[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"viral-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:viral-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,45,71,97,130,152,177,206,235,260,281,312,336,357,387],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100363560","phase-1-tetravi-multivirus-ctl-for-treatment-of-ebv-cmv-adenovirus-and-bk-infections-post-allogeneic-sct-100363560",false,"NCT04013802","TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.","Administration of Most Closely HLA-matched Multivirus-specific Cytotoxic T-Lymphocytes for the Treatment of EBV, CMV, Adenovirus, and BK Virus Infections Post Allogeneic Stem Cell Transplant","TETRAVI","Inclusion Criteria:\n\n1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood.\n\n   Or Received CAR-T cells targeting an antigen expressed on normal virus specific T cells\n2. Treatment for Infection\u002FDisease will fall into one of 3 categories (options):\n\n   * Option 1: Persistent, increasing or recurrent infections despite 7 days of standard therapy;\n\n     * a. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet, letermovir or cidofovir. 56, 57\n\n       * i. CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination.\n       * ii. CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx or bronchoalveolar lavage.\n     * b. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir.\n\n       * i. Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or lung or nasopharynx.\n       * ii. Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or lung or nasopharynx.\n     * c. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg\u002Fm2 in patients for 1-4 doses with a CD20+ve tumor.58\n\n       * i. EBV infection: defined as: (1) Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR;\n       * ii. (2) Or clinical or imaging findings consistent with EBV lymphoma and\u002For elevated EBV viral load in peripheral blood.\n     * d. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined (section 1.1.5). Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy.\n\n       * i. BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine or lung.\n       * ii. BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids or lungs and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site.\n     * e. JC virus: Treatment of JC virus infection or disease without suitable alternative treatment option. Given the high homology (\\>90%) between JC and BK and the fact that BKVSTs targeting VP1 and Large T (as targeted in our multivirus MVSTs) have been administered to treat JCV-PML, and produced viral clearance from the cerebrospinal fluid, it is likely that our MVSTs will have efficacy against JC virus. Given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to JML, which is almost uniformly fatal, and the apparent activity of BK virus- directed T cells against JC virus infected cells, we propose including patients with JC virus on this study, unless a suitable alternative therapy is available.\n\n       * i. JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood.\n       * ii. JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site.\n   * Option 2: Early treatment for single or multiple infections with EBV, CMV, adenovirus, and\u002For BK virus will be allowed for patients deemed to be unable to tolerate standard therapy. Patients with multiple CMV, EBV, Adenovirus, and BK virus infections are eligible given that at least one infection is persistent despite standard therapy as defined above. Patients with multiple infections or reactivations are eligible to enroll.\n   * Option 3: For patients having adenovirus and BK virus, the requirement to fail one week of standard therapy would be waived if they meet one of the criteria below:\n\n     1. They are ≤100 days post- transplant\n     2. They are currently receiving other nephrotoxic agents or marrow-suppressive agents\n     3. They have adenovirus copy number ≥10,000 copies\u002Fml\n3. Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg\u002Fkg\u002Fday methylprednisolone (or equivalent).\n4. Hgb ≥ 7.0 gm\u002Fdl\n5. Available MVSTs must be partially HLA matched with recipient and HLA match must be verified by one of the Principal Investigators.\n6. Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).\n7. Written informed consent and\u002For signed assent line from patient, parent or guardian.\n\nExclusion Criteria\n\n1. Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.\n2. Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.\n\n   Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n3. Patients who are less than 28 days removed from their allogeneic hematopoietic stem cell transplant or who have received donor lymphocyte infusions (DLI) or CAR-T within 28 days.\n4. Patients with active acute GVHD grades II-IV.\n5. Uncontrolled relapse of malignancy\n6. Requirement for FiO2 \\> 50% oxygen to maintain oxygen saturation \\> 90% (peripheral pulse-ox). Note: patients requiring oxygen at FiO2\\\u003C=50% to maintain arterial oxygen saturation \\>90% are eligible to receive MVSTs if the reason for this oxygen requirement is believed attributable to the virus being treated.","ALL",{"count":19,"type":20},47,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have received a product that depletes virus specific T cells.\n\nThe patient must have had a myeloablative or non-myeloablative allogeneic HSCT using either bone marrow, single\u002Fdouble umbilical cord blood, or peripheral blood stem cells (PBSC) or CAR T cell product targeting an antigen expressed on virus specific T cells. After a transplant, while the immune system grows back, the patient is at risk for infection. Some viruses can stay in the body for life and are normally controlled by a healthy immune system, but if the immune system is weakened, like after a transplant, they can cause life threatening infections. He\u002Fshe must have had an infection with one or more of the following viruses -Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus (AdV), Human polyomavirus type I (BKV), and human polyomavirus type II (JCV)- that has persisted or recurred despite standard therapy.\n\nIn this study, the investigators want to use white blood cells that have been trained to treat viral infections. In an earlier study the investigators showed that treatment with such specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical for patients who already have an infection. In a subsequent study, the investigators were able to create multivirus-specific T cells (VSTs) from the blood of healthy donors and created a bank of these cells. The investigators then successfully used these banked cells to treat virus infections after a stem cell transplant. In this study the investigators have further modified their production method to decrease the potential side effects and the investigators want to find out if they can use these banked VSTs to fight infections caused by the viruses mentioned above.",[26],"Viral Infection",[28,29,30,31],"cytomegalovirus (CMV)","BK virus","Epstein-Barr virus (EBV)","adenovirus","RECRUITING","2026-06-09",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":38,"type":36},"2021-03-08",{"date":40,"type":20},"2031-05-01",{"name":42,"class":43},"Baylor College of Medicine","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100643095","protein-biomarkers-and-host-rna-expression-profiles-in-congenital-cytomegalovirus-infection-100643095","NCT07635368","Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection","Inclusion Criteria:\n\n1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program.\n2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period.\n3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling.\n\nExclusion Criteria:\n\n1. DBS samples not approved for research use.\n2. DBS samples with insufficient blood material for RNA expression profiling and\u002For proteomic analyses.\n3. Samples with inadequate analytical quality for molecular or proteomic analyses.",true,"0 Days","28 Days",{"count":55,"type":20},630,"OBSERVATIONAL","This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.",[59,60,61,62,26],"Congenital Cytomegalovirus","Cytomegalovirus Infections","Neonatal Infection","Sensorineural Hearing Loss","2026-06-04",{"date":33,"type":36},{"date":66,"type":36},"2026-04-21",{"date":68,"type":20},"2026-12-31",{"name":70,"class":43},"Rigshospitalet, Denmark",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100377674","phase-1-treatment-of-refractory-bk-infections-with-related-donor-bk-specific-cytotoxic-t-cells-ctls-100377674","NCT04197596","Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)","A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients","Inclusion Criteria:\n\n.1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either\n\n* Increasing urine and\u002For plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND\u002FOR\n* Medical intolerance to anti-viral therapies including:\n\n  * 2 renal toxicity with cidofovir or other \\> grade 2 toxicities secondary to cidofovir And\u002For\n* known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.\n\n1.3 Performance Status \\> 30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test\n\nExclusion:\n\n1. Patient with acute GVHD \\> grade 2 or extensive chronic GVHD at the time of BK CTL infusion\n2. Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of BK CTL infusion\n3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion\n4. Thymoglobulin (ATG) or Alemtuzumab within 30 days\n5. Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30%\n6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.\n7. Any medical condition which could compromise participation in the study according to the investigator's assessment\n8. Known HIV infection\n9. Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.\n10. Known hypersensitivity to iron dextran\n11. Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n12. Known human anti-mouse antibodies","1 Month","79 Years",{"count":81,"type":20},40,[23,83],"PHASE2","BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).",[26,86],"Primary Immune Deficiency Disorder","2026-04-10",{"date":89,"type":36},"2026-04-15",{"date":91,"type":36},"2020-07-01",{"date":93,"type":20},"2027-06-30",{"name":95,"class":43},"New York Medical College",7,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":51,"sex":17,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100629122","viromes-in-infants-presenting-with-a-septic-syndrome-100629122","NCT07470541","Viromes in Infants Presenting With a Septic Syndrome","V-NOURSSE","Inclusion criteria :\n\nFor participants :\n\n* Age \\\u003C 3 months\n* Fever ≥38°C confirmed in pediatric emergency department\n\nFor control group :\n\n* Age \\\u003C 3 months\n* Children requiring general anesthesia or managed in the pediatric emergency department, or during hospitalization or consultation, for a non-infectious condition requiring venipuncture\n\nExclusion criteria :\n\nFor participants :\n\n* Lack of parental\u002Flegal guardian consent\n* Lack of affiliation with a social security scheme\n* Antibiotic treatment within 8 days prior to inclusion\n\nFor control group :\n\n* Lack of parental\u002Flegal guardian consent\n* Lack of affiliation with a social security scheme\n* Antibiotic treatment within 8 days prior to inclusion\n* Infectious episode within 8 days prior to inclusion","0 Months","3 Months",{"count":107,"type":20},130,[109],"NA","Fever in infants younger than 3 months is a common reason for emergency department visits and is associated with a significant risk of serious bacterial infections. Because it is difficult to distinguish bacterial from viral infections at presentation, management is often aggressive and includes invasive procedures, hospitalization, and empiric antibiotic therapy.\n\nDespite advances in molecular diagnostics, the etiology of fever remains unidentified in a substantial proportion of cases. This study aims to assess the presence of pathogenic viruses in respiratory and intestinal samples from febrile infants younger than 3 months compared with afebrile controls, and to explore associations with clinical, biological, environmental, and socio-economic factors",[112,26,113],"Fever","Bacterial Infections",[115,116,117,118],"fever in infants under 3 months","Viruses","Respiratory infection multiplex PCR","Virome","NOT_YET_RECRUITING","2026-03-16",{"date":122,"type":36},"2026-03-17",{"date":124,"type":20},"2026-04-01",{"date":126,"type":20},"2028-03-31",{"name":128,"class":43},"University Hospital, Montpellier",1,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":129},"100380189","phase-2-trial-of-scheduled-versus-treatment-administration-of-donor-derived-viral-specific-t-cells-for-viral-infections-after-stem-cell-transplant-100380189","NCT04230356","Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant","A Randomized Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells (VSTs) for Control of Viral Infections After Allogeneic Stem Cell Transplant","SCHEDULED ARM:\n\nInclusion Criteria:\n\n* Recipient must be at least 21 days after stem cell infusion\n* Clinical status must allow tapering of any steroids to \\\u003C 0.5mg\u002Fkg prednisone or other steroid equivalent\n* No critical illness making VST infusion hazardous\n\nExclusion Criteria:\n\n* Active acute GVHD grades II-IV.\n* Uncontrolled relapse of malignancy.\n* Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point.\n\nTREATMENT ARM\n\nInclusion Criteria:\n\n* Blood adenovirus PCR ≥1,000\n* Blood CMV PCR ≥ 500\n* Blood EBV PCR ≥ 9,000\n* Plasma BKV PCR \\>1,000\n* Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.\n* Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis\n* Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.\n* Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy.\n* No active acute GVHD grades II-IV\n* No uncontrolled relapse of malignancy\n* No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.\n* Clinical status must allow tapering of any steroids to \\\u003C 0.5mg\u002Fkg prednisone or other steroid equivalent",{"count":138,"type":20},180,[83],"The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).\n\nStem cell transplant reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections.",[142,26],"Allogeneic Stell Cell Transplant","2026-03-10",{"date":145,"type":36},"2026-03-12",{"date":147,"type":36},"2021-01-27",{"date":149,"type":20},"2028-06",{"name":151,"class":43},"Children's Hospital Medical Center, Cincinnati",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100415591","phase-1-adoptive-t-lymphocyte-administration-for-chronic-norovirus-treatment-in-immunocompromised-hosts-100415591","NCT04691622","Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts","ATLANTIC","Inclusion Criteria:\n\nParticipant Inclusion Criteria for NST Infusion:\n\n1. Participants must meet one of the following criteria:\n\n   1. Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood OR\n   2. Primary immunodeficiency disorder (as defined by clinical and laboratory evaluations)81 and have not undergone HSCT, OR\n   3. Recipients of solid organ transplant.\n2. Documentation of chronic norovirus infection:\n\n   a. Chronic norovirus infections will be defined as having consecutive positive norovirus stool tests (2 or more) spanning a minimum three-month period with attributable signs and symptoms of norovirus disease.\n3. Participants receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to \\\u003C0.5 mg\u002Fkg\u002Fday of prednisone (or equivalent) a minimum of 7 days prior to infusion.\n\n   a. Treatment with enteral topical steroids such as Budesonide at standard doses may be continued if previously utilized but should not be newly initiated in the 3 months after NST therapy.\n4. For participants who have undergone HSCT, participants must have stable donor chimerism within the 30 days prior to NST infusion.\n\n   a. Stability will be defined as i. \\>95% donor chimerism in CD33 and\u002For whole blood chimerism. OR ii. \\>90% donor chimerism with \\\u003C5% change between subsequent tests separated by at least 1 week.\n5. For recipients of solid organ transplants, participants must have stable graft function on maintenance immunosuppression, without evidence of rejection in the past 2 months prior to infusion, as defined by:\n\n   a. Stability of relevant functional testing in the previous 2 months, defined as: i. Renal transplant: renal function ≥ grade 3 per the National Kidney Foundation K\u002FDOQI Clinical Practice Guidelines for Chronic Kidney Disease (2002) ii. Cardiac transplant: maintenance of LVEF \\>40% iii. Lung transplant: lack of baseline oxygen requirement iv. Liver transplant: AST\u002FALT ≤3x upper limit normal and bilirubin ≤2x upper limit normal b. Donor-derived cell free DNA \\\u003C2x upper limits for assay in the previous 2 months, c. Stable donor-specific antibody profile in the previous 2 months. i. No increase in antibody titers between most recent testing in the previous 2 months and prior testing.\n6. Karnofsky\u002FLansky score \\>50\n7. 3 months to 80 years of age at enrollment.\n8. ANC ≥500\u002Ful.\n9. Hemoglobin ≥7.0g\u002Fdl (level can be achieved with transfusion).\n10. Platelets ≥20 K\u002Ful (level can be achieved with transfusion).\n11. Bilirubin ≤2x upper limit normal.\n12. AST ≤3x upper limit normal.\n13. Serum creatinine ≤2x upper limit normal OR estimated GFR ≥30 ml\u002Fhr.\n14. Pulse oximetry of ≥90% on room air.\n15. Negative pregnancy test in female participant of childbearing age.\n16. Written informed consent and\u002For signed assent line from participant, parent or guardian.\n\nDonor Inclusion Criteria:\n\n1. Donors who have fulfilled eligibility as per United States Food and Drug Administration (FDA) regulations outlined in 21 Code of Federal Regulations (CFR) 1271 subpart C. This includes that donors have been deemed in good health by donor physician based on physical examination and laboratory testing. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for NST generation provided that there are no new reasons for ineligibility since the stem cell collection.\n2. For third-party banking, donors must be between 2 to 35 years of age (females) or 2 to 40 years of age (males).\n3. Donor or guardian of pediatric donor capable of providing informed consent.\n4. Donor (related or unrelated) must have completed Infectious Disease (ID) testing up to 7 days before or after the collection of blood for NST manufacturing. The following tests will be performed:\n\n   * HBsAg\n   * HBc Antibody\n   * HCV Antibody\n   * HIV 1\u002F2 Antibody\n   * HTLV I\u002FII Antibody\n   * T. Cruzi Antibody (Chagas)\n   * CMV Total Antibody\n   * Syphilis (T. Pallidum IgG and IgM)\n   * HBV, HCV, HIV Nucleic Acid testing (NAT)\n   * WNV NAT\n5. Female donors of childbearing age must have a negative pregnancy test and not be lactating.\n\nExclusion Criteria:\n\nParticipants Exclusion Criteria for NST Infusion:\n\n1. Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to NST infusion, including ATG, Alemtuzumab, Basiliximab, Tocilizumab, Brentuximab, or other medications under this category as determined by the investigators.\n\n   a) If alemtuzumab has been received within 6 weeks prior to NST infusion, plasma levels should be obtained to ensure drug clearance (≤0.16 pg\u002Fml).\n2. Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to NST infusion.\n3. Participants with SCID who have undergone α\u002Fβ TCR depleted HSCT within the past 100 days post-transplant.\n4. Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to NST infusion.\n5. Participants with uncontrolled or progressing infections other than norovirus. Uncontrolled infections are defined as bacterial, fungal, or non-targeted viral infections with either clinical signs of worsening despite standard therapy, or chronic gastrointestinal symptoms that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n\n   1. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to NST infusion and or no chronic gastrointestinal symptoms associated with this bacterial infection.\n   2. For fungal infections, participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to NST infusion.\n6. Participants must not have other active gastrointestinal infections to which symptoms may be attributable, including parasitic infections (cryptosporidium, giardiasis), viral infections aside from norovirus (CMV colitis, rotavirus, adenovirus), or bacterial infections with C. difficile, Yersinia, Campylobacter, Salmonella, Shigella, or enteroinvasive or enterotoxigenic E. coli.\n\n   a) Testing for unrelated gastrointestinal (GI) infections must be performed within 14 days prior to NST infusion, and must include: i. Crytosporidium\u002FGiardia testing via antigen or PCR testing. ii. Stool viral testing for rotavirus and adenovirus via antigen or PCR testing.\n\n   iii. Stool bacterial culture or PCR testing. iv. C. difficile toxin PCR. b) Determination of active infection versus chronic carriage\u002Fshedding will be made by the investigators and clinical providers and will depend on the presence of clinical symptoms corresponding with the timing of positive test results, presence of a clinical response to targeted therapy, and by histological or other testing if clinically indicated.\n7. Participants with active and uncontrolled relapse of malignancy (if applicable).\n\n   1. Failure of primary engraftment is defined as failure to achieve platelet and\u002For neutrophil engraftment (ANC \\\u003C500\u002Ful and\u002For platelets \\\u003C20 K\u002Ful) following HSCT.\n   2. Secondary graft failure is defined as \\\u003C5% donor chimerism (CD3+ or CD34+) or permanent loss of neutrophil and\u002For platelet engraftment (ANC \\\u003C500\u002Ful and\u002For platelets \\\u003C20 K\u002Ful) at any time after primary engraftment.\n8. Participants with symptomatic gastrointestinal conditions aside from norovirus, including active inflammatory bowel disease or graft versus host disease (grades 2 to 4).\n9. Participants who have received a small bowel transplant.\n10. Participants receiving checkpoint inhibitors within the previous 3 months prior to NST infusion, including nivolumab, pembrolizumab, or other related medications.\n11. For SOT recipients, alteration in immunosuppression as follows:\n\n    1. Any intensification of immunosuppression (including but not limited to pulse dose corticosteroids or new biologic therapies) in the previous 2 months,\n    2. Alteration of maintenance immunosuppression (including changes in the number of agents or dosing goals) in the previous month.\n12. Participants who have received enteral immunoglobulin, nitazoxanide, or other experimental therapies for norovirus infection within 28 days prior to NST infusion.\n13. Co-enrollment in other trials is restricted, other than enrollment on natural history or observational studies. Study staff should be notified of co-enrollment as it may require the approval of the investigator or sponsor.\n\nDonor Exclusion Criteria:\n\n1\\. Donation of cells would pose a physical or psychological risk to the donor","80 Years",{"count":161,"type":20},48,[23],"This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.",[26,165,166],"Hematopoietic Stem Cell Transplantation (HSCT)","Primary Immunodeficiency Disorders (PID)","2026-01-23",{"date":169,"type":36},"2026-01-26",{"date":171,"type":36},"2022-03-17",{"date":173,"type":20},"2028-10-30",{"name":175,"class":43},"Children's National Research Institute",3,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":51,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":129},"100485636","effects-of-mouthrinse-on-the-microbiome-of-the-oral-cavity-and-gi-tract-100485636","NCT05603650","Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract","Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract","Microbiome","Inclusion Criteria:\n\n* Eligible men and non-pregnant and non-lactating women of all races age 18-25.\n* Volunteers must consent to participate in all scheduled exam visits and procedures.\n* Volunteers must be available for follow up on the telephone.\n* Healthy gums or gums that bleed when you brush them.\n\nExclusion Criteria:\n\n* Volunteers unable or unwilling to sign the informed consent form.\n* Less than 20 teeth (excluding third molars).\n* Individuals who have taken antibiotics in the previous 3 months.\n* Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data.","18 Years",{"count":187,"type":20},200,[109],"The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.",[191,192,193,26],"Oral Bacterial Infection","Oral Infection","Microbial Colonization",[195,196],"Oral Microbiome","Fecal Microbiome","2025-12-16",{"date":199,"type":36},"2025-12-17",{"date":201,"type":36},"2021-09-01",{"date":203,"type":20},"2027-12",{"name":205,"class":43},"University of California, Irvine",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":213,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":234},"100249954","phase-2-third-party-viral-specific-t-cells-vsts-100249954","NCT02532452","Third Party Viral Specific T-cells (VSTs)","Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients","Inclusion Criteria:\n\n* Immunocompromised patient with evidence of viral infection or reactivation\n* Age \\>1 day\n* Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion\n* Clinical status must allow tapering of steroids to \\\u003C 0.5mg\u002Fkg prednisone or other steroid equivalent\n* Must be able to receive CTL infusion in Cincinnati\n* Informed consent obtained by PI or sub-investigator either in person or by phone\n\nExclusion Criteria:\n\n* Active acute GVHD grades II-IV\n* Uncontrolled bacterial or fungal infection\n* Uncontrolled relapse of malignancy requiring treatment with chemotherapy\n* Infusion of ATG or alemtuzumab within 2 weeks of VST infusion\n* Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days","2 Days",{"count":215,"type":20},750,[83],"The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.",[26,219,220],"Viral Reactivation","Infection in an Immunocompromised Host",[222,223,224,225,226,227],"Epstein-Barr Virus (EBV)","Adenovirus (ADV)","Cytomegalovirus (CMV)","T-Cells","Donor","BK virus (BKV)","2025-12-10",{"date":197,"type":36},{"date":231,"type":36},"2015-09-02",{"date":203,"type":20},{"name":151,"class":43},4,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":176},"100212886","phase-1-donor-derived-viral-specific-t-cells-vsts-100212886","NCT02048332","Donor-Derived Viral Specific T-cells (VSTs)","Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant","VSTs","Inclusion Criteria:\n\n* Recipient must be at least 21 days after stem cell infusion\n* Clinical status must allow tapering of steroids to 0.5mg\u002Fkg prednisone or other steroid equivalent\n* Recipient must have achieved engraftment with ANC ≥ 500\n\nExclusion Criteria:\n\n* Active acute GVHD grades II-IV\n* Uncontrolled bacterial or fungal infection\n* Uncontrolled relapse of malignancy requiring treatment with chemotherapy\n* Infusion of ATG or alemtuzumab within 2 weeks of VST infusion","4 Weeks",{"count":215,"type":20},[23,83],"In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant.\n\nThe investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death.\n\nStem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find an easier way to treat these infections.",[248,26,219],"Allogeneic Stem Cell Transplant",[222,223,250,251,252,253,28,227],"t-cells","donor","transplant","children",{"date":197,"type":36},{"date":256,"type":36},"2014-02-05",{"date":258,"type":20},"2027-01",{"name":151,"class":43},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":51,"sex":17,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":129},"100512498","school-inner-city-air-study-100512498","NCT05953233","School Inner City Air Study","Inclusion Criteria:\n\nChildren\n\n* Grades K-5 (age 6-12 years)\n* Attend one of the schools that the study team has permission to obtain classroom\u002Fschool environmental samples\n* Have no plans to move schools within the upcoming 12 months\n* Subject and\u002For parent guardian must be able to understand and provide informed consent and also willing to participate in the study\n\nAdults\n\n* Adult (age 21 or older) parent, caretaker, or household member of child participating in this study, or teacher in classroom participating in study\n* Able to understand and provide informed consent\n\nExclusion Criteria:\n\nChildren\n\n* Contraindication to or inability to participate in home self-collection of nasal swab samples\n* Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)\n* Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance\n* Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures\n\nAdults\n\n* Contraindication to or inability to participate in home self-collection of nasal swab samples\n* Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)\n* Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance\n* Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures","6 Years","90 Years",{"count":187,"type":20},[109],"The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners. The main questions it aims to answer are:\n\n* Do classroom HEPA cleaners reduce exposure to viruses?\n* Do classroom HEPA cleaners reduce student and teacher infections?\n* Do classroom HEPA cleaners reduce infections in family members?",[26],"2025-12-04",{"date":274,"type":36},"2025-12-11",{"date":276,"type":36},"2024-09-15",{"date":278,"type":20},"2030-08",{"name":280,"class":43},"Massachusetts General Hospital",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":51,"sex":17,"minAge":185,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":299,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":129},"100587639","a-rhinovirus-challenge-study-to-investigate-exacerbations-and-immune-responses-in-bronchiectasis-100587639","NCT06931002","A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis","Human Bronchiectasis Rhinovirus Challenge to Define Immunopathogenesis of Exacerbation","BARRIER","Inclusion Criteria:\n\n* For healthy volunteers:\n\n  1\\) Age 18 to 65 years.\n* For bronchiectasis study subjects:\n\n  1. Confirmed diagnosis of bronchiectasis aged 18-65 years with bronchiectasis severity index score of 0-8 .\n  2. For Pseudomonas colonised individuals, isolation of Pseudomonas aeruginosa in two or more cultures, at least 3 months apart in a 2-year period.\n\nExclusion Criteria:\n\n* For healthy volunteers and bronchiectasis study subjects:\n\n  1. Any medical co-morbidity impacting the study in the opinion of the medical team\n  2. Current smoking history within last 12 months or ex smoking history \\>5 pack years\n  3. Pre-existing serum neutralising antibodies to RV-A16 (strain to be used for challenge)\n  4. Close contact with infants or elderly individuals either at home or workplace\n  5. Pregnancy or breastfeeding\n* For bronchiectasis study subjects:\n\n  1\\) Individuals with bronchiectasis secondary to cystic fibrosis, primary immunodeficiency, primary ciliary dyskinesia and allergic bronchopulmonary aspergillosis 2) Individuals with other significant chronic lung disease diagnoses (eg. interstitial lung disease) which would impact the study in the opinion of the medical team 4) FEV1 \\\u003C 50% predicted 8) Recent antibiotics for exacerbations within the preceding 6 weeks and prophylactic antibiotics (azithromycin or nebulised antibiotics) within preceding 4 weeks 9) Corticosteroid use (inhaled, nasal or systemic) within preceding 4 weeks.","65 Years",{"count":291,"type":20},54,[109],"The goal of this study is to determine if viral infection with the common cold leads to an exacerbation in participants with bronchiectasis. The investigators will compare the participants with bronchiectasis to a group of healthy participants. The main questions it aims to answer are:\n\n* Does viral infection with the common cold lead to an exacerbation in bronchiectasis?\n* Does the immune response differ to that of a healthy participant?\n\nParticipants will attend for a screening visit to see if they are eligible. All participants who are eligible and have consented to take part will have baseline investigations done including blood tests and a bronchoscopy. They will be given a spray of a virus that causes the common cold into their nose. They will then be followed up over the next 6 weeks with some of the following procedures at each study visit; spirometry, nasosorption, nasal lavage, nasal brushing, blood test, sputum collection and a bronchoscopy. Participants will be asked to keep a daily record of their symptoms throughout the study.",[295,296,297,26,298],"Bronchiectasis Adult","Bronchiectasis With Acute Exacerbation","Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa","Rhinovirus Infection",[300,301,302],"bronchiectasis","rhinovirus","case control study","2025-07-04",{"date":305,"type":36},"2025-07-09",{"date":307,"type":36},"2024-07-24",{"date":309,"type":20},"2027-10-30",{"name":311,"class":43},"Imperial College London",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100458167","revive-frailty-rehabilitation-and-outcomes-in-critically-ill-adult-and-pediatric-survivors-of-covid-19-or-ari-100458167","NCT05246098","REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI","REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or Acute Respiratory Infection","REVIVe","Inclusion Criteria:\n\n* Adult and pediatric survivors of COVID-19 or acute respiratory infection admitted to participating intensive care units (ICUs) and PICUs. The investigators define children as less than, and adults as greater than or equal to, 18 years old, respectively. The investigators will include adults and pediatrics with a confirmed diagnosis of COVID-19, pediatric patients with MIS-C, and adults and pediatrics with suspected or proven acute respiratory infection with onset within 14 days of ICU\u002FPICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high flow oxygen therapy.\n\nExclusion Criteria:\n\n* Patients who were admitted to ICU for \\\u003C24 hours",{"count":321,"type":20},900,"Background: Many adults and some children with COVID-19 or acute respiratory infection become critically ill and need advanced life support in the Intensive Care Unit (ICU). Frailty is a medical condition of reduced function and health. Adults with frailty have a lower chance of surviving critical illness. The investigators are still learning about critically ill adults with COVID-19 or acute respiratory infection, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19 or acute respiratory infection. Rehabilitation can help survivors of COVID-19 or acute respiratory infection by improving strength and improve quality of life (QOL).\n\nObjectives: The main goal of this research study is to see if patients with frailty have a lower chance of surviving COVID-19 or acute respiratory infection critical illness and more health problems after survival than patients without frailty. The investigators will also study the types of rehabilitation received by patients with COVID-19 or acute respiratory infection.\n\nMethods: The investigators will include adults and children with COVID-19 or acute respiratory infection who are admitted to the ICUs that participate in the study. The investigators will gather data about each patient, including before and during their illness.\n\nOutcomes: The investigators will collect level of frailty, function, and types of therapy, or rehabilitation received by patients. In adults, the investigators are most interested in learning if frailty influences mortality, or death. In children, the investigators are most interested in whether children with COVID-19 or acute respiratory infection critical illness are more likely to develop frailty. The investigators will also study post-hospital discharge location in survivors (e.g., home, rehabilitation).\n\nRelevance: The COVID-19 pandemic is a global public health crisis. It is critical to understand how COVID-19 and other acute respiratory infection critical illness affects groups of people who are at higher risk, and the impact on outcomes that are important to patients, like functioning and QOL. The results will help policy makers plan post-hospital services for survivors, help healthcare workers understand the importance of rehabilitation practice for patients with COVID-19 or acute respiratory infection, and help researchers develop treatments to improve QOL after COVID-19 or acute respiratory infection.",[324,325,26],"Respiratory Disease","COVID-19","2024-11-04",{"date":328,"type":36},"2024-11-06",{"date":330,"type":36},"2022-08-24",{"date":332,"type":20},"2025-10-01",{"name":334,"class":43},"McMaster University",28,{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":44},"100331417","phase-1-adoptive-cord-blood-immunotherapy-for-ebv-cmv-bkv-and-adenovirus-reactivationinfection-or-prophylaxis-100331417","NCT03594981","Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation\u002FInfection or Prophylaxis","Adoptive Cord Blood ImmunotHerapy Using Expanded Cord Blood T Cells for EBV, CMV, BKV and Adenovirus Reactivation\u002FInfection or ProphylaxiS","Inclusion Criteria:\n\nInclusion Criteria at the Time of Procurement\n\n* Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for transplant.\n* Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6\u002F6 HLA class I (serological) and II (molecular) antigens. The unit selected for CTL expansion must be either:\n\n  1. be cryopreserved in two fractions, with a minimum of 2.5x107 total nucleated cells (TNC) per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the CTLs to give at day 30 or beyond as described below. OR\n  2. be cryopreserved with a cell dose that totals \\> 3x10e7 TNC per kg pre thaw. On thaw, 20% of the total volume will be used for CTL manufacture to give at day 30 or beyond and the remaining 80% will be used for the primary transplant.\n  3. For recipients of double CBT, if possible both CB units should be cryopreserved in two fractions and T-cells will be made from both units if possible.\n\nInclusion Criteria at the Time of CTL Infusion\n\n* Recipients of at least one unmanipulated cord blood unit as described above (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV\u002FAdenoviral\u002FBKV and\u002For EBV infection or reactivation.\n* Lansky\u002FKarnofsky scores ≥60\n* Absolute neutrophil count (ANC) greater than 500\u002Fu\n* No evidence of GVHD \\> Grade II at time of enrollment\n* Life expectancy \\> 30 days\n* Absence of severe renal disease (Creatinine \\\u003C 3x normal for age)\n* Absence of severe hepatic disease. Direct bilirubin must be \\\u003C 3 mg\u002Fdl and AST \\\u003C 5x upper limit of normal\n* Patient must be at least 30 days post transplant to be eligible to receive CTL\n* Written informed consent and\u002For signed assent line from patient, parent or guardian\n\nExclusion Criteria:\n\nExclusion Criteria at the Time of Procurement\n\n* Pregnant or lactating\n* Patients with active central nervous system disease\n* Patients with Karnofsky performance status \\\u003C70%\n* Patients with grade 3 or 4 or primary myelofibrosis\n* Patients with suitable related donors Exclusion Criteria at the Time of CTL Infusion\n* Pregnant or lactating\n* Patient on Fi02 of \\>60%\n* Unable to wean steroids to ≤0.5 mg\u002Fkg\u002Fday prednisone or equivalent\n* Patients with Grade 3 hyperbilirubinemia\n* Patients with other uncontrolled infections (except CMV and\u002For adenovirus and\u002For EBVemia and\u002For BK viruria\u002Fviremia). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease\n* Patients who have received investigational (IND) product within 28 days of screening for CTL infusion under this study",{"count":344,"type":20},36,[23,83],"This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating.\n\nThe scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells\u002Fm2, 2 x107cells\u002Fm2 and 5x107cells\u002Fm2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.",[26],"2024-08-27",{"date":350,"type":36},"2024-08-28",{"date":352,"type":36},"2018-01-24",{"date":354,"type":20},"2025-11",{"name":356,"class":43},"Catherine Bollard",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":51,"sex":17,"minAge":185,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":367,"conditions":368,"keywords":372,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":129},"100553594","lung-immune-challenge-study-controlled-exposure-to-inhaled-resiquimod-r848-100553594","NCT06488118","Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)","Lung Immune Challenge Study Controlled Exposure to Inhaled Resiquimod (R848) to Study Mechanisms of Inflammation","Inclusion Criteria:\n\n* Male or female aged between 18 and 60 years.\n* Willing and able to give informed consent for participation in the study.\n* Female participants of child-bearing potential and male participants whose partner is of child-bearing potential must be willing to ensure that they or their partner use effective contraception during the study.\n* Clinically acceptable laboratory measurements and ECG at enrolment.\n* Ability to expectorate sputum.\n* Optional additional swab for SARS-CoV-2 testing will be collected from participants if required by local or\u002Fand national health and safety policies at the time of sampling.\n\nFor healthy volunteers:\n\n* No clinical history of asthma\n* Normal baseline spirometry i.e. FEV1\u002FForced Vital Capacity (FVC) ratio z-score greater than the lower limit of normal.\n\nFor volunteers with asthma:\n\n* Physician-diagnosed mild to moderate asthma which is not poorly controlled as evidenced by an Asthma Control Questionnaire (ACQ-5) score of ≤1.5.\n* They are permitted to be on inhaled corticosteroids (ICS), long-acting beta agonist (LABA) and long-acting muscarinic antagonists (LAMA).\n* Pre-bronchodilator FEV1 ≥70% predicted.\n* Evidence of bronchial hyperreactivity as evidenced by either (i) Bronchodilator reversibility (increase FEV1 ≥12% and 200 mL); (ii) Positive methacholine challenge (PC20 \\< 8mg\u002Fml), or (iii) Positive challenge test as per current CUH policy.\n\nExclusion Criteria:\n\n* Upper respiratory tract infection in preceding 14 days.\n* Lower respiratory tract infection in preceding 28 days.\n* Female participants who are pregnant, lactating or planning pregnancy.\n* Respiratory diseases (other than asthma where specified).\n* Significant extrapulmonary medical conditions.\n* Extreme obesity (BMI \\>40).\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Participants who have participated in another research study involving an investigational product in the past 12 weeks.\n* No newly prescribed courses of medication including corticosteroids in the four weeks before first study dose other than mild analgesia, vitamins, and supplements.\n* Smoking tobacco or vaping products in previous 6 months.\n* Smoking history of \\>5 pack years.","60 Years",{"count":344,"type":20},[109],"Respiratory viral infections can be a cause of significant illness, particularly in vulnerable individuals as seen in the COVID-19 pandemic. An underactive or overactive immune response can lead to ineffective resolution of inflammation after an infection, especially in people with airway diseases such as asthma. A better understanding of immune responses to infection that does not rely on cell or animal models is crucial to help develop better treatments for lung inflammation.\n\nAn established method of studying inflammation in humans is through careful and controlled exposure (or \"challenge\") with a mimic of a virus to simulate an infection in a similar manner to that of a virus, but with the advantage of not causing an infection. The investigators have already developed a well-tolerated mimic of human viral infection using a sterile substance called Resiquimod (or R848). Since it does not contain living organisms there is no possibility of being infected. This has been used previously as a nasal spray to cause a mild short-lived inflammation that mimics a mild cold. This has been used safely in a range of people of different ages including those who have asthma.\n\nThere are differences however in how the nose and lungs respond to viral infections. This is particularly true in those with airway diseases such as asthma, who have cells in the airways of their lungs that respond in a different way to inflammatory triggers (such as viruses).\n\nThe current study aims to build on previous research by developing a new approach of studying inflammation in the lungs using a small volume of Resiquimod. This will be done by gently inhaling a fine mist through a mouthpiece into the lungs. Blood and phlegm samples would then be collected to assess inflammation and how well people tolerate the procedure.",[369,370,371,26],"Innate Immunity","Mucosal Immunity","Asthma",[371,373,374,375,376,369,377],"Immunology","Viral infection","Airway Epithelium","Respiratory Medicine","Sputum","2024-07-08",{"date":380,"type":36},"2024-07-10",{"date":382,"type":36},"2024-05-24",{"date":384,"type":20},"2025-07",{"name":386,"class":43},"Akhilesh Jha",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":17,"minAge":394,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":398,"briefSummary":399,"conditions":400,"keywords":404,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100508613","isotonic-saline-for-children-with-bronchiolitis-100508613","NCT05902702","Isotonic Saline for Children With Bronchiolitis","Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority Trial","Inclusion Criteria:\n\n* Children aged 0-12 months, whose parents give informed consent to participate, with symptoms of bronchiolitis including at least one of:\n\n  * Runny nose\n  * Dry and persistent cough\n  * Labored breathing (tachypnea, retractions, nasal flaring)\n  * Grunting\n  * Cyanosis or apnea\n  * Wheezing or crackles on auscultation\n  * O2 saturations below 92 %\n  * Difficulties feeding\n\nExclusion Criteria:\n\n* Children with cystic fibrosis or other serious congenital lung diseases\n* Children in whom treatment with short-acting beta-2 agonist is initiated (as this is delivered in nebulized isotonic saline).","1 Day","12 Months",{"count":397,"type":20},300,[109],"The goal of this randomized clinical trial is to investigate the optimal supportive treatment of bronchiolitis in infants from 0-12 months of age. The main question\\[s\\] it aims to answer are:\n\n* To investigate whether isotonic saline should be used as supportive treatment for children with bronchiolitis, and if so, identify the optimal route of administration. The primary outcome is duration of hospitalization.\n* To investigate the current epidemiology of the viral pathogens causing bronchitis in children in Denmark, and to assess whether children infected with specific pathogens might benefit from treatment with isotonic saline.\n\nThe children are randomized after inclusion through computer randomization to one of the 3 arms in the study:\n\n1. Nebulized isotonic saline\n2. Nasal irrigation with isotonic saline\n3. No treatment with saline\n\nThe investigators will compare treatment with saline (both methods) with no treatment, and the investigators will also compare the two methods of delivery of saline (nebulized vs. nasal irrigation).",[401,324,402,26,403],"Bronchiolitis","Asthma in Children","Acute Respiratory Infection",[405,406,407,408],"Nebulized saline","Nasal saline drops","Nasal saline irrigation","Respiratory severity score","2023-06-13",{"date":411,"type":36},"2023-06-15",{"date":413,"type":20},"2023-09",{"date":415,"type":20},"2029-09",{"name":417,"class":43},"Slagelse Hospital"]