[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ministry of Health, Saudi Arabia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":180},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,82,115,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100637908","phase-2-shield-t1d-shingrix-and-glp-1-agonist-for-beta-cell-preservation-in-recent-onset-type-1-diabetes-100637908",false,"NCT07614412","SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.","Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.","SHIELD-T1D","Inclusion Criteria:\n\n1. Diagnosis of Type 1 Diabetes (T1D) according to American Diabetes Association (ADA) criteria.\n2. Age 18 to 50 years (inclusive) at the time of screening.\n3. Randomization within 100 days of the first insulin injection.\n4. Confirmed residual beta-cell function, defined as a peak stimulated C-peptide level ≥0.2 nmol\u002FL during a Mixed Meal Tolerance Test (MMTT) performed at screening.\n5. Presence of at least one T1D-related autoantibody (GADA, IA-2A, ZnT8A, or ICA).\n6. Willingness to comply with intensive insulin therapy and glucose monitoring.\n7. Females of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis (DKA) within 4 weeks of screening.\n2. Prior use of any immunotherapy or investigational agents for T1D.\n3. Current or prior use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.\n4. History of pancreatitis or medullary thyroid carcinoma.\n5. Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis).\n6. Pregnancy or breastfeeding.\n7. Significant renal, hepatic, or cardiovascular disease.\n8. History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide.\n9. Current use of systemic corticosteroids or other immunosuppressive medications.","ALL","18 Years","50 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by progressive destruction of pancreatic beta cells mediated by autoreactive T lymphocytes, resulting in absolute insulin deficiency. Preservation of residual beta-cell function at the time of diagnosis is a critical therapeutic window, as even marginal endogenous insulin secretion - reflected by detectable C-peptide levels - is associated with improved glycemic control, reduced hypoglycemia burden, and decreased long-term vascular complication rates.\n\nThis study evaluates the hypothesis that combinatorial immunomodulation - using the AS01B adjuvant system within the Recombinant Zoster Vaccine (RZV; Shingrix, GSK) alongside metabolic and cytoprotective support via a GLP-1 receptor agonist (semaglutide) - can synergistically preserve residual beta-cell function in adults within 100 days of T1D diagnosis. The AS01B adjuvant system activates innate immune pathways that promote regulatory T-cell (Treg) expansion and shift the immunological milieu toward tolerance, while GLP-1 receptor agonism provides direct beta-cell cytoprotection, reduces glucotoxicity, and may suppress autoimmune cytokine signaling.\n\nSHIELD-T1D is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial enrolling 240 adults (18-50 years) diagnosed with T1D within 100 days, with confirmed residual beta-cell function (stimulated C-peptide ≥0.2 nmol\u002FL). Participants are randomized 1:1:1:1 to one of four arms: (1) Shingrix alone, (2) Semaglutide alone, (3) Shingrix + Semaglutide combination, or (4) dual placebo. The primary endpoint is change in 2-hour stimulated C-peptide AUC during a Mixed Meal Tolerance Test (MMTT) from baseline to 12 months.\n\nThis phase II randomized, double-blind, placebo-controlled multicenter trial will evaluate the efficacy and safety of the recombinant zoster vaccine (Shingrix) and a glucagon-like peptide-1 (GLP-1) receptor agonist, alone and in combination, for preservation of residual beta-cell function in adults with recent-onset type 1 diabetes. The working hypothesis is that combining AS01 adjuvant-mediated immunomodulation with the metabolic and cytoprotective actions of a GLP-1 receptor agonist will provide dual protection for pancreatic beta cells, slowing autoimmune destruction and improving functional insulin secretion compared with placebo.",[28],"Type 1 Diabetes Mellitus",[30,31,32,33,34,35,36,37,38],"Type 1 Diabetes","Beta-cell preservation","C-peptide","GLP-1 receptor agonist","Recombinant zoster vaccine","Shingrix","AS01 adjuvant","Immunomodulation","Autoimmunity","NOT_YET_RECRUITING","2026-05-21",{"date":42,"type":43},"2026-05-29","ACTUAL",{"date":45,"type":22},"2027-01-01",{"date":47,"type":22},"2028-12-31",{"name":49,"class":50},"Ministry of Health, Saudi Arabia","OTHER_GOV",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":51},"100628869","phase-2-aiph-tb-ai-optimised-pyrazinamide-hydroxychloroquine-vs-standard-ripe-for-drug-sensitive-pulmonary-tuberculosis---a-phase-ii-rct-100628869","NCT07467252","AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT","A Phase II, Open-Label, Randomised, Parallel-Group, Active-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of AI-Optimised Pyrazinamide 1,500 mg \u002F Hydroxychloroquine 200 mg Twice Daily (AIPH-TB Protocol) Versus Standard Four-Drug RIPE Regimen in Adults With Newly Diagnosed Drug-Sensitive Pulmonary Tuberculosis","AIPH-TB-RCT-P2","Inclusion Criteria:\n\n* Confirmed diagnosis of drug-sensitive pulmonary tuberculosis (bacteriologically confirmed by positive sputum smear microscopy or GeneXpert MTB\u002FRIF)\n* Age 18 to 65 years\n* Naive to anti-tuberculosis treatment (no previous TB treatment or less than 1 month of TB treatment in the past)\n* Willing to provide written informed consent\n* Able to comply with study visits and procedures\n* HIV-negative or HIV-positive with CD4 count ≥200 cells\u002Fmm³ on stable antiretroviral therapy\n\nExclusion Criteria:\n\n* Drug-resistant tuberculosis (confirmed resistance to Rifampicin or Isoniazid)\n* Severe hepatic impairment (Child-Pugh Class C) or ALT\u002FAST \\>3 times upper limit of normal\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Known hypersensitivity to Pyrazinamide, Hydroxychloroquine, or any RIPE drugs\n* Pregnancy or breastfeeding\n* Retinal disease or known contraindications to Hydroxychloroquine\n* Concomitant use of medications with significant interactions with study drugs\n* Extrapulmonary tuberculosis as the primary site\n* Currently enrolled in another clinical trial","65 Years",{"count":62,"type":22},200,[25],"Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of patients. Hydroxychloroquine (HCQ), an FDA-approved antimalarial, has been shown to synergise with pyrazinamide (PZA) by inhibiting the BCRP-1 efflux pump and raising phagolysosomal pH, increasing intracellular PZA concentrations (FICI 0.38 in vitro). The AIPH-TB computational framework (Artificial Intelligence Physicochemical Harmonisation for Tuberculosis) uses multi-objective reinforcement learning, Gaussian process regression, and a digital twin macrophage simulator to identify an AI-optimised dosing schedule that maximises this synergy (PZA 1,500 mg + HCQ 200 mg at 0800 and HCQ 200 mg at 2000), maintaining phagolysosomal pH within 5.2-5.8 for 18 of 24 hours. The computational model predicts FICI 0.28 (strongly synergistic), 9.4-fold increase in intracellular PZA concentration, 99.5% cure rate, and \\\u003C1.5% hepatotoxicity. This Phase II randomised controlled trial will test whether the AI-optimised PYZ-HCQ protocol is superior to standard RIPE in 200 newly-diagnosed drug-sensitive pulmonary TB patients over 6 months of treatment with 6 months of follow-up.",[66],"Pulmonary Tuberculosis",[68,69,70,71,72,73],"Tuberculosis","Pyrazinamide","Hydroxychloroquine","Artificial Intelligence","Drug-Sensitive TB","AIPH-TB","2026-03-09",{"date":76,"type":43},"2026-03-12",{"date":78,"type":22},"2026-09",{"date":80,"type":22},"2028-06",{"name":49,"class":50},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":51},"100601672","post-extubation-use-ram-cannula-versus-short-binasal-prong-interfaces-in-preterm-infants-100601672","NCT07113535","Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants","RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Inborn preterm neonates ≤ 32 weeks of gestational and\u002For birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.\n\nExclusion Criteria:\n\n* Outborn preterm neonates\n* Major congenital malformations.","24 Hours","28 Days",{"count":92,"type":22},90,[94],"NA","Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs.\n\nThe investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation.\n\nThe investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.",[97,98,99],"Premature","Respiratory Distress Syndrome","Extubation",[101,102,103,104,105,106],"nasal interface","noninvasive respiratory support","premature","RAM cannula","Chest ultrasound","Diaphragm","2025-08-04",{"date":109,"type":43},"2025-08-08",{"date":111,"type":22},"2025-08",{"date":113,"type":22},"2027-12-31",{"name":49,"class":50},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100518101","phase-2-caffeine-as-an-adjuvant-therapy-for-late-preterm-infants-with-respiratory-distress-100518101","NCT06026163","Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress","Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial","CAT\u002FLPT","Inclusion Criteria:\n\n* Newborn infants at gestational age 34 0\u002F7 through 36 6\u002F7\n* Presented with respiratory distress\n* Require respiratory support in the form of any of the following :\n\nA) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.\n\nExclusion Criteria:\n\n1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.\n\n3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.\n\n5- Late preterm with history of maternal substance abuse","1 Day","3 Days",{"count":126,"type":22},134,[25,128],"PHASE3","Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg\u002Fkg and maintenance dose of 10 and 20 mg\u002Fkg\u002Fday reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.\n\nThe investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.\n\nThe investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.",[131,132,133],"Prematurity","Respiratory Disease","Ventilator Lung; Newborn",[135,136,137,138],"caffeine","preterm","newborn","respiratory support","RECRUITING","2025-06-24",{"date":142,"type":43},"2025-06-27",{"date":144,"type":43},"2023-10-12",{"date":146,"type":22},"2028-01-01",{"name":49,"class":50},2,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":17,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":179,"locationsCount":51},"100379264","safe-threshold-to-discontinue-phototherapy-in-hemolytic-disease-of-newborn-100379264","NCT04218318","Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn","Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial","Inclusion Criteria:\n\nHealthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:\n\n1. positive DAT and blood group iso-immunization (ABO \u002F RH incompatibility);and \u002For\n2. HGB decline by 2g\u002Fdl within 24hour.\n\nExclusion Criteria:\n\n* Major congenital abnormalities,\n* Surgical problems,\n* Direct hyperbilirubinemia\n* Sepsis",true,"1 Hour","14 Days",{"count":160,"type":22},84,[94],"We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.\n\nObjectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.",[164,165],"Hemolytic Disease of Newborn","Neonatal Hyperbilirubinemia",[167,168,169,170,171,172],"Jaundice","Newborn","Hyperbilirubinemia","Rebound hyperbilirubinemia","Phototherapy","Hemolysis","2025-01-01",{"date":175,"type":43},"2025-01-03",{"date":177,"type":43},"2019-10-01",{"date":45,"type":22},{"name":49,"class":50},""]