[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital Universitario 12 de Octubre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":311},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,51,68,101,131,159,190,218,245,282],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100642060","phase-1-early-neutralizing-antibodies-in-infants-living-with-hiv-to-enhance-their-life-2-100642060",false,"NCT07655141","Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)","A Phase 1\u002F2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS in Combination With VRC07-523LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV","ENABLE 2","Inclusion Criteria:\n\n* Infants from 1 to 365 days old at the time of enrolment.\n* Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.\n* Weight \\> 2.5 kg at enrolment.\n* ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).\n* Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).\n* Parent or legal guardian able to provide Informed consent (IC).\n\nExclusion Criteria:\n\n* Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.\n* Previous receipt of bNAbs against HIV.\n* Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.\n* Intravenous (IV) immunoglobulins received within 90 days before IMP administration.\n* Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator\u002Fdesignee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to:\n* Evidence of active tuberculosis (TB) disease at the time of enrolment.\n* Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician.\n* Severe acute malnutrition with complications.\n* Severe neurological illness.\n* Hemodynamically significant severe congenital heart disease.\n* Active malignancies.\n* Life-threatening bleeding disorder.\n* Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral\u002Fparenteral prednisone or equivalent at 2 mg\u002Fkg\u002Fday, and length of therapy \\\u003C14 days.\n* Unwillingness to have blood drawn\n* Unable to receive SC medications.\n* Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).\n\nAny social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.","ALL","1 Day","1 Year",{"count":21,"type":22},73,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and Cameroon. The study will also learn how the body processes ePGT121v1-LS and VRC07-523-LS and whether caregivers and health workers find this treatment approach acceptable.\n\nThe main questions it aims to answer are:\n\n* Are ePGT121v1-LS and and VRC07-523-LS safe and well tolerated in infants living with HIV?\n* Does adding ePGT121v1-LS and VRC07-523-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48?\n* How long does it take participants receiving ePGT121v1-LS and VRC07-523-LS to achieve viral suppression compared with standard treatment alone?\n* How does ePGT121v1-LS and VRC07-523-LS behave in the body after repeated subcutaneous injections?\n\nResearchers will compare infants receiving ePGT121v1-LS and VRC07-523-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression.\n\nParticipants will:\n\n* Continue taking standard oral ART.\n* Receive 4 subcutaneous injections of ePGT121v1-LS and VRC07-523-LS or placebo every 12 weeks.\n* Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring.\n* Have follow-up visits for 48 weeks.\n* Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.",[29],"HIV -1 Infection",[31,32,33,34,35,36,37,38],"HIV","broadly neutralizing antibody","ePGT121v1-LS","viral load","safety","infant","children","VRC07-523-LS","NOT_YET_RECRUITING","2026-06-12",{"date":42,"type":43},"2026-06-17","ACTUAL",{"date":45,"type":22},"2027-01-01",{"date":47,"type":22},"2029-12-31",{"name":49,"class":50},"Hospital Universitario 12 de Octubre","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":67,"locationsCount":4},"100641640","phase-1-early-neutralizing-antibodies-in-infants-living-with-hiv-to-enhance-their-life-100641640","NCT07655128","Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life","A Phase 1\u002F2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV","ENABLE 1",{"count":59,"type":22},87,[25,26],"The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa. The study will also learn how the body processes ePGT121v1-LS and whether caregivers and health workers find this treatment approach acceptable.\n\nThe main questions it aims to answer are:\n\n* Is ePGT121v1-LS safe and well tolerated in infants living with HIV?\n* Does adding ePGT121v1-LS to standard ART increase the number of infants who achieve HIV viral suppression by week 48?\n* How long does it take participants receiving ePGT121v1-LS to achieve viral suppression compared with standard treatment alone?\n* How does ePGT121v1-LS behave in the body after repeated subcutaneous injections?\n\nResearchers will compare infants receiving ePGT121v1-LS plus ART to infants receiving standard ART plus placebo (saline) to see if ePGT121v1-LS improves HIV viral suppression.\n\nParticipants will:\n\n* Continue taking standard oral ART.\n* Receive 4 subcutaneous injections of ePGT121v1-LS or placebo every 12 weeks.\n* Attend regular clinic visits for safety checks, blood tests, and HIV viral load monitoring.\n* Have follow-up visits for 48 weeks.\n* Participate in evaluations of treatment adherence and acceptability from the perspective of caregivers and health workers.",[29],[31,32,33,34,35,36,37],{"date":42,"type":43},{"date":45,"type":22},{"date":47,"type":22},{"name":49,"class":50},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":99,"locationsCount":100},"100629377","intraventricular-hemorrhage-in-kangaroo-care-vs-incubator-care-100629377","NCT07473882","Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care","Kangaroo Care in Extremely Preterm Newborns Versus Incubator Care and Intraventricular Hemorrhage: A Multicenter RCT","KANVIH","Inclusion Criteria:\n\n* Preterm infants born at 28 weeks of gestational age or less, admitted to the NICU and born at the study center (inborn), less than 72 hours old, with a parent or legal guardian present who is willing to provide kangaroo care.\n\nExclusion Criteria:\n\n* Preterm infants in the immediate postoperative period following major surgery.\n* Preterm infants with congenital abdominal wall malformations.\n* Preterm infants requiring immobilization.\n* Preterm infants who are clinically unstable and unable to tolerate kangaroo care.\n* Preterm infants whose parents decline participation in the study.","1 Minute","72 Hours",{"count":79,"type":22},314,[81],"NA","This clinical study aims to find out whether kangaroo care (skin-to-skin contact between parents and their extremely premature newborns) can help protect the babies' brains by reducing the risk of bleeding in the brain during the first days of life. To do this, the extremely premature newborns will be randomly assigned to one of three groups: kangaroo care in a side-lying position, kangaroo care in a face-down position, or standard care in an incubator. Researchers will monitor the babies for signs of brain bleeding and other health measures to determine which approach is safest. The main hypothesis is that kangaroo care in the side-lying position may lower the risk of severe brain bleeding compared with the other positions or remaining in the incubator.",[84,85,86],"Kangaroo Care","Premature Infant","IVH- Intraventricular Hemorrhage",[88,89,90,91,92,93],"patient positioning","kangaroo-Mother care Method","Skin to Skin","Extremely Premature Infant","cerebral hemorrhage","incubator care","2026-03-11",{"date":96,"type":43},"2026-03-16",{"date":45,"type":22},{"date":47,"type":22},{"name":49,"class":50},1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":112,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":100},"100616890","implementation-of-biomarker-based-care-for-mtbi---impacts-braini-study-100616890","NCT07311486","Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study","BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY","IMPACTS-BRAINI","Inclusion Criteria:\n\n* -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)\n\n  1. The presence of a plausible traumatic mechanism observed\u002For related by the patient´s recount of the injury event.\n  2. Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.\n  3. At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.\n  4. a GCS between 15 and 13, at least 30 minutes after injury.\n* Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.\n\nExclusion Criteria:\n\n* · GCS 3-12 on admission\n\n  * Age Below 18 years\n  * Time of injury unknown\n  * Time to injury exceeding 12 hours\n  * Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)\n  * Penetrating head trauma\n  * Patient with mechanical ventilation from the trauma scene or prehospital management\n  * Venipuncture not feasible","18 Years",{"count":111,"type":22},1000,"2 Weeks","OBSERVATIONAL","This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.\n\nThe study seeks to answer two primary questions:\n\n1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care.\n2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.\n\nTo assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.",[116],"Mild Traumatic Brain Injury (mTBI)",[118,119,120,121],"Biomarker","GFAP","UCH-L1","Implementation","RECRUITING","2025-12-21",{"date":125,"type":43},"2025-12-31",{"date":127,"type":43},"2025-07-15",{"date":129,"type":22},"2026-05-01",{"name":49,"class":50},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":157,"locationsCount":158},"100600310","prognostic-model-of-postnatal-circulation-in-pulmonary-atresia-critical-stenosis-with-intact-ventricular-septum-100600310","NCT07095829","Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum","Development and Validation of a Prognostic Model of Postnatal Circulation in Fetuses With a Diagnosis of Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Absence of flow at the pulmonary valve (PA) or presence of thickened and domed. pulmonary valve cusps with a pinhole jet of flow.\n* Doppler evidence of ductal-dependent pulmonary circulation.\n* Intact ventricular septum.\n\nExclusion Criteria:\n\n* Poor imaging windows and incomplete\u002Fpoor quality scan\n* Termination of pregnancy\n* Cases initially included that undergo prenatal pulmonary valvuloplasty later on in pregnancy.\n* Unconfirmed PA-CS\u002FIVS at birth.\n* Functional PA-CS\u002FIVS (Ebstein malformation, monochorionic twins)\n* Any associated cardiac defect except persistent left superior vena cava and aberrant right subclavian artery.\n* Any significant (i.e that might influence outcome) extracardiac anomaly and\u002For known genetic syndromes. Also, if such a condition is present at inclusion but diagnosed only after birth, the case will be retrospectively excluded.","16 Weeks","28 Weeks",{"count":141,"type":22},150,"Pulmonary atresia (PA)\u002Fcritical stenosis (CS) with intact ventricular septum (PA\u002FCS-IVS) is a rare congenital heart disease (CHD), that presents heterogeneously. Prognosis is conditioned by the possibility of achieving a primary repair with biventricular circulation (BV) or a one-and-a-half ventricle solution vs. a palliative approach bound to a univentricular (UV) circulation in which both survival and quality of life are significantly impaired. Predicting UV circulation prenatally is still a challenge.\n\nThe aim of this study is: 1\u002F to evaluate the natural history of the disease and develop a prognostic model for the prediction of transplantation-free survival with a biventricular or a one-and-a-half repair at 2 years postnatal age 2\u002F To develop a model to predict the risk of right ventricle dependent coronary circulation 3\u002F To evaluate prenatal and postnatal outcomes in non-intervened fetuses with a confirmed postnatal diagnosis of PA-CS\u002FIVS including Intrauterine death, neonatal\u002FInfant death, number of required postnatal procedures, need for oxygen support, need for cardiac transplantation",[144,145,146],"Pulmonary Atresia With Intact Ventricular Septum","Congenital Heart Disease","Fetal Cardiac Disorder",[148,149,150],"Prognosis","Prenatal diagnosis","Ultrasound","2025-09-08",{"date":153,"type":43},"2025-09-15",{"date":155,"type":43},"2024-02-01",{"date":47,"type":22},{"name":49,"class":50},2,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":167,"targetDuration":19,"studyType":113,"phases":4,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100584969","genetic-characterization-of-patients-with-arrhythmia-induced-cardiomyopathy-100584969","NCT06896266","Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy","Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy","UNCHAINED-I","Inclusion Criteria:\n\n* Presence of atrial fibrillation or atrial flutter not self-limited.\n* Performance of a cardiac imaging test with systolic function analysis (echocardiogram, magnetic resonance, CT scan) during the clinical course of the arrhythmia, exhibiting a left ventricular ejection fraction (LVEF) \\\u003C50%. In order for the test to be representative, the maximum time between the performance of the imaging test and the rhythm control procedure will be 3 months, in the absence of intervening cardiovascular events that may have caused a variation in LVEF. In the event that the patient had a previously known LVEF \\\u003C50%, the change with respect to this attributable to tachyarrhythmia has to be ≥10%.\n* Signature of informed consent.\n* Ability to understand and accept participation in the study.\n\nExclusion Criteria:\n\n* Refusal of informed consent.\n* Legal or juridical incapacity.\n* Age \\\u003C18 years.\n* Life expectancy less than 1 year.\n* Impossibility of a follow-up of at least 6 months.\n* Presence of a ventricular rate \\>140 beats per minute, limiting the validity of imaging measurements.\n* Presence of known factors causing systolic ventricular dysfunction:\n\n  * Prior cardiomyopathy diagnosis.\n  * Severe mitral or aortic valve disease.\n  * Non-revascularizable ischemic heart disease.\n  * Context of peri-resuscitation cardiopulmonary care.\n  * Abusive alcohol consumption, defined as \\>80 grams of ethanol or \\>7 standard alcoholic beverages per day.\n  * Active treatment with chemotherapeutic agents or radiation therapy to the thorax.\n  * Known infection with Trypanosoma cruzi, Borrellia burgdorferi or other infectious agent causing cardiomyopathy.",{"count":168,"type":22},109,"The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are:\n\nI. Does patients with arrhythmia-induced cardiomyopathy have a greater proportion of genetic mutations compared with other types of cardiomyopathy or general population? II. Have the genetics any prognostic impact in patients with arrhythmia-induced cardiomyopathy?",[171,172,173],"Arrhythmia","Cardiomyopathy","Arrhythmia-induced Cardiomyopathy (AiCM)",[175,176,177,178,179,180],"atrial fibrillation","atrial flutter","heart failure","arrhythmia-induced cardiomyopathy","cardiomyopathy","genetics","2025-05-09",{"date":183,"type":43},"2025-05-14",{"date":185,"type":43},"2024-12-01",{"date":187,"type":22},"2026-12",{"name":49,"class":50},4,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100569739","wide-antral-pulmonary-vein-isolation-in-atrial-fibrillation-ablation-with-a-single-shot-technique-wider-pvi-100569739","NCT06698159","Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)","Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial","WIDER-PVI","Inclusion Criteria:\n\n* Age over 18 years old.\n* Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 years after diagnosis.\n* Clinical indication to undergo a pulmonary vein isolation procedure using balloon cryoablation.\n\nExclusion Criteria:\n\n* Severe left atrial dilatation (indexed volume \\>48 ml\u002Fm2 or area \\>40 cm2 or indexed diameter \\>3.0 cm\u002Fm2).\n* Previous endocardial or surgical ablation of atrial fibrillation.\n* Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy less than 1 year.\n* Inability to understand or give informed consent.\n* Performance of other left atrial ablations in addition to pulmonary veins.\n* Need to use another catheter in addition to the cryoablation catheter to complete pulmonary vein isolation.\n* Contraindication to anticoagulation or intolerance to heparin.\n* Presence of intra-atrial thrombus.\n* Reversible cause of atrial fibrillation.\n* Severe mitral or aortic valve disease.\n* Congenital heart disease.\n* Pregnancy or the prospect of pregnancy in the next 12 months.",{"count":199,"type":22},440,[81],"The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \\>30 seconds duration and in overall arrhythmic load.",[203,204],"Atrial Fibrillation","Atrial Fibrillation (Paroxysmal)",[206,207,208],"atrial fibrilation","cryoballoon","cryoablation","2024-11-18",{"date":211,"type":43},"2024-11-20",{"date":213,"type":43},"2024-11-01",{"date":215,"type":22},"2027-06-30",{"name":49,"class":50},17,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":225,"targetDuration":227,"studyType":113,"phases":4,"briefSummary":228,"conditions":229,"keywords":234,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100548590","registry-of-patients-in-shock-treated-with-vasopressin-100548590","NCT06422975","Registry of Patients in Shock Treated With Vasopressin","Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units","Inclusion Criteria:\n\n* Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and\u002For critical care unit, according to best clinical practice.\n\nExclusion Criteria:\n\n* Non-consent by patient\u002Flegal representatives",{"count":226,"type":22},500,"90 Days","Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin).\n\nSeptic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up.\n\nThe Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1.\n\nThe rationale for its use in septic shock would be:\n\n* endogenous vasopressin deficiency present in septic shock;\n* as a catecholamine-sparing strategy, reducing the side effects of catecholamines;\n* its potential nephroprotective effect;\n* its use should be early.\n\nThe uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.",[230,231,232,233],"Vasopressin Causing Adverse Effects in Therapeutic Use","Shock","Vasopressor Adverse Reaction","Vasopressin Deficiency",[235,231],"Vasopressin","2024-07-11",{"date":238,"type":43},"2024-07-15",{"date":240,"type":43},"2024-07-09",{"date":242,"type":22},"2026-06",{"name":49,"class":50},24,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":281,"locationsCount":100},"100533361","clinical-trial-for-the-evaluation-of-customized-3d-printed-niv-nasal-masks-in-premature-infants-100533361","NCT06224816","Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants","Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants","M3DPREMAT","Inclusion Criteria:\n\n* Newborn prematurity\n* Age: less than 30 days of life\n* Required respiratory support with non-invasive ventilation (NIV)\n* Premature infant has not been on NIV for more than 3 days before being included in the trial.\n* Signature of the Informed Consent (IC)\n\nExclusion Criteria:\n\n* Failure to meet entry criteria\n* Cyanotic congenital heart disease diagnosis\n* Presence of serious malformations\n* Presence of airway malformations","0 Days","30 Days",{"count":256,"type":22},60,[81],"Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).\n\nPremature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.\n\nTo compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm \\\u003C 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and\u002For sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.",[260],"Premature Lungs",[262,263,264,265,266,267,268,269,270,271,272,273,274,275],"Neonatology","Nasal mask","3D printing","Additive manufacturing","Newborn","Premature","Prematurity","Neonate","Non-Invasive Ventilation (NIV)","Oxygen saturation","SolidWorks","3D scanner","Customized device","Continuous positive airway pressure (CPAP)","2024-04-16",{"date":278,"type":43},"2024-04-18",{"date":276,"type":43},{"date":187,"type":22},{"name":49,"class":50},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":290,"minAge":109,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":300,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":4},"100509848","side-effects-screening-and-early-intervention-to-impact-in-quality-of-life-of-gynaecological-cancer-patients-100509848","NCT05918770","Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients","Telemedicine-guided Patients Reported Outcome Measures (PROMs): Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients","HALIS","Inclusion Criteria:\n\n* Women aged ≥18 diagnosed with ovarian, tubal and primary peritoneal, cervical and endometrial cancer who are candidates for surgery during the study period.\n\nExclusion Criteria:\n\n* Patients unable to complete by themselves the screening questionnaires included.","FEMALE",{"count":292,"type":22},168,[81],"The goal of this randomized study is to assess the impact on self-perceived quality of life (QoL) of systematic screening and early treatment of aftereffects in patients with gynaecological cancers. The main question it aims to answer is if systematic screening with validated questionaries (see in detailed description), diagnosis and early treatment of lower-limb lymphoedema, anxiety-depression, sexual dysfunction and sarcopenia-malnutrition all have a positive impact on the self-perceived QoL by gynaecological cancer patients. Participants will access the screening questionnaires and QoL questionaries on a free online app on their mobile devices. In the experimental group, in case of positive screening, patients will be referred to specialised care to early treatment of the aftereffects. Researchers will compare this group with standard usual care (opportunistic treatment) to see if systematic screening and early treatment lead to a better QoL.",[296,297,298,299],"Quality of Life","Gynaecological Cancer","Lymphedema, Lower Limb","Sexual Dysfunction",[301,302],"quality of life","Gynaecological cancer","2023-06-23",{"date":305,"type":43},"2023-06-26",{"date":307,"type":22},"2023-09",{"date":309,"type":22},"2026-09",{"name":49,"class":50},""]