Clinical Research Directory

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).

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.

Virtual Assistant for Exercise Adherence in Older ADULTS

This study will evaluate the effectiveness of a virtual assistant-guided exercise program to improve adherence in older adults. In a nonrandomized controlled clinical trial, the experimental group will complete a 12-week, home-based program (60-minute sessions, 3 times per week) supported by a virtual assistant (BOT). The control group will comprise community-dwelling older adults already engaged in the municipal program Enguera se saludable, which delivers an in-person exercise program of comparable frequency and duration. The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed. Secondary outcomes include muscle strength, balance, functional capacity, health-related quality of life, and the user experience and usability of the virtual assistant.

A Cross-Cultural Randomized Controlled Trial Using a Multi-Level Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families

The FLOW project involves the implementation and rigorous evaluation of an evidence-based, multi-level mentalization prevention program targeting social and psychological determinants of well-being in four European countries (Germany, Lithuania, Spain, and Switzerland). Prevention programs will be tailored to the needs of 8-10 year old children in elementary schools and their parents. All children will participate in a project day focused on mental health. Parents will either attend one of two parent trainings of varying lengths or receive a parenting guidebook. A total of 5,000 children, along with their teachers and parents, are included in the survey. To measure long-term effects, surveys are conducted over the course of a whole year. The project examines the following hypotheses: Primary hypotheses: A multilevel mentalization based prevention program will lead to significantly greater improvements in well-being and mental health among children and parents compared to control groups, as measured at the post-intervention assessment. Secondary hypotheses: 1. A universal prevention program on mental health enhances help-seeking behavior and reduces mental health stigma among children, parents and teachers at post and follow-up measurement. 2. A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement. 3. A multi-level mentalization based prevention program leads to greater improvements in well-being and mental health among children and parents than control groups, as measured at follow-up. 4. A multi-level mentalization based prevention program leads to greater improvements in parental efficacy and family adjustment in parents and reduces parental stress compared to control groups at post and follow-up measurement. 5. The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.

Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease

The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.

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.

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.

Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

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.

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.

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 \[LNG-IUS\]).

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.

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.

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.

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.

Glucose Observation and Wearable Use for Prevention

The GLOW UP study is a single-center, prospective, observational case-control study conducted in St. Gallen, Switzerland. The primary aim of the study is to examine to what degree lifestyle data collected from wearable devices and a smartphone app can identify individuals with prediabetes (vs. normoglycemic) in a real-world setting. The study also aims to characterize variability in lifestyle and glycemic patterns and to examine how between- and within-person differences relate to diabetes risk; to identify personalized predictors of early metabolic dysregulation. The study also evaluates new image-based meal tracking algorithms for predicting glycemic control and examines how reminder messages influence adherence to a \~4-week meal logging protocol. The study aims to enroll 200 adults aged 45 years and older with a BMI of at least 25 kg/m² and no known diagnosis of diabetes, including 100 participants with prediabetes and 100 normoglycemic (metabolically healthy) controls. Participants will be classified at the baseline visit using HbA1c and fasting plasma glucose (FPG) tests, with prediabetes defined as HbA1c 5.7-6.4% and/or FPG 5.6-6.9 mmol/L, and normoglycemia defined as HbA1c \<5.7% and FPG \<5.6 mmol/L, following clinical standards. During the \~4-week observational period, participants will be asked to wear a smart ring, a wrist-worn smartwatch, and a blinded continuous glucose monitor (CGM). Participants will be asked to log/take-images of their meals via a study app and to complete brief questionnaires (e.g., tracking mood, stress, and contextual meal annotations) via ecological momentary assessments. FPG and HbA1c samples will be collected at baseline to classify participants as prediabetic or normoglycemic, and again at follow-up (\~4 weeks), which will serve as the primary outcome to evaluate associations between lifestyle and wearable-derived data and diabetes risk status.

Primary HPV-based Cervical Cancer Screening Algorithms in Botswana

Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and automated visual evaluation (AVE) for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will determine safe screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.

Implementation of PrEP Care Among Women in Family Planning Clinics

This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.

Enhancing Mental and Physical Health of Women Veterans 3.0

Women Veterans are the fastest growing segment of VA users, with most users in midlife. 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. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 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 18 VA facilities from 4 regions.

Proactive Telemedicine to Improve Healthcare Access and Prevention in Rural Primary Care (PTM)

The study evaluates whether Proactive Telemedicine (PTM) can improve healthcare access for individuals who have not contacted their primary care team for at least one year, compared with face-to-face visits. PTM consists of brief, remote behavioral interventions addressing modifiable risk factors such as tobacco use, alcohol consumption (AUDIT-C: Alcohol Use Disorders Identification Test - Consumption), physical activity (IPAQ: International Physical Activity Questionnaire), and Mediterranean diet adherence (PREDIMED: Prevención con Dieta Mediterránea). PTM follows national preventive protocols including PAPPS (Programa de Actividades Preventivas y de Promoción de la Salud) and uses validated tools such as EuroQol-5D-5L (EQ-5D-5L) to measure healthcare accessibility and quality-of-life outcomes. This randomized non-inferiority trial aims to determine whether PTM is as effective and safe as traditional in-person consultations.

Enhancing Oral Cancer Awareness

To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention

Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients

the purpose of this study is to evaluate the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients

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 evaluate a clinical decision support (CDS) tool in the form of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will have the clinical care pathway available, but will not be reminded of the pathway when tapering a patient. The intervention arm will receive a nudge when prescribing a tapering opioid strategy to a patient to use the clinical care pathway. The rate of opioid tapering in line with CDC guidelines will be examined as well as long-term patient outcomes of opioid overdose or poisoning using existing patient health records. The study period will be approximately 18 months.

Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)

This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.