Clinical Research Directory

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

Evaluation of Clinical Decision Support in Opioid Tapering

The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will examine the state of tapering in primary care across the system as well as conduct stakeholder interviews to understand the resources available across the system to support providers in tapering and identify opportunities for clinical decision support to be implemented to support guideline concordant tapering. Utilization of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering will be examined. The rate of opioid tapering in line with CDC guidelines will be examined as well as long term patient outcomes of opioid overdose of poisoning using existing patient health records. The study period will be approximately 8 months.

A Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)

Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm research. This omission is concerning, as firearms are now the leading cause of injury and death among U.S. youth. Existing YVP strategies such as Emerging Leaders address general violence risk but do not directly target firearm-related risks or suicide prevention. There remains a critical gap in prevention strategies that integrate firearm-specific content while leveraging established program infrastructure.

Adding Aprepitant to a Multimodal Strategy for the Prevention of Postoperative Nausea and Vomiting in High-risk Outpatient Surgical Patients

Postoperative nausea and vomiting (PONV) are a frequent and debilitating complications after surgery, affecting up to 80% of patients at high risk in the absence of prophylaxis. Despite the rigorous application of the recommendations from the American Society of Anesthesiologists (ASA) at CHUM, a recent local study reveals a prevalence of 25% PONV at home after outpatient surgery. However, the therapeutic options at home remain limited. This study aims to evaluate if the addition of 40 mg aprepitant to a multimodal strategy for preventing PONV improves clinical outcomes in high-risk patients undergoing outpatient surgery.

Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.

Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases

This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and/or immunosuppressive therapy. Patients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening. Patients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.

Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer

To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system \[LNG-IUS\]).

Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes. The main questions this study aims to answer are: Does continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients. Participants will: Be randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals. The study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and/or genital) before inclusion.

Hybrid Delivery to Increase Access and Sustainability: Evaluating ezParent Implementation

The goal of this study is to evaluate the effects of the hybrid ezParent program (e.g., web-based training program plus synchronous group sessions) on parent and child outcomes in a community setting serving parents of children 2-5 years old. Parent participants will complete surveys at baseline, and 10 and 24-weeks post baseline.

Juntos: A Pilot Test of a Dating Violence Intervention for Latine Families

In this trial, we will be pilot-testing a family-based dating violence prevention program for Latine caregivers and adolescents. Participants will be randomized 1:1 to receive a community-based 6 week intervention or to a wait-list control where they will receive a resource guide.

Effect of Implementing Prevention Measures Through Personalized Information in Emergency Departments on Adherence to Prevention Measures

Prevention, a cornerstone of public health, remains underutilized despite its proven effectiveness. Vaccinations, screenings, reduced consumption of toxic substances, and healthy lifestyle and dietary habits can significantly reduce morbidity and mortality. However, participation rates in France remain low compared to those of neighboring European countries, particularly with regard to cancer screenings and vaccination coverage. A lack of information, motivation, or unequal access hinders adherence to preventive measures. Some of these factors can be addressed. Emergency departments, although rarely utilized for prevention, serve a diverse population and could serve as a strategic lever for educating the public about preventive health measures. Personalized information, supported by a digital tool, could improve adherence to preventive measures. An interactive questionnaire was developed to tailor the information provided to patients based on their personal characteristics. The information delivered in this way would be more targeted for each patient and more likely to have a positive impact on the implementation of various preventive measures. The purpose of this study is to determine whether a digital tool that provides personalized prevention information is more effective than general, non-personalized information in improving adherence among patients visiting the emergency department to the preventive measures recommended for them.

Advancing North Shore Community Health Through Ocean-raised and faRm-grown Foods (ANCHOR Study)

This study is testing a new way to support healthy eating by providing free meal kits through a food pantry. Adults who use The Open Door food pantry will receive meal kits that include fresh produce, seafood, and other ingredients, along with simple recipes and optional cooking demonstrations, over a 3-month period. The goal is to learn whether these meal kits are helpful, easy to use, and a good fit for the community. Researchers will also look at whether they help improve access to healthy foods, diet quality, and confidence with cooking. Participants will be asked to complete short surveys at the beginning and end of the study, and some may be invited to join a group discussion to share their experiences. Overall, the study aims to improve programs that connect people to healthy, locally sourced food and to inform future efforts to support nutrition and food access in the community.

A Randomized Controlled Trial of Doxycycline Post Exposure Prophylaxis to Prevent Incident Bacterial STIs Among Women in the United States

The bacterial sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis cause multiple adverse outcomes in women, and prevention strategies are critically needed. This project will determine the efficacy of doxycycline post-exposure prophylaxis (doxy PEP) to prevent STIs among women through a phase IV, open-label, randomized controlled trial.

Early Test of an Innovative Child Maltreatment (CM) Prevention Strategy

Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.

Active Pauses for Musculoskeletal Disorder Prevention in Workers

The goal of this clinical trial is to learn if short exercise breaks at work can prevent muscle and joint pain in workers. The main questions it aims to answer are: Do strength exercises help workers move better and feel less pain? Are strength exercises better than stretching exercises for worker health? Researchers will compare a strength exercise program to a mobility (stretching) program to see which one works better to improve physical health and work ability. Participants will: Perform short exercise breaks (5 minutes) at their workplace every day for 8 weeks. Attend one supervised session per week to learn the exercises. Complete simple physical tests (like standing up from a chair) and answer surveys about their health at the start and end of the study.

Psychological and Lifestyle Factors That Predict Adherence of Multi-domain Interventions for Promoting Brain Health

Ageing is associated with a rising burden of neurological disorders, particularly dementia, which are now the leading cause of disability worldwide. Many dementia cases could potentially be prevented by modifying lifestyle factors such as physical inactivity, unhealthy diet, poor sleep, low social engagement and psychological distress. The Barcelona Brain Health Initiative (BBHI), a longitudinal cohort of more than 6,000 adults aged 40-75 years, has shown substantial inter-individual variability in lifestyle and psychological profiles and has identified subgroups at higher risk for poorer brain health. ToBrainHealth is an 8-week, three-arm controlled intervention nested within BBHI. It evaluates different levels of personalisation and support to optimise healthy lifestyle behaviours using the ToBrainHealth platform, a digital platform that delivers recommendations, collects self-reported behaviours and integrates data from wearable activity trackers. A total of 120 BBHI volunteers classified as moderate- or high-risk based on previous lifestyle and psychological questionnaires will be selected (40 per arm). Allocation to study arms will be pseudo-randomised, stratified by age, sex, and lifestyle and psychological profiles. The three groups are: (1) a control group receiving only generic, non-personalised education about healthy lifestyles and regular online questionnaires, without use of ToBrainHealth platform tailoring; (2) a digital personalised intervention group using ToBrainHealth platform to deliver tailored lifestyle recommendations, adaptive intervention strategies and remote asynchronous supervision, supported by data from questionnaires and wearables; and (3) a digital personalised intervention plus intensive health-coaching group, which receives the same ToBrainHealth platform-based programme plus structured, proactive support and supervision by health professionals to enhance motivation and adherence. The primary outcome is adherence to the lifestyle intervention, operationalised as the percentage of recommended activities and goals achieved during the 8-week programme, based on platform's logs, questionnaires and wearable data. The study will test whether lifestyle and psychological profile increases adherence compared with generic education, and whether adding intensive coaching provides additional benefit (expected gradient: coaching \> digital only \> control). Secondary outcomes include the clinical impact of the intervention on brain-health-related measures. All participants will undergo pre- and post-intervention assessments including a brief medical evaluation (vital signs and anthropometrics), a digital neuropsychological battery, and questionnaires on motivation, lifestyle and psychosocial variables. These data will be analysed together with existing BBHI longitudinal information to explore changes in cognitive performance, health status and psychological wellbeing, and to characterise patterns and predictors of adherence across intervention arms. The trial will also assess feasibility and acceptability of ToBrainHealth platform as a remote monitoring and coaching tool for brain-health promotion. Results are expected to generate new knowledge on the role of psychological and lifestyle profiles in adherence, and to inform scalable, technology-supported, personalised interventions aimed at preserving brain health and reducing the long-term risk of cognitive decline in community-dwelling adults.

Effects of 8 Weeks of Two Exercise Programs on Risk Factors Associated With Epicondylitis in Amateur Padel Players

Background: The physical demands of padel can increase the risk of injuries, particularly lateral epicondylitis in the elbow. Key risk factors include deficits in forearm muscle strength and rotator cuff weakness. Prevention programs focus on forearm strengthening, with no studies on rotator cuff strength. This study aims to compare two exercise programs designed to reduce risk factors for lateral epicondylitis in amateur padel athletes, specifically wrist extensor strength, grip strength, and rotator cuff strength.

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).

Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders

Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.

Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access (EDUVVC)

The aim of this project is to evaluate, in a prospective cohort of PICC line patients, adherence to the project and understanding of the messages. The transmission of knowledge and the acquisition of skills by patients with this type of invasive device will enable them to play an active role in their own care, and could help to reduce the frequency of risks. This project is part of a collaborative approach that includes the creation of a mobile application for therapeutic education and monitoring (application under development). The evaluation of the device will be the subject of a national PHRC with national structures (SPIADI and PRIMO). The aim is to create a city-hospital collaboration to improve risk management.

Abatacept s.c. for aGVHD Prevention in Haplo-HCT

Acute graft-versus-host disease (aGVHD) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (HCT), particularly for that with a HLA-mismatched donor. Abatacept has been demonstrated as a potent drug to reduce the risk of aGVHD, but the efficacy of subcutaneous form has yet been investigated. This trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of aGVHD after haplo-identical HCT.

Effects of Carbon Fiber Insoles on CMJ and Sprint Performance

This study evaluates the effects of VKTRY carbon fiber insoles on vertical jump and sprint performance in moderately active men. Participants will perform tests with and without insoles, assessing both objective performance and subjective perception using a Likert-type scale.