[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adverse-effects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adverse-effects":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100588067","phase-2-magic-ruxolitinib-for-agvhd-100588067",false,"NCT06936566","MAGIC Ruxolitinib for aGVHD","Phase 2 Study of Ruxolitinib-Based Primary Treatment for Acute GVHD","MAGIC V","Inclusion Criteria:\n\n* Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I \\[\\\u003C50% BSA rash\\])\n* High risk cohort: Minnesota high risk GVHD 3 GVHD that developed after DLI for mixed chimerism or poor graft function is allowed\n* No prior systemic acute GVHD treatment. Topical or non-absorbed steroids are permitted.\n* All donor types, HLA-matches, conditioning regimens, or GVHD prophylaxis strategies are acceptable\n* ≥18 years of age\n* Standard risk cohort: Hematopoietic engraftment with absolute neutrophil count (ANC) ≥ 1000\u002FμL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.\n* High risk cohort: Hematopoietic engraftment with ANC ≥ 500\u002FuL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.\n\nExclusion Criteria:\n\n* Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry\n* Prior use of ruxolitinib to treat GVHD at any time\n* Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression\n* Relapse prior to development of GVHD unless subsequently in remission for at least 3 months\n* GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval\n* Uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)\n* Severe organ dysfunction within 3 days of enrollment including requirement for dialysis, mechanical ventilation, continuous BiPAP, or continuous high flow oxygen by nasal cannula, or total bilirubin ≥ 3x upper limit of normal not due to GVHD.\n* A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment (except for mild oral or ocular GVHD)\n* Corticosteroids \\>10 mg\u002Fday methylprednisolone (or other methylprednisolone equivalent, MPE) for any indication within 5 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions\u002FIV meds\n* Participation in clinical trials using experimental agents not approved by the FDA for any indication within 14 days of enrollment or five half-lives, whichever is longer provided any prior adverse events have improved to ≤grade 1\n* Patients who are pregnant or nursing\n* History of allergic reaction to ruxolitinib or any JAK inhibitor","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This clinical trial will study ruxolitinib-based treatment of acute graft-versus-host-disease (GVHD) that developed following allogeneic hematopoietic cell transplant. Acute GVHD occurs when donor cells attack the healthy tissue of the body. The most common symptoms are skin rash, jaundice, nausea, vomiting, and\u002For diarrhea. The standard treatment for GVHD is high dose steroids such as prednisone or methylprednisolone, which suppresses the donor cells, but sometimes there can be either no response or the response does not last. In these cases, the GVHD can become dangerous or even life threatening. High dose steroid treatment can also cause serious complications. Researchers have developed a system, called the Minnesota risk system, to help predict how well the GVHD will respond to steroids based on the symptoms present at the time of diagnosis. The Minnesota risk system classifies patients with newly diagnosed acute GVHD into two groups with highly different responses to standard steroid treatment and long-term outcomes. This protocol maximizes efficiency because all patients with grade II-IV GVHD are eligible for screening and treatment is assigned according to patient risk. Patients with lower risk GVHD, Minnesota standard risk, have high response rates to steroid treatment. In this trial the researchers will test whether ruxolitinib alone is as effective (non-inferior) as steroid-free therapy and safe. Patients will be randomized to two different doses of ruxolitinib to identify the dose which maximizes efficacy while minimizing toxicities such as hematologic and infectious toxicities. Patients with higher risk GVHD, Minnesota high risk, have unacceptable outcomes with systemic corticosteroid treatment alone and the researchers will test whether adding ruxolitinib, a proven effective second line GVHD treatment, can improve outcomes when added to systemic corticosteroids as first line treatment.",[27,28,29],"Acute Graft-versus-host Disease","Allogeneic Bone Marrow Transplantation","Adverse Effects","RECRUITING","2026-03-18",{"date":33,"type":34},"2026-03-23","ACTUAL",{"date":36,"type":34},"2025-05-14",{"date":38,"type":21},"2028-04-14",{"name":40,"class":41},"John Levine","OTHER",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":78,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100585650","digital-transformation-of-continuity-of-care-for-peripherally-inserted-central-catheters-spadcare-experience-100585650","NCT06905119","Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience","SpadCare","Inclusion Criteria:\n\n* Patients \\>18 years.\n* Sign the informed consent form.\n* Have a Smartphone and accept the use of the APP.\n* Patient with a PICC inserted by the Infusion and Vascular Access Team of the University Hospital of Navarra and with a planned use of at least one month.\n\nExclusion Criteria:\n\n* Patients with limitations in the use of digital resources or lack of Smartphone.\n* Patients who do not want to install the APP on their Smartphone\n* Patients who do not authorize access to their Computerized Medical Record (HCI).",{"count":51,"type":21},201,[53],"NA","The study focuses on patients who require outpatient infusion of therapy (\"Infusions, Intravenous\"\\[Mesh\\]) \"Administration, Intravenous\"\\[Mesh\\] (\"Home Infusion Therapy\"\\[Mesh\\]) \"Parenteral Nutrition, Home\"\\[Mesh\\] via a peripherally inserted central catheter (PICC) (\"Central Venous Catheters\"\\[MeSH\\] \"Catheterization, Central Venous\"\\[MeSH\\] \"Catheterization, Peripheral\" \\[MeSH\\] \"Vascular Access Devices\"\\[Mesh\\] )",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,29,76,77],"Infusions, Intravenous","Administration, Intravenous","Home Infusion Therapy","Parenteral Nutrition, Home","Central Venous Catheters","Catheterization, Central Venous","Catheterization, Peripheral","Vascular Access Devices","Patient Education as Topic","Patient Participation","User-Computer Interface","Smartphone","Mobile Applications","Computers, Handheld","Digital Health","Nursing","Care Givers","Delivery of Health Care","Home Nursing","Self Administration","Catheter-Related Infections","Telemedicine",[62,63,64,77,68],"2025-09-11",{"date":81,"type":34},"2025-09-12",{"date":83,"type":34},"2023-05-04",{"date":85,"type":21},"2026-07-31",{"name":87,"class":41},"Fundacion Miguel Servet",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":88},"100605664","effect-of-probiotic-intake-in-healthy-population-100605664","NCT07165457","Effect of Probiotic Intake in Healthy Population","Clinical Evaluation of a Probiotic in Healthy Population (PROBIO)","PROBIO","Inclusion Criteria:\n\n* Healthy men and women aged between 18 and 70 years.\n* Stable body weight (±5%) during the three months prior to study initiation.\n* Physical examination and vital signs within normal limits or clinically irrelevant for the study.\n* Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements.\n* Ongoing pharmacological\u002Fhormonal treatment will be permitted provided it does not affect the parameters under investigation and the dosage has been stable for at least three months prior to study initiation.\n* Willingness to undergo all study procedures, including daily consumption of one probiotic capsule during the intervention.\n* Availability in terms of time and location to attend the two scheduled in-person clinical evaluation sessions.\n\nExclusion Criteria:\n\n* Volunteers undergoing pharmacological treatment with unstable dosing (less than 3 months prior to study initiation) will be excluded, particularly if treatments:\n* Affect gastrointestinal function.\n* Include chronically prescribed stomach protectants.\n* Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.\n* Subjects who have undergone surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or bariatric surgery.\n* Presence of systemic intestinal, hepatic, or renal diseases, such as uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver disease will not be excluded).\n* Alcohol consumption exceeding the sex-specific limits (\\>14 units\u002Fweek for women, \\>20 units\u002Fweek for men).\n* Pregnancy, lactation, or plans to become pregnant during the study period.\n* Use of nutritional supplements that may affect study outcomes (e.g., weight-loss supplements, newly initiated fiber supplements, probiotics, postbiotics, etc.).\n* Subjects with any type of cancer currently undergoing treatment, or with less than five years since cancer remission.\n* Known allergy to any component of the investigational product.\n* Presence of cognitive and\u002For psychological impairments.\n* Anticipated poor compliance or, in the investigator's opinion, difficulty adhering to study procedures.\n* Participation in any weight loss or body composition modification treatments.\n* Use of antibiotics within 15 days prior to the baseline visit.",true,"70 Years",{"count":100,"type":21},20,[53],"The main objective of this project is to evaluate the absence of adverse gastrointestinal effects following the consumption of a daily probiotic capsule during 15 days.\n\nThe secondary objective of this study is to verify the absence of any adverse effects other than gastrointestinal ones following the daily consumption of a probiotic during 15 days in a healthy population.\n\nSpecific objectives are:\n\n* To evaluate changes in gastrointestinal health through self-reported questionnaire.\n* To determine the adherence to probiotic consumption.\n* To analyse headache, tiredness\u002Ffatigue, muscle or joint pain, fever or low-grade fever, chills, allergic reactions, difficulty sleeping, dizziness and general discomfort by General Adverse Effects Questionnaire.\n\nTarget sample size is 20 subjects.\n\nParticipants will be allocated in one group (experimental group).\n\nParticipants will visit nutritional intervention unit at Clinical Investigation Day 1 (day 1) and at Clinical Investigation Day 2 (day 15).",[29,104],"Healthy",[106,107,108,109],"Probiotic","Supplement","Microbiota","Gastrointestinal tract","NOT_YET_RECRUITING","2025-09-02",{"date":113,"type":34},"2025-09-10",{"date":115,"type":21},"2025-09-04",{"date":117,"type":21},"2025-10-07",{"name":119,"class":41},"Clinica Universidad de Navarra, Universidad de Navarra"]