Randomized Controlled Trial

Prostate cancer is the most common cancer among men in Denmark, often developing slowly without symptoms. This trial evaluates a complex intervention designed to improve how general practitioners GPs use prostate specific antigen PSA tests in line with national guidelines. The goal is to reduce overdiagnosis and overtreatment caused by unnecessary PSA testing, by promoting evidence-based practice among GPs in quality clusters. The intervention involves a cluster package including a pre-recorded podcast for GPs, a two-hour cluster meeting with educational material and group discussions, and two sets of hand-outs to support GPs in their clinics. Quality clusters are randomized to either receive this intervention over six months or act as a control group, which will be offered the intervention afterward. Participants, who are quality clusters of GPs, will be involved in cluster meetings and use the provided materials. Researchers will measure changes in PSA testing frequency among men during the six-month intervention period, as well as variations between GPs. The study includes assessments of PSA test use before and after the intervention to evaluate its impact on clinical practice.

Researchers are evaluating the SIESTA intervention, a culturally tailored sleep hygiene program designed to improve sleep health in urban Latino middle school children aged 11 to 13 years who typically sleep 9 hours or less per night. The study aims to see if SIESTA participants have better sleep outcomes, improved sleep hygiene behaviors, and less sleep-related impairment compared to a control group receiving general health education. This large-scale randomized trial will enroll 300 children from Providence, Rhode Island and San Juan, Puerto Rico. The SIESTA intervention involves four one-hour group sessions conducted remotely by a trained facilitator, plus two 90-minute individualized sessions with the child and caregiver delivered at home. The program focuses on key sleep hygiene principles tailored to urban Latino children, including sleep duration, sleep environment, and strategies to improve sleep quality. The control group participates in four group sessions on basic sleep hygiene and general child health topics, along with two individualized sessions, but without tailored behavioral strategies. Participants will complete surveys at baseline, end of treatment, and at 4, 8, and 12 months post-intervention. They will wear electronic sleep watches to objectively track sleep duration and quality throughout the study. Researchers will assess primary outcomes such as sleep duration and efficiency and secondary outcomes including sleep disturbances and sleep-related impairments. The study also involves a process evaluation to understand program reach, adoption, and implementation in urban school settings. Total participation lasts about 14 months.

Researchers are exploring how generative artificial intelligence genAI can improve the clarity and understanding of informed consent materials used in clinical research. The study focuses on testing whether large language models like ChatGPT and NotebookLM, alongside AI tools such as ElevenLabs, can simplify these documents to help participants better comprehend study procedures and risks. This pilot aims to promote truly informed consent, potentially increasing study enrollment, participant willingness, and data accuracy. The study involves different groups reviewing or listening to versions of informed consent forms ICFs. Participants may review the original or AI-simplified ICF text or listen to podcasts based on either version. There are specific groups including adult participants, clinical investigators who conduct trials, and individuals involved in Institutional Review Board IRB activities. Each group experiences different formats of the consent material to assess understandability. During the study, participants understanding will be evaluated immediately after reviewing or listening to the materials using the Quality of Informed Consent QUIC measure. Researchers will also track the time taken to read and understand the consent forms and assess participant comprehension of the study. The study is sponsored by the University of California, Los Angeles and involves adults aged 60 and over as patients, as well as clinical staff and IRB members, with assessments conducted on the first day of participation.

Researchers are investigating a new method to improve imaging during laparoscopic anatomical liver resection in patients with primary liver cancer. This randomized, double-blinded trial compares a novel protocol that mixes indocyanine green ICG with human serum albumin HSA to the standard ICG protocol. The study aims to provide better evidence on how to optimize ICG use for clearer fluorescence imaging, which may help surgeons define liver segments and tumor margins more precisely during surgery. Participants will be randomly assigned to one of two groups. The experimental group receives an intravenous infusion of the ICG-albumin complex after ligation of the target hepatic portal vein, while the control group receives a standard bolus injection of ICG alone. The infusion in the experimental group is given slowly until sufficient fluorescence is observed. This study includes a screening period before surgery and follow-up visits scheduled up to 36 months post-surgery. During the study, patients will be monitored closely with assessments including a 5-point fluorescence imaging score by independent experts as the primary outcome. Secondary outcomes include operation time, blood loss, tumor margin status, complications, liver function recovery, and long-term recurrence and survival. Safety is monitored by reporting adverse reactions and complications. Data collection and analysis will help determine if the new protocol can improve surgical precision and outcomes. The total participation time includes screening, surgery, hospitalization, and long-term follow-up visits.

This research aims to evaluate whether using a blood culture prediction tool based on machine learning is as effective as current practices for adult patients in the emergency department who need a blood culture analysis. The study focuses on patients who have a clinical indication for blood cultures as determined by their treating physician. The primary goal is to compare 30-day mortality rates, with additional outcomes including hospital admission rates, in-hospital mortality, and length of hospital stay. Participants will be randomly assigned to one of two groups. In the intervention group, doctors will use the blood culture prediction tool to decide whether to perform the blood culture test if the predicted chance of a positive result is less than 5%, the test will be cancelled. In the control group, all patients will undergo blood culture analysis as usual. This randomized controlled trial aims to see if the prediction tool can reduce unnecessary blood cultures and associated issues without increasing risks. During the study, patients will be monitored for 30 days to assess mortality, with hospital admission, in-hospital mortality, and length of stay tracked up to 90 days. Data such as laboratory results and vital signs are collected to support predictions. Safety and outcomes will be carefully reviewed to determine if the tool offers a non-inferior approach compared to standard blood culture testing. Participation duration and follow-up will be based on these timelines to capture relevant clinical outcomes.

Researchers are evaluating the bioequivalence of two forms of paclitaxel protein-bound particles for injectable suspension albumin-bound in patients with breast cancer. This randomized, open-label, two-period crossover Phase 1 study aims to compare the test product with the reference product Abraxane400 mg doses to determine if they have similar effects on the body. The study focuses on breast cancer patients who have specific treatment histories and meet defined health criteria. Participants will receive a single intravenous infusion of either 260 mgm2 of the test paclitaxel protein-bound particles or 260 mgm2 of Abraxane400 mg in separate periods. The study involves random assignment to one of these treatments and later crossover to the other, allowing each participant to receive both treatments in a controlled sequence. The intervention groups are monitored without masking, meaning both researchers and participants know which treatment is administered. Throughout the study, participants will be closely monitored for up to 72 hours after dosing to measure peak plasma concentration Cmax, area under the plasma concentration versus time curve AUC0-t and AUC0-1, and other pharmacokinetic parameters such as time to peak concentration and elimination half-life. Adverse events will be tracked for up to 6 months. Participants will undergo blood tests and other health assessments to monitor safety and drug behavior. The total duration of involvement will depend on the timing of the crossover and follow-up periods.

Researchers are evaluating ways to improve how clinical trials enroll and keep family members of intensive care unit ICU patients involved. This study focuses on testing four different strategiestwo for recruitment and two for retentionwithin three ongoing trials involving ICU patient families. The goal is to find better methods to engage families in ICU research, helping to generate stronger evidence to support family engagement practices. The study uses a 2x2 factorial design to randomly assign 160 participants into groups receiving different combinations of recruitment and retention strategies. These include providing a written consent form with a visual infographic to explain key information and offering compensation through e-gift cards for completing enrollment questionnaires. Participants will be enrolled over about six months in three existing ICU family member studies FAME, VR-Family, and NGAGE. Participants will be monitored for the percentage recruited from those approached and the percentage retained through six months of follow-up after enrollment. Researchers will collect data on enrollment and retention rates to assess which strategies work best. The study involves consenting family members who can communicate in English or French and have a relative expected to stay in the ICU for more than 48 hours. Safety and adherence will be tracked, and the study will conclude by the end of 2026.

This trial is focused on patients with suspected or known common bile duct stones measuring 10 mm or larger. Researchers are comparing the effectiveness of two types of basket catheters, the Vortic Catch V basket catheter and an ordinary basket catheter, in removing these stones. The study is randomized and aims to evaluate how well each device clears stones during procedures following endoscopic papillary large balloon dilation. Participants will undergo stone removal procedures using either the Vortic Catch V basket catheter or the ordinary basket catheter after balloon dilation of the bile duct opening. This comparison aims to assess the removal ability of the two devices when used in this specific clinical setting. The study involves a parallel design where participants are randomly assigned to one of the two catheter groups. During the trial, participants will be monitored for the percentage of stones cleared and the total procedural time. Researchers will also track adverse events and any morbidities or mortality occurring within 30 days after the procedure. The study is designed to provide detailed information on the performance and safety of these devices for bile duct stone removal, with the trial expected to conclude by the end of 2026.

Researchers are investigating whether coronary computed tomography angiography CCTA can be used instead of invasive coronary angiography ICA for people with non-ST-segment elevation acute coronary syndrome NSTEACS. This study aims to see if CCTA can safely and effectively guide treatment decisions, potentially reducing complications, improving comfort, speeding up care, and lowering costs compared to the traditional invasive approach. The trial is randomized and evaluates outcomes in individuals suspected of having this heart condition. Participants are assigned to one of two groups one group receives CCTA plus team-based interventional triage, where a specialized team reviews the CCTA results to plan treatment the other group receives the standard conventional ICA. Both procedures occur during hospital admission. The study monitors participants over time to compare these diagnostic and treatment strategies. During the study, researchers will track major heart-related events over one year, including heart attacks, death from cardiovascular causes, and need for unplanned procedures. They will also evaluate quality of life, angina symptoms, radiation exposure during hospital stay, and length of hospitalization. Participants provide informed consent and receive follow-up assessments to measure these outcomes and ensure safety throughout the trial.

Researchers are investigating the effects of the dental procedure called Deep Marginal Elevation DME on gum and bone health in patients with deep dental cavities, specifically Class II caries. This study aims to understand how DME influences inflammatory and microbiological markers in the periodontal environment, including the status of gingival tissues and bone levels. The research focuses on markers found in gingival fluid and bone changes seen through radiographic imaging to shed light on DMEs impact. The treatment involves elevating the deep margin of the cavity using resin-modified glass ionomer cement, followed by adhesive bonding and placement of a nanofilled composite restoration. This method helps improve access to the restoration margin and supports better sealing and plaque control. Participants will receive this single DME procedure as part of the study. During the study, gingival fluid samples will be collected to measure microbiological and inflammatory markers such as IL-1b2, TNF-b1, MMP-8, PGE2, and CRP. Radiographs will assess bone level, bone density, and crestal bone loss. Clinical evaluations including Gingival Index, Bleeding Index, and Clinical Attachment Loss will be performed. These assessments will take place one month after the intervention to monitor changes and safety. The total participation spans this follow-up period.