[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación Cardioinfantil Instituto de Cardiología\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100583051","evaluating-the-impact-of-a-functional-and-cognitive-strategy-in-patients-with-long-covid-19-100583051",false,"NCT06871293","Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19","Impact of Functional and Cognitive Rehabilitation, in Adults With Chronic Noncommunicable Diseases and Long Covid-19 , on Their Functional and Cognitive Capacity, Quality of Life, and the Evolution of Their Baseline Condition, in Bogotá D.C.","Inclusion Criteria:\n\n* Covid-19 confirmed.\n* History of arterial hypertension or diabetes mellitus before entering the institutional registries of the FCI-IC or HOMIL, institutional registries of the FCI-IC or HOMIL or before having the diagnosis of SARSCoV-2 infection.\n* Persistence of two or more concurrent symptoms, related to Covid-19 prologue, for at least 4 weeks (persistent, intermittent, or intermittent).\n* At least one of these symptoms must have an impact on activities of daily living. They can be physical (fatigue, dyspnea, myalgias, arthralgias) or neuropsychiatric (cognitive, sleep and emotional alterations).\n* Symptoms unexplained by underlying disease or other condition concomitant with SARS-CoV-2 infection. SARS-CoV-2 infection (determined by prior medical history review and participant interview).\n\nparticipant interview).\n\n\\- Ability to read and attend functional and cognitive rehabilitation sessions or to receive the with evidence-based informational messages.\n\nExclusion Criteria:\n\n* Age \\>80 years.\n* Severely advanced baseline comorbidities prior to SARS-CoV-2 infection.\n* Presence of chronic respiratory disease (partial or permanent supplemental oxygen use), cardiac failure (LVEF\\\u003C40%) or advanced renal disease (GFR\\\u003C30%).\n\nheart failure (LVEF\\\u003C40%) or advanced renal disease (GFR\\\u003C30).\n\n* Two hospitalizations in the year prior to admission to the institutional registries of the FCI-IC and the HOMIL for the patient's underlying disease.\n* Dependence on a caregiver.\n* Orthopedic or cardiopulmonary problems that contraindicate the performance of aerobic exercise.\n* Neuropsychiatric or cognitive limitations that limit understanding or following commands and performing attention exercises.","ALL","18 Years","80 Years",{"count":20,"type":21},374,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19.\n\nResearchers will compare a structured rehabilitation program to informational support through evidence-based messages to determine if rehabilitation leads to better functional and cognitive outcomes in patients with Long Covid-19.\n\nParticipants will be randomly assigned to one of two groups:\n\n1. Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises.\n2. Informational support: Receiving weekly evidence-based educational messages for 8 weeks.\n\nParticipants will undergo assessments at baseline, post-intervention, and six months later, including a six-minute walk test, handgrip strength measurement, and questionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function, and quality of life.",[27,28,29,30,31,32],"Long COVID-19 Syndrome","COVID 19","Noncommunicable Disease","Hypertension","Diabetes Mellitus","Long COVID",[34,35,36,37,30,31,38,39],"Covid 19","Sars CoV 2","Post-acute Covid-19 syndrome","Long Covid","Noncommunicable disease","Rehabilitation","RECRUITING","2026-04-08",{"date":43,"type":44},"2026-04-13","ACTUAL",{"date":46,"type":44},"2025-10-30",{"date":48,"type":21},"2027-01-01",{"name":50,"class":51},"Fundación Cardioinfantil Instituto de Cardiología","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":17,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":52},"100595673","phase-4-randomized-control-study-in-resuscitation-of-sepsis-trial-100595673","NCT07035509","Randomized Control Study in REsuscitation of SEpsis Trial","Randomized Control Study on Normal Saline vs Plasmalite vs Plasma in REsuscitation of SEpsis Trial (RESET) - A Feasibility and Comparative Study","RESET","Inclusion criteria\n\n* Age: ≥1 month (corrected gestational age) to 18 years.\n* Diagnosis of sepsis with at least one of the following conditions:\n* Signs of poor perfusion: prolonged capillary refill ≥2 sec, weak peripheral pulses, unexplained metabolic acidosis (base deficit \\> (-)5.0 mEq\u002FL), altered. mental status, lactate ≥2 mmol\u002FL (sample drawn without tourniquet use. (Appendix 2). OR\n* Systolic blood pressure (SBP) below the 5th percentile for age.\n* Signed informed consent from the patient's legal guardian.\n\nExclusion Criteria:\n\n* Receipt of ≥2 boluses of NS 0.9% or balanced solution in the last 24 hours for the current sepsis episode (bolus defined as ≥10 mL\u002Fkg (max. 500 mL) of NS\u002FRL given in \\\u003C30 min).\n* Known allergic reaction to plasma-derived products.\n* Known IgA deficiency.\n* Suspected or confirmed congestive heart failure.\n* Nephrotic syndrome.\n* Known chronic kidney disease with fluid overload or congestive heart failure.\n* Diagnosed hemorrhagic dengue fever confirmed by antigen or serology (NS1 or IgM positive).","4 Weeks",{"count":63,"type":21},150,[65],"PHASE4","Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of SEpsis Trial (RESET): A Comparative and Feasibility Study This research study, called the REsuscitation of SEpsis Trial (RESET), is a randomized clinical trial comparing crystalloids and synthetic plasma for fluid resuscitation in children with sepsis. Below, we explain some key aspects you should be aware of.\n\nWhat is a Clinical Trial? A clinical trial is a type of medical research designed to gather more information on how our bodies respond to medications or other treatments.\n\nMost new medical treatments must be evaluated in clinical trials before they can be approved by government agencies. These agencies ensure that new treatments are not only safe but also beneficial for patients-what medicine refers to as being \"safe and effective.\" If a new treatment has not yet been approved, it is considered \"experimental.\"\n\nResearchers analyze the results of multiple clinical trials to determine which medications work best and how they function. The advancement of medical science requires the participation of many people in numerous studies worldwide.\n\nWhat is the Purpose of This Study? This study evaluates whether Octaplas LG helps children and adolescents with sepsis and whether it improves the function of blood vessels inflamed due to infection. Sepsis occurs when an infection severely affects a person's health.\n\nOctaplas LG is a medication approved for use in Colombia. It is known as pharmaceutical plasma and is obtained from voluntary donors worldwide. It undergoes an ultra-detailed sterilization process using the most advanced techniques for processing blood derivatives. In medicine, fresh frozen plasma (FFP) is typically used, which is the equivalent of Octaplas LG but with far fewer industrial sterilization processes. These additional processes in Octaplas LG significantly reduce the risk of transmitting infections.\n\nAlthough Octaplas LG is approved by INVIMA, its use for fluid resuscitation has not yet been approved.\n\nThis study will compare Octaplas LG with normal saline solution and Ringer's lactate, which are commonly used for rehydrating patients. All three treatments will be administered in the same manner.\n\nWhy is My Child Being Asked to Participate?\n\nYour child is being invited to participate in this clinical study because:\n\nThey are receiving care in the pediatric intensive care unit (PICU). They are between one month and 18 years old. They have been diagnosed with sepsis and require fluid resuscitation. Your child's participation is voluntary. If you decide not to participate, your child will not lose any medical benefits. Your child's doctor has determined that they may be a good candidate for this study. You are free to discuss participation with your family, friends, or another physician.\n\nSome members of your child's healthcare team may also be involved in this research. They are dedicated to your child's care as well as the objectives of this study. However, you are not obligated to participate. If you choose to enroll your child, you will be asked to sign an informed consent form.\n\nHow Will My Child Be Assigned to a Treatment Group? Upon admission to the pediatric intensive care unit (PICU), if your child has a confirmed sepsis diagnosis and requires intravenous fluids or plasma to support heart function, they will be randomly assigned to one of the three treatment groups.\n\nRandomization is a research method used in clinical trials to assign patients to study groups in an unbiased way-similar to drawing numbers from a hat. Neither you, your child's doctor, nor the researchers will choose which group your child is placed in. Instead, a computer will randomly assign them to a group.\n\nTreatment Groups:\n\nGroup 1: Normal Saline (0.9% Sodium Chloride)\n\nYour child will receive the standard treatment for sepsis, including antibiotics, intravenous fluids, heart function monitoring, mechanical ventilation if needed, and blood pressure medications (vasopressors) if necessary.\n\nGroup 2: Ringer's Lactate\n\nIn addition to standard sepsis management, your child will receive Ringer's lactate, another commonly used resuscitation fluid in pediatric sepsis.\n\nGroup 3: Octaplas LG\n\nIn addition to standard sepsis management, your child will receive pharmaceutical synthetic plasma, which contains proteins and essential blood components that have undergone advanced processing to eliminate the risk of infectious disease transmission.\n\nHow Many Children Will Participate in This Study? At Fundación Cardioinfantil-Instituto de Cardiología, we are seeking the participation of approximately 150 children in this study.\n\nHow Long Will My Child Be in the Study? Your child will remain in their assigned treatment group for up to 28 days from PICU admission or until they no longer require intensive care hospitalization.",[68,69],"Septic Shock","Pediatric Critical Illness",[71,72,73,74,75,76],"sepsis","Septic shock","Fluid bolus","plasma","pediatric","crystalloids","NOT_YET_RECRUITING","2025-06-16",{"date":80,"type":44},"2025-06-25",{"date":82,"type":21},"2025-07-01",{"date":84,"type":21},"2026-07-15",{"name":50,"class":51},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100550886","progressive-structured-simulation-based-surgical-training-program-process---open-vascular-surgery-100550886","NCT06452901","PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery","PROCESS","Inclusion Criteria:\n\n* Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.\n* Over 18 years old.\n\nExclusion Criteria:\n\n* Serious illnesses, such as advanced cancer, decompensated cardiovascular diseases, or severe neurological disorders, could be exclusion criteria due to concerns about the participant's safety and ability to complete the study.\n* Participants who have known allergies to components of the interventions or have experienced severe adverse reactions in the past will be excluded from the study.\n* Any medical condition that could interfere with the participant's ability to complete assessments or follow study guidelines could be a reason for exclusion. This could include, for example, severe physical disabilities or illnesses requiring continuous hospitalization.\n* Individuals who cannot provide valid informed consent due to cognitive issues, mental impairment, or legal incapacity will be excluded from the study.\n* Individuals who have had prior exposure to structured simulation programs in vascular surgery will be excluded. Previous familiarity with simulation could influence study outcomes, introducing a prior learning bias that could distort the assessment of the intervention's effectiveness.",true,{"count":95,"type":21},45,[24],"A triple-arm, randomized, simple-blinded clinical trial will be conducted. A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair (AAOR), Group 2: vascular anastomosis (VA) and AAOR, and Group 3: specific micro-surgical skills, VA and AAOR. Surgical residents of general, vascular, or cardiovascular surgery programs will be included. Sample size calculation resulted in 45 participants, 15 in each group. Simple blinding will involve external evaluators. Randomization will occur as a simple randomization.",[99,100,101],"Vascular Diseases","Competency-Based Education","Simulation Training","2024-06-06",{"date":104,"type":44},"2024-06-11",{"date":106,"type":21},"2024-07-21",{"date":108,"type":21},"2025-01-15",{"name":50,"class":51},""]