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 evaluating whether time-restricted eating (TRE) can lower the chance of gestational diabetes mellitus (GDM) in pregnant women at high risk. This study is a randomized controlled trial involving 240 women in early pregnancy. The goal is to compare the effects of eating within a 10-hour window versus following usual eating habits on the development of GDM over three months. Participants are randomly assigned to two groups. The TRE group will consume prescribed calories within a daily 10-hour window from 8:30 am to 6:30 pm, drinking only noncaloric beverages outside this time, during 14 to 26 weeks of pregnancy. The standard of care (SOC) group will eat the same calories but follow their usual eating schedules. Both groups will engage in about 30 minutes of moderate exercise daily and receive diet and exercise counseling throughout the study. During the study, all participants will undergo a 75g oral glucose tolerance test around 26 weeks to check for GDM. Researchers will measure the incidence of GDM and monitor various newborn outcomes at delivery and shortly after, including birth weight and health complications. Maternal blood tests, weight gain, mood, sleep, quality of life, and pregnancy-related health issues will also be tracked. The study lasts through pregnancy with detailed follow-up until delivery and shortly beyond.

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 mg/m2 of the test paclitaxel protein-bound particles or 260 mg/m2 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 strategies—two for recruitment and two for retention—within 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 research aims to compare the ability to remove large bile duct stones (10 mm or larger) using two different basket catheter devices. The study evaluates the Vortic Catch V basket catheter against an ordinary basket catheter following a procedure called endoscopic papillary large balloon dilation. The trial is randomized and designed to assess which device is more effective in clearing the stones during the procedure. Participants will undergo removal of common bile duct stones using either the Vortic Catch V basket catheter or the ordinary basket catheter after receiving endoscopic papillary large balloon dilation. The two groups receive these different devices in a randomized manner to compare their performance directly. During the study, researchers will measure the percentage of stones successfully cleared and the total procedure time. They will also monitor the number of adverse events and complications, including morbidities and mortality over a 30-day period. This helps evaluate both the effectiveness and safety of the devices during and after the treatment.

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.