery is not well understood. Methods All kidney-only transplant recipients with DGF from the E-DGF trial were included. DGF duration was defined as the time between transplant and the last dialysis session. The association of standardized serum creatinine (Scr) and B2M on postoperative Days 1-7 with DGF recovery was analyzed. Results 97 recipients… ➡️➡️➡️

Effect of Messaging on Support for Breast Cancer Screening Cessation Among Older US Women: A Randomized Clinical Trial Abstract Many older women are screened for breast cancer beyond recommended guidelines. This study aimed to investigate the impact of a message on older women’s support for and intentions of stopping breast cancer screening. Intervention A pilot-tested breast cancer screening cessation message was delivered to a hypothetical older woman with serious illnesses and functional impairment. The message was attributed to 1 of 3 sources: clinician, news story, or family member. Participants were divided into 4 groups to assess the message’s effect. Main… ➡️➡️➡️

Vital parameter monitoring in harsh environment by the MedSENS in-ear multisensor device ABSTRACT Accurate assessment of vital parameters is crucial for diagnosing and prioritizing critically ill patients, especially in out-of-hospital settings where suitable devices may be lacking. We conducted a pilot study to extensively validate a novel in-ear device designed for non-invasive measurement of core body temperature (Tc), oxygen saturation (SpO2), and heart rate (HR) in harsh environments. The study involved participants being exposed to controlled ambient temperatures of 20 °C, 5 °C, and — 10 °C, in randomized order. The prototype’s measurements were compared with commercial esophageal and tympanic… ➡️➡️➡️

Adverse Event Assessment in Parenting Program: Multisite Trial Results Key Findings Clinical trial results from the RISE project revealed that adverse event (AE) assessment in parenting programs significantly improved over three phases of study, with 100% response rate achieved in the final phase. During the intervention, no serious adverse events (SAE) were registered, and the frequency of reported AEs remained generally low. Practical Solutions An active AE assessment procedure was developed and tested, yielding a comprehensive AE assessment tool for use in similar interventions. Recommendations for future studies based on the experiences are outlined. Value Cost-benefit considerations are crucial in… ➡️➡️➡️

Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial Abstract We evaluated whether using multiplex real-time PCR in addition to standard microbiological testing is safer and more effective than standard testing alone in reducing antibiotic use for community-acquired pneumonia (CAP). In this randomised trial, adults hospitalized with CAP were enrolled at four Spanish hospitals and randomly assigned to undergo either multiplex real-time PCR plus standard microbiological testing or standard testing alone. The main goal was to measure the days of antibiotic therapy (DOT). The study found that there was no significant difference… ➡️➡️➡️

Nutritional Support in Hospitalised Patients with Diabetes and Risk for Malnutrition Secondary Analysis of an Investigator-Initiated, Swiss, Randomised Controlled Multicentre Trial Objective: Investigating the effects of nutritional support on mortality in hospitalised patients with diabetes and nutritional risk. Design: Secondary analysis of a Swiss-wide multicentre, randomised controlled trial. Participants: Patients with diabetes and risk for malnutrition. Interventions: Individualised nutritional support versus usual care. Primary Outcome Measure: 30-day all-cause mortality. Results: The study included 445 patients with diabetes, showing a 25% lower risk for mortality with nutritional support compared to usual care, although not statistically significant. There was no increase in… ➡️➡️➡️

Sweat Lactate Sensor for Detecting Anaerobic Threshold in Heart Failure: LacS-001 Clinical Trial Abstract A prospective clinical trial (LacS-001) aimed to investigate the safety and correlation between sweat lactate threshold (sLT) and ventilatory threshold (VT) in patients with heart failure (HF). 50 HF patients participated in incremental exercise tests while using a sweat lactate-monitoring sensor. The primary outcomes were a correlation coefficient of ≥ 0.6 between sLT and VT, similarities as assessed by the Bland-Altman analysis, and standard deviation of the difference within 15 W. A correlation coefficient of 0.651 (95% confidence interval, 0.391-0.815) was achieved in 32/50 cases. The… ➡️➡️➡️

Nontargeted Metabolomic Profiling Analysis of Corn Silk Treatment for Type 2 Diabetes Mellitus Medicine (Baltimore). 2024 Aug 16;103(33):e39396 Patients with newly diagnosed type 2 diabetes mellitus (T2DM) were studied to understand the effects of corn silk treatment. The study found that patients receiving corn silk experienced a significant decrease in glycosylated hemoglobin and fasting blood glucose after 3 months of treatment. An untargeted metabolomics study identified 73 differential metabolites, indicating that corn silk water extract may reduce blood glucose in T2DM patients through multiple pathways, including oxidative phosphorylation and purine metabolism. Practical Solutions and Value Clinical trials play a crucial… ➡️➡️➡️

Pelvic Floor Muscle Training in Women with Urinary Incontinence and Pelvic Organ Prolapse: A Protocol Study Objective To assess the impact of pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) function and quality of life (QoL) in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Methods This study will involve 32 women with SUI and cystocele (stage I and II) in a randomized, controlled, parallel, and blinded clinical trial. The intervention will consist of 16 PFMT sessions conducted twice a week, with assessments before, during, and after treatment. Statistical analysis will be performed using descriptive… ➡️➡️➡️

Study Title Self-reported menstrual cycle is positively influenced by a well-designed, energy-controlled ketogenic diet compared to a low-fat diet in overweight/obese women of reproductive age Study Information Published in PLoS One on August 16, 2024, this study aimed to compare the effects of a ketogenic diet (KD) and a low-fat diet (LFD) on menstrual patterns in pre-menopausal overweight and obese women. Key Findings Both diets resulted in significant weight loss, primarily from fat mass, and improvements in insulin sensitivity and serum lipids. The KD led to an increase in fasting capillary beta-hydroxybutyrate (R-βHB) levels, independent of supplementation. Women on the… ➡️➡️➡️

Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial Objective To evaluate the orexin receptor antagonist suvorexant for reducing delirium in older adults at high risk for delirium after hospitalization. Design and Participants Double-blind, placebo-controlled, phase 3 randomized clinical trial conducted at 50 hospitals in Japan. Study population included Japanese adults aged 65 to 90 years at high risk for delirium and hospitalized for acute disease or elective surgery. Intervention Participants were randomized 1:1 to suvorexant (15 mg) or placebo taken at bedtime for up to 7 days while in the hospital. Main Outcomes and… ➡️➡️➡️

The Effect of Promoting Factors on Learning by Four Different Delivery Modes BMC Med Educ. 2024 Aug 15;24(1):880. doi: 10.1186/s12909-024-05864-7. Background: Developing effective teaching methods in the digital era is crucial due to challenges in maintaining students’ concentration. This study assessed the effects of learning-promoting factors across group boundaries and within RCT learning groups, comparing online versus live teaching effectiveness. Methods: Participants’ experiences in Concentration, Anticipation, Liking, and Desire to reuse were evaluated online after a lesson on diagnosing pediatric respiratory issues in Live, Live-stream, Vodcast, or Podcast settings. Learning was assessed using a Webropol e-Test immediately and five weeks… ➡️➡️➡️

EXULTANT Trial: Improving Tuberculosis Diagnosis in HIV-Positive Hospitalized Patients Overview The EXULTANT trial aims to evaluate a new screening strategy for diagnosing tuberculosis (TB) in hospitalized people living with HIV (PLHIV) in Tanzania and Mozambique. The trial focuses on the impact of using multiple specimens (sputum, stool, and urine) for TB diagnosis, along with urine lipoarabinomannan lateral flow (LF-LAM) testing, regardless of TB symptoms. Methods The trial is a multicenter, randomized controlled trial conducted across eleven hospitals. The intervention arm will use Xpert MTB/RIF Ultra® testing from multiple samples, along with urine LF-LAM testing, while the control arm will follow… ➡️➡️➡️

Impact of Vojta Therapy on Chronic Lower Back Pain Key Findings: Combining Vojta therapy (VT) with standard care and electrotherapy significantly improved posture, reduced depression, and enhanced self-esteem in patients with chronic lower back pain (LBP). Study Details: A randomized controlled trial involving 148 patients diagnosed with chronic LBP. Patients were split into LBP-VT (n = 82) and LBP-USC (n = 66) groups. Practical Solutions and Value: Incorporating VT with standard care and electrotherapy led to better functional parameter improvements, reduced depression, and improved self-esteem compared to standard care alone. Clinical Trial Impact: Clinical trials play a vital role in… ➡️➡️➡️

Benefits of Home-Based Foot Neuromuscular Electrical Stimulation for Older Adults Introduction Many older adults experience lower leg pain and circulation issues, impacting their daily function and quality of life. This study examined the effects of home-based foot neuromuscular electrical stimulation (NMES) using Revitive® on self-reported function, leg pain, and other leg symptoms. Methods A randomized placebo-controlled study with three groups (2 NMES, 1 Sham) and three assessments was conducted. The participants’ self-reported function, leg pain, overall leg symptoms, and ankle blood flow were measured. Statistical analysis was used to compare the groups. Results Out of 129 participants, 114 completed the… ➡️➡️➡️

Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial) ABSTRACT Insomnia is a common sleep disorder that affects breast cancer patients, impacting their quality of life. This trial aims to test the feasibility and effectiveness of nurse delivered Sleep Restriction Therapy (SRT) for newly diagnosed breast cancer patients with acute insomnia. METHODS The trial will recruit 50 newly diagnosed breast cancer patients with acute insomnia and randomize them to receive either nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will… ➡️➡️➡️

Efficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial ABSTRACT In this study, we aim to evaluate the effectiveness and safety of Shi cervical rotational manipulation (SCRM) in patients diagnosed with atlantoaxial joint subluxation (AJS). SCRM is a traditional Chinese medicine (TCM) manual therapy commonly used to address this condition. We will conduct a prospective randomized controlled clinical trial at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. The trial will involve 96 AJS patients who will be randomly assigned to receive either SCRM or basic cervical… ➡️➡️➡️

Relative motion splints versus metacarpophalangeal joint blocking splints in the management of trigger finger: Study protocol for a randomized comparative trial ABSTRACT Hand-based metacarpophalangeal joint (MCPJ) blocking splints are commonly used for trigger finger (TF), but finger-based relative motion (RM) splints are also used without evidence. This trial aims to compare the effectiveness, function, occupational performance, and wearability of MCPJ blocking and RM splints after 6 weeks of TF management. METHODS AND ANALYSIS The trial involves 36 individuals assigned to either RM or MCPJ blocking splint groups. Participants must be aged ≥21 years and diagnosed with TF involving ≥1 finger.… ➡️➡️➡️

Exploring the Impact of Environment on Physical Activity in Patients with COPD Practical Solutions and Value Individuals with chronic obstructive pulmonary disease (COPD) often have reduced physical activity levels, which can lead to poorer outcomes. Traditional trials aimed at increasing physical activity have not been very successful. To address this, an ecological model incorporating individual, social, environmental, and political factors is being used to promote physical activity. This study aims to analyze the effects of walking in a suggested environment and free walking on physical activity levels in individuals with COPD. The clinical trial involves 38 volunteers diagnosed with COPD… ➡️➡️➡️

Increasing Cancer Screening Participation Study Overview: A clinical trial investigated the effectiveness of increasing cervical and colorectal cancer screening participation by leveraging attendance at breast cancer screenings. The trial was conducted in the Central Denmark Region from September 2021 to May 2022. Intervention: At selected breast cancer screening units, women attending were offered self-sampling kits for cervical and colorectal cancer screening if they were overdue. The control group received standard screening offers. Key Findings: Six months after the intervention, the total coverage for cervical and colorectal cancer screening was higher in the intervention group compared to the control group. Among… ➡️➡️➡️