Clinical Research Directory

Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units

Frailty is not related exclusively to age, but represents a state of increased biological and clinical vulnerability characterized by reduced functional reserve and greater susceptibility to adverse events, even in response to minor stress factors. In patients with complex conditions, such as severe acquired brain injuries, early detection and prompt treatment of clinical deterioration are essential to reduce the risk of acute readmission, complications, and in-hospital mortality. Many of these events are potentially predictable and preventable, given the presence of appropriate monitoring systems. Advanced care models, including early warning systems, have been developed to support healthcare professionals in identifying patients at risk by detecting significant changes in physiological parameters. In recent years, technological innovations-particularly in the fields of robotics and telemedicine-have created new opportunities to enhance clinical monitoring, enabling more systematic data collection and timely clinical assessment. Social assistive robots are emerging as promising tools in healthcare settings. These systems can support clinicians and nurses in routine monitoring activities, help reduce workload, and facilitate more efficient and personalized care. By integrating robotic assistance with digital health platforms, it may be possible to support patient monitoring and clinical workflow, particularly in high-complexity environments such as neurorehabilitation units. This study focuses on the use of an innovative robotic telemedicine system based on the integration of the MOVER-L prototype with the ROB.IN.CARE platform, owned by Item Oxygen Srl, which purchased the platform from CO-ROBOTICS S.R.L. through the PON SI-ROBOTICS project. The system is designed to support the monitoring of patients' clinical conditions by integrating physiological and clinical data and identifying predefined signs of potential deterioration. It supports healthcare professionals by providing clinical information and automated alerts that prompt healthcare-professional review. The study is a low-intensity, non-randomized controlled pilot feasibility interventional study conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and allocated to one of two groups: a control group receiving standard care and an experimental group monitored using the robotic system in addition to usual care. The primary objective of the study is to evaluate the feasibility, usability, safety, and reliability of this robotic telemedicine solution in a real clinical setting. In addition, the study assesses its acceptability among both patients and healthcare professionals. These aspects are evaluated using predefined feasibility and technical measures together with validated assessment tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Indicator Tool (HSE). The specific role and interpretation of these measures are defined in the study protocol. The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with the acquisition and integration of physiological and clinical data through a dedicated software architecture. The platform incorporates algorithms designed to stratify clinical risk and assess patient severity. It utilizes established clinical scoring systems, such as the Modified Early Warning Score (MEWS) for early detection of clinical deterioration, the quick Sequential Organ Failure Assessment (qSOFA) for risk assessment in patients with suspected infection, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury. The present pilot study is intended to characterize the feasibility of integrating the MOVER-L/ROB.IN.CARE system into routine neurorehabilitation practice, including its technical performance, usability, safety, acceptability, and integration into the clinical workflow. The findings are intended to identify implementation requirements and sources of variability and to inform the design of subsequent adequately powered studies evaluating the clinical impact of robotic monitoring.

Transcendental Meditation Intervention to Reduce Burnout and Enhance Resilience Among NewYork-Presbyterian Hospital and Weill Cornell Medicine Employees and Residents

The goal of this study is to learn if a meditation intervention called Transcendental Meditation or TM can be used in a small department at Weill Cornell Medicine to help reduce employees' levels of burnout, anxiety, insomnia, and depression as well as to determine the feasibility and acceptability of the meditation practice by Weill Cornell employees. The main question the study aims to answer is whether: • Levels of burnout, anxiety, insomnia, and depression will be decreased, and overall mental well-being will improve over a 3.5-month period before and after TM intervention. Participants will attend 9 sessions total (8 group sessions and 1 individual session) with a certified TM instructor from The David Lynch Foundation Institute for Mental Health and Resilience where they will gain experience in proper TM techniques. Also, participants will conduct 2 of their own TM sessions at home daily during the course of this study.

The ACT-PrEP Study

AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among pregnant and postpartum women PRIMARY OBJECTIVE: To evaluate the effect of the intervention on 3-month PrEP persistence among pregnant and postpartum women (PPW) SECONDARY OBJECTIVE: Determine the proportion of PPW initiating PrEP Determine the prevalence of STIs among pregnant and postpartum women Determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs Determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women STUDY DESIGN AND POPULATION: One-site, two-arm, individually randomized controlled type-1 hybrid implementation pilot This pilot study will follow a type-1 hybrid implementation-effectiveness design to be implemented at a public sector primary healthcare centre with a high HIV/STI burden (Gugulethu Community Health Centre). Enrollment: 120 pregnant women attending a routine care visit. Follow-up visits may fall in the post-partum period depending on age of gestation upon enrollment. Inclusion criteria include: 1) age ≥18 years; 2) HIV-negative, 3) minimum gestational age of 18 weeks for pregnant women, and 4) eligible for PrEP as per South African guidelines. Exclusion criteria include: 1) inability to provide informed consent, 2) medical contraindications to PrEP. Sexual partners of PPW will be engaged through the distribution of HIV/syphilis self-test kits, and 10 healthcare providers will participate in cognitive behavioral counselling (CBC) training and competency assessments.

Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study

The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are: * What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality? * What are the preliminary effects of the HSNP on dietary intake/quality, cardiometabolic, and gut health in college students with poor dietary quality? * What are the barriers associated with HSNP implementation in college students with poor dietary quality? Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (within two weeks prior to starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health. * Be asked to come to the Nutrition Center for weeks 1 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials * Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)

PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.

The study investigators aim to test an online support platform for Michigan youth aged 8-18 years enrolled in elementary, middle, or high school and their parent/caregiver. The online support platform will be hosted on the Computerized Intervention Authoring System (CIAS) 3.0 and will provide evidence-based cognitive behavioral coping skills for physical (pain) and mental (stress, mood) health symptoms, with additional substance use prevention content for youth aged 12 and older. Evaluations will occur at baseline and then a post assessment approximately 8 weeks later.

Digital Support Strategies for Caregiver Home Practice

This project is a pilot trial of the Engaging Families home practice smartphone application (or "app") as an add on to a family-based prevention program. Although there are many evidence-based preventive interventions delivered to caregivers to prevent youth substance use and mental illness and promote youth positive family and youth outcomes, the impact of these interventions is often limited by low home practice of intervention skills among caregivers. The Engaging Families home practice app is a digital behavior change intervention that was developed to support caregivers in practicing intervention skills at home. Researchers will ask participants if the app was acceptable and feasible for daily use at home. Researchers may also compare how often caregivers who use the study app do home practice of intervention skills compared with caregivers who do not receive the home practice app but are encouraged to use an app to help schedule their activities.

An MHH Intervention in Bangladesh Health Systems

Over 50% of Bangladeshi women and girls use old cloths as menstrual absorbents due to cost, comfort, and familiarity. A substantial proportion, comprising 52% of adolescent girls and 62% of women washed the cloths with soap and water. However, more than 60% dried it in hiding instead of drying openly under the sun and over 40% of adolescent and women stored the cloths in a secret place for reuse rather than with regular clothes. Nevertheless, the minimal alternatives often necessitate the use of locally available disposable sanitary pads despite the cost. Still there are some factors which jeopardize the proper menstrual health and hygiene. These include lack of suitable sanitation facilities, availability and accessibility to affordable quality hygienic menstrual products for adolescent girls and women at home, educational institutions and at workplaces, insufficient water, sanitation facilities with proper disposal methods for used products and prevailing taboos and misconception surrounding menstruation and menstrual health hygiene. Consequently, women and girls in Bangladesh adopt unsafe and unhygienic practices to manage menstruation and face significant challenges and health problems that impact various aspects of lives. There are limited options for menstrual hygiene management. Menstrual hygiene management product which is low-cost, comfortable, easy to use and made can be the sustainable option and also align with strategic directions of national menstrual hygiene management strategy-2021. This proposal addresses lack of a proper solution for menstrual hygiene management as a barrier to a quality life for a woman. Rather than trying to shift over 50% of menstruating women and girls into an environmentally unfriendly and high-cost method of using single-use disposable pads, the investigators will develop and trial a low-cost intervention to improve MHH practices among the women and girls in Bangladesh. Improving MHH facilities at household level through the community level health systems structure can improve MHH knowledge, practice. The investigators hypothesize that the combination of the participatory BCC materials addressing social marginalization, MHH, and reproductive health, the provision of Sultana cloth pads and Sultana washer and dryer bags, and MHH Working Group meetings will increase uptake (at least 70%) and acceptability, feasibility and willingness (at least 50%) to pay for intervention products, improve knowledge, practices of menstruating women and girls in Bangladesh. The objectives are to assess the acceptability and feasibility of using Sultana cloth pad and Sultana washer and dryer bags, to assess the effect of Sultana cloth pad and Sultana washer and dryer Bags on improved MHH knowledge and practices and to measure the impact on MHH self-efficacy and quality of life. This study will be a cRCT conducting near Dhaka. There will be 331 menstruating women and adolescent girls in each arm (control and intervention). Before conducting the cRCT, first the investigators will call for a consultative meeting of the prior "MHH Working Group" that the investigators formed as part of the BMGF-funded "Piloting menstrual hygiene management interventions among urban and rural schools in Bangladesh" project, align this proposed trial objectives and hold meetings, when required, to collect the feedback and discuss the process required to achieve the targeted policy changes and to scale out the MHH interventions (Sultana cloth pad and Sultana washer and dryer bags) in the health systems. The investigators will train relevant facilitators (FWV/CHCPs) to deliver monthly sessions on puberty, MHH, and SRHR to menstruating women and adolescent girls. The investigators will conduct baseline survey to explore current MHH knowledge, practices, attitudes self-efficacy and stigma. Then in the intervention clusters, the investigators will roll out the interventions through the existing reproductive health programs in the health system and community clinics to ensure broad outreach and accessibility. In the control clusters, the investigators will not implement any strategy. The investigators will conduct monthly fidelity assessments with randomly selected participants to explore whether the Sultana cloth pad, Sultana Washer and Dryer Bag are distributed and training is provided as planned, if the participants receive the intended quantity of materials and duration of engagement, quality of delivery, participant responsiveness (level of use, understanding, and satisfaction with the intervention products), reach (proportion of intended participants who received the intervention), and differentiation (ensuring control clusters do not receive or access intervention components) and any modifications (if any or required). Then an endline survey will be conducted to assess the improved MHH knowledge, practices, attitudes, intervention uptake and reduced stigma at the end of the cRCT.

The Increasing Mindfulness Engagement Project

The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application. 1. Does receiving text messages increase engagement in a mindfulness app? 2. Does an integrated gaming app increase engagement in a mindfulness app? Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will: 1. Use a mindfulness and gaming mobile health application for 28-days. 2. Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.

Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward

The goal of this feasibility study is to explore the use of wireless continuous vital sign monitoring in an orthopaedic setting among orthopaedic nurses and patients undergoing adult spinal deformity surgery. In addition to the standard care National Early Warning Score the participants in this study will be monitored by CPC12S a wearable sensor that is worn on the chest using electrodes measuring electrocardiography single lead (ECG), Heart rate, respiratory rate, SpO2, blood pressure and temperature. Main hypotheses: The use of wireless continuous vital sign monitoring in daily clinical practice for patients undergoing ASD surgery is feasible in terms of increased acceptability among orthopeadic surgical nurses measured over 12 months with a response rate of at least 80% with an average score of ≥5 at the last measurement in each of the four dimensions of the USE questionnaire: Usefulness, ease of use, ease of learning and satisfaction. The following parameters will be evaluated: Primary outcome: 1. The feasibility in terms of acceptability of the concept of wCVSM among orthopedic surgical ward nurses. Secondary outcomes: 2. The feasibility in terms of acceptability of the concept of wCVSM in patients undergoing ASD surgery. 3. The technical fidelity of wCVSM, assessed by data collected of vital signs, display of alerts to staff nurses and response to the alerts. 4. The frequency of vital sign deviations in patients after ASD surgery using wCVSM compared to NEWS2. 5. Clinical outcomes of patients undergoing ASD surgery including surgical complications, reinterventions, ICU admissions, unplanned ward transfer, and admissions to another department.

TAG TEAM - Trans Adolescent Group Therapy

This project will study the effect of the TAG TEAM group CBT program on the mental health of trans and gender diverse adolescents. TAG TEAM was co-designed by researchers and clinicians with a group of trans and gender diverse young people to help trans and gender diverse adolescents understand and cope with minority stress. Minority stress includes experiences like discrimination and rejection. TAG TEAM focuses on learning and practicing skills to support mental health and wellbeing. It also includes group discussions and activities with other trans and gender diverse young people. TAG TEAM groups are run by a psychologist and a trans peer facilitator. A trans peer facilitator is a trans and gender diverse person who is there to share their experience of being trans and to support participants in the group sessions.

The New Beginnings Podcast: Brief Audio Intervention for Parents From Divorced and Separated Families

The goal of this study is to learn if the New Beginnings Podcast can help children whose parents are going through a divorce or separation. The podcast shares parenting strategies that have been shown to help in past in-person and online programs. This study will also look at how easy it is for parents to use the podcast and how helpful they find it. The main questions it aims to answer are: 1. Do parents find the podcast easy to use, helpful, and relevant? 2. Does listening to the podcast improve children's mental health? 3. Does the podcast help parents build stronger relationships with their children and reduce conflict between parents? Researchers will compare families who use the podcast to families on a waitlist to see if the podcast makes a difference. Participants will: 1. Listen to podcast episodes over the course of the study 2. Answer questions about their experiences with the podcast 3. Complete surveys about their child's well-being, their parenting, and family relationships This study will include 80 parents and their children.

HIV Self-testing for Partners of HIV-uninfected Postpartum Women

The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.