[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Southern Medical University, China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":157},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,75,102,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100642268","phase-3-how-precision-diets-through-gut-bacteria-affect-anemia-in-nepalese-adolescent-100642268",false,"NCT07661602","How Precision Diets, Through Gut Bacteria, Affect Anemia in Nepalese Adolescent","Gut Microbiota-Mediated Effects of Precision Dietary Interventions on Anemia Among Nepalese Adolescents","Inclusion Criteria:\n\n* Female adolescents aged 15-19 years\n* Enrolled in selected schools\n* Resident in Kathmandu for at least 6 months\n* Provision of written informed assent and parental consent\n\nExclusion Criteria:\n\n* Current pregnancy\n* Known genetic blood disorders (thalassemia, sickle cell disease)\n* Chronic metabolic, inflammatory, or infectious diseases affecting hematological parameters\n* Acute illness at time of screening\n* Use of iron, folic acid, vitamin B12 supplements, antibiotics, or probiotics within the past 3 months\n* History of helminth infection or deworming treatment within the past 6 months\n* Participation in other nutrition intervention studies","FEMALE","15 Years","19 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study aims to evaluate whether a food-based nutrition intervention using goat liver can improve anemia among adolescent girls in Kathmandu, Nepal, and compare its effectiveness with the current standard iron and folic acid supplementation. It will also investigate how diet and the gut microbiota (the community of beneficial microorganisms living in the intestine) may influence iron absorption and response to treatment.\n\nAnemia is a major public health problem among adolescent girls in Nepal. During adolescence, rapid growth and the onset of menstruation increase the body's need for iron and other nutrients involved in blood formation. If left untreated, anemia can impair physical growth, reduce learning ability and concentration, decrease work capacity, weaken immunity, and negatively affect future reproductive health. Although weekly iron-folic acid supplementation programs are widely implemented, anemia remains common, suggesting that additional strategies may be needed.\n\nRecent research indicates that gut microbiota may affect iron metabolism by influencing nutrient absorption, inflammation, and overall intestinal health. Dietary habits can alter the composition of gut bacteria, which may partly explain why individuals respond differently to iron interventions. However, little is known about these relationships among Nepalese adolescents. This study seeks to fill that knowledge gap and explore whether a locally available food-based intervention can provide a practical and sustainable alternative or complement to conventional supplementation.\n\nThe research will be conducted among adolescent girls aged 15 to 19 years enrolled in selected schools in Kathmandu. The study has two phases. In the first phase, you will undergo screening to determine the prevalence and types of anemia. Blood samples will be collected to measure hemoglobin, iron status, vitamin B12, folate, and inflammation-related biomarkers. Stool samples will be collected to analyze gut microbiota composition. Information on dietary intake, food frequency, dietary diversity, and other relevant characteristics will also be obtained through structured questionnaires.\n\nGirls identified with anemia and meeting the eligibility criteria will be invited to participate in the randomized intervention phase. You will be randomly assigned to receive either the standard iron-folic acid supplementation recommended by national programs or a goat liver-based dietary intervention for 12 weeks. Random assignment ensures a fair comparison between interventions and minimizes bias.\n\nGoat liver was selected because it is rich in highly bioavailable heme iron as well as vitamin B12, folate, vitamin A, and other nutrients important for blood production. As a commonly available food in Nepal, it may represent a culturally acceptable and sustainable nutrition-based strategy for improving anemia.\n\nDuring the intervention, you will be monitored regularly to assess adherence and wellbeing. At the end of the 12-week period, blood and stool samples will be collected again to evaluate changes in hemoglobin levels, iron-related biomarkers, nutritional status, and gut microbiota composition. The study will compare improvements between intervention groups and examine whether changes in gut microbiota are associated with better anemia outcomes.\n\nParticipation is entirely voluntary. Written informed consent from parents or guardians and informed assent from adolescent participants will be obtained before enrollment. You may withdraw from the study at any time without penalty. All personal information and laboratory results will remain confidential and will be stored using coded identifiers to protect privacy.\n\nBlood collection will be performed by trained healthcare professionals using standard safety procedures, and stool samples will be collected using appropriate collection kits and instructions. Participants found to have severe anemia or other important medical conditions during the study will be referred for appropriate medical care according to national guidelines.\n\nThe findings from this study are expected to provide important evidence on whether a locally available food-based intervention can effectively improve anemia among adolescent girls while also enhancing understanding of the relationship between diet, gut microbiota, and iron metabolism. The results may help inform future nutrition policies, school health programs, and precision nutrition strategies for anemia prevention and treatment in Nepal and other similar settings.",[27],"Anemia",[29,30,31,32,33,34,35,36],"Anaemia","iron deficiency anemia","adolescent girls","goat liver supplementation","food-based intervention","precision nutrition","gut microbiome","dietary intervention","NOT_YET_RECRUITING","2026-06-22",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2026-11",{"name":47,"class":48},"Southern Medical University, China","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100634661","evaluating-the-implementation-via-audit-and-feedback-100634661","NCT07542587","Evaluating the Implementation Via Audit and Feedback","Evaluating the Implementation of Clinical Competency for Hypertension and Diabetes in Primary Care Via Audit and Feedback: a Multicentre, Randomized Implementation Trial Across Four Nations","Inclusion Criteria:\n\n* In Mozambique, the inclusion criteria are nurses, general medicine technicians, and physicians in PHC facilities.\n* In Zanzibar, Tanzania, the inclusion criteria are clinical officers, nurses, and other healthcare providers involved in consultation, examination, diagnosis, and treatment in PHC facilities.\n* In Nepal, the inclusion criteria are medical officers, health assistants, and senior auxiliary health workers in PHC facilities.\n* In China, the inclusion criteria of PHC facilities are primary and secondary hospitals, community health centers (stations) and clinics, as well as township health centers and village health clinics; and the inclusion criteria of research participants are practicing (assistant) physicians and rural physicians working in healthcare facilities that meet the above criteria, with a scope of practice only including general practice and internal medicine.\n\nExclusion Criteria:\n\n* In Mozambique, the exclusion criteria are healthcare providers from other departments, such as tuberculosis, malaria, human immunodeficiency virus\u002Facquired immune deficiency syndrome, or emergency services, as well as students currently on internship.\n* In Nepal, the exclusion criteria are interns or students present during the visit.",true,"ALL",{"count":60,"type":21},324,[62],"NA","The ability of primary healthcare (PHC) providers to practice in accordance with evidence-based guidelines and norms is a critical component of improving the quality of primary healthcare. Implementation science seeks to promote the routine use of evidence-based practices by identifying barriers to their implementation and developing strategies, such as audit and feedback (AnF), to overcome them. However, because the effects of AnF show significant heterogeneity across studies, this research focuses on systematically developing an optimized AnF strategy and rigorously evaluating its effectiveness in improving clinical practice compared to no intervention. The development of an optimized AnF strategy involves a preparation phase, which utilizes expert consultation and a Best-Worst Scaling (BWS) survey to identify key candidate components and assess resource constraints, followed by an optimization phase utilizing a 2×2×2×2 factorial design randomized controlled trial (RCT) to determine the most effective combination of AnF components. Subsequently, in the evaluation phase, a two-arm, multicentre RCT will be conducted across four nations (Nepal, Mozambique, Tanzania, and China). Primary healthcare providers (PHPs) will be 1:1 randomly assigned to either the optimized AnF intervention group or a no intervention control group based on randomly permuted blocks (sizes 2, 4, and 6), stratified by country. Care quality will be assessed using the gold standard method of Unannounced Standardized Patients (USPs). The primary outcome is the proportion of completed guideline-recommended quality checklist items for the consultation of hypertension and Type II diabetes cases among all items. This outcome will be expressed as a continuous score ranging from 0% to 100%. Furthermore, a mixed-methods research strategy will be employed to extract Context-Mechanism-Outcome (CMO) elements and construct a Causal Pathway Diagram (CPD). This study will provide a robust empirical foundation for using an optimized AnF strategy to improve the quality of primary healthcare in developing countries. By deconstructing \"why, for whom, and under what circumstances\" the intervention works through the CMO framework and CPD, this study will provide vital mechanistic evidence for the future scale-up of this model, contributing a comprehensive and universal research paradigm to the field of implementation science.",[65,66],"Hypertension","Diabetes","2026-04-17",{"date":69,"type":41},"2026-04-21",{"date":71,"type":21},"2026-08",{"date":73,"type":21},"2027-12",{"name":47,"class":48},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":58,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100553007","optimize-audit-and-feedback-to-implement-evidence-based-practices-in-primary-health-care-100553007","NCT06480487","Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE","Optimize Audit and feedbaCk To Implement eVidence-based prAcTices in Primary Health carE in Nepal, Mozambique, Tanzania and China: a Factorial Trial (ACTIVATE Trial)","ACTIVATE","Inclusion Criteria:\n\n* In Mozambique, the inclusion criteria are nurses, technicians of general medicine and doctors in public primary healthcare facilities.\n* In Zanzibar, Tanzania, the inclusion criteria are clinical officers, nurses and doctors in public primary healthcare facilities.\n* In Nepal, the inclusion criteria are doctors, health assistants, and senior auxiliary health workers in public primary healthcare facilities.\n* In China, the inclusion criteria are doctors practicing in public primary healthcare facilities.\n\nExclusion Criteria:\n\n-The exclusion criteria are endocrinologists or diabetes specialists, interns, or students working during the time of visit.","18 Years","80 Years",{"count":86,"type":21},344,[62],"The investigators will use two phases of Multiphase Optimization Strategy (MOST) - preparation and optimization phases. In the preparation phase, Audit and Feedback (AnF) intervention will be prepared. First, the investigators will use scoping review to develop conceptual frameworks for AnF components. The outcome indicators and resource constraints for intervention will be identified based on the literature reviews. Second, an expert consultation meeting will be conducted to develop a set of candidate components for the AnF intervention. Around 10 relevant scholars and primary healthcare workers will be invited to rank the components that researchers conclude from the literature. The top 7 ranked components will be assessed by Best-Worst Scaling (BWS) questionnaires to finally identify 3 key components for AnF intervention.\n\nIn the optimization phase, the investigators will identify AnF intervention that will lead to the best desired results within key resource constraints in terms of effectiveness , efficiency, economy and scalability. First, the investigators will realistically and comprehensively assess the quality of care provided by primary healthcare facilities of the four Low and Middle Income countries (LMICs) using USP. Second, a 2×2×2 factorial design (RCT) will be conducted to determine how the results of quality of care can be fed back to primary healthcare workers in the four LMICs in order to optimize the impact of improving healthcare quality. To achieve this goal, the factorial trial will involve the 3 identified key AnF components at 2 levels each, for a total of 8 intervention groups (i.e. 8 different ways to conduct audit and feedback). By randomly assigning healthcare facilities to one of these 8 different ways to conduct audit and feedback, the investigators can obtain the change in the quality of care after implementing audit and feedback interventions in these facilities. Then, through statistical analysis, the investigators can estimate main and interaction effects for AnF components on improving the quality of primary health care. After that, the optimal combination of AnF components will be determined by trade off of the effects of AnF components and resource constraints in local primary healthcare implementation settings. Study details are as follows.",[65,66],[91,92,93],"Audit and feedback","Quality of care","Primary health care","2025-04-23",{"date":96,"type":41},"2025-04-27",{"date":98,"type":21},"2025-05",{"date":100,"type":21},"2025-10-31",{"name":47,"class":48},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":57,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100569837","artificial-intelligence-driven-virtual-standardized-pediatric-patients-trial-100569837","NCT06699433","Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial","Utilizing Artificial Intelligence-driven Virtual Standardized Pediatric Patients to Enhance the Capabilities of Primary Healthcare Doctors in China for Managing Common Pediatric Diseases: a Randomized Controlled Trial","1. Inclusion and Exclusion Criteria for Research Institutions\n\n   Inclusion Criteria:\n   * Primary and secondary hospitals\n   * Community health centers (stations) and clinics, as well as township health centers and village health clinics\n\n   Exclusion Criteria:\n   * Specialized medical institutions (such as specialized hospitals and dental clinics)\n   * Public health prevention and treatment institutions (such as tuberculosis prevention centers)\n   * Ethnic medicine institutions (such as Mongolian and Tibetan hospitals)\n   * Hospitals above the secondary level\n   * Hospitals that have not yet been graded (due to their short establishment time and potentially unstable operations)\n2. Inclusion and exclusion criteria for research subjects\n\nInclusion Criteria:\n\n* Practicing (assistant) doctors and rural doctors working in medical institutions that meet the above conditions\n* With a scope of practice only including general practice, internal medicine, surgery, and pediatrics\n\nExclusion Criteria:\n\n-None",{"count":110,"type":21},459,[62],"Background: China's healthcare system for children faces significant challenges, particularly due to the limited pediatric service capacity of primary healthcare institutions. A shortage of effective and accessible training tools for primary care doctors further hinders progress in addressing this gap. Technological advancements, especially in artificial intelligence, offer a potential solution to improve pediatric care. Artificial intelligence-driven virtual standardized patients (VSPs), leveraging internet and virtual simulation technologies, simulate clinical cases with specific disease characteristics, providing an innovative, efficient, and flexible training method. VSPs are increasingly utilized in medical education, clinical reasoning, and licensure exams. This study focuses on using VSPs to improve the management of common pediatric conditions, which are major health concerns for children and impose significant psychological and financial burdens on families.\n\nMethods: This study will involve a three-arm randomized controlled trial to evaluate the effectiveness of a virtual pediatric standardized patient platform in enhancing primary care doctors' management of common pediatric diseases. At least 459 participants, including general practitioners, internal medicine practitioners, surgeons, and pediatricians from more than 10 provinces across China, will be randomly assigned to one of three groups: the virtual patient platform group, the case teaching manual group, or the case teaching video group. Five virtual patient cases covering pneumococcal pneumonia, rotavirus enteritis with hypovolemic shock, hand-foot-and-mouth disease, acute appendicitis, and respiratory failure will be developed, along with corresponding case teaching materials. After a two-week learning period, participants' disease management abilities will be assessed using clinical vignettes. The primary outcome is adherence to best clinical practice guidelines, categorized into full adherence, partial adherence, and nonadherence.\n\nDiscussion: This study aims to leverage artificial intelligence for capacity enhancement, targeting the shortcomings of primary care pediatrics and using VSP to help enhance primary care pediatrics capacity. It is a randomized controlled trial involving over 300 primary healthcare institutions across more than 10 provinces in China, ensuring broad and representative participation from both developed and underdeveloped regions.",[114,115,116,117,118],"Pneumococcal Pneumonia","Rotavirus Enteritis With Hypovolemic Shock","Hand-foot-and-mouth Disease","Acute Appendicitis","Respiratory Failure (Pediatric Patients)","RECRUITING","2024-12-15",{"date":122,"type":41},"2024-12-19",{"date":124,"type":21},"2024-12",{"date":126,"type":21},"2025-01",{"name":47,"class":48},3,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":58,"minAge":83,"maxAge":84,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100532877","phase-2-the-effectiveness-of-hp-and-tmz-synergism-on-adult-recurrence-gbm-100532877","NCT06218524","The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM","Clinical Study for Evaluating the Effectiveness of Haloperidol and Temozolomide Synergism on Adult Recurrence Glioblastoma","Inclusion Criteria:\n\n* Adult patients\n* Primary GBM underwent surgery and TMZ chemoradiotherapy, and MRI confirmed the tumor recurrence\n* Without severe cardiac diseases\n\nExclusion Criteria:\n\n* Child patients (\\\u003C18 years)\n* Recurrence tumors grow fast, which needs surgery removal\n* H3K27M midline glioblastoma\n* Suffered with severe cardiac diseases",{"count":137,"type":21},200,[139],"PHASE2","The study of investigators indicated that TMZ can up-regulate dopamine D2 receptor (DRD2) expression, and mediates Ferroptosis inhibition and chemoresistance of GBM. The clinical data also proved that the DRD2 expression in recurrent GBM is significantly higher than that in primary GBM. Moreover, the DRD2 antagonist haloperidol can attenuate the above function of DRD2, and increase the sensitivity of GBM to the TMZ by inducing fatal autophagy and ferroptosis. In xenograft mice, the combined usage of haloperidol and Temozolomide (TMZ) can significantly inhibit tumor growth and increase overall survival. The investigators' findings have been published in Clinical cancer research. Haloperidol known as a butylbenzene antipsychotic drug, has been widely used in several kinds of mental illnesses, such as depression, schizophrenia, and Bipolar disorder. And the safe dosage of the haloperidol is clear so far. So in this study, the investigators will recruit the patients who suffered from recurrent GBM, and evaluate the effectiveness of single TMZ chemotherapy or combined with haloperidol.",[142],"Glioblastoma Multiforme",[144,145,146,147,148],"Chemoresistance","Autophagy","Ferropotosis","DRD2","Haloperidol","2024-01-22",{"date":151,"type":41},"2024-01-23",{"date":153,"type":21},"2024-12-01",{"date":155,"type":21},"2028-07-31",{"name":47,"class":48},""]