[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospital Universitario La Paz\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":285},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,49,81,116,138,161,185,211,239,264],{"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":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100629842","telematic-cognitive-training-and-mindfulness-in-pediatric-patients-after-car-t-cell-therapy-single-hematopoietic-allogeneic-transplant-or-chemotherapy-100629842",false,"NCT07479927","Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy","Randomized Controlled Clinical Trial of Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy. The PsyCARTkids Project","PsyCARTkids","Inclusion Criteria:\n\n* Diagnosis of acute B-cell lymphoblastic leukemia.\n* Previous treatment with CAR-T therapy, chemotherapy, and\u002For hematopoietic stem cell transplantation.\n* Age between 8 and 18 years.\n* Native Spanish speaker or high proficiency in Spanish sufficient to understand study procedures and complete assessment instruments.\n* Access to a computer, tablet, or smartphone with an Internet connection.\n\nExclusion Criteria:\n\n* Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.\n* Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.","ALL","8 Years","18 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","This randomized controlled clinical trial evaluates neurocognitive, biopsychological, and brain connectome outcomes in children and adolescents with acute lymphoblastic leukemia who have previously received Chimeric Antigen Receptor T-cell therapy (CAR T-cell therapy), chemotherapy, and\u002For hematopoietic stem cell transplantation (HSCT).\n\nParticipants will receive a multimodal, telematic psychological intervention combining digital cognitive training and an adapted mindfulness-based emotional regulation program. Outcomes will be compared with a waitlist control group and intervention sequences will be counterbalanced: (1) cognitive training followed by mindfulness; and (2) mindfulness followed by cognitive training.\n\nNeurocognitive performance, emotional-behavioral functioning, executive functioning and EEG-based functional connectivity will be assessed at baseline, post-intervention and at 6 months follow-up.",[28],"Acute Lymphoblastic Leukemia",[30,31,32,33,34,35],"Acute lymphoblastic leukemia","CAR T-cell therapy","Pediatric oncology","Neuropsychology","Mindfulness","Biopsychosocial outcomes","RECRUITING","2026-03-14",{"date":39,"type":40},"2026-03-18","ACTUAL",{"date":42,"type":40},"2025-12-19",{"date":44,"type":22},"2027-12-30",{"name":46,"class":47},"Hospital Universitario La Paz","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":48},"100614336","decision-making-in-labor-admission-using-transperineal-ultrasound-vs-vaginal-examination-100614336","NCT07278271","Decision-Making in Labor Admission Using Transperineal Ultrasound vs. Vaginal Examination","Toma de Decisiones en la Admisión Hospitalaria al Parto Con Ecografía Transperineal vs. Tacto Vaginal: Estudio Aleatorizado Controlado","Inclusion Criteria:\n\n* Women aged 18 to 45 years\n* Singleton pregnancy\n* Gestational age ≥ 37 weeks (term pregnancy)\n* Spontaneous uterine contractions at the time of presentation to the emergency department\n* Cephalic presentation\n* Willingness and ability to provide written informed consent\n\nExclusion Criteria:\n\n* Premature rupture of membranes (PROM)\n* Multiple gestation\n* Known high-risk pregnancy (e.g., preeclampsia, intrauterine growth restriction, insulin-dependent diabetes)\n* Previous cesarean delivery\n* Breech or other non-cephalic presentation\n* Elective cesarean section planned or requested\n* Refusal to undergo vaginal delivery\n* Inability or unwillingness to comply with the study protocol","FEMALE","45 Years",{"count":59,"type":22},170,[25],"This clinical trial aims to determine whether transperineal ultrasound (a perineal external scan) can improve decision-making for hospital admission in term pregnant women in labor compared to traditional vaginal examination. Term pregnant women (\\>37 weeks) presenting with contractions at the emergency department will be randomly assigned to undergo either a transperineal ultrasound or a vaginal examination upon arrival. The study will evaluate whether ultrasound-based assessment reduces the rate of labor inductions and decreases patient discomfort during the admission evaluation. All participants will receive standard clinical evaluation and follow-up according to the assigned method, report discomfort levels using a standardized scale, and have labor outcomes recorded - including induction, oxytocin use, time to delivery, and mode of delivery -, to determine whether ultrasound improves clinical decision-making and maternal comfort.",[63],"Labor Active Dilated Cm",[65,66,67,68,69,70,71,72],"Transperineal ultrasound","Intrapartum ultrasound","Vaginal examination","Hospital admission in labor","Term pregnancy","Angle of progression","Cervical dilatation","Ultrasound vs vaginal exam","2025-12-10",{"date":75,"type":40},"2025-12-12",{"date":77,"type":40},"2024-01-29",{"date":79,"type":22},"2026-03",{"name":46,"class":47},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":89,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100612981","silac-laser-technique-for-pilonidal-sinus---la-paz-cohort-study-100612981","NCT07260643","SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.","Valuation of Laser-Assisted (SiLaC®) Technique for the Management of Pilonidal Sinus in Adults: A Prospective Single-Center Cohort at Hospital Universitario La Paz.","SiLaC-LaPaz","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of chronic pilonidal sinus disease.\n* Undergoing surgery using the SiLaC (Sinus Laser-Assisted Closure) technique.\n* Signed informed consent for the use of anonymized clinical data for research purposes.\n\nExclusion Criteria:\n\n* Patients with inflammatory bowel disease or complex anorectal fistulas.\n* Severe immunosuppression (active chemotherapy, high-intensity immunosuppressive therapy, uncontrolled HIV).\n* Prior pelvic radiotherapy.\n* Missing essential clinical data required for outcome assessment",{"count":21,"type":22},"6 Months","OBSERVATIONAL","Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the sacrococcygeal region that frequently affects young adults, often causing pain, drainage, and recurrent infection. Traditional surgical approaches such as wide excision or flap techniques may result in prolonged healing times, relevant postoperative pain, and recurrence rates up to 20-30%.\n\nThe SiLaC (Sinus Laser-Assisted Closure) technique is a minimally invasive procedure that uses a 1470-nm diode laser fiber to ablate the sinus epithelium and induce concentric contraction of the tract. International studies have reported promising results with faster recovery, minimal wound care, and low morbidity.\n\nThis prospective single-center cohort study aims to evaluate the clinical outcomes and perceived recovery time of adult patients treated with the SiLaC® technique at Hospital Universitario La Paz (Madrid, Spain). The main outcome is the total recovery time perceived by patients after surgery. Secondary outcomes include postoperative complications, recurrence rate, pain intensity, need for wound care, and patient satisfaction. Data will be collected from medical records and structured follow-up interviews.",[94,95,96,97,98],"Pilonidal Sinus Disorder","Pilonidal Cyst Without Abscess","Pilonidal Sinus","Pilonidal Cysts","Pilonidal Sinus Treatment",[100,101,102,103,104,105,106],"Pilondal sinus","Pilonidal Cyst","SilaC","laser-assisted closure","minimal invasive surgery","coloproctology","postoperative recovery","NOT_YET_RECRUITING","2025-12-02",{"date":110,"type":40},"2025-12-09",{"date":112,"type":22},"2025-12-01",{"date":114,"type":22},"2026-08-31",{"name":46,"class":47},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":48},"100608600","phase-4-use-of-tacrolimus-and-mtor-inhibitors-with-anticipatory-therapy-vs-tacrolimus-and-mycophenolic-acid-with-universal-prophylaxis-in-renal-recipients-at-high-risk-of-posttransplant-cytomegalovirus-100608600","NCT07203664","Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus.","Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus. Phase 4 Clinical Trial. TIMTOR STUDY.","Inclusion Criteria:\n\n* Age 18 years or more.\n* Positive pre-transplant Ig G CMV serology.\n* Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).\n* Agree to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Patients with negative pre-transplant Ig G CMV serology.\n* HIV-infected patients.\n* Patients receiving induction therapy with basiliximab.\n* Patients who cannot comply with the follow-up protocol.\n* Patients who cannot receive iMTOR as initial maintenance immunosuppressive therapy, such as patients with chronic kidney disease secondary to hepatorenal polycystic kidney disease and patients who are expected to undergo complex vascular surgery.\n* Patients who for any reason should not be included in the study according to the evaluation of the research team.",{"count":124,"type":22},30,[126],"PHASE4","The overall objective of this project is to optimise preventive treatment of CMV infection\u002Fdisease in renal transplant recipients at increased risk of CMV post-transplantation. The specific objectives are: (1) To compare the incidence of CMV infection\u002Fdisease at 6 months post-transplant in Ig G CMV positive (R+CMV) recipients receiving induction treatment with thymoglobulin and one of the two maintenance immunosuppressive treatment regimens used in routine clinical practice : tacrolimus and MTOR inhibitors (group 1) or tacrolimus and mycophenolic acid (group 2); (2) To monitor CMV-specific cellular immunity before transplantation, at 15, 30 and 90 days post-transplantation. For this purpose, an exploratory phase 4 clinical trial has been designed in which will select 30 R+CMV patients receiving renal transplantation with induction treatment with thymoglobulin. After signing informed consent, patients will be randomised to receive one of the two immunosuppression regimens indicated above. The patients in group 1 will receive early therapy as a CMV prevention strategy and patients in group 2 will receive universal prophylaxis for 3 months. Follow-up visits to will be conducted according to the usual protocol and clinical and virological variables will be collected. In addition, blood samples will be collected for the assessment of CMV-specific cellular immunity before and after transplantation. The primary endpoint is the presence of CMV infection\u002Fdisease post-renal transplantation at 6 months. Secondary variables include renal function, acute rejection, patient and graft survival and the occurrence of surgical or haematological complications.",[129],"Evaluate the Effectiveness of CMV Prevention Strategies in Kidney Transplant Recipients","2025-10-01",{"date":132,"type":40},"2025-10-02",{"date":134,"type":22},"2025-10-30",{"date":136,"type":22},"2026-12-31",{"name":46,"class":47},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":48},"100608770","early-diagnosis-of-primary-biliary-cholangitis-pbc-in-patients-with-positive-anti-mitochondrial-antibodies-ama-and-normal-alkaline-phosphatase-alp-100608770","NCT07205874","Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)","Inclusion Criteria:\n\n* Signed informed consent\n* Positive AMA (≥1:40 titer)\n* Persistently normal ALP\n\nExclusion Criteria:\n\n* Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis\n* Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids\n* Contraindications for liver biopsy\n* Concomitant debilitating disease or poor prognosis\n* Pregnancy","80 Years",{"count":146,"type":22},80,"The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is:\n\n• Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.",[149],"Primary Biliary Cholangitis (PBC)",[149,151,152],"Anti-Mitochondrial Antibodies (AMA)","Alkaline Phosphatase (ALP)","2025-09-25",{"date":155,"type":40},"2025-10-03",{"date":157,"type":40},"2025-09-15",{"date":159,"type":22},"2026-05",{"name":46,"class":47},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":91,"phases":4,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":48},"100590982","implementation-of-an-efferent-loop-stimulation-protocol-prior-to-ileostomy-closure-at-la-paz-university-hospital-100590982","NCT06974500","Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital","IInclusion Criteria:\n\n1. Subjects must be able to understand the purpose and risks of the study, provide informed consent, and authorise the use of confidential health information.\n2. Patients over 18 years of age who, regardless of the underlying cause, have an ileostomy and a medical indication for intestinal transit reconstruction by a general surgeon.\n3. Subjects who are able and willing to participate and to comply with follow-up for the duration of the study.\n\nExclusion Criteria:\n\n1. Subjects with an ileostomy who do not wish to undergo intestinal reconstruction.\n2. Subjects who are unable to complete at least two weeks of efferent loop stimulation prior to reconstruction surgery.\n3. Subjects who do not provide consent to participate in the study.",{"count":168,"type":22},68,"2 Years","Stoma creation is a common surgical procedure, employed in certain contexts within general surgery, particularly in colorectal and emergency surgery. Although stoma formation is a life-saving technique, the diversion of intestinal contents has pathophysiological, aesthetic, and psychological repercussions on patients' lives. Stomas may be either permanent or temporary. In temporary cases, a second intervention is required to perform ileostomy closure and restore normal intestinal transit.\n\nSeveral studies indicate that stimulation of the efferent loop prior to ileostomy closure yields benefits in patients' postoperative outcomes. Currently, there is no established protocol for this intervention at Hospital Universitario La Paz. However, implementing such a protocol-given that it is a simple, inexpensive, and accessible intervention-could offer significant cost-effectiveness. It may reduce complications and hospital stay, improve patients' quality of life, and represent a valuable contribution to the General Surgery Departmen",[172,173,174],"Postoperative Ileus","Colorectal Cancer Control and Prevention","Stoma - Ileostomy",[176],"Ileostomy , Stoma, Colorectal, Posoperative","2025-05-07",{"date":179,"type":40},"2025-05-16",{"date":181,"type":40},"2025-01-01",{"date":183,"type":22},"2027-04-01",{"name":46,"class":47},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100563303","intervention-based-on-the-mediterranean-diet-during-pregnancy-and-the-first-two-years-for-the-improvement-of-neurological-development-100563303","NCT06614413","Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years for the Improvement of Neurological Development","Randomized Controlled Clinical Trial: Dietetic-nutritional Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years, First Thousand Days, for the Improvement of Neurological Development","CONMED","1. Inclusion Criteria:\n\n   a. Fluency in the Spanish language, singleton pregnancy\n2. Exclusion Criteria:\n\n   1. Children conceived with assisted reproduction techniques\n   2. Fetal anomalies and congenital infections\n   3. Neonatal anomalies diagnosed after birth\n   4. Intellectual development disorder, due to clinical judgment, inability to attend visits\n   5. Participation in another controlled trial\n   6. Vegetarian diet",true,{"count":195,"type":22},534,[25],"The main objective is to evaluate the effect of the Mediterranean diet during pregnancy and the first two years of the child\\'s life on the child\\'s neurodevelopment and behavior (externalizing and internalizing disorders) measured at one and a half and two years. Secondary objectives are to evaluate the effect of the Mediterranean diet on: body composition at two years of age in infants (densitometry) and of the mother at 3 months postpartum, the incidence of allergic disease in infants, the fetal and infant ́s growth and metabolic risk in the mother during pregnancy and in the boy\u002Fgirl at two years (fasting glucose: insulin, HOMA), LDL and HDL cholesterol, and micronutrient status (iron, calcium, phosphorus, magnesium, sodium, potassium, chloride, selenium, zinc and LCPUFAs).\n\nRandomized controlled clinical trial with a 1:1 ratio, parallel and open label. Group 1: Mother-child binomial with nutritional intervention; Group 2: Mother-child binomial as a control group (with follow-up without intervention).\n\nAssuming a loss of 25% (10% at follow-up, 15% failure of nutritional intervention) we would need a sample size of 267 patients per group. 1. Evaluation of neurodevelopment using the Bayleys scale version -III, at 2 years of age. 2.\n\nBehavioral assessment CBCL at 1.5 and two years and BRIEF-P at two years.",[199,200,201,202],"Diet, Mediterranean","Pregnancy Related","Child Development","Infant Behaviour","2024-09-25",{"date":205,"type":40},"2024-09-26",{"date":207,"type":22},"2024-10-01",{"date":209,"type":22},"2029-02",{"name":46,"class":47},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":4},"100557635","musical-training-in-cochlear-implant-users-100557635","NCT06540677","Musical Training in Cochlear Implant Users","Use of Meludia to Evaluate the Benefits of Music Training in Cochlear Implant Users: a Randomized","Inclusion Criteria:\n\n* Group A: New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid (Spain) between September 2024 and September 2027 will be invited to participate in the study.\n\nGroup B: Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027. Within this group this group, it will be required that pediatric CI have been implanted before the age of 3 years.\n\nAll participants in both groups will have been implanted either unilaterally or bilaterally with CI devices from the manufacturer MED-EL (Innsbruck, Austria).\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they have visual or motor impairments that prevent them from seeing the computer screen and pressing the correct keys, or if there is evidence of cognitive decline. Participants who have previously used Meludia software will also be excluded.","6 Years",{"count":146,"type":22},[25],"With this protocol we want to investigate the degree to which the use of Meludia training (the online self-paced music training application) can improve music perception, music enjoyment, and speech understanding in pediatric and postlingually deafened adult CI users. The study also aims to assess the participants' changes in cognitive skills (attention and memory) and quality of life.\n\nParticipant recruitment Group A: New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid (Spain) between September 2024 and September 2027 will be invited to participate in the study.\n\nGroup B: Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027. Within this group this group, it will be required that pediatric CI have been implanted before the age of 3 years.\n\nBoth in the Group A and in the Group B, participants at the time of enrolment will be randomly divided 1:1 into two groups, with subjects being instructed to practice with Meludia music training application (intervention group: MT group) and participants in the non-MT group non receiving music training (NMT group).\n\nWe will establish 20 minute sessions three times per week over a period of 4 weeks for participants in the MT group. After this period, all the participants will be evaluated (session 1). An additional training period of 12 weeks, also with 20-min sessions three times per week, will then be conducted in the MT group, followed by another evaluation (session 2).\n\nThe ongoing protocol for music training cannot replace conventional tools in the rehabilitation of CI users. However, after scientific-based improvement of music practice protocols (easily implementable, low-priced, and with little probability of adverse effects) as an auditory practice rehabilitation along with the conventional methods, music training may provide an important tool for the aural rehabilitation plan",[223],"Deafness; Perception, Bilateral",[225,226,227,228,229,230],"Cochlear implant","Musical training","Auditory Perception","Speech Perception","Cognitive Function","Quality of life","2024-08-06",{"date":233,"type":40},"2024-08-09",{"date":235,"type":22},"2024-09-01",{"date":237,"type":22},"2027-09-30",{"name":46,"class":47},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":17,"minAge":247,"maxAge":144,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":48},"100551705","phase-4-cpap-effect-on-lipid-profile-and-hyperuricemia-in-patients-with-dyslipidemia-and-moderate-severe-obstructive-sleep-apnea-100551705","NCT06463561","CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea","Effect of 12 Months of Treatment With Continuous Positive Airway Pressure on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea. A Randomized, Open-labell, Parallel Clinical Trial","CPAPLIP","Inclusion Criteria:\n\n* Subjects from 35 to 80 years old\n* Diagnosis of dyslipidemia. It will be considered as such, the existence of a previous clinical record of a diagnosis of dyslipidemia associated with treatment with lipidlowering agents, treatment with lipid-lowering agents or the presence of an altered blood test in the last two months, using the following cut-off points: total cholesterol ≥ 200 mg\u002Fdl, triglycerides ≥ 180 mg\u002Fdl, HDL-cholesterol ≤ 40 mg\u002Fdl or LDL-cholesterol ≥ 150 mg\u002Fdl.\n* Moderate-severe sleep apnea, defined by AHI \\> 15 h-1 .\n\nExclusion Criteria:\n\n* Predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events.\n* Patients with indications for CPAP treatment according to the International Sleep Consensus: hypertensive, excessive daytime sleepiness (Epworth Sleepiness Scale \\> 11) or impaired sleep-related quality of life considered relevant by their regular physician.\n* Professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing).\n* Pretreatment with CPAP","35 Years",{"count":249,"type":22},220,[126],"Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia.\n\nObjectives:\n\nMain objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA.\n\nSecondary objectives:\n\n* To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA.\n* To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA.\n* To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA.\n* To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA.\n* To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA.\n* To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA.\n* To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones.\n* To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid.\n\nDesign Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment.\n\nStudy population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications.\n\nSample size: 110 patients in each treatment arm.\n\nTreatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms:\n\n1. Conventional hygienic-dietary recommendations and promotion of daily physical activity.\n2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP).\n\nEfficiency variables\n\n* Main variables: LDL-cholesterol and uric acid.\n* Total cholesterol, HDL-cholesterol and triglycerides.\n* Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein.\n* Systemic biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A\u002Fhypocretin 1 and ghrelin).\n* Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.\n\nSafety variables\n\n* Clinical adverse event reporting.\n* CPAP compliance (average hours of use per day).\n* Epworth Sleepiness Questionnaire.\n* Development of cardiovascular events.",[253,254,255],"Sleep Apnea","Dyslipidemias","Hyperuricemia","2024-07-11",{"date":258,"type":40},"2024-07-15",{"date":260,"type":40},"2024-07-12",{"date":262,"type":22},"2028-01-31",{"name":46,"class":47},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":193,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":48},"100519114","subjective-and-audiological-benefit-of-bonebridge-bci602-with-two-different-fitting-strategies-100519114","NCT06039332","Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies","Inclusion Criteria:\n\n* 18 years of age or older\n* Unilateral and\u002For bilateral conductive or mixed hearing loss (CHL\u002FMHL) in indication range.\n* Implanted with a BCI602 device.\n* Willingness and ability to use the hearing system and to perform all tests required for the study\n* Signed, and dated informed consent before the start of any study specific procedure\n* Native speaker\n\nExclusion Criteria:\n\n* Profound unilateral sensorineural hearing loss, often termed Single sided deafness (SSD)\n* Retrocochlear, or central auditory disorders\n* Any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures\n* Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study.\n* Fluctuating hearing loss.",{"count":48,"type":22},[25],"The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria).\n\nThe BB augments hearing by providing acoustic input to the inner ear via bone conduction.\n\nIn 2017 Hodgetts \\& Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated.\n\nThe aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.",[274,275,276],"Bone Conduction Deafness","Quality of Life","Hearing Loss, Mixed","2023-09-09",{"date":279,"type":40},"2023-09-15",{"date":281,"type":40},"2023-06-27",{"date":283,"type":22},"2026-06-27",{"name":46,"class":47},""]