[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infections":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,65,0,25,[9,50,80,106,132,164,197,224,246,286,313,341,369,389,418,444,461,480,503,530,551,584,608,633,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100130517","phase-1-a-phase-i-study-of-mozobil-in-the-treatment-of-patients-with-whims-100130517",false,"NCT00967785","A Phase I Study of Mozobil in the Treatment of Patients With WHIMS","A Phase I Study of MozobilTM in the Treatment of Patients With WHIMS","* INCLUSION CRITERIA:\n\nAll of the following inclusion criteria must be met for a subject to be enrolled in this study:\n\n* Clinical diagnosis of WHIMS and documented severe infection\n* Must be greater than or equal to 18 and less than or equal to 75 years of age\n* Willingness to interrupt medications to raise the white count (WBC) such as G-CSF or GM-CSF for at least 2 days before and while on the study drug\n* Must not be pregnant or breastfeeding\n* Must have a personal physician\n* Must be willing to provide blood, plasma, serum, and DNA samples for storage\n* Subjects must agree not to become pregnant or to impregnate a female. If of childbearing potential, must agree to consistently use two types of contraception throughout study participation. Acceptable forms of contraception include the following:\n\n  1. Condoms, male or female, with or without a spermicide\n  2. Diaphragm or cervical cap with spermicide\n  3. Intrauterine device\n  4. Contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method\n  5. Male partner has previously undergone a vasectomy for which there is documentation of aspermatogenic sterility\n\nEXCLUSION CRITERIA:\n\nIf any of the following exclusion criteria are met, a subject will not be enrolled in this study:\n\n* Absence of a diagnosis of WHIMS\n* Patient is less than 18 years old\n* Absence of a documented history of severe infection\n* Neutropenia due to maturation defects in the myeloid lineage or that the PI feels is unlikely to benefit from this medication\n* Pregnant women or breastfeeding\n* History of serious cardiac arrhythmia or cardiac defects that make such more likely\n* Renal failure (calculated creatinine clearance \\[CrCl\\] \\\u003C15 mL\u002Fmin or requiring dialysis)\n* Signs or symptoms of active microbial infection at the time of study entry.\n* Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study\n* Unwillingness to undergo testing or procedures associated with this protocol","ALL","18 Years","75 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\n* WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is caused by various genetic changes that increase the activity of the chemokine receptor, CXCR4. Excessive function of this receptor causes mature neutrophils (part of the white blood cells) to be retained within the bone marrow rather than being released to the blood and is one of the causes of severe inherited neutropenia (low white blood counts). In neutropenia, the body is less able to fight off infection. Patients with WHIMS usually are at risk for skin, soft tissue, sinus, and lung infections, which can result in loss of hearing, teeth, and lung function.\n* Current treatment for WHIMS consists of regular injections of a white blood cell growth stimulating medication called granulocyte colony stimulating factor (G-CSF), and supplemental immunoglobulin (antibody). These therapies are expensive, nonspecific, have significant side effects and toxicities, and do not fully correct all problems, especially warts and cancers related to human papillomavirus (HPV).\n* A drug called Mozobil has been approved for use in combination with G-CSF to increase the number of stem cells that can be collected prior to bone marrow transplantation. Mozobil may offer a specific and well-tolerated new treatment for WHIMS and other syndromes characterized by neutropenia.\n\nObjectives:\n\n* To evaluate whether Mozobil is safe and effective to treat neutropenia (low white blood cell count) in patients with WHIMS.\n* To determine an appropriate treatment dose of Mozobil, within currently approved dosage levels.\n\nEligibility:\n\n\\- Individuals between 18 and 75 years of age who have been diagnosed with WHIMS and have a history of severe infections.\n\nDesign:\n\n* Potential participants will undergo a screening with a medical history, physical examination, questionnaire, heart and lung function scans, and blood and urine samples. Tests will also be done for hepatitis B and C virus, and human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome (AIDS), as well as to check neutrophil function.\n* Patients who are being treated with G-CSF will stop injections for 2 days before being admitted to the National Institutes of Health (NIH) Clinical Center.\n* Patients may participate in a Dose Escalation study and receive increasing doses of Mozobil over 5 days of treatment until their white blood cell count improves sufficiently or the maximum approved dose is reached. Blood samples will be taken regularly throughout the treatment process. Patients will then receive an additional dose of Mozobil at the maximum approved dose or the dose sufficient to cause improvement, before restarting the G-CSF injections.\n* Patients may also participate in a long-term Chronic Dosing study and receive Mozobil once or twice a day for up to a maximum of 60 months.",[29,30,31,32,33],"Leukopenia","Neutropenia","Infections","Warts","Myelokathexis",[30,35,33,32,36],"Hypogammaglobulinemia","Immunodeficiency","RECRUITING","2026-06-27",{"date":40,"type":41},"2026-06-30","ACTUAL",{"date":43,"type":41},"2010-01-06",{"date":45,"type":22},"2026-12-31",{"name":47,"class":48},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":4,"leadSponsor":79,"locationsCount":49},"100058416","natural-history-management-and-genetics-of-the-hyperimmunoglobulin-e-recurrent-infection-syndrome-hies-100058416","NCT00006150","Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)","* INCLUSION CRITERIA:\n\nPatients may be included in this study who:\n\n* Were referred to the NIH with a diagnosis or a suspicion of Hyper IgE syndrome.\n* Are patients referred for other immune syndromes that demonstrate some of the characteristics of HIES.\n\n  * \\>=1 month for affected subjects\n  * Aged \\>=2 years for unaffected subjects\n* For unaffected subjects, are able to understand and have the willingness to sign a written informed consent document.\n\nUnaffected biological relatives of HIES patients are also eligible to enroll in a separate relative cohort.\n\nEXCLUSION CRITERIA:\n\nCoronary CTA will not be performed on any patient younger than 30 years or with contraindication to IV contrast media. This includes patients with 1) creatinine value of \\>1.3 mg\u002FdL, 2) history of multiple myeloma, 3) Use of metformin-containing products less than 24 hours prior to contrast media, and 4) history of significant allergic reaction to CT contrast agents despite the use of premedication.\n\nSubjects with a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation, may be excluded.",true,"1 Month","120 Years",{"count":60,"type":22},600,"OBSERVATIONAL","The Hyper IgE Syndromes (HIES) are primary immunodeficiencies resulting in eczema and recurrent skin and lung infections. Autosomal dominant Hyper IgE syndrome (AD-HIIES; Job's syndrome) is caused by STAT3 mutations, and is a multi-system disorder with skeletal, vascular, and connective tissue manifestations. Understanding how STAT3 mutations cause these diverse clinical manifestations is critical to our complete understanding of bone metabolism, bronchiectasis, dental maturation, and atherosclerosis. Bi-allelic mutations in DOCK8 cause a combined immunodeficiency previously described as autosomal-recessive Hyper IgE syndrome. These individuals suffer from extensive viral infections as well as have a high incidence of malignancy and mortality. The pathogenesis of this disease and long-term natural history is being investigated. Therefore, we seek to enroll patients and families with a confirmed or suspected diagnosis of HIES syndrome for extensive phenotypic and genotypic study as well as disease management. Patients will be carefully examined by a multidisciplinary team and followed longitudinally. Through these studies we hope to better characterize the clinical presentation of STAT3-mutated HIES, DOCK8 deficiency and other causes of the hyper IgE phenotype, and to be able to identify further genetic etiologies, as well as understand the pathogenesis of HIES. We seek to enroll 300 patients and 300 relatives....",[31,64,65,66,67],"Pneumonia","Immune System Diseases","STAT3 Transcription Factor","Job Syndrome",[69,70,71,72,36,73,74,75],"DOCK8 Deficiency","PGM3 Deficiency","STAT3 Mutation","Job's Syndrome","Natural History","Hyperimmunologobulin E Syndrome","HIE Syndrome",{"date":40,"type":41},{"date":78,"type":41},"2000-08-10",{"name":47,"class":48},{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100609925","phase-3-supporting-weak-immune-system-during-autoimmune-therapy-testing-panzyga-to-prevent-infections-100609925","NCT07220915","Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy (\"PROTECT\")","Inclusion Criteria:\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis\u002Fmyositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.\n2. Have hypogammaglobulinemia (IgG levels \\\u003C5 g\u002FL as confirmed by the central laboratory).\n3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..\n4. Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component\n2. Have a current major infection at Screening or had \\>1 major infection within 6 months prior to Baseline\n3. Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline\n4. Have a known IgA deficiency with antibodies to IgA\n5. Have a known blood hyperviscosity or other hypercoagulable states\n6. Have been diagnosed with primary immunodeficiency.\n7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy\n8. Have a severe kidney disease (as defined by eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n9. Have a body weight \\>140 kg\n10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1\u002F2 antigen\u002Fantibody immunoassay followed by positive HIV-1\u002FHIV-2 antibody differentiation immunoassay)\n11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and\u002For low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.\n12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).\n13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study\n14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration\n15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.\n16. If female, are pregnant or lactating\n17. Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator",{"count":88,"type":22},360,[90],"PHASE3","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy",[35,93,94,31],"Autoimmune Conditions","Rheumatic Conditions","NOT_YET_RECRUITING","2026-06-16",{"date":98,"type":41},"2026-06-17",{"date":100,"type":22},"2026-06",{"date":102,"type":22},"2029-12",{"name":104,"class":105},"Octapharma","INDUSTRY",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100512092","phase-2-rhu-pgsn-for-acute-respiratory-distress-syndrome-ards-100512092","NCT05947955","Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)","A Phase 2 Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections","Inclusion Criteria:\n\n1. Infection followed within a week of documented bilateral infiltrates\u002Fopacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist\n\n   * Investigator or designee to note radiologic findings in the electronic case report form (eCRF)\n   * Radiology report and conclusion should be summarized in the eCRF\n   * A digital copy of the radiograph uploaded and saved for review\n2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L\u002Fmin of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.\n3. Age ≥18 years\n4. Informed consent obtained from subject\u002Fnext of kin\u002Flegal proxy\n5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team\n6. During the course of the study starting at screening and for at least 3 months after their final study treatment:\n\n   1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods\n   2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner\n   3. All subjects must agree not to donate sperm or eggs\n\nExclusion Criteria:\n\n1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.\n2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection\n3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO)\n4. Pregnant or lactating women\n5. Previous splenectomy\n6. Any vaccination in the previous 30 days\n7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days\n8. Known allergy to study drug or excipients\n9. Weight \\>125 kg\n10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months\n11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease\n12. Chronic mechanical ventilation or dialysis\n13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy \\\u003C6 months unrelated to acute infection in the opinion of the Investigator.",{"count":60,"type":22},[26],"BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P\u002FF ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.",[117,31],"Acute Respiratory Distress Syndrome",[119,120,121],"moderate to severe ARDS","respiratory failure","rhu-pGSN","2026-06-12",{"date":124,"type":41},"2026-06-15",{"date":126,"type":41},"2024-10-03",{"date":128,"type":22},"2027-03-01",{"name":130,"class":105},"BioAegis Therapeutics Inc.",70,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":163},"100492978","phase-3-po-vs-iv-antibiotics-for-the-treatment-of-infected-nonunion-of-fractures-after-fixation-100492978","NCT05699174","PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","POvIV2","Inclusion Criteria:\n\n1. 1\\. Bone fracture (proximal to and including the tarsal\u002Fmetatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.\n2. Infection as determined by either\n\n   1. FRI criteria\n   2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon\n3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks\n\nExclusion Criteria:\n\n1. Patients with a high risk of amputation based on the initial managing physician\n2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment\n3. Incarcerated or institutionalized patients\n4. Patients who are unable to return for required follow-up visits and\u002For medical co-morbidities which preclude treatment with a general anesthetic\n5. Patients with a prior history of chronic infection at the index site before fracture fixation\n6. Patients with pathological fractures from a neoplastic process\n7. History of Paget's Disease\n8. The patient, or a designated proxy, unwilling to provide consent\n9. The patient must be available for follow-up for at least 12 months following infection treatment",{"count":141,"type":22},250,[90],"This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.",[31,145,146,147,148,149,150,151,152],"Infected Wound","Nonunion of Fracture","Injury Leg","Amputation","Internal Fixation; Complications, Infection or Inflammation","Fracture","Lower Extremity Fracture","Antibiotic Side Effect","2026-06-09",{"date":155,"type":41},"2026-06-11",{"date":157,"type":41},"2023-05-30",{"date":159,"type":22},"2028-09-29",{"name":161,"class":162},"Major Extremity Trauma Research Consortium","OTHER",13,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":172,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":195,"locationsCount":49},"100639817","large-algorithm-setting-and-validation-study-100639817","NCT07607470","Large Algorithm Setting and Validation Study","A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing","LAVA","Inclusion Criteria:\n\nBiologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:\n\n* Abnormal vaginal discharge\n* Vaginal or vulvar itching, burning, or irritation\n* Painful or uncomfortable intercourse\n* Vaginal odor\n* Painful or frequent urination\n\nExclusion Criteria:\n\n* Participants who do not meet the above-described inclusion criteria will be excluded from the study.\n* Previously enrolled in this study\n* Contraindication to vaginal swab sampling","FEMALE",{"count":174,"type":22},1000,"In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.\n\nThe Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.",[177,178,31,179,180,181,182,183,184,185,186,187,188],"Bacterial Infections","Bacterial Infections and Mycoses","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Urogenital Disease","Candidiasis","Mycoses","Vulvovaginitis","Vulvar Diseases","Vaginosis, Bacterial","2026-05-20",{"date":191,"type":41},"2026-05-26",{"date":189,"type":22},{"date":194,"type":22},"2027-01",{"name":196,"class":105},"Nanopath, Inc",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100475518","cied-infection-quality-initiative-demonstration-project-100475518","NCT05471973","CIED Infection Quality Initiative Demonstration Project","The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project","RECTIFY","Inclusion Criteria:\n\n* Age ≥18 years\n* Cardiovascular Implantable Electronic Device (CIED) in place\n* Presumed CIED infection, as defined by:\n\n  1. Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia\n  2. Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection\n\nExclusion Criteria:\n\n* Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and\u002For it is unlikely that extraction would change overall prognosis\n* Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection\n* Patients with left ventricular assist devices (LVADs)",{"count":206,"type":22},200,[208],"NA","The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.",[31],[212,213],"Cardiac Implantable Electronic Devices","Quality improvement","2026-05-04",{"date":216,"type":41},"2026-05-06",{"date":218,"type":41},"2023-05-10",{"date":220,"type":22},"2027-03-31",{"name":222,"class":162},"Duke University",3,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":56,"sex":172,"minAge":18,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":49},"100504294","effect-of-drain-care-on-infection-rate-and-quality-of-life-in-implant-based-breast-reconstruction-100504294","NCT05846438","Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.","Inclusion Criteria:\n\n* undergoing breast surgery with placement of tissue expander and drains, acceptance of protocol and procedures, age \\> 18\n\nExclusion Criteria:\n\n* no existing wounds, previous infections related to implant device if delayed, refusal by patient","100 Years",{"count":232,"type":22},100,[208],"The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection. The main questions it aims to answer are:\n\n* Is there an increased risk of infection\u002Fcomplications with showering 48 hours after drain tubes are in place\n* Does showering after 48 hours with drain tubes in place affect quality of life.",[31,236],"Quality of Life","2026-04-28",{"date":239,"type":41},"2026-05-05",{"date":241,"type":41},"2023-03-15",{"date":243,"type":22},"2028-03-15",{"name":245,"class":162},"University of Missouri-Columbia",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":257,"conditions":258,"keywords":269,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":284,"locationsCount":49},"100506981","prevalence-incidence-and-risk-signature-of-chronic-kidney-disease-in-sub-saharan-africa-100506981","NCT05881447","Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa","Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in a Primary Care Setting in Semirural Sub-Saharan Africa","RenalTWO","Inclusion Criteria:\n\nall adult patients (≥18 years) attending the outpatients department of the Bagamoyo district hospital (BDH) or the associated Fukayosi and Yombo dispensary\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* not living in the BDH catchment area\n* not of African decent\n* not willing to come back for follow-up visits","99 Years",{"count":256,"type":22},1200,"Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.",[259,260,261,262,263,264,265,266,31,267,268],"Chronic Kidney Diseases","Type 2 Diabetes Mellitus","Arterial Hypertension","Obesity","Cardiovascular Diseases","HIV Infections","Anemia","Underweight","Albuminuria","Dyslipidemias",[270,271,272,265,273,274,275,276,277],"CKD","Risk factors","Cardiovascular disease","Point of care diagnostics","Albumin creatinine ration (ACR)","Estimated glomerular filtration rate (eGFR)","Kidney Disease: Improving Global Outcomes (KDIGO)","HbA1c","2026-04-23",{"date":280,"type":41},"2026-04-29",{"date":282,"type":41},"2023-06-21",{"date":45,"type":22},{"name":285,"class":162},"Swiss Tropical & Public Health Institute",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100482971","collection-of-blood-samples-for-new-diagnostic-devices-2-100482971","NCT05568966","Collection of Blood Samples for New Diagnostic Devices 2","Collection of Venous and Capillary Blood Samples for the Research, Optimisation and Calibration of New Diagnostic Devices 2","NOVEL-2","Inclusion Criteria\n\n* Subject 18 years of age.\n* Willing and able to provide written informed consent and comply with study procedures.\n* Patients attending a definitive care team with research capabilities which has been enroled in this collection study.\n* Patients who can read and understand written English.\n* The subject must present as one of the following cohorts:\n\n  1. Group A - Embolism Cohort - Patients presenting with symptoms indicative of thromboembolic events.\n  2. Group B - Infection or Inflammation Cohort - Patients presenting with symptoms indicative of infection or inflammatory disorders.\n  3. Group C - Cardiovascular Cohort - Patients presenting with symptoms indicative of heart failure or acute coronary syndrome.\n  4. Group D - Renal Cohort - Patients presenting with symptoms indicative of renal disorders.\n  5. Group E - Other Cohort. - Patients who are not eligible for any of the above groups.\n\nExclusion Criteria\n\n* Subject \\\u003C18 years of age.\n* Vulnerable populations deemed inappropriate for the study by the sites Principal Investigator.\n* Patients who have previously been enroled in any LumiraDx NOVEL study in the past 3 months and re-entry would breach the 24mL and or 6 fingersitck maximums.",{"count":295,"type":22},20000,[208],"To research and develop new state of the art diagnostic biomarkers on the LumiraDx Platform that are comparable to the approved gold standard reference methods and will radically enhance clinicians and patients ability to monitor health conditions and improve outcomes by delivering the results near patient at the point of care.",[299,300,301,302,31],"Embolism and Thrombosis","Cardiovascular","Renal","Inflammation","2026-04-17",{"date":305,"type":41},"2026-04-22",{"date":307,"type":41},"2022-07-11",{"date":309,"type":22},"2026-08-20",{"name":311,"class":105},"LumiraDx UK Limited",7,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":321,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100498466","phase-4-improving-therapeutic-drug-monitoring-and-dosing-for-vancomycin-in-young-infants-with-infections-vancapp-part-2-100498466","NCT05770622","Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)","The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)","VANCAPP","Inclusion Criteria:\n\n* Infants aged 0 - 90 days old\n* Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)\n\nExclusion Criteria:\n\n* Infants with a corrected gestational age of less than 25 weeks\n* Infants weighing less than 500g.\n* Known allergy to any glycopeptide antibiotic\n* Vancomycin administered within the previous 72 hours\n* Infants receiving any form of extracorporeal life support\n* Renal impairment","0 Days","90 Days",{"count":324,"type":22},40,[326],"PHASE4","A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.",[329,31,330],"Sepsis","Bacteremia","2026-04-15",{"date":333,"type":41},"2026-04-20",{"date":335,"type":41},"2024-11-10",{"date":337,"type":22},"2027-04",{"name":339,"class":162},"Murdoch Childrens Research Institute",4,{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":172,"minAge":18,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":49},"100632319","single-versus-double-drains-in-the-axillary-and-pectoral-regions-after-modified-radical-mastectomy-100632319","NCT07512141","Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy","Comparative Analysis of Quilting Sutures With a Single Axillary Drain Versus Double Drains in the Axillary and Pectoral Regions for the Prevention of Seroma After Modified Radical Mastectomy","SVDD","Inclusion Criteria:\n\n* All patients older than 18 years but less than 70 years of age,\n* Diagnosed with breast carcinoma.\n* All the patients undergoing upfront MRM,\n* All patients undergoing MRM post-neoadjuvant chemotherapy.\n\nExclusion Criteria:\n\n* Mastectomy \\& sentinel lymph node biopsy\n* Breast reconstruction surgery\n* Defect covering flaps","70 Years",{"count":351,"type":22},60,[208],"Normally, after this surgery, skin is stitched in the usual simple way, with no quilting, and two drains are put in to remove serosa, one under the arm and one on the chest. In this study, the investigator will use a different type of stitch called a quilting stitch, which helps stick the skin to the chest muscle so there is less serosa collection. The investigator will compare two groups:\n\n* Group A: Quilting stitches with two drains (one under the arm and one on the chest).\n* Group B: Quilting stitches with one drain only (under the arm).",[355,31,356],"Seroma Following Procedure","Pain, Postoperative",[358,359,360],"Seroma","Mastectomy","Breast","2026-03-30",{"date":363,"type":41},"2026-04-06",{"date":365,"type":41},"2026-03-27",{"date":220,"type":22},{"name":368,"class":162},"Sindh Institute of Urology and Transplantation",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":49},"100630425","evaluation-and-assessment-for-communicable-diseases-in-migrants-hosted-in-reception-centers-100630425","NCT07487506","Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers","REACH - Responsive Evaluation and Assessment for Communicable Diseases in Migrants Hosted in Reception Centers","REACH","Inclusion Criteria:\n\n* All asylum seekers residing in reception centers who are 18 years of age or older, have been in Italy for at least 2 months but no more than 36 months, who express their consent to undergo screening.\n\nExclusion Criteria:\n\n* Individuals under the age of 18; Asylum seekers who have been in Italy for less than 2 months or for more than 36 months; Refusal to consent to participate in the study",{"count":141,"type":22},[208],"A single-centre, non-profit experimental clinical trial. The aim of the study is to estimate the prevalence of a range of infections and infectious diseases in a cohort of asylum seekers staying in initial reception centres, who have been in Italy for at least 2 months but no more than 36 months. The infections of interest are: latent tuberculosis and active tuberculosis, HIV, HBV, HCV, syphilis, strongyloidiasis, schistosomiasis, filariasis, and intestinal helminthiasis.",[31],"2026-03-24",{"date":361,"type":41},{"date":384,"type":41},"2025-04-08",{"date":386,"type":22},"2026-09-08",{"name":388,"class":162},"IRCCS Sacro Cuore Don Calabria di Negrar",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":407,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":49},"100618245","healing-electroceutical-dressing-for-the-recovery-of-open-wounds-hero-100618245","NCT07329114","Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)","Prospective, Unblinded, Randomized, Controlled Investigation to Evaluate the Clinical Efficacy of PowerHeal™ Bioelectric Bandage in Managing Infected Traumatic Wounds","HERO","Inclusion Criteria:\n\n1. Female and male participants 18-105 years of age\n2. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine\n3. At least one infected traumatic wound(s) between 20-40 cm2 in size. Probable or confirmed wound infection(s) will be determined by on-site physicians' clinical judgment and the presence of two or more of the following clinical indicators of wound infection:\n\n   1. Presence of worsening pain (from the moment of injury)\n   2. Erythema (redness)\n   3. Warmth (heat)\n   4. Edema (swelling)\n   5. Purulent exudate (drainage)\n   6. Delayed healing\n   7. Discoloration\n   8. Friable granulation\n   9. Foul odor\n   10. Wound margin breakdown or necrosis with or without fever\n   11. Pustules, vesicles, boils\n4. Participant or legal representative provides written informed consent prior to investigation procedures\n5. Participant understands and agrees to adhere to planned investigation procedures\n\nExclusion Criteria:\n\n1. Allergy to silver or zinc\n2. Women who are pregnant or nursing\n3. Women of childbearing potential without a documented negative pregnancy test during the current hospitalization or women of childbearing potential who refused pregnancy testing during screening\n4. Sponsor or contract research organization (CRO) staff directly involved in the conduct of the investigation, and site staff supervised by the investigator, and their respective family members\n5. \\> 60 days from the initial traumatic injury\n6. Known prisoner\n7. The patient is expected to be discharged from the hospital within the next 24 hours\n8. Medical condition other than the acute traumatic wound (and its manifestations) that is likely to result in death within 14 days of randomization\n9. Moribund condition, defined as life expectancy less than 48 hours from randomization\n10. Patients undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life\n11. Expected inability or unwillingness to participate in study procedures\n12. In the opinion of the investigator, participation in the investigation is not in the best interest of the patient\n\nNote: Allergies to parabens and acrylates will also be considered. While they are not direct exclusions, participants with these allergies should avoid being enrolled.","105 Years",{"count":399,"type":22},150,[208],"The goal of this clinical trial is to determine whether the wireless electroceutical dressing (WED) called PowerHeal™ Bioelectric Bandage, improves care of infected wounds by clearing the infection and helping the wound heal better.\n\nThe main hypotheses it aims to answer are:\n\n1. WED promotes wound closure, as determined by wound area measurement\n2. WED manages wound infection in civilian and military wounds in Ukraine, as determined by clinical assessment of wound infection by measuring the numbers and types of relevant microbes.\n\nResearchers will compare to see if PowerHeal™ Bioelectric Bandage the dressing used in the SOC group\n\nParticipants will get their dressings changed per the protocol, wound image and swab will be taken.",[403,404,405,406,31],"Wound Heal","Wound Infection","Wound Healing Delayed","Wound of Skin",[408],"bandage","2026-03-04",{"date":411,"type":41},"2026-03-06",{"date":413,"type":41},"2026-02-11",{"date":415,"type":22},"2027-08",{"name":417,"class":162},"Chandan Sen",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":425,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":443},"100548834","l-citrulline-to-improve-adverse-outcomes-in-admitted-children-echilibrist-clinical-trial-2-inpatients-100548834","NCT06426147","L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)","A Randomised, Double-blind, Placebo-controlled Trial of L-Citrulline Oral Supplementation to Improve Short and Long-term Outcomes of Admitted Febrile Paediatric Patients With Biomarker-determined High-risk of Adverse Outcomes","Inclusion Criteria:\n\n* Enrolled in the initial prognostic screening component.\n* Sick children with fever (axillary temperature\\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease.\n* 1m-\\\u003C60 months of age.\n* With an indication for admission, or having already been admitted to hospital due to their illness.\n* With an sTREM-1 PoC result classifying their disease as of \"moderate-high risk\" (\"yellow\" or \"red\") upon study recruitment and within D3.\n* Residents in the study area or willing to be contacted and traced during the study duration.\n* Willing to sign an informed consent document.\n* Willing to undergo and adhere to study procedures as explained in the IC document.\n\nExclusion Criteria:\n\n* Admission to hospital for social reasons (and not on account of their disease).\n* Children for which informed consent document has not been signed.\n* Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet.\n* Concurrent participation in any other clinical trial.\n* Patient under NPO or \"nothing by mouth\" prescription .\n* Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth.\n* Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening.\n* Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study.","0 Months","60 Months",{"count":428,"type":22},2200,[208],"In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project (\"Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival\") has the two-fold objective of:\n\n1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the \"prognostic\" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and\n2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\\\u003C60 months identified as \"moderate-to-high risk\" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo.\n\nThis second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \\~888 children 1-\\\u003C60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg\u002Fkg\u002Fday depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia.",[432,31,433],"Infectious Disease","Child, Only","2026-02-19",{"date":436,"type":41},"2026-02-23",{"date":438,"type":41},"2025-12-08",{"date":440,"type":22},"2027-08-01",{"name":442,"class":162},"Barcelona Institute for Global Health",2,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":18,"enrollmentInfo":450,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":4},"100505538","a-cohort-study-on-anti-microbial-stewardship-in-picu-100505538","NCT05862688","A Cohort Study on Anti-microbial Stewardship in PICU","Inclusion Criteria:\n\n* Patients admitted to the ICU for more than 48 hour\n\nExclusion Criteria:\n\n* Patients admitted to ICU less than 48 hours",{"count":174,"type":22},"Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. Critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. Initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. Antimicrobial stewardship teams can assist ICU providers in managing and implementing these tactics. ICUs would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy.",[31],"2026-02-12",{"date":455,"type":41},"2026-02-17",{"date":457,"type":22},"2026-07-01",{"date":45,"type":22},{"name":460,"class":162},"Children's Hospital of Fudan University",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":163},"100590880","bacillus-cereus-invasive-infections-in-preterm-neonates-hospitalized-in-french-hospitals-100590880","NCT06973174","Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals","Inclusion Criteria:\n\n* Premature newborn (i.e born before 37 last menstrual periods) with invasive infection caused by B. cereus (strains isolated from blood culture and cerebrsopinal fluid)\n\nExclusion Criteria:\n\n* None","143 Days",{"count":324,"type":22},"Background. Bacillus cereus group (Bc) comprises twenty-six closely related species of spore-forming environmental bacteria. Recently, increased sepsis and septic shock caused by Bc were reported in preterm neonates (PN), and the mortality rate can reach up to 30%. Using Whole Genome Sequencing (WGS) increasingly used to characterize Bc strains, The team aimed to determine an accurate identification to the species level of the strains involved in Bc invasive infections in preterm neonates in France and study their virulome profile.Methods. The team performed WGS for 40 neonate clinical strains responsible for invasive infections in PN. A screening of virulence genes was performed to characterize strains associated with poor prognosis. Clinical data were collected and all clinical and genomic findings were analyzed for risk factors for death.\n\n\"",[329,31],"2026-01-27",{"date":473,"type":41},"2026-01-28",{"date":475,"type":41},"2010-01-01",{"date":477,"type":22},"2026-12-30",{"name":479,"class":162},"Centre Hospitalier Universitaire de Nice",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":49},"100622125","personalized-immunological-score-for-the-prediction-of-severe-infectious-events-in-immunocompromised-patients-and-tailored-management-periscope-100622125","NCT07379554","Personalized Immunological Score for the Prediction of Severe Infectious Events in Immunocompromised Patients and Tailored Management (PERISCOPE)","PERISCOPE","Inclusion Criteria:\n\nadult hematopoietic stem cell transplant recipients (a-HSCTR)\n\n* pediatric hematopoietic stem cell transplant recipients (p-HSCTR)\n* solid organ transplant recipients (SOTR), including kidney, heart and lung transplanted patients.\n\nWritten informed consent\n\nExclusion Criteria:\n\n* no written informed consent",{"count":399,"type":22},"Transplants have improved clinical conditions for many patients with haematological diseases and end-stage organ diseases. However, immunosuppressive therapies that are necessary for avoiding organ rejection have a crucial impact in the occurrence of opportunistic infections. Despite the development of effective antimicrobial agents, infectious diseases are still related to mortality and morbidity in immunocompromised patients. Immune function assays can be adopted for monitoring T-cell function and eventually modify immunosuppression. Given the inverse relationship between cellular immune reconstitution and risk of infection, many transplant centers prospectively monitor immune recovery post-transplant. Some basic methods are useful, including white blood cells and T-lymphocyte subsets count. Given the complexity of immune responses required to resolve infections, functional assays are necessary and the only available FDA-approved one is Cyclex-Immuknow. Viral infections are common in patients with T-cell deficiencies and are of particular concern in those receiving high dose steroids. Opportunistic infections are common during the period of highest immunosuppression while community acquired infections, including fungal and respiratory viruses infections, have to be considered in the long-term period. Reduced CD4+ and CD8+ T-lymphocyte counts correlate with risk of opportunistic infection, including human cytomegalovirus (HCMV). Moreover, a decrease in human Rhinovirus (HRV) load in pediatric hematopoietic stem cell transplant recipients (HSCTRs) was associated with a significant increase in T-CD4+, T-CD8+ and NK lymphocytes, suggesting that cellular immunity have a crucial role in viral clearance and infectious control. A recent study showed that poor NK-cell cytotoxic activity is associated with increased risk for severe infections in kidney-graft recipients, suggesting that assessment of NK-cell function may be used as a predictor of infection in immunocompromised patients. Moreover, it has been recently reported that NKG2C genotype influences receptor function and NKG2C+ NK cell number in HCMV seropositive subjects. In detail, NKG2C genotype is significantly associated with HCMV viremia frequency and related disease after lung transplant and with symptomatic CMV infection after kidney transplant. Beside the use of non-specific immunological markers, the lack of standardized quantitative measures of protective immune functions specific for different opportunistic pathogens represents a challenge for clinicians. Overall, a comprehensive approach based on the use of combined non-specific and pathogen-specific immune assays may help in the definition of a composite immune risk profile of immunocompromised patients. The ultimate goal of this research is the definition of algorithms of infectious risk in immunocompromised patients, leading to a more adherent administration of immunosuppressive and antimicrobial therapies as well as to a personalized strategy of patients' management. Moreover, the design of new immunological assays that can be standardized and used in the clinical practice will be obtained.\n\nCurrently, even if an immunological monitoring of immunocompromised patients is recommended, no standardized assays and protocols are available, especially for the use of antigen-specific or functional assays. The introduction of diagnostics algorithms will be useful for the stratification of patients at high risk of infections that will be monitored more frequently in order to prevent severe infections. Similarly, the administration of immunosuppressive drugs or ad hoc therapies might be tailored according to the risk of infections or complications. Objective is to identify a composite immune score measured either before or one month after transplant\u002Fchemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months.\n\nPrimary endpoint:\n\nTo identify a composite immune score measured either before or one month after transplant\u002Fchemotherapy able to define the risk for clinically significant infections (e.g. infections requiring antimicrobial therapy or hospitalization) during the following three months.\n\nSecondary endpoints:\n\n* To evaluate the prognostic effect of the immunological score measured before or at first month after transplant\u002Fchemotherapy on the risk of severe infection during the following 6-12 months\n* To compare the role of the composite immunological score with specific assays against each pathogen.\n* To develop simple and rapid assays using whole blood to evaluate specific pathogen responses",[490,491,31],"Immunocompromised Patients","Transplant Patients",[493,494],"Immunological score","severe infections","2026-01-23",{"date":497,"type":41},"2026-01-30",{"date":499,"type":41},"2024-04-04",{"date":100,"type":22},{"name":502,"class":162},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":56,"sex":172,"minAge":4,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":340},"100527281","encore-moms-engaging-communities-to-reduce-morbidity-from-maternal-sepsis-aim-1-100527281","NCT06145724","EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 1)","EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle","Inclusion Criteria:\n\nBirthing Person (EMR evaluation):\n\n-Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025\n\nExclusion Criteria:\n\nBirthing Person (EMR evaluation)\n\n-Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2020-2025 timeframe",{"count":511,"type":22},33183,[208],"Sepsis is the second leading cause of maternal death in the U.S. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.",[515,31],"Maternal Sepsis",[517,518,519,520],"Post Partum Period","Pregnancy","Maternal Health","Electronic Health Record","2026-01-20",{"date":523,"type":41},"2026-01-21",{"date":525,"type":41},"2025-06-01",{"date":527,"type":22},"2026-09-20",{"name":529,"class":162},"Columbia University",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":49},"100619644","head-only-draping-in-pediatric-tonsillectomy-100619644","NCT07347301","Head-Only Draping in Pediatric Tonsillectomy","30-Day Postoperative Infection Rate in Pediatric Tonsillectomy: Head-Drape vs. Full-Body Surgical Draping","Inclusion Criteria:\n\n1. Pediatric patients \\\u003C18 years at time of surgery.\n2. Scheduled for tonsillectomy, with or without adenoidectomy, without any other procedures requiring full-body draping.\n3. Ability to complete 30-day outcome assessment (i.e., remain in follow-up or reachable via phone\u002Felectronic health record).\n4. Parent\u002Fguardian able to provide parental permission and consent for both them and their children.\n\nExclusion Criteria:\n\n1. Significant deviation from planned surgical technique during case.\n2. Pre-existing systemic infection prior to surgery.\n3. Known immunodeficiency or current systemic immunosuppressive therapy.",{"count":206,"type":22},[208],"This single-center, interventional study will compare 30-day postoperative infection rates in pediatric tonsillectomy performed with either head-only draping or traditional full-body draping. Secondary analyses will evaluate differences in waste production, material and disposal costs, and provider attitudes between the two draping techniques. This study will randomize participants 1:1 to either the head-only draping cohort (intervention) or the full-body draping cohort (control).",[541,31],"Tonsillectomy","2026-01-09",{"date":544,"type":41},"2026-01-16",{"date":546,"type":22},"2026-02-02",{"date":548,"type":22},"2026-12-01",{"name":550,"class":162},"NYU Langone Health",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":56,"sex":17,"minAge":559,"maxAge":322,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":568,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":49},"100619311","gastrointestinal-symptoms-and-tolerance-in-infants-fed-goat-or-cows-milk-based-infant-formula-100619311","NCT07342972","Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula","Effect of a Goat-milk Based Infant Formula on Gastrointestinal Symptoms and Tolerability in Healthy Term Infants: a Double-blind Randomized Controlled Trial","MESK-2","Inclusion Criteria:\n\n* Age between 14 days and 90 days.\n* Healthy singleton term infants born between 37 weeks and 42 weeks of gestation.\n* Infants who have received CMF for at least 7 consecutive days.\n* Exclusive formula feeding.\n* Cow's Milk-related Symptoms Score (CoMiSS®) value at baseline of ≥6 and \\\u003C10.\n* Parents' or caregivers, aged ≥18 years, willing to give informed consent and adhere to study protocol\n\nExclusion Criteria:\n\n* Exclusively or partially feeding with human milk\n* Introduced to solid food, supplementary feeding, use of pre- and\u002For probiotics as a supplement\n* Congenital or recurrent chronic conditions and\u002For malabsorption that could interfere with study parameters.\n* Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and\u002For lactose intolerance.\n* Receiving medication (on own initiative or prescription) with regard to FGID (i.e. reflux medication)\n* Sibling already participating in this study\n* Participation in another clinical trial","14 Days",{"count":561,"type":22},144,[208],"This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.",[565,566,31,236,567],"Gastrointestinal Tolerance","Gastrointestinal Symptoms","Anthropometrics",[569,570,571,572,573,574],"Formula","Infant","Goat milk-based infant formula","RCT","Gastrointestinal symptoms","Gastrointestinal tolerance","2026-01-06",{"date":577,"type":41},"2026-01-15",{"date":579,"type":22},"2026-02",{"date":581,"type":22},"2027-09",{"name":583,"class":105},"Ausnutria Hyproca B.V.",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":592,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":606,"locationsCount":49},"100512296","trial-to-reduce-antimicrobial-use-in-nursing-home-residents-with-alzheimers-disease-and-other-dementias-20-100512296","NCT05950607","Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0","Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)","TRAIN-AD 2","Inclusion Criteria:\n\n1. Age \\> 60\n2. A diagnosis of dementia (any type)\n3. Cognitive Functional Scale (CFS) \\> 1\n4. NH length of stay \\>90 days\n\nThe CFS score categorizes cognitive impairment status based on data in the electronic health record into: 1. None, 2. Mild, 3. Moderate, and 4. Severe (advanced). For the primary outcome, the analysis will be restricted to residents with a CFS score of 3 or 4.\n\nExclusion Criteria:\n\n1. Less than 60 years of age\n2. Living in nursing home for less than 90 days\n3. Does not have diagnosis of dementia\n4. Does not meet CFS \\>1 score","60 Years","106 Years",{"count":595,"type":22},750,[208],"The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.",[599,600,31],"Dementia","Alzheimer Disease","2026-01-02",{"date":575,"type":41},{"date":604,"type":41},"2023-11-13",{"date":40,"type":22},{"name":607,"class":162},"Hebrew SeniorLife",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":56,"sex":17,"minAge":615,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":632},"100580192","phase-3-assessment-of-immunogenicity-reactogenicity-and-safety-of-the-drug-gng-de-in-comparison-with-the-reference-drug-100580192","NCT06834100","Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug","Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE","Inclusion Criteria:\n\n1. Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.\n2. Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and\u002For the parent\u002Fadoptive parent informed consent form (Parent Information Sheet, PIS) signed by one of parents\u002Fadoptive parents (for participants aged 3-17 years old inclusive).\n3. Negative result of SARS-CoV-2 antigen rapid test at screening.\n4. Negative pregnancy test result in fertile females of reproductive age. For females not reached puberty, and for girls\u002Fwomen unable to childbirth (with past infertility, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, menopause for more than 2 years), the pregnancy test shall not be performed.\n5. For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception (abstinence, condoms in combination with spermicide and\u002For hormonal contraception) during the study.\n\n   For participants aged 3-13 years old inclusive and females incapable of childbearing, the consent to use reliable methods of contraception is not required.\n6. The consent of a participant and\u002For a parent\u002Fan adoptive parent of a participant to cooperate in good faith with the investigator and the center staff, come to appointed visits, fill out the observation diary and comply with the requirements of the Protocol.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any component of the test\u002Freference drug.\n2. Evident severe systemic reactions to any vaccines in anamnesis.\n3. Impossibility of intramuscular injections.\n4. Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test\u002Freference drug (the deltoid muscle area).\n5. Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.\n6. Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and 1.\n7. The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.).\n8. The history of meningococcal infection.\n9. Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening.\n10. The history of convulsive syndrome or the advanced neurological disease.\n11. The history of Guillain-Barré syndrome.\n12. The history of mental diseases.\n13. Drug administration:\n\n    * the history of meningococcal mono- or polyvalent vaccine, influenza vaccine within 14 days before screening, other vaccines within 30 days before screening;\n    * immunostimulants less than 30 days before screening;\n    * the immunosuppressive therapy, including systemic corticosteroids, prescribed for more than 5 days, or in the daily dose of more than 1 mg\u002Fkg\u002Fday of prednisolone or its equivalent - less than 30 days before screening;\n    * antipyretics, analgesics - for less than 24 hours before Visits 0 and 1;\n    * systemic antibacterial drugs-- for less than 72 hours before Visits 0 and 1;\n    * anticoagulants - for less than 3 weeks before Visits 0 and 1;\n    * immunoglobulins, blood or plasma products - for less than 3 months before Visits 0 and 1.\n14. Planning the administration of vaccines with the exception of the test\u002Freference drug during the clinical study.\n15. Surgical interventions performed less than 3 months before screening.\n16. Participation in another clinical study less than 30 days before screening.\n17. Other conditions that, in the opinion of the investigator, interfere to the enrollment.","3 Years","55 Years",{"count":618,"type":22},240,[90],"Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug",[31,622],"Meningococcal","2025-12-24",{"date":625,"type":41},"2025-12-29",{"date":627,"type":41},"2025-02-12",{"date":629,"type":22},"2025-12-31",{"name":631,"class":105},"NPO Petrovax",17,{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":642,"conditions":643,"keywords":646,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":4},"100617203","couples-and-microbial-diversity-100617203","NCT07315568","Couples and Microbial Diversity","COUPLES AND MICROBIAL DIVERSITY","CLARITY","Inclusion Criteria:\n\n* Problems in conceiving the past 12 months\n* Over 18 years old\n* Fluent in Finnish\n\nExclusion Criteria:\n\n* Needs for donated gametes (except for female homosexual couples)",{"count":206,"type":22},"Couples and Microbial Diversity (CLARITY) - study is a prospective study that investigates the risks and dynamics of different microbes and transmission among couples to optimize the prevention and control strategies as well as improvement for infertility treatments.\n\nThe study will be conducted at the Infertility Clinic of Tampere University Hospital, Tampere Finland; and will recruit 200 couples undergoing infertility investigations and treatments. Oral and genital tract samples will be collected at baseline and every six months during a two-year follow-up period. Background information will be obtained through a secure online questionnaire.\n\nCouples who achieve pregnancy will be followed according to the CLARITY protocol until delivery, after which families will transition to the CLARITY-Baby extension study. Samples from both the newborn and parents will be collected at delivery and again at six months postpartum, accompanied by an online follow-up questionnaire completed by the parents.",[644,645,31],"Infertility","Transmission",[647,648,644,649],"Human Microbiome","HPV","Microbial Diversity","2025-12-18",{"date":601,"type":41},{"date":653,"type":22},"2026-01-05",{"date":655,"type":22},"2031-12-30",{"name":657,"class":162},"Tampere University Hospital",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":664,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":668,"conditions":669,"keywords":672,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":443},"100586152","infectious-complications-after-esophagectomy-100586152","NCT06911658","Infectious Complications After Esophagectomy","Infectious Complications, Associated Factors, and Prognosis After Esophagectomy for Cancer: A French, Multicenter, Retrospective Study - CIFO-study","CIFO","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Underwent esophagectomy for cancer between January 1, 2017, and December 31, 2024\n* Scheduled admission to intensive care for postoperative monitoring\n\nExclusion Criteria:\n\n* Opposition to the use of data",{"count":667,"type":22},350,"Infectious complications represent the most common postoperative adverse events following esophagectomy for cancer, such as pneumonia (15% of cases). These complications increase immediate risks, lengthen hospital stays, and worsen patient quality of life.\n\nThe population includes patients admitted to intensive care after esophagectomy for cancer between January 1, 2017, and December 31, 2024.\n\nThe study focuses on this population due to the increasing incidence of esophageal cancer, the increased use of surgery for these indications, and the importance of postoperative infections in these complex procedures, despite their understudied nature in the current literature. Identifying modifiable risk factors could lead to corrective measures and thus improve the prognosis of postoperative patients.\n\nThe research focuses primarily on the incidence, types, factors, and prognosis associated with the occurrence of infections after esophagectomy for cancer. It also includes an analysis of the pathogens involved, their resistance profiles, and the antibiotic therapies used in first-line probabilistic treatment.",[670,671,31,64],"Esophagectomy","Postoperative Complications",[673,674],"Postoperative infection","Esophagectomy complications","2025-12-09",{"date":677,"type":41},"2025-12-17",{"date":679,"type":41},"2025-08-27",{"date":681,"type":22},"2026-07-28",{"name":683,"class":162},"Assistance Publique - Hôpitaux de Paris"]