[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"feasibility-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:feasibility-study":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,81,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100637308","how-gut-health-affects-immune-responses-to-the-oral-rotavirus-vaccine-in-adults-in-zambia-100637308",false,"NCT07626606","How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia","Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy","Rota-Omics","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 50 years.\n* Able and willing to provide written informed consent.\n* Reside within Lusaka district and available for scheduled follow-up.\n* Willing to undergo two endoscopy procedures with serial sample collection.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).\n* Known severe immunodeficiency (HIV with CD4 \\\u003C 200 cells\u002Fmm³, current cancer chemotherapy, systemic corticosteroids equivalent to \\>20 mg\u002Fday prednisolone for \\>2 weeks).\n* Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).\n* Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.\n* Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.\n* Any condition judged by the investigator to compromise participant safety or data integrity.\n* Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier.\n\nPregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.",true,"ALL","18 Years","50 Years",{"count":22,"type":23},43,"ESTIMATED","OBSERVATIONAL","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.\n\nA 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.\n\nThe 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.\n\nThe 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.\n\nOne 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.\n\nThe 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.\n\nIn 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.\n\nOverall, 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.",[27,28,29,30],"Feasibility Study","Vaccine Immune Response","Rota Virus Gastroenteritis","Transcriptomics",[30,32,33,34,35,36],"Feasibility","Microbiome","Immunity","Rotavirus","Vaccine","RECRUITING","2026-06-02",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":41},"2026-03-30",{"date":45,"type":23},"2026-12-31",{"name":47,"class":48},"Centre for Infectious Disease Research in Zambia","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100565705","visual-arts-interventions-with-older-adults-100565705","NCT06645652","Visual Arts Interventions With Older Adults","Feasibility and Preliminary Effects of a Drawing-based Intervention on Cognition and Wellbeing of Community-Dwelling Adults at Risk for ADRD","Inclusion Criteria:\n\n* 55-85 years of age\n* Able to understand and speak English and follow study procedures\n* Does not have a psychological or neurological condition that would prevent from being able to give consent to participate\n* Less than 2 years of formal visual arts training\n\nExclusion Criteria:\n\n* Formal diagnosis of dementia or other neurological disease, including Mild Cognitive Impairment\n* A final score below 17 on the Montreal Cognitive Assessment - Blind (phone) version\n* Abnormal visual acuity prohibitive of tablet-based training\n* Physical handicap (motor or perceptual) that would impede training procedures\n* Medical illness requiring treatment and\u002For significant absences during the study timeline","55 Years","85 Years",{"count":60,"type":23},50,"INTERVENTIONAL",[63],"NA","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 50 participants.",[27],[67,68,69,70,71],"Cognition","Perception","Aged","Healthy Volunteers","Learning","2026-04-15",{"date":74,"type":41},"2026-04-20",{"date":76,"type":41},"2025-10-01",{"date":78,"type":23},"2026-09-30",{"name":80,"class":48},"Northeastern University",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":18,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":61,"phases":92,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":49},"100633658","the-new-beginnings-podcast-brief-audio-intervention-for-parents-from-divorced-and-separated-families-100633658","NCT07529548","The New Beginnings Podcast: Brief Audio Intervention for Parents From Divorced and Separated Families","\"The New Beginnings Podcast: A Small-scale Randomized Controlled Trial of a Parenting Podcast to Improve Outcomes for Children From Divorced Families\"","NBP-P","Inclusion Criteria:\n\nFor Parents, eligibility criteria are:\n\n1. divorced, separated, separated but never married, or divorcing\u002Fseparating within the last two years;\n2. one or more children between the ages of 8-18 years old;\n3. have in-person contact with their child(ren) at least three hours per week or have at least one overnight visit every other week;\n4. have access to a smartphone with internet that can play audio files;\n5. English speaking.\n\nFor children, eligibility criteria are:\n\n1. have a parent who is participating in the trial;\n2. be between the ages of 8-18 and\n3. have access to a computer to complete assessments. If a parent has more than one child aged 8-18 interested in participating, we will randomly select one child to ensure independence of responses.\n\nExclusion Criteria:\n\n\\-","8 Years",{"count":91,"type":23},80,[63],"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.\n\nThe main questions it aims to answer are:\n\n1. Do parents find the podcast easy to use, helpful, and relevant?\n2. Does listening to the podcast improve children's mental health?\n3. Does the podcast help parents build stronger relationships with their children and reduce conflict between parents?\n\nResearchers will compare families who use the podcast to families on a waitlist to see if the podcast makes a difference.\n\nParticipants will:\n\n1. Listen to podcast episodes over the course of the study\n2. Answer questions about their experiences with the podcast\n3. Complete surveys about their child's well-being, their parenting, and family relationships\n\nThis study will include 80 parents and their children.",[95,96,97,98,27,99,100,101],"Parent Child Relationship","Parenting Intervention","Parenting Behaviour","Interparental Conflict","Acceptability","Appropriateness","Child Mental Health",[103,104,105,106,107,108,96,109,101],"Parenting","Divorce","Separation","Separated and Divorced Parents","Podcast","Prevention","New Beginnings Program","2026-04-10",{"date":112,"type":41},"2026-04-14",{"date":114,"type":41},"2025-08-15",{"date":116,"type":23},"2026-12",{"name":118,"class":48},"Charla Aubrey Rhodes",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":61,"phases":130,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":49},"100621148","feasibility-and-safety-of-sciatic-nerve-paraneural-sheath-block-using-a-mid-femoral-lateral-approach-100621148","NCT07366853","Feasibility and Safety of Sciatic Nerve Paraneural Sheath Block Using a Mid-Femoral Lateral Approach","Feasibility and Safety of Intraneural Sciatic Nerve Block Via Lateral Mid-femoral Approach: A Clinical Study","iSNB-LF","Inclusion Criteria:\n\n1. Patients scheduled for elective unilateral surgery below the knee (e.g., internal fixation for ankle, metatarsal, or calcaneal fractures; hallux valgus correction; flatfoot reconstruction).\n2. American Society of Anesthesiologists (ASA) physical status class I or II.\n3. Aged 18 to 65 years.\n4. Ability to understand the study procedure and provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to peripheral nerve block:\n\n   * Known allergy or history of toxicity to local anesthetics.\n   * Pre-existing neuropathy in the operative limb.\n   * Severe coagulopathy.\n   * Infection at the intended needle puncture site.\n   * Systemic infection.\n2. Requirement for simultaneous surgery at a site other than the unilateral lower limb below the knee.\n3. Previous surgery or significant scarring in the area of the planned needle insertion for the sciatic nerve block.\n4. Body mass index (BMI) \\> 35 kg\u002Fm².\n5. Patients receiving chronic pain therapy or with a history of opioid abuse.\n6. Inability to communicate or cooperate with the study assessments (e.g., due to cognitive impairment, language barrier, or psychiatric disorder).\n7. Pregnancy or lactation.","65 Years",{"count":129,"type":23},200,[63],"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.",[133,27,134],"Adverse Effect","Safety and Effectiveness",[136,137,138,139,140,32,141],"Sciatic Nerve Block","Subparaneural Block","Lateral Mid-femoral Approach","Popliteal Approach","Ultrasound-guided","Safety","NOT_YET_RECRUITING","2026-01-16",{"date":145,"type":41},"2026-01-26",{"date":147,"type":23},"2026-01-01",{"date":149,"type":23},"2026-10-01",{"name":151,"class":48},"General Hospital of Ningxia Medical University"]