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Abstract Background Regulatory barriers present significant challenges to clinical trial approval during both “peacetime” and pandemics, particularly for multi-country clinical trials sponsored by academic institutio...

Background and purpose: Deviations in radiotherapy quality can significantly affect clinical trial outcomes, including overall survival. Radiotherapy quality assurance (RTQA) is a systematic process by which a RT plan is...

Recent advances in Alzheimer’s disease research have reshaped how clinical trials are designed and interpreted, particularly through the use of targeted monoclonal antibodies, biomarker-guided enrollment, and novel dru...

Abstract Knee osteoarthritis (KOA) is a degenerative joint condition characterized by progressive cartilage deterioration and chronic pain, leading to functional impairment. Bone marrow-derived orthobiologics, such as bo...

Abstract Background and objectives The under-representation of vulnerable groups in clinical trials, including persons with disabilities, could affect the applicability of trial findings to real-world public health inter...

Successful completion of industry-sponsored clinical trials requires effective collaboration between sponsors and clinical research sites recruiting patients. As pharmaceutical companies specialize in more therapy areas,...

Abstract Background Acute liver failure (ALF) is a life-threatening syndrome characterized by rapid deterioration of liver function, resulting in high mortality and posing a substantial global health burden. Human embryo...

PurposeTo explore the efficacy and safety of combined low-concentration atropine and orthokeratology lenses (AOK) for slowing the progression of myopia.MethodsIn this randomized, placebo-controlled, double-blinded, multi...

Abstract Background The internal jugular vein (IJV) cannulation in the decubitus position is required in some urgent and special clinical situations, increasing the difficulty of performance. Although ultrasound guidance...

Pregnant women, particularly those in the first trimester, have been historically excluded from clinical trials, resulting in substantial evidence gaps for the prevention and treatment of malaria in early pregnancy. Desp...

Abstract Purpose To investigate the 1-year preventive efficacy of dual-surface aberration-increasing (DSAI) lenses on axial elongation and refractive change in non-myopic children. Methods This was a 2-year randomized, c...

Abstract Background This study aimed to compare the time-dependent changes in optic nerve sheath diameter (ONSD) associated with low-pressure (8 mmHg) and high-pressure (14 mmHg) pneumoperitoneum during laparoscopic ch...

Abstract Background Immediate implant placement (IIP) requires sufficient primary stability to permit implant-supported immediate provisionalization, which supports peri-implant soft tissue contour during healing, partic...

Abstract Background Prestorage leukoreduction of red blood cell (RBC) bags prevents accumulation of pro‐inflammatory mediators and experimentally attenuates post‐transfusion inflammation in healthy dogs. However, the...

IntroductionProbiotics have demonstrated positive effects on obesity and type 2 diabetes (T2D) in various studies. Postbiotics, specifically nonliving bacterial lysates derived from cell walls and DNA, are increasingly r...

Abstract Background Large language models (LLMs) are increasingly used by the public to seek health information, including explanations of medical treatments and clinical trials. Objective The objective of this study was...

To address the objective in a clinical trial to estimate the mean or mean difference of an expensive endpoint Y, one approach employs a two-phase sampling design, wherein inexpensive auxiliary variables W predictive of Y...

Abstract Background It is estimated that almost all women undergoing cesarean section experience some pain in the immediate postpartum period. In the face of pain that limits self-care and care for the newborn, antalgic ...

Although the literature on clinical trial methodology is quite robust, the voices of study staff as key influencers of this process are lacking, particularly for rural and underserved pediatric clinical trials. Using qua...

Abstract Background Lower respiratory tract infection (LRTI) is a leading cause of hospitalization and antibacterial use globally. In low- and middle-income countries (LMICs), limited diagnostic resources contribute to i...

Background Sentinel lymph node biopsy (SLNB) has been the standard treatment procedure for clinically node-negative (cN0) breast cancer (BC). Three randomized trials (Z0011, AMAROS and SENOMAC) have shown that patients w...

Abstract BackgroundChronic musculoskeletal pain (CMP) imposes a significant psychological, physical, and emotional burden on millions of adults in the United States. A challenge in treating CMP is its tendenc...

Abstract Background Hospital rehospitalizations within 30 days represent a burden for patients and the healthcare system. Improving the care during the hospital discharge period could decrease the risk of avoidable reho...

Abstract Precise placement of orthodontic mini-implants (OMIs) in the anterior palate, particularly in the median and paramedian regions, is essential for reliable skeletal anchorage. Digitally planned insertion guides m...