[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perfusion-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perfusion-complications":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100613300","phase-1-assessment-of-topical-minoxidil-on-intraoperative-flap-perfusion-and-cutaneous-flap-viability-in-breast-recon-100613300",false,"NCT07264790","Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon","Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction","Inclusion Criteria:\n\n1. Female sex \\> 18 years old\n2. Genetic predisposition to cancer\n3. Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction\n4. Capable of giving informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of breast cancer\n2. History of cancer\n3. Currently pregnant or planning to be pregnant (for women of child-bearing potential)\n4. Male sex","FEMALE","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at the time of surgery. Patients will undergo randomization of their breasts to determine which breast will receive the experimental intervention and which breast will serve as the internal control (receive placebo). The experimental breast will receive the novel pharmacologic delay treatment, 5% minoxidil, while the internal control breast will receive the current standard of care, which does not include any topical application prior to surgery - a placebo control will be used.\n\nThis will be a triple-blind study, where both the participants and investigators will be blinded to which breast will receive the intervention. The patients will receive two bottles \"compound A\" and \"compound B\" with directions from the pharmacy for which compound to apply to each breast.\n\nProduct will be applied for 2 weeks prior to planned surgery. Surgery will proceed without any changes to standard practice.",[26,27,28,29],"Breast Reconstruction","Perfusion; Complications","High Risk for Breast Cancer","Genetic Predisposition","RECRUITING","2026-04-01",{"date":33,"type":34},"2026-04-06","ACTUAL",{"date":36,"type":20},"2026-04",{"date":38,"type":20},"2027-09",{"name":40,"class":41},"Duke University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100597825","transcutaneous-electrical-stimulation-and-controlled-heat-in-people-with-and-without-diabetes-100597825","NCT07063524","Transcutaneous Electrical Stimulation and Controlled Heat in People With and Without Diabetes","Principle Investigator","TENS","Inclusion Criteria:\n\n* Male or Female aged between 45-75 years old\n* Clinical diagnosis of Type I or Type II diabetes\n* Controlled diabetes mellitus (HbA1c ≤ 7%)\n\nExclusion Criteria:\n\n* Pregnancy\n* Current smoker\n* Diagnosed neuropathy\n* Uncontrolled hypertension (HTN)\n* Allergy to tape or electrodes\n* Diagnosis of dementia\n* History of knee joint replacement\n* Significant joint pain (e.g., back, hip, or ankle) that may limit the ability to wear a boot for 60 minutes\n* Contraindications to TENS, including:\n\n  * Presence of pacemakers\n  * Dermatological conditions\n  * Abnormal sensation in the knees\n* Severe medical or neurological conditions, including:\n\n  * Chronic obstructive pulmonary disease\n  * Cardiovascular disease\n  * Arteriosclerosis obliterans\n  * Cerebrovascular accident\n  * Lumbar disc disorders (e.g., herniation)\n  * Rheumatoid arthritis\n* Fear of electrical stimulation",true,"ALL","45 Years","75 Years",{"count":56,"type":20},20,[58],"NA","The investigators would like to see if the combination of TENS and controlled heat in a boot increases blood flow to the foot more than baseline or heat alone in people with and without diabetes. This may help people with diabetes and a diabetic wound that will not heal.",[61,62,27],"Diabetes","Heat","2025-07-02",{"date":65,"type":34},"2025-07-14",{"date":67,"type":34},"2024-05-10",{"date":69,"type":20},"2025-12-30",{"name":71,"class":41},"Western Michigan University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":42},"100576524","a-monitoring-system-based-on-the-multifactorial-dynamic-perfusion-index-to-predict-and-prevent-the-onset-of-postoperative-acute-kidney-injury-after-cardiac-surgery-based-on-a-dynamic-collection-of-hemodynamic-and-clinical-parameters-during-cardiopulmonary-bypass-100576524","NCT06786416","A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass","PEQUOD 2","Inclusion Criteria:\n\n* patients undergoing cardiac surgery with cardiopulmonary bypass\n* patients \\>18 years for WP1 and WP3; patients \\\u003C6 years and weight \\\u003C20 kg for WP2\n* willingness to participate and sign the informed consent\n\nExclusion Criteria:\n\n* chronic renal failure on dyalisis for WP1 and WP3\n* emergency surgery for all WP\n* refusal to partecipate",{"count":80,"type":20},800,"OBSERVATIONAL","This project is based on a predictive alghorithm (Multifactorial Dynamic Perfusion Index-MDPI) already published and covered by a patent. The MDPI is based on a dynamic collection of 7 different variables during cardiopulmonary bypass (CPB) and provides a probability index for postoperative acute kidney injury. The study design is a multicenter observational prospective trial developed through 3 work packages, addressing (1) external validation of the MDPI in a series of 800 adult cardiac surgery patients collected in 2 Institutions (2) development of a novel MDPI to be applied in infants \\\u003C 20 kg undergoing cardiac surgery (200 patients) and (3) verification of of other possible outcomes that may be predicted by the MDPI. Since many of the predictive variables are modifiable by the perfusionist\u002Fanesthesiologist during CPB, it is a tool that allows therapeutic manouvres. Ultimately, the MDPI will be incorporated in a dedicated monitor to provide an on-line \"flight control\" during CPB. Work package 1 will be performed at Units 1 and 2; the parameters composing the MDPI will be collected using the existing CPB monitors that routinely measure the hematocrit, the oxygen delivery, the time of exposure to a pre-defined critical oxygen delivery, the mean arterial pressure, and the CPB duration. Blood lactates and transfusions will be manually inputed. The MDPI will be calculated off-line and tested for association and predictivity (discrimination and calibration) with respect to postoperative AKI defined according to the K-DIGO classification. Workpackage 2 is dedicated to infants, with the purpose of developing an MDPI dedicated to low-weight infants (I-MDPI). This will be develop in Unit 1 that performs congenital heart surgery. The same variables of the MDPI will be collected, plus additional variables specific for infants (blood to prime the oxygenator, plasma for the same purpose; venous oxygen saturation, and others). The variables being independently associated with AKI will enter a logistic regression equation that will be the basis for the I-MDPI. Workpackage 3 considers that AKI is associated with a prolonged mechanical ventilation time, prolonged stay in the intensive care unit and in the hospital; and mortality. Therefore, the MDPI may be predictive of other postoperative complications, apart from AKI, and even of mortality. Some of the factors included in the MDPI may directly (low hematocrit) or indirectly (prolonged CPB duration, excessive hemodilution, low mean arterial pressure) affect the hemostatic system and\u002For trigger packed red cells transfusions. Additionally, CPB itself is a determinant of a coagulophatic state with associated postoperative bleeding which, in turns, increases the mortality. The specific aim 3 is to confirm the hypothesis that the MDPI may be predictive of one or more of this non-AKI postoperative complications and of 30-days mortality. In the same series of work package and aim 1, these complications will be collected and the MDPI tested for predictive ability of each one of these complications and 30-days mortality. At present, the MDPI can only be calculated off-line, and this greatly limits its applicability. The last step of the aim 3 is based on the involvement of software experts and partnership with companies interested in including the MDPI into their existing monitors; as such, the MDPI patent would be given under licence of the existing patent owned by the IRCCS Policlinico San Donato.",[84,85,86,87,88,89,27],"Cardiac Diseases","Cardio-pulmonary Bypass","Acute Kidney Injury","Adult Cardiac Surgery","Infants Cardiac Surgery","Extracorporeal Circulation; Complications",[91,92,93],"cardiopulmonary bypass","acute kidney injury","cardiac surgery","2025-01-15",{"date":96,"type":34},"2025-01-22",{"date":98,"type":34},"2024-09-18",{"date":100,"type":20},"2026-09",{"name":102,"class":41},"IRCCS Policlinico S. Donato"]