Clinical Research Directory

How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia

The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally. A major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses. The RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term "omics" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses. The study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health. One important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations. The study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases. In addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response. Overall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.

Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke

The CanStim consensus working group (multidisciplinary team of experts in rTMS from institutions across Canada) developed consensus recommendations for a protocol to deliver rTMS as an adjunct to a standard behavioral intervention to improve functional outcomes after stroke in a national stroke rehabilitation clinical trial. The overall goal of this multi-center feasibility trial is not to demonstrate that rTMS is effective, but to demonstrate that each site can recruit the assigned number of patients within a certain period, perform the stimulation procedure in conjunction with the protocol-specified intervention, complete the therapy protocol and enter complete datasets for each patient into the CanStim database. A secondary aim is to identify potential weaknesses of the consensus protocol that may need to be modified before performing a larger scale trial testing for the efficacy of the intervention. A tertiary goal is to examine sex differences in neurophysiological recovery (motor evoked potential and arm functional movement recovery) after 15 treatment sessions of repetitive transcranial magnetic stimulation (rTMS) and to identify sex and gender-related factors that predict the post-stroke recovery.

Colchicine And Dialysis Patients; a Feasibility Study

Colchicine is an inexpensive drug that has been available for decades. Trials, which excluded patients with kidney disease, showed that colchicine decreased the number of heart attacks and strokes. The investigators cannot be sure if these results will apply to dialysis patients and a clinical trial exploring the effect of colchicine on heart attacks and strokes specifically in dialysis patients is needed. Colchicine may also be beneficial for dialysis patients as it may help arteriovenous fistulas to last longer. An arteriovenous fistula is a connection made between an artery and a vein in the arm, allowing for access to a person's bloodstream as part of dialysis. Sometimes, these connections can get too narrow in some parts, stopping them from working properly. These narrowings can be treated with a balloon inserted into the vein with the help of an x-ray. Balloons coated with a drug called paclitaxel, which works like colchicine, can be helpful, so the investigators think colchicine may help too. At present, colchicine is often avoided in patients receiving dialysis. Patients on haemodialysis take a number of medications already and have significant comorbidity. Therefore, it is possible that a higher proportion would have difficulty tolerating colchicine. These concerns mean that a large trial assessing the potential benefits of colchicine in this population cannot begin without further data on feasibility. This feasibility study will establish whether low dose colchicine is tolerated and acceptable to dialysis patients and will help the investigators to plan recruitment to future clinical trials. The investigators will give colchicine to 100 dialysis patients. The investigators will monitor the participants for side effects and see how many continue to take it for the planned period of 3 months. If feasibility is confirmed, there are then strong rationales for large clinical trials exploring the effect of colchicine on both mortality and vascular access outcomes in dialysis patients.

Visual Arts Interventions With Older Adults

The present study investigates the feasibility, acceptability, and preliminary effects of a novel visual arts-based intervention in an older adult population. In a randomized controlled design, two arts-based interventions will be evaluated with a group of 40 participants.

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.

ASSIST Ethiopia: Feasibility Clinical Investigation of the Odonassist™ Medical Device

The Innovation The OdonAssist™ is a medical device for assisted vaginal delivery (AVD), that is defined by the need of additional procedure to facilitate childbirth in order to reduce foetal-maternal risks. Increasing access to AVD has been identified by the World Health Organization (WHO) as one of the priorities for improving maternal health globally. The OdonAssist™ is a frugal innovation born in the southern hemisphere in an unconventional environment. It was invented by an Argentinian mechanic, Jorge Odon. Its potential to improve maternal and neonatal health is now recognised. It has been designed to be safe, simple to use and better accepted than current devices (forceps, suction cup). Two studies conducted in England and one in France have confirmed these characteristics and funding has recently been obtained for a randomised clinical investigation in five French hospitals. Project Rationale The present project aims to conduct a feasibility study at Saint Luke's Hospital in Wolisso, a poorly resourced hospital in rural Ethiopia, in order to test the device in a low-income country and assess its acceptability. In addition, with the aim of investigating the efficiency and budgetary impact of this new device, and considering the wider perspective of a future scale-up, data will be collected on its cost-effectiveness, in order to compare it with the reference interventions at local level (vacuum and caesarean section). Main research questions: 1. Is it feasible to introduce the OdonAssist™ (new intervention) at the hospital Saint Luke's in Ethiopia, in terms of preliminary data on safety, efficacy, acceptability by mothers and healthcare providers? 2. What are the estimated healthcare-related costs of the OdonAssist™ (new intervention) in comparison to traditional alternatives, that are vacuum-assisted delivery or cesarean section during the second stage of labor? Study population Participants will be assisted with the OdonAssist™ medical device in case they have provided informed consent and they present medical indication for AVD as per protocol. The study will also collect data on a nested cohort of women and babies delivered either by vacuum extractor or by second-stage cesarean section. The information gained from this study will be used to plan for future impact evaluation and cost utility studies relevant for the implementation and for the scaling up of the OdonAssist™ in low resource settings. The study site will be Saint Luke's Hospital, Wolisso, Oromia region, Ethiopia.

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.

Feasibility and Safety of Sciatic Nerve Paraneural Sheath Block Using a Mid-Femoral Lateral Approach

This study is designed as a randomized controlled trial aiming to evaluate the feasibility and safety of ultrasound-guided mid-femoral lateral approach sciatic nerve paraneural sheath block, in order to provide a new sciatic nerve block approach for clinical practice that offers greater patient comfort and higher precision, thereby facilitating its use for specific patient populations and less experienced operators.