[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital Clinic of Barcelona\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":698},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,55,84,113,132,159,169,205,233,259,285,315,341,367,390,417,458,486,513,534,561,588,614,639,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100054043","intraoperative-cognitive-load-in-anesthesia-nurses-across-anesthetic-phases-100054043",false,"NCT07568158","Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases","Carga Cognitiva Intraoperatoria Del Enfermero\u002Fa de Anestesia Según la Fase Del Acto Anestésico: Estudio Observacional Con NASA-TLX","ENCOPER","Inclusion Criteria:\n\n* Registered nurse anesthetist actively working at Hospital Clínic de Barcelona.\n* Minimum 3 months in the current anesthesia nursing position.\n* Voluntary participation with signed informed consent.\n* Scheduled surgery (including deferred urgent surgery) or solid organ transplantation.\n* General anesthesia (endotracheal intubation or laryngeal mask airway) or spinal anesthesia with sedation.\n* Minimum duration of 30 minutes.\n\nExclusion Criteria:\n\n* Refusal to participate or withdrawal of informed consent.\n* Spinal anesthesia without sedation.\n* Exclusive regional anesthesia without sedation.\n* Sedation alone without regional technique.\n* Duration less than 30 minutes.\n* Cases involving an unexpected intraoperative emergency requiring urgent additional personnel.\n* Cases started under spinal anesthesia converted to general anesthesia for any clinical or technical reason.",true,"ALL","18 Years",{"count":22,"type":23},50,"ESTIMATED","8 Months","OBSERVATIONAL","The goal of this observational study is to measure the cognitive load (mental effort) of anesthesia nurses during real surgical procedures at Hospital Clínic de Barcelona, Spain. The main questions it aims to answer are:\n\n* Does cognitive load vary across the three phases of anesthetic care (induction, maintenance, and emergence\u002Frecovery)?\n* Is cognitive load higher during general anesthesia than during spinal anesthesia with sedation?\n* How do surgical specialty and patient complexity relate to cognitive load?\n* How does monitor alarm perception relate to cognitive load during surgery?\n\nParticipants (anesthesia nurses) will complete the NASA Task Load Index (NASA-TLX) questionnaire - a validated 6-item tool measuring mental effort - three times per surgical case: after induction or spinal block, during maintenance, and after patient awakening or sedation reversal. They will also answer 4 brief questions about alarm management at the end of each case. No changes are made to clinical care. Participation adds approximately 11 minutes per surgical case.",[28,29,30,31,32,33],"Alarm Fatigue","Perioperative","Patient Safety","Cognitive Load","Performance","Cognitive Load, Performance",[35,36,37,38,39,30,40,41],"NASA-TLX","Anesthesia Nursing","Perioperative Nursing","Mental Workload","Intraoperative","Monitor Alarms","Operating Room","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2026-06-01",{"date":50,"type":23},"2027-02-28",{"name":52,"class":53},"Hospital Clinic of Barcelona","OTHER",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":54},"100644280","algorithm-based-timing-of-delivery-using-the-sflt-1plgf-ratio-in-early-onset-severe-preeclampsia-map-2-study--management-based-on-angiogenic-markers-in-preeclampsia-2-study--100644280","NCT07665112","Algorithm-Based Timing of Delivery Using the sFlt-1\u002FPlGF Ratio in Early-Onset Severe Preeclampsia. (MAP 2 Study : Management Based on Angiogenic Markers in Preeclampsia 2 Study )","Multicenter Randomized Trial of an sFlt-1\u002FPlGF Ratio-Based Algorithm for Timing of Delivery in Early-Onset Severe Preeclampsia: The MAP 2 Study","MAP 2","Inclusion criteria :\n\n* Women aged 18 or older\n* Singleton pregnancies\n* Diagnosed with severe preeclampsia per 2020 ACOG criteria, between 30.0 and 33.6 weeks by first-trimester ultrasound.\n\nExclusion criteria :\n\n* Major fetal malformations\n* Confirmed genetic syndromes.","FEMALE",{"count":65,"type":23},386,"INTERVENTIONAL",[68],"NA","Preeclampsia is a serious pregnancy complication caused by abnormal placental development and function. It can lead to high blood pressure and damage to organs such as the liver, kidneys, brain, or cardiovascular system. In these cases, the only definitive treatment is delivery. However, deciding when to deliver is challenging: delaying delivery increases risks for both mother and baby, while delivering too early increases complications related to prematurity.\n\nThis study aims to evaluate whether a blood test measuring the sFlt-1\u002FPlGF ratio an angiogenic marker that reflects placental function and predicts complications more accurately than traditional clinical criteria can help determine the optimal timing of delivery in women with severe preeclampsia between 30 weeks and 33 weeks plus 6 days of gestation. It is a multicenter, randomized controlled clinical trial conducted in 11 referral hospitals in Spain and will include 386 singleton pregnancies.\n\nParticipants will be randomly assigned to one of two groups. In the control group, standard expectant management will be followed, aiming to continue the pregnancy until 34 weeks if maternal and fetal conditions remain stable, and the sFlt-1\u002FPlGF results will be masked. In the study group, delivery timing will be guided by the sFlt-1\u002FPlGF ratio: if the ratio is greater than 655, delivery will be planned from 30 weeks onward; if greater than 110, delivery will be planned from 34 weeks; and if 110 or lower, pregnancy may continue until 37 weeks.\n\nThe study has two primary outcomes. The first is a composite of severe maternal complications, including neurological, hepatic, renal, respiratory, or cardiovascular dysfunction, severe hypertension, placental abruption, or fetal death. The second is a composite of neonatal complications, including admission to the neonatal intensive care unit or neonatal death.\n\nThe goal is to demonstrate that using angiogenic markers reduces maternal complications without significantly increasing neonatal complications. If successful, this approach could support more individualized management of early-onset severe preeclampsia, improving maternal safety while carefully balancing the risks of prematurity for the newborn.",[71],"Severe Preeclampsia",[73,74],"Angiogenic biomarkers","sFlt-1\u002FPlGF ratio","NOT_YET_RECRUITING","2026-06-18",{"date":78,"type":46},"2026-06-24",{"date":80,"type":23},"2026-07-01",{"date":82,"type":23},"2029-12-31",{"name":52,"class":53},{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":66,"phases":94,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":54},"100641438","physical-activity-in-bed-rest-hospitalized-high-risk-pregnant-women-100641438","NCT07657000","Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.","Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women","BedRest-1","Inclusion Criteria:\n\n* Maternal age of 18 or more\n* Delivery not expected within 1 week after recruitment.\n* Language ability to understand the study.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Fetal death\n* Severe mental health disorders and substance abuse disorders.",{"count":93,"type":23},140,[68],"This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even while in bed and seeks to address physical and emotional health challenges during hospitalization. The study will compare outcomes between participants who follow the exercise program and those receiving standard care. Primary outcomes include physical and emotional health parameters, quality of life, and sleep quality. Secondary outcomes focus on feasibility, adherence, and participant satisfaction. This research addresses the gap in physical activity guidelines for pregnant individuals on bed rest and explores the potential benefits of exercise to improve maternal well-being and postpartum recovery.",[97,98,99],"Bed Rest","Pregnancy","Pregnancy Complications",[101,98,102,103,104,105],"Bed rest","Pregnancy complications","Hospitalization","Exercise","Exercise adaptations","2026-06-17",{"date":76,"type":46},{"date":109,"type":23},"2026-09",{"date":111,"type":23},"2029-09",{"name":52,"class":53},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":54},"100580166","clinical-and-cpet-parameters-that-predict-improvement-in-functional-capacity-after-tavi-100580166","NCT06833762","Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI","Determining Clinical and Cardiopulmonary Exercise Testing Parameters That Predict Improvement in Functional Capacity and Complications After Transcatheter Aortic Valve Implantation","Inclusion Criteria:\n\n* All those patients ≥ 18 years of age with severe aortic stenosis approved for transfemoral TAVI.\n\nBoth sexes, male and female will be included in the study.\n\nExclusion Criteria:\n\nVery severe aortic stenosis, defined as a valve area of ≤0.6 cm2\n\n, mean gradient ≥60 mmHg or Vmax \\>5 m\u002Fs\n\n* Previous syncope\n* Proven exercise-induced arrhythmias\n* Previously known dynamic left ventricular outflow tract (LVOT) obstruction, defined as LVOT gradient of ≥ 30 mmHg by echocardiography\n* Concomitant coronary artery disease pending percutaneous coronary intervention\n* Inability to consent\n* Physical limitation to perform an exercise test\n* Non-elective procedure\n* Valve-in-valve procedure",{"count":121,"type":23},161,"Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation",[124],"Aortic Stenosis Disease",{"date":126,"type":46},"2026-06-22",{"date":128,"type":46},"2025-01-01",{"date":130,"type":23},"2026-07",{"name":52,"class":53},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":66,"phases":142,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100641673","impact-of-ambulatory-physiological-stimulation-of-the-efferent-limb-prior-to-ileostomy-closure-on-colorectal-microbiota-composition-and-histopathological-findings-100641673","NCT07640113","Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings","The STIMIC Trial: A Multicenter Randomized Control Trial Evaluating the Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings","STIMIC","Inclusion criteria:\n\n1. Patients 18 yo and older, with a loop ileostomy after colorectal surgery for malignant or benign disease and a barium enema that rules out colorectal anastomotic leak or stenosis.\n2. Patients must be self-sufficient in their stoma care or dispose of assistance by a family member or healthcare provider.\n3. Patients must reside no further than 50km from the hospital and dispose of postoperative home-assistance by a family member or healthcare provider.\n\nExclusion criteria:\n\n1. Patients with a terminal ileostomy or a closed distal limb, inaccesible to preoperative stimulation.\n2. Patients with the diagnosis of inflammatory bowel disease.\n3. Patients incapable of comprehending or signing the informed consent.",{"count":141,"type":23},90,[68],"BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection. Temporary diversion of intestinal transit does not reduce the risk of anastomotic failure, but it does lower the morbidity and mortality associated with potential pelvic sepsis. Unfortunately, a second surgical procedure is required to restore intestinal continuity, and this carries its own risk of complications, the most common being postoperative ileus (temporary paralysis of bowel motility associated with abdominal distension, absence of bowel movements, nausea, and vomiting), which occurs in up to 20% of cases.\n\nSeveral strategies have been proposed to reduce this problem, including stimulation of the efferent limb of the ileostomy (the part that is connected to the unused colon). This intervention consists of instilling a substance through the efferent limb of the ileostomy into the colon, simulating natural intestinal transit. It emerged as a harmless alternative aimed at reversing changes in the excluded colon in preparation for restoration of intestinal continuity. Several Spanish studies have investigated this technique, concluding that it is safe and significantly reduces the rate of postoperative ileus, thereby shortening hospital stay. Regarding the mechanism by which this intervention may be effective, there are studies investigating the changes that occur during diversion of intestinal transit:\n\n1. Histopathology: reduced muscular contractility and the presence of intestinal villi in the efferent intestinal limb and excluded colon, which improve once intestinal flow is restored.\n2. Microbiome: significant loss of microbiota in the defunctionalized colon, which progressively recovers with natural intestinal transit and reintroduction of a fiber-rich diet.\n\nStructural and microbiota-related changes favor the development of diversion colitis, a condition associated with erratic bowel habits once intestinal transit is restored. In an attempt to reverse this condition, several products have been tested for stimulation of the efferent limb of the ileostomy: probiotics, short chain fatty acids, saline solution with a thickening agent, and the patient's own intestinal contents, a well-tolerated and effective technique, in some cases superior to saline-based alternatives.\n\nOverall, the available evidence is of low quality due to the limited number of patients studied and protocol variability. For this reason, we propose the implementation of a protocol for stimulation of the distal ileostomy limb prior to ileostomy closure, either with saline solution and thickening agent (the most widely described technique in the literature) or physiological stimulation using the patient's own intestinal contents.\n\nThe protocol consists of several sessions in which the instilled volume is progressively increased. This intervention will be performed on an outpatient basis, once daily, during the two weeks prior to surgery.\n\nThis process promotes the onset of bowel movements through the anus, which progressively become more formed and less frequent, approaching a more normal bowel habit. Only minor adverse effects have been described with this technique, including cramp-like abdominal pain in 27.6% of sessions. Recently, a nationwide study confirmed the favorable clinical outcomes following distal ileostomy limb stimulation before ileostomy closure. However, to our knowledge, no studies have evaluated its effect on intestinal microbiota.\n\nHYPOTHESIS Distal limb stimulation of the ileostomy before its closure helps in the recovery of the colorectal microbiome and tissue. This associates with lower postoperative complications, specially postoperative ileus.\n\nOBJECTIVES To gain knowledge regarding changes in intestinal microbiota composition before and after stimulation, in order to better understand recovery of intestinal function following this procedure. We will also analyze outcomes after ileostomy closure following efferent limb stimulation, determining the incidence of postoperative complications, particularly postoperative ileus.\n\nMETHODOLOGY\n\nPatients will be randomly assigned to one of three groups:\n\n1. Control (no intervention other than the usual preoperative protocol)\n2. Stimulation with serum and thickener\n3. Stimulation with own stoma output\n\nSamples will be collected in all patients:\n\n1. Stoma output\n2. Stool, before stimulation, if performed\n3. Stool, after stimulation, if performed\n4. Stool, a month after surgery\n\nFor a group of patients, the ones recruited at Hospital Clínic, rectal biopsies will also be collected before and after stimulation, to compare the effect of the treatment in the colonic tissue. We will collect clinical data during the whole process regarding postoperative complications.",[145,146,147],"Ileostomy Stoma","Stoma Stimulation","Microbiome Analysis",[149,150,151],"efferent limb stimulation","ileostomy closure","colorectal microbiome","2026-06-15",{"date":106,"type":46},{"date":155,"type":23},"2026-06",{"date":157,"type":23},"2028-03",{"name":52,"class":53},{"id":160,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":161,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":162,"keywords":163,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":54},"100636628",{"count":22,"type":23},[28,29,30,31,32,33],[35,36,37,38,39,30,40,41],{"date":106,"type":46},{"date":48,"type":46},{"date":167,"type":23},"2027-01-01",{"name":52,"class":53},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":179,"studyType":25,"phases":4,"briefSummary":180,"conditions":181,"keywords":186,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":54},"100641518","prospective-multicentre-observational-registry-of-peri-procedural-anaesthesia-sedation-and-related-medication-exposure-in-patients-with-brugada-syndrome-100641518","NCT07655102","Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome","BRUGADA-ANAESTHESIA Registry: Prospective Multicentre Observational Registry of Peri-procedural Anaesthesia, Sedation and Related Medication Exposure in Patients With Brugada Syndrome","PROSP_BRUGANAE","Patients should match all the inclusion criteria to be entered for data collection:\n\n* Documented type 1 Brugada ECG pattern (spontaneous, fever-related, or induced by sodium-channel blocker challenge\u002Fother recognised provocation test) with a diagnosis considered compatible with Brugada syndrome by the treating cardiology team.\n* Undergoing general anaesthesia, monitored sedation, loco-regional anaesthesia for any surgical, diagnostic, interventional, obstetric or other non-surgical procedure (including epidural analgesia for labour and sedation for endoscopy).\n\nPatients with one or more exclusion criteria will not be included for data collection and analysis:\n\n* No documented type 1 Brugada ECG pattern, uncertain diagnosis without sufficient supporting data.\n* Refusal to participate in the study.",{"count":178,"type":23},200,"30 Days","The goal of this observational study is to evaluate the perioperative risk of malignant ventricular arrhythmias in adult patients diagnosed with Brugada Syndrome undergoing anaesthetic procedures. Brugada Syndrome is a rare inherited cardiac condition associated with an increased risk of life-threatening arrhythmias, and perioperative management remains challenging due to limited high-quality evidence.\n\nThe main questions it aims to answer are:\n\n* What is the incidence of malignant ventricular arrhythmias during anaesthesia and up to 30 days after the procedure?\n* Are anaesthetic drugs traditionally considered \"non-recommended\" associated with an increased risk of perioperative arrhythmic events?\n\nResearchers will also explore the relative contribution of anaesthetic drugs versus perioperative physiological factors (e.g., haemodynamic changes, fever, bradycardia) in triggering arrhythmias.\n\nParticipants will:\n\n* Undergo anaesthetic procedures (general, locoregional, or sedation) as part of routine clinical care\n* Have clinical data collected prospectively from electronic medical records during the perioperative period\n* Be followed for 30 days after the procedure to assess outcomes, including arrhythmias, complications, ICU admission, and mortality\n\nThis is a multicentre, prospective observational registry, and no additional interventions or changes to standard clinical practice will be performed.",[182,183,184,185],"Brugada Syndrome (BrS)","Ventricular Arrhythmia","Anesthesia","Sedation",[187,188,184,189,190,191,192,193,194,195,196,197],"Brugada Syndrome","Anaesthesia","Perioperative Care","Ventricular Arrhythmias","Cardiac Arrhythmias","Perioperative Risk","Anesthetic Drugs","Propofol","Sodium Channel Blockers","Observational Registry","Multicentre Study","2026-06-12",{"date":106,"type":46},{"date":201,"type":23},"2026-07-20",{"date":203,"type":23},"2028-12-20",{"name":52,"class":53},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":66,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":54},"100641660","the-green-room-virtual-nature-for-mental-well-being-in-the-acute-psychiatry-ward-100641660","NCT07655063","The Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward","The Green Room: A Mixed-Methods Randomized Controlled Trial Evaluating Virtual Reality-Based Nature Exposure in an Acute Psychiatry Ward","GREEN ROOM","Inclusion Criteria:\n\nAdults aged 18 to 65 years. Admitted to the Acute Psychiatry Ward (regardless of voluntary or involuntary legal status).\n\nSufficient cognitive and clinical stability to provide informed consent and engage with the VR equipment, as determined by the clinical team.\n\nAbility to communicate effectively in Spanish.\n\nExclusion Criteria:\n\nHistory of photosensitive epilepsy or severe seizure disorders. Presence of active facial injuries, infections, or skin conditions that prevent the hygienic use of the VR headset.\n\nPre-existing severe vertigo, balance disorders, or high susceptibility to motion sickness.\n\nAcute clinical state involving high risk of agitation or behavioral dysregulation that could compromise participant or equipment safety.\n\nSevere visual or hearing impairments that cannot be corrected and would hinder the VR experience.\n\nPatients who have previously participated in the study during a prior admission are not eligible for re-enrolment.",{"count":214,"type":23},120,[68],"This study evaluates the feasibility, acceptability and clinical impact of a virtual reality (VR)- based nature intervention in an acute psychiatric inpatient unit. Participants are randomly assigned to recieve VR nature sessions (using Nature Treks VR on Meta Quest 3) in addition to standard care, or standard care alone. The primary outcome is change in percieved stress (PSS-19) from admission to discharge. The study uses a mixed-methods design combining randomized controlled trial with a qualitative phase.",[218,219,220],"Mental Disorders","Psychiatric Hospitalization","Stress (Psychology)",[222,223,224,225,226],"virtual reality","nature exposure","Acute psychiatry","Inpatient","Mental health",{"date":106,"type":46},{"date":229,"type":23},"2026-06-10",{"date":231,"type":23},"2026-12",{"name":52,"class":53},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":66,"phases":242,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":256,"leadSponsor":258,"locationsCount":54},"100635869","continuous-glucose-monitoring-versus-self-monitoring-of-blood-glucose-in-women-with-gestational-diabetes-100635869","NCT07558291","Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes","Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes: A Pilot Randomized Clinical Trial","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years\n* Singleton pregnancy\n* Diagnosis of gestational diabetes mellitus (GDM) according to local two-step protocol (abnormal 50 g glucose challenge test followed by abnormal 100 g oral glucose tolerance test with at least 2 abnormal values)\n* Gestational age between 24 and 28 weeks at time of GDM diagnosis\n* Access to a compatible smartphone or digital device with internet connection to allow synchronization and remote upload of glucose data (CGM or SMBG)\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Preexisting type 1 or type 2 diabetes mellitus\n* History of bariatric surgery\n* Treatment with metformin during pregnancy\n* Chronic systemic corticosteroid therapy\n* Known contraindications to use of a CGM sensor (e.g., severe dermatologic conditions at insertion site)\n* Inability to comply with study procedures or follow-up",{"count":241,"type":23},100,[68],"Gestational diabetes mellitus (GDM) is a type of diabetes that is first diagnosed during pregnancy. It causes high blood sugar levels and can increase the risk of health problems for both the mother and the baby. Babies may grow larger than expected (macrosomia), which can make delivery more difficult and increase the risk of birth complications. Mothers with GDM are also more likely to need insulin treatment and may have a higher risk of high blood pressure during pregnancy. Good blood sugar control is important to reduce these risks.\n\nThe usual way to monitor blood sugar in women with GDM is by self-monitoring of blood glucose (SMBG). This involves pricking the finger several times a day to measure blood sugar levels. Although this method provides useful information, it only shows glucose levels at specific moments and may miss changes that happen during the night or between measurements.\n\nContinuous glucose monitoring (CGM) is a newer method that uses a small sensor placed under the skin to measure glucose levels throughout the day and night. It provides more detailed information about blood sugar patterns and does not require frequent finger pricks. CGM has been shown to improve blood sugar control in people with type 1 and type 2 diabetes, but its benefits in women with gestational diabetes are not yet fully known.\n\nThe purpose of this study is to compare continuous glucose monitoring (CGM) with standard finger-prick monitoring (SMBG) in pregnant women diagnosed with gestational diabetes between 24 and 28 weeks of pregnancy. The study will evaluate whether CGM is practical to use, whether women are satisfied with it, and whether it may help improve blood sugar control and pregnancy outcomes.\n\nA total of 100 pregnant women with gestational diabetes will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:\n\nOne group will use a continuous glucose monitoring device.\n\nThe other group will continue with standard finger-prick blood glucose monitoring.\n\nBoth groups will receive the same medical care, including dietary advice, physical activity recommendations, and insulin treatment if needed. Participants will attend regular pregnancy visits every 2 to 3 weeks until delivery, as part of usual care. No extra hospital visits are required because of the study. Women using CGM will receive training on how to use the device.\n\nThe researchers will compare blood sugar control, the need for insulin, pregnancy complications, and newborn outcomes such as birth weight and episodes of low blood sugar after birth. The study will also assess how satisfied women are with their glucose monitoring method and how it affects their quality of life.\n\nThis is a pilot study, which means its main goal is to determine whether a larger study should be carried out in the future. The results will help researchers understand whether continuous glucose monitoring could improve the care of women with gestational diabetes and their babies.",[245],"Gestational Diabetes Mellitus (GDM)",[247,248,249,250,251],"Gestational Diabetes Mellitus","Continuous Glucose Monitoring","Glycemic Control","Patient-Reported Outcomes","Self-Monitoring of Blood Glucose","2026-05-12",{"date":254,"type":46},"2026-05-14",{"date":80,"type":23},{"date":257,"type":23},"2027-05-31",{"name":52,"class":53},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":66,"phases":268,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":282,"leadSponsor":284,"locationsCount":54},"100553817","effects-of-mechanical-insufflation-exsufflation-with-optimized-settings-on-wet-mucus-volume-during-invasive-ventilation-100553817","NCT06491017","Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation","Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Suctioned Wet Mucus Volume During Invasive Ventilation","Inclusion Criteria:\n\n* Adults (\\> 18yo).\n* Endotracheal intubation and invasive mechanical ventilation for \\> 48h and active humidification for \\> 24h.\n* Richmond Agitation-Sedation Scale -3 to -5.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with hemodynamic instability (MAP \\\u003C 60 or \\> 110, Heart Rate \\\u003C 50 or \\> 130, new onset arrhythmias), respiratory instability (PEEP \\> 12cmH2O, SpO2 \\\u003C 90% or fraction of inspired oxygen (FiO2) \\> 60%).\n* Undrained pneumothorax\u002Fpneumomediastinum.\n* Unstable intracranial pressure (ICP \\> 20mmHg or MAP \\\u003C 60).\n* Severe bronchospasm.\n* Post cardiothoracic surgical patients.\n* Active pulmonary tuberculosis.\n* Bronchoesophageal or bronchopleural fistulas.\n* Prone position.\n* Pregnancy.",{"count":267,"type":23},26,[68],"Retention of airway secretions is a frequent complication in critically ill patients requiring invasive mechanical ventilation (MV).This complication is often due to excessive secretion production and ineffective secretion clearance.\n\nMechanical insufflator-exsufflator (MI-E) is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device. A positive airway pressure is delivered to the airways, in order to hyperinflate the lungs, followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows.\n\nHowever, there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients. Inspiratory and expiratory pressures of ±40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds, respectively, are often used as a standard for MI-E programming in the daily routine practice, but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias.\n\nThe investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours.",[271,272],"Mucus Retention","Mechanical Ventilation Complication",[274,275,276,277],"Mechanical insufflation-exsufflation","Physiotherapy","Mucus retention","mechanical ventilation","2026-05-07",{"date":280,"type":46},"2026-05-08",{"date":280,"type":46},{"date":283,"type":23},"2028-12",{"name":52,"class":53},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":66,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":54},"100532991","lesion-formation-with-pulsed-field-versus-cryobaloon-ablation-as-assessed-by-cardiac-magnetic-resoncance-100532991","NCT06220006","Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance","PULSED-ICE-CMR","Inclusion Criteria:\n\n* Patients scheduled for first-time atrial fibrillation catheter ablation\n\nExclusion Criteria:\n\n* age \\\u003C18 years\n* long-standing persistent atrial fibrillation\n* prior left atrial ablation\n* pregnancy or lactation\n* reduced left ventricular ejection fraction\n* GFR \\\u003C30%\n* BMI \\>35%\n* left atrial diameter \\>55 mm\n* cardiac implantable electronic device",{"count":293,"type":23},104,[68],"This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System).",[297],"Atrial Fibrillation",[299,300,301,302,303,304,305,306],"Atrial fibrillation","Catheter ablation","Ablation lesion","Pulmonary vein isolation","Pulsed field ablation","Cryoballoon ablation","Cardiac magnetic resonance","Late gadolinium enhancement","2026-04-01",{"date":309,"type":46},"2026-04-07",{"date":311,"type":46},"2023-11-01",{"date":313,"type":23},"2026-11-01",{"name":52,"class":53},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":66,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":54},"100531262","randomized-study-of-physiological-vs-right-ventricular-pacing-in-patients-with-normal-ventricular-function-post-tavi-100531262","NCT06197503","Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI","Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)","PHYSTAVIII","Inclusion Criteria:\n\n* Successful implantation of TAVI according to VARC-3 criteria.\n* Indication of cardiac pacing due to AV block according to ESC Guidelines.\n* LVEF\\> 50%.\n* The patient must indicate their acceptance to participate in the study by signing an informed consent document.\n\nExclusion Criteria:\n\n* Ventricular dysfunction: LVEF \\\u003C50%.\n* Transapical TAVI.\n* Participating currently in a clinical investigation that includes an active treatment.\n* Patients with left bundle branch block but without indication of pacing (AV block).\n* Life expectancy \\\u003C12 months.",{"count":324,"type":23},48,[68],"Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.",[328,329,330,331,332],"Transcatheter Aortic Valve Implantation","Physiological Pacing","Right Ventricular Pacing","AV Block","Preserved Left Ventricular Systolic Function","2026-03-30",{"date":335,"type":46},"2026-03-31",{"date":337,"type":46},"2023-11-30",{"date":339,"type":23},"2026-12-15",{"name":52,"class":53},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":66,"phases":351,"briefSummary":352,"conditions":353,"keywords":356,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":54},"100524196","conduction-system-pacing-vs-biventricular-pacing-in-systolic-dysfunction-and-wide-qrs-mortality-heart-failure-hospitalization-or-cardiac-transplant-100524196","NCT06105580","Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant","Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant","CONSYST-CRT II","Inclusion Criteria:\n\n* Patient must indicate acceptance to participate in the study by signing an informed consent document.\n* Patient must be ≥ 18 years of age.\n* Left bundle branch block, QRS ≥130 and LVEF \\\u003C=35%. No indication of stimulation for AV block.\n* Non-left bundle branch block, QRS ≥150 and LVEF \\\u003C=35%.\n* Resynchronization therapy indication for ventricular dysfunction (LVEF \\\u003C40%) and indication of cardiac pacing for AV block.\n* LVEF \\\u003C=35% in NYHA class III or IV, atrial fibrillation and intrinsic QRS \\>=130 ms, provided a strategy to ensure biventricular capture is in place.\n\nExclusion Criteria:\n\n* Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.\n* Pregnancy.\n* Participating currently in a clinical investigation that includes an active treatment.",{"count":350,"type":23},320,[68],"Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial).\n\nSuperiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.",[354,355],"Cardiac Resynchronization Therapy","Heart Failure",[357,358,359],"left bundle branch pacing","biventricular pacing","cardiac resynchronization therapy",{"date":361,"type":46},"2026-04-03",{"date":363,"type":46},"2023-11-27",{"date":365,"type":23},"2028-01",{"name":52,"class":53},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":66,"phases":377,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":54},"100455730","physiological-pacing-for-av-block-to-prevent-pacemaker-induced-cardiomyopathy-100455730","NCT05214365","Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy","Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study","PHYSPAVB","Inclusion Criteria:\n\n* The patient must be ≥ 18 years of age.\n* The patient must indicate their acceptance to participate in the study by signing an informed consent document.\n* Patients with EF\\> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.\n\nExclusion Criteria:\n\n* Inability to understand and sign the informed consent.\n* Patients with severe comorbidities and life expectancy \\\u003C1 year.\n* Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.\n* Patients who cannot come to our center to carry out the follow-up of the study.","100 Years",{"count":178,"type":23},[68],"The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.",[380,381],"Conduction System Pacing","Conventional Ventricular Pacing",[383],"Pacemaker-induced cardiomyopathy",{"date":335,"type":46},{"date":386,"type":46},"2022-02-01",{"date":388,"type":23},"2026-09-01",{"name":52,"class":53},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":66,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100632140","extended-versus-short-prehabilitation-programme-for-patients-with-advanced-ovarian-cancer-undergoing-major-surgery-100632140","NCT07509814","Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery","Efficacy of an Extended Prehabilitation Program Versus Standard in Patients With Advanced Ovarian Cancer Within ERAS Protocols","SOPHIE II","Inclusion Criteria:\n\n* Patients diagnosed with advanced ovarian cancer (FIGO III and IV)\n* Clinical indication of neoadjuvant chemotherapy followed by cytoreductive surgery\n* No contraindications for exercise training\n* Give written consent to participate\n\nExclusion Criteria:\n\n* Patients diagnosed with advanced ovarian cancer scheduled for cytoredutive surgery followed by chemotherapy (no neoadjuvant)\n* Patients with deteriorated functional state (ECOG ≥2) or those with contraindication to exercise training (severe or unstable cardiorespiratory, metabolic, musculoskeletal or neurological conditions)",{"count":399,"type":23},225,[68],"Standard treatment for advanced ovarian cancer includes a combination of cytotoxic chemotherapy and citorreductive surgery. During neo-adjuvant administration of chemotherapy, many patients experience a decline in their functional capacity, leading to an increased risk of postoperative complication as a combination of potential malnutrition, decreased physical activity levels and increased anxiety. Prehabilitation programs conducted within Enhanced Rescovery After Surgery (ERAS) pathways have shown to reduce postoperative complications and length of hospital stay in a diverse group of cancer surgeries and, according to some preliminary evidence, can also increase tumour response in patients receiving neoadjuvant chemotherapy. The aim of this study is to compare two modalities of prehabilitation (extended versus estandard) on postoperative complications and response to neoadjuvant chemotherapy. A total of 225 patients will be randomized in a 2:1 ratio to extended prehabilitation (initiated at the onset of neoadjuvant therapy) or standard prehabilitation (initiated after the course of neoadjuvant therapy is completed). In both groups the prehabilitation program will be delivered in the same manner, including supervised (virtual or facility-based) exercise training, nutritional optimization and psychological support and will be supported by a digital platform.",[403],"Ovarian Cancer With Peritoneal Carcinosis",[405,406,407,408,409],"Prehabilitation","Neoadjuvant Therapy","Interval surgery","Postoperative Complications","Treatment response","2026-03-29",{"date":361,"type":46},{"date":307,"type":23},{"date":414,"type":23},"2028-12-31",{"name":52,"class":53},5,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":19,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":66,"phases":428,"briefSummary":429,"conditions":430,"keywords":440,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":54},"100631599","heterologous-cord-blood-derived-red-blood-cell-for-transfusion-in-extremely-preterm-infants-100631599","NCT07502781","Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants","Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants","Inclusion Criteria:\n\n* Signed informed consent obtained from parents or legal guardians.\n* Gestational age at birth \\\u003C 28 weeks or birth weight \\\u003C 1000 g.\n* Admission to one of the participating neonatal intensive care units (NICUs) in the Barcelona area.\n\nExclusion Criteria:\n\n* Prior red blood cell transfusion during the fetal or neonatal period.\n* Maternal-fetal immunization (e.g., isoimmunization).\n* Fetal hydrops.\n* Major congenital malformations.\n* Congenital infections.\n* Immediate need for blood before randomization (e.g., hemorrhagic shock, consumptive coagulopathy).\n* Participation in another clinical trial that could interfere with the primary outcome.","23 Weeks","28 Weeks",{"count":427,"type":23},176,[68],"Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red blood cell transfusions during their hospital stay.\n\nCurrently, transfusions are given using red blood cells donated by adults. An alternative option is to use red blood cells collected from umbilical cord blood, which may be more similar to a newborn's own blood. This approach has been used in some neonatal units with encouraging results and no reported safety concerns.\n\nThis study aims to determine whether transfusion with umbilical cord blood improves clinical outcomes and reduces potential side effects compared to standard adult donor blood transfusion in extremely preterm infants. We hypothesize that umbilical cord blood transfusion will be at least as safe as adult donor blood and may provide clinical benefits.\n\nAbout 115 extremely preterm infants admitted to neonatal units in Catalonia will participate. If parents agree, their baby will be randomly assigned to receive either compatible umbilical cord blood or compatible adult donor blood if a transfusion becomes necessary. Babies will only receive a transfusion if they clinically need one. If cord blood is not available at the time of transfusion, the baby will receive compatible adult donor blood regardless of the assigned group.\n\nTo evaluate the response to treatment, small blood samples will be collected at birth, at one month of life, and 24 hours after any transfusion. These samples are taken at the same times as routine blood tests, so participation does not require additional needle sticks. The amount of blood collected is minimal (about 0.2 mL per sample).\n\nIn addition, a painless and non-invasive sensor will be placed on the baby's head for 24 hours to measure oxygen delivery to the brain. Urine samples will also be collected before and after transfusion to help assess how oxygen reaches body tissues.\n\nParticipation will continue until the baby reaches 36 weeks of postmenstrual age or is discharged from the hospital, whichever comes first.",[431,432,433,434,435,436,437,438,439],"Extremely Premature Infant","Anemia Neonatal","Blood Transfusion","Umbilical Cord Blood","Fetal Hemoglobin","Bronchopulmonary Dysplasia (BPD)","Retinopathy of Prematurity (ROP)","Death; Neonatal","Intensive Care Units, Neonatal",[441,442,443,444,445,446,447,448,449,450],"Cord blood red blod cell transfusion","Umbilical cord blood transfusion","Extremely preterm infants","Neonatal anemia","Fetal hemoglobin","Adult donor red blood cells","Bronchopulmonary dysplasia","Retinopathy of prematurity","Oxygen delivery","Days requiring oxygen supplementation","2026-03-27",{"date":335,"type":46},{"date":454,"type":23},"2027-01",{"date":456,"type":23},"2029-12",{"name":52,"class":53},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":66,"phases":468,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":54},"100620514","non-invasive-mapping-guided-atrial-fibrillation-ablation-100620514","NCT07358611","Non-invasive Mapping-Guided Atrial Fibrillation Ablation","ELectrocardiographic Imaging-guided Substrate Ablation in Patients With Atrial Fibrillation - a PILOT Study of a Personalized Therapy","ELISA-AF","Inclusion Criteria:\n\nAblation-naïve patients with:\n\n1. Persistent AF planned for catheter ablation plus\n2. Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml\u002Fm2 or LA area ≥20 cm2)\n\nExclusion Criteria:\n\n* Previous cardiac ablation\n* Age \\\u003C18 years\n* Pregnancy or lactation\n* Previous stroke\u002FTIA\n* Severe left ventricular dysfunction (LVEF \\\u003C35%)\n* Renal failure (GFR \\\u003C30 ml\u002Fmin)\n* Dermal disease or hypersensitivity predisposing for skin irritation or exanthema",{"count":467,"type":23},30,[68],"The goal of this pilot study is to test if noninvasive global mapping can guide catheter ablation defining personalized targets and improve the therapy of atrial fibrillation. It will also test the safety of such an approach. The main questions it aims to answer are:\n\n* Does ablation of targets defined by noninvasive global mapping improve rates of acute atrial fibrillation termination?\n* Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional \"empirical\" ablation approach (pulmonary vein isolation).\n\nParticipants will:\n\n* Undergo a personalized catheter ablation approach employing both a noninvasive global mapping system and a conventional intracardiac mapping system\n* Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up\n* Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up",[471],"Atrial Fibrillation (AF)",[299,300,473,474,475,476,477],"Atrial fibrillation drivers","Personalized atrial fibrillation therapy","Electroanatomical mapping","Electrocardiographic imaging","Body surface mapping","2026-01-14",{"date":480,"type":46},"2026-01-22",{"date":482,"type":23},"2026-01-31",{"date":484,"type":23},"2027-12-31",{"name":52,"class":53},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":66,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":512,"locationsCount":54},"100601215","multimodal-prehabilitation-program-that-combines-physical-exercise-psychological-intervention-and-nutritional-support-to-improve-the-response-to-neoadjuvant-chemoterhapy-in-early-breast-cancer-patients-100601215","NCT07107594","Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients","Multimodal Intervention During Neoadjuvant Chemotherapy in Patients With Early-breast Cancer as a Strategy to Improve Treatment Response: DIANA Trial (Multimodal Prehabilitation: DIet, ANxiety Control Psychotherapy, Physical Activity)","DIANA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC).\n* Age ≥ 18 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Contraindication or physical inability to perform moderate-to-high intensity physical exercise.\n* Pregnant or breastfeeding patients.\n* Presence of other active synchronous neoplasms.\n* Metastatic breast cancer (stage IV).\n* Patients already engaging in regular physical exercise: more than 150 minutes of moderate or intense aerobic exercise per week.\n* Male breast cancer patients.\n* Personal history of a previous malignancy treated with chemotherapy.\n* Severe or poorly controlled psychiatric illness (including uncontrolled active substance abuse).",{"count":495,"type":23},214,[68],"The aim of this clinical trial is to evaluate whether following a multimodal prehabilitation program including physical exercise, nutritional support and psychological intervention during neoadjuvant chemotherapy in breast cancer patients could improve the pathological response to chemotherapy.\n\n214 women with non-metastatic breast cancer with indication of chemotherapy before surgery will be eligible to participate. Patients will be randomly assigned to either the intervention group or the control group.\n\n* Patients assigned to the intervention group (107 women) will undergo a directed multimodal prehabilitation program during the chemotherapy (4-6 months), including structured physical exercise, psychological intervention and nutritional guidance.\n* Patients assigned to the control group (107 women) will undergo standard clinical management for their disease without multimodal prehabilitation.\n\nThe response to chemotherapy between the two groups will be evaluated and compared. It is expected that multimodal prehabilitation will increase the response to chemotherapy and will improve the postoperative recovery of patients and their quality of life, as well as reducing the number of complications from surgery and chemotherapy treatment. Changes in the tumor microenvironment are also expected after prehabilitation.",[499,405],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[501,502,405,503,504,505,506],"Breast cancer","Early breast cancer","Multimodal prehabilitation","Neoadjuvant chemotherapy","Lifestyle","Quality of life",{"date":508,"type":46},"2026-01-15",{"date":510,"type":46},"2025-01-14",{"date":157,"type":23},{"name":52,"class":53},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":66,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":533,"locationsCount":54},"100540256","effect-of-cpap-treatment-in-patients-with-severe-uncontrolled-asthma-the-asthma-sleep-trial-100540256","NCT06314477","Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial","Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study","Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.\n* Apnea hypopnea rate greater than or equal to 15\u002Fhour\n* Punctuation in the Epworth Sleepiness Scale ≤10\n* Obtaining informed consent.\n\nExclusion Criteria:\n\n* Previous treatment with CPAP\n* Patient with central sleep apnea or Cheyne-Stokes respiration\n* Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,\n* Resistant hypertension\n* Active Smoking\n* Unstable comorbidities or medications may interfere with asthma control\n* Pregnancy\n* Any process that reduces life expectancy to \\\u003C1 year,\n* Any medical or social factor that may limit CPAP compliance",{"count":521,"type":23},138,[68],"The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)",[525,526],"Obstructive Sleep Apnea","Asthma","2025-12-04",{"date":529,"type":46},"2025-12-11",{"date":531,"type":46},"2023-12-27",{"date":231,"type":23},{"name":52,"class":53},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":542,"minAge":20,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":66,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":54},"100611229","frequency-dependent-effects-of-percutaneous-femoral-nerve-stimulation-on-quadriceps-strength-in-athletes-with-patellar-tendinopathy-100611229","NCT07237867","Frequency-Dependent Effects of Percutaneous Femoral Nerve Stimulation on Quadriceps Strength in Athletes With Patellar Tendinopathy","Frequency-Dependent Effects of Percutaneous Femoral Nerve Stimulation on Strength in Athletes With Patellar Tendinopathy: a Randomized Controlled Trial","ppns","Inclusion Criteria:\n\n* Adults aged 18 to 40 years.\n* Recreational or competitive athletes with clinically diagnosed patellar tendinopathy for at least 3 months.\n* Ultrasound-confirmed patellar tendinopathy, including hypoechoic areas, tendon thickening, or neovascularization consistent with clinical diagnosis.\n\nPresence of pain during tendon-loading activities (e.g., jumping, running, squatting).\n\n* Ability to perform maximal voluntary isometric contractions of the quadriceps.\n* Ability to comply with all study procedures and attend all experimental sessions.\n* Written informed consent obtained prior to participation.\n\nExclusion Criteria:\n\n* Previous knee surgery or traumatic knee injury within the past 12 months.\n* Complete or partial patellar tendon rupture.\n* Neurological disorders affecting lower limb strength or motor control.\n* Contraindications to electrical stimulation, including implanted electrical devices (e.g., pacemaker).\n* Current lower-limb radiculopathy or neuropathy.\n* Skin infections, open wounds, or dermatological conditions at the stimulation site.\n* Use of analgesics, anti-inflammatories, or corticosteroid injections within the past 48 hours.\n* Participation in another interventional study in the previous 30 days.\n* Pregnancy or suspected pregnancy.","MALE","40 Years",{"count":545,"type":23},19,[68],"This study investigates the immediate effects of different peripheral electrical nerve stimulation protocols applied to the femoral nerve on quadriceps strength in athletes with patellar tendinopathy. Patellar tendinopathy is a common overuse injury that often reduces quadriceps activation and limits sports performance. Peripheral percutaneous nerve stimulation (PPNS) and transcutaneous electrical nerve stimulation (TENS) are frequently used in rehabilitation, but their frequency-dependent effects on muscle strength are not well established.\n\nIn this randomized crossover trial, each participant receives three stimulation protocols in separate sessions: high-frequency PPNS (100 Hz), low-frequency PPNS (2 Hz), and conventional TENS. All stimulation is delivered at the maximal tolerated motor threshold and, for PPNS conditions, under ultrasound guidance. Quadriceps maximal isometric strength is evaluated using an isometric force sensor before and after each intervention.\n\nThe primary objective is to compare the acute changes in maximal voluntary contraction (MVC) following each stimulation protocol. The study aims to clarify whether different stimulation frequencies can enhance, reduce, or have no effect on quadriceps strength in this athletic population.\n\nBy identifying frequency-specific neuromodulatory responses, this study may help clinicians and sports practitioners select the most appropriate stimulation parameters to optimize rehabilitation and performance in individuals with patellar tendinopathy.",[549],"Patellar Tendinopathy \u002F Jumpers Knee",[551,552],"Peripheral Percutaneous Nerve Stimulation","Transcutaneous Electrical Nerve Stimulation","2025-11-29",{"date":555,"type":46},"2025-12-05",{"date":557,"type":46},"2025-09-20",{"date":559,"type":23},"2025-12-15",{"name":52,"class":53},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":66,"phases":571,"briefSummary":572,"conditions":573,"keywords":576,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":54},"100610867","effectiveness-of-m-cimt-of-the-upper-limb-in-acute-post-stroke-patients-m-cimt-modified-constraint-induced-movement-therapy-100610867","NCT07233161","Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients. (m-CIMT, Modified Constraint-induced Movement Therapy)","Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients.","m-CIMT","Inclusion Criteria:\n\n* Ischaemic stroke.\n* Hospitalised patient (first 15 days).\n* Ability to understand and execute simple instructions.\n* Over 18 years of age.\n* Upper limb motor deficit.\n* Sign the informed consent document.\n\nExclusion Criteria:\n\n* Unstable clinical\u002Fmedical condition.\n* Limitation of the upper limb due to a previous stroke.\n* Strokes affecting both upper limbs bilaterally.\n* Fractures\u002Fdislocations in the joints of the affected upper limb that may affect recovery.\n* Severe behavioural disturbance.",{"count":570,"type":23},66,[68],"m-CIMT therapy is the restriction of the unaffected upper extremity in conjunction with an upper extremity specific exercise protocol to improve the functionality and use of the affected upper extremity.",[574,575],"Isquemic Stroke","Upper Limb Weakness Due to Central Neurologic Injury",[567,577,578,579],"stroke","upper limb weakness","upper limb","2025-11-14",{"date":582,"type":46},"2025-11-18",{"date":584,"type":46},"2025-04-23",{"date":586,"type":23},"2026-12-20",{"name":52,"class":53},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":66,"phases":597,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":54},"100592716","creation-of-arteriovenous-fistulas-for-hemodialysis-using-the-end-to-side-anastomotic-technique-vs-piggyback-100592716","NCT06997042","Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.","Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback. Randomized Clinical Trial","Inclusion Criteria:\n\n* Age \\> 18 years\n* Able to meet protocol requirements, including follow-up.\n* Incident or prevalent patient with advanced chronic kidney disease in the hemodialysis stage (stage 5D).\n* In predialysis patients (stage 5), if renal replacement therapy (hemodialysis) is anticipated to be required within the next 6 months (based on standard clinical criteria).\n* Who, based on their associated pathology and according to medical criteria, can withstand the initial surgery and arteriovenous access maintenance procedures.\n* Have a current ultrasound with preoperative venous and arterial mapping.\n* Meet the anatomical requirements for AVF creation:\n\n  * Wrist: artery \\>2 mm, vein \\>2 mm in diameter\n  * Elbow: artery \\>3 mm, vein \\>3 mm in diameter\n  * Absence of arterial calcification or occlusion, or other aberrant arterial anatomy.\n  * Adequate arterial and venous patency.\n  * Vein-to-skin distance \\\u003C5 mm.\n* Candidate for creation of a native arteriovenous fistula for hemodialysis, either distal (radiocephalic) or proximal (humerocephalic or humerobasilic).\n* No immediate transplant scheduled within the next 60 days (inclusion on the kidney transplant waiting list is not a contraindication for entry into the study, nor for the creation of an arteriovenous fistula).\n* No prior arteriovenous surgeries in the same or proximal location.\n* Correct understanding of the study conditions and acceptance to participate.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Life expectancy \\\u003C1 year.\n* Arteriovenous prostheses (non-native fistulas), previous arteriovenous fistula repairs, arteriovenous accesses created in the lower extremities, and unusual (exotic) accesses.\n* Known or suspected central venous stenosis\u002Focclusion on the side of the planned access.\n* Repair of previous arteriovenous accesses (proximal reanastomoses).\n* Biological immunosuppression.\n* History or evidence of serious systemic illness, including:\n\n  * Cardiac disease (New York Heart Association functional class III or IV, as evidenced by the inability to lie still), myocardial infarction within 6 weeks prior to randomization, ventricular tachyarrhythmia requiring ongoing treatment, or unstable angina.\n\nSuspected or documented hypercoagulable or hypocoagulable state or Clinically significant active infection (White blood count \\> 15,000 cells\u002Fmm3) other than the use of a treated CVC.\n\n* Any other condition that, in the investigator's judgment, prevents an adequate evaluation of the safety and efficacy of the study or poor compliance.\n* Patient unwilling or unable to attend follow-up follow-ups.",{"count":596,"type":23},130,[68],"This study is designed to compare two surgical techniques used to create arteriovenous fistulas (AVFs), which are necessary for hemodialysis in patients with advanced chronic kidney disease (CKD). AVFs are preferred over other forms of vascular access because they last longer and have fewer complications. However, many AVFs fail to mature properly, making them unusable for dialysis.\n\nThe two techniques being studied are the traditional End-to-Side (ETS) method and a newer technique called Piggyback Straight Line Onlay Technique (pSLOT). Early studies suggest that pSLOT may reduce complications like narrowing (stenosis), clotting (thrombosis), and failure of the AVF, but more robust data from randomized clinical trials is needed.\n\nPatients aged 18 or older with stage 4 or 5 CKD, who are eligible for a new AVF and meet health criteria, may participate. During the operation, participants are randomly assigned to receive either the ETS or pSLOT technique. The procedure is done under local or regional anesthesia. Follow-up appointments are scheduled at 1 and 12 months to assess fistula maturation, blood flow, and whether it can be successfully used for dialysis. Remote follow-ups are allowed if needed.\n\nParticipation is voluntary, requires informed consent, and all data is kept strictly confidential. The study follows national and international ethical standards and has been approved by an ethics committee.",[600],"Chronic Kidney Disease Requiring Hemodialysis",[602,603,604,605],"hemodialysis","vascular access","arteriovenous fistula","piggyback","2025-09-12",{"date":608,"type":46},"2025-09-18",{"date":610,"type":46},"2025-05-01",{"date":612,"type":23},"2027-12-01",{"name":52,"class":53},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":66,"phases":623,"briefSummary":624,"conditions":625,"keywords":628,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":54},"100597533","high-flow-nasal-oxygenation-in-transcatheter-aortic-valve-replacement-procedures-tavr-highflow-ii-100597533","NCT07059728","High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II","Uso de Lentillas de Alto Flujo en Procedimientos de sustitución de válvula aórtica transcatéter. Impacto en Las Complicaciones Respiratorias y Biomarcado- Res y Resultados clínicos. TAVR-Highflow","Inclusion Criteria:\n\n* Transfemoral TAVR elective procedure\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Refusal to participate\n* Known allergy to propofol or remifentanil.\n* Non-femoral surgical access.\n* Presence of a basal skull fracture or pneumothorax\n* Procedure duration \\\u003C 45 minutes\n* Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons\n* Need to convert to general anesthesia for non-respiratory complications within 45 minutes.",{"count":622,"type":23},452,[68],"Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy.\n\nPatients selected for this procedure often have a profile associated with multiple comorbidities which predispose them to certain complications.\n\nTAVI procedures were initially performed under general anesthesia. However, due to improved procedure times and anesthetic techniques, sedation has become the current trend to preform them.\n\nWhen sedation for these procedures requires deep planes, hypoxia is more likely to occur due to respiratory depression, apnea, or airway obstruction. This is even more common in TAVR patients population, as obesity, sleep apnea, elevated ASA classification, advanced age, and combined cardiorespiratory disease are highly prevalent.\n\nFor all these reasons, TAVR constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk.\n\nThe provision of supplemental oxygen through nasal cannulae or face masks can prevent the development of hypoxia. Unfortunately, non-humidified nasal oxygen cannot exceed 2-5 L\u002Fmin without causing damage to the nasal mucosa, and the percentage of oxygen delivered through variable-flow face masks is unpredictable.\n\nOn the other hand, high-flow nasal oxygen therapy (HFNO) can provide humidified gas flow rates of up to 70 L\u002Fmin through specially adapted nasal cannulae and reliably deliver oxygen concentrations between 21% and 100%. The use of HFNC could be justified in this context and could improve the outcomes and safety of these procedures, increasing oxygen content and minimizing hypercapnia.\n\nThe study's hypothesis is HFNO will prevent hypoxemia and control hypercapnia during sedation for transcatheter aortic valve implantation (TAVI) better than conventional oxygen theraphy. Clinical and serological biomarkers of tissue injury will decrease with the use of HFNO. Clinical complications will decrease with the use of HFNO.\n\nThe study population would be all patients \\>18 years of age undergoing TAVI procedure and who agree to participate in the study in 8 centers in Barcelona.",[626,627],"Aortic Stenosis Treated With TAVI","Sedation; Aged; Hemodynamics",[629,630,185],"Aortic Stenosis","TAVR","2025-09-09",{"date":633,"type":46},"2025-09-15",{"date":635,"type":46},"2025-02-01",{"date":637,"type":23},"2027-07",{"name":52,"class":53},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":66,"phases":648,"briefSummary":649,"conditions":650,"keywords":654,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":4},"100605547","analysis-of-the-influence-of-dialysis-fluid-composition-on-vascular-calcification-in-patients-with-chronic-kidney-disease-undergoing-hemodialysis-100605547","NCT07163936","Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis","CalCio-HD","Inclusion Criteria:\n\n* Adults (≥18 years old) on maintenance hemodialysis for more than 3 months\n* Clinically stable patients with a well-functioning vascular access\n* Residual urine output ≤ 250 mL\u002Fday\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy or intolerance to any component of the dialysates\n* Active malignancy or infectious\u002Finflammatory disease\n* Planned living donor kidney transplant before study completion\n* Current treatment with vitamin K antagonists (coumarins)\n* Severe hypocalcemia or poorly controlled secondary hyperparathyroidism\n* Any condition that, in the investigator's judgment, contraindicates participation or affects study compliance",{"count":647,"type":23},80,[68],"The goal of this clinical trial is to find out if using a citrate-based dialysate with added magnesium during hemodialysis can help slow down or prevent the hardening of blood vessels (vascular calcification) in adults on long-term dialysis.\n\nThe main questions the study will try to answer are:\n\nDoes citrate-based dialysate with magnesium improve the blood's ability to prevent calcium buildup (measured by a test called T50) compared to acetate-based dialysate?\n\nDoes it modify magnesium, calcium and parathyroid hormone (PTH) levels in the blood?\n\nDoes it lower the chances of heart problems or death?\n\nResearchers will compare two groups: one will receive acetate-based dialysate, and the other will receive citrate-based dialysate with magnesium.\n\nParticipants will:\n\nReceive one of the two types of dialysate during their regular hemodialysis sessions for 12 months\n\nHave regular blood tests\n\nBe monitored for any heart problems and for overall health during the study",[651,652,653],"Vascular Calcification","Hemodialysis","Cardiovascular Disease (CKD)",[602,655,656,657,658,659,660,661],"dialysate","citrate dialysate","acetate dialysate","magnesium supplementation","calcification propensity","vascular calcification","dialysate composition","2025-09-01",{"date":631,"type":46},{"date":665,"type":23},"2025-09-03",{"date":667,"type":23},"2026-09-06",{"name":52,"class":53},{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":677,"enrollmentInfo":678,"targetDuration":4,"studyType":66,"phases":680,"briefSummary":681,"conditions":682,"keywords":684,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":54},"100605340","relief-multimodal-prehabilitation-to-treat-fatigue-in-patients-with-primary-biliary-cholangitis-100605340","NCT07161245","RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis","A Randomized Clinical Trial on the Improvement of Fatigue in Patients With Primary Biliary Cholangitis by Implementation of a Multimodal Rehabilitation Program and Study of Its Pathophysiological Mechanisms","RELIEF","Inclusion Criteria:\n\n* Age ≥18 years\n* PBC diagnosis according to EASL guidelines\n* Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire\n\nExclusion Criteria:\n\n* Age \\> 80 years\n* Severe pruritus\n* Decompensated cirrhosis\n* Other causes of liver disease than PBC\n* Liver transplant (LT) o placement on a waiting-list for LT\n* Uncontrolled thyroid disesase\n* Anemia with haemoglobin \\\u003C11g\u002Fdl\n* Uncontrolled cardiovascular risk factors\n* BMI \\> 35,\n* Acute myocardial infarct or unstable angina the past 6 months\n* Muscle disease or systemic disease with potential muscle involvement\n* Dysautonomy\n* Untreated osteoporosis\n* Untreated celiac disease\n* Alcohol consumption \\> 14 standard drinks (SD) in women and \\>21 (SD) in men per week\n* Chronic kidney disease ≥ 4 KDIGO stage\n* Malignancy in the past two years (except for non melanoma skin cancer and in situ cervical carcinoma)\n* Not capable of performing or following the prehabilitation program\n* Involvement in a clinical trial the previous 2 months\n* Refusal of informed consent\n\nFor the study of the pathophysiology of fatigue, additional exclusion criteria will be established: Severe depression or neuropsychiatric disease, 2) Treatment with centrally acting drugs, 3) Muscular or systemic disease with potential muscle involvement, 4) Immunosuppressive treatment, 5) Sleep disorder, 6) Obesity (BMI \\>30).","80 Years",{"count":679,"type":23},64,[68],"The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary cholangitis. Consequently, this improvement is anticipated to enhance quality of life and cognitive symptoms, while also positively impacting emotional, social, and occupational aspects.\n\nFrom a pathophysiological perspective, it is hypothesized that chronic cholestasis and\u002For immune system activation, with the release of pro-inflammatory cytokines, leads to both central and peripheral alterations causing fatigue.\n\nAt the central level, systemic inflammation may induce neuronal senescence in the basal ganglia, resulting in altered functional connectivity networks dependent on these regions and\u002For structural and connectivity changes in areas involved in interoception, such as the insula and anterior cingulate cortex.\n\nAt the peripheral level, the hypothesis is that chronic inflammation mediated by anti-mitochondrial antibodies causes mitochondrial metabolic dysfunction in muscle cells, which would be reflected in changes observed in the gene expression analysis of these cells.\n\nImprovement in fatigue following the multimodal intervention program is expected to be associated with normalization of the immunological profile, enhanced functional brain connectivity, and improved mitochondrial metabolism in muscle.",[683],"Primary Biliary Cholangitis (PBC)",[685,686,687,688,689,690],"FATIGUE","PREHABILITATION","PHYSICAL ACTIVITY","MINDFULNESS MEDITATION","NUTRITION","QUALITY OF LIFE",{"date":692,"type":46},"2025-09-08",{"date":694,"type":46},"2025-02-06",{"date":696,"type":23},"2026-12-31",{"name":52,"class":53},""]