[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación de investigación HM\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":181},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,80,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644647","multimodal-sleep-promotion-in-surgical-icu-patients-100644647",false,"NCT07672509","Multimodal Sleep Promotion in Surgical ICU Patients","Multimodal Sleep Promotion Intervention in Adult Postoperative Intensive Care Unit Patients: Two-Center Non-Randomized Controlled Pilot Study","MULTISLEEP","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients admitted to an adult intensive care unit after surgery.\n* Expected ICU stay of at least one night.\n* Patients with clinical stability and adequate pain control allowing participation in the intervention and completion of study assessments.\n* Patients able to understand and complete the questionnaires, either independently or with minimal assistance.\n* Patients without language barriers that prevent study participation.\n\nExclusion Criteria:\n\n* Patients with acute neurological impairment or moderate to severe cognitive dysfunction.\n* Patients receiving invasive mechanical ventilation with ongoing sedation.\n* Patients with a severe pre-existing sleep disorder requiring specific treatment not available in the ICU setting.\n* Patients unable to provide questionnaire responses due to communication limitations or clinical condition.\n* Patients with language barriers preventing participation in study procedures and completion of study assessments","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction.\n\nEnvironmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited.\n\nThis two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care.\n\nThe primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.",[27,28],"Sleep Wake Disorders","Critical Illness",[30,31,32,33,34,35],"Sleep Quality","ICU Patients","Sleep Promotion","Sleep Hygiene","Patient Experience","Humanization of Care","NOT_YET_RECRUITING","2026-06-26",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2026-11-30",{"name":46,"class":47},"Fundación de investigación HM","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100641617","virtual-reality-for-pediatric-perioperative-preparation-100641617","NCT07650695","Virtual Reality for Pediatric Perioperative Preparation","Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 3 to 12 years.\n* Scheduled for elective surgery under anesthesia.\n* Parent or legal guardian owns a mobile phone.\n* Ability to understand simple instructions, according to clinical judgment and developmental level.\n* Sufficient Spanish language proficiency of the child and at least one parent or legal guardian.\n* Written informed consent from parents or legal guardians and child assent when applicable.\n\nExclusion Criteria:\n\n* Emergency or urgent surgery.\n* Moderate to severe neurodevelopmental disorder or intellectual disability limiting understanding of the intervention or study scales.\n* Severe visual or hearing impairment preventing use of virtual reality.\n* History of photosensitive epilepsy, severe vertigo, severe motion sickness, or other conditions that could worsen with virtual reality.\n* Severe decompensated psychiatric disorder.\n* Use of intense sedative premedication before baseline assessment that prevents evaluation of preoperative anxiety.","3 Years","12 Years",{"count":58,"type":21},56,[24],"This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff.\n\nThe VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery.\n\nThe study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.",[62,63,64,65],"Preoperative Anxiety","Fear","Pediatric Surgery","Preoperative Care",[67,64,68,69,70,71,72],"Virtual Reality","Perioperative Care","children","Nursing intervention","fear","anxiety","2026-06-12",{"date":75,"type":40},"2026-06-16",{"date":42,"type":21},{"date":78,"type":21},"2027-04-01",{"name":46,"class":47},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":93,"conditions":94,"keywords":117,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.",{"count":89,"type":21},25,[91,92],"PHASE1","PHASE2","Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[118,119,120,121,122,123,124,125,126,127,128,129,130,104,131,132,133,134,135,136,137,138,139,115,140],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","RECRUITING","2026-06-02",{"date":144,"type":40},"2026-06-04",{"date":146,"type":40},"2024-09-20",{"date":148,"type":21},"2029-12",{"name":46,"class":47},1,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":150},"100563976","phase-2-sasanlimab-as-maintenance-treatment-based-on-clinical-response-to-neoadjuvant-treatment-in-molecularly-categorized-muscle-invasive-bladder-cancer-patients-100563976","NCT06623162","Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients","Selective Bladder-Sparing Trial with Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients","SASAN-SPARING","Inclusion Criteria:\n\n1. Patients who sign a written informed consent approved by an IEC for the participation in this trial.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of ≤ 1 within 28 days prior to registration (Appendix 6).\n4. Histological evidence of localized muscle-invasive urothelial cancer of the bladder (i.e., pT2-T4 \u002F N0 \u002F M0). Candidate for cystectomy as per treating physician.\n5. Absence of metastasis as confirmed by CT or MRI scan of pelvis, abdomen and chest no more than 4 weeks pre-enrolenrment.\n6. Patients candidates to receive neoadjuvant therapy with gemcitabine and cisplatin. Note:MVAC treatment will not be allowed.\n7. All subjects must have adequate archival tissue identified at screening (i.e., at least 15 unstained slides or paraffin block). Subjects without archival tissue must be discussed with the Sponsor-investigator.\n8. Adequate organ and bone marrow function as defined below:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n   2. Hemoglobin (HgB) ≥ 9 g\u002FdL.\n   3. Platelet count ≥ 100 x 10\\^9\u002FL.\n   4. Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula).\n   5. Bilirubin ≤ 1.5 × upper limit of normal (ULN). Note: subjects with Gilbert Syndrome, who have total bilirubin \\< 3.0 mg\u002FdL are eligible.\n   6. Hepatic enzymes Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\< 3 x ULN.\n9. Female patients must either:\n\n   a. Be of nonchildbearing potential: i. Postmenopausal \\*(defined as at least 1 year without any menses) prior to screening , or ii. Documented surgically sterile (e.g. hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).\n   * Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects. OR b. If of childbearing potential: i. Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, ii. And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), iii. And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control (Appendix 7) per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration.\n10. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n11. Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 6 months after the final study drug administration.\n12. Male patients must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n14. Patient agrees not to participate in another interventional study while on treatment in the present study\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with systemic chemotherapy or other approved anticancer treatments for muscle-invasive urothelial cancer of the bladder. Note: In case of prior non muscle-invasive bladder cancer NMIBC, Mitomycin or Bacillus Calmette Guerin (BCG) treatment are allowed.\n\n  2\\. Another malignancy that is progressing or required active treatment , with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).\n\n  3\\. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Note: Patients with diabetes type I, vitiligo, psoriasis, or hypothyroid or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n\n  4\\. Patients that have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 28 days prior to the first dose of trial treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid).\n\n  5\\. History of allogeneic organ transplant. 6. Active non-infectious pneumonitis, pulmonary fibrosis, or known history of immune mediated pneumonitis.\n\n  7\\. Active infection requiring systemic therapy. Patients with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, or known HIV infection.\n\n  8\\. Live attenuated vaccines within 4 weeks prior to the first dose of sasanlimab and through 30 days following the last dose of sasanlimab are not allowed.\n\nNote: influenza and SARS-CoV-2 vaccines which are inactivated are allowed. 9. Clinically significant cardiovascular diseases, including any of the following:\n\n1. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to start of study treatment.\n2. Congestive heart failure requiring treatment (New York Heart Association Class ≥2).\n3. Uncontrolled hypertension, defined as persistent systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite optimal therapy.\n4. History or presence of clinically significant or uncontrolled sustained cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).\n5. History of thromboembolic or cerebrovascular events ≤3 months prior to the first dose of study treatment, including ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli. Note: Participants with either deep vein thrombosis or pulmonary emboli that do not result in hemodynamic instability are allowed to enroll as long as they are stable, asymptomatic and on stable anticoagulants for at least 2 weeks. Note: Participants with thromboembolic events related to indwelling catheters or other procedures may be enrolled. 10. Major surgery less than 28 days prior to the first dose of study treatment. 11. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A \\[IgA\\] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis.\n\n   12\\. Known or suspected hypersensitivity to active ingredients or excipients of the study drug.\n\n   13\\. Pregnant or breastfeeding. 14. Any serious or uncontrolled medical disorder, psychiatric or social condition that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.",{"count":160,"type":21},70,[92],"Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients",[164,165],"Mibc","Muscle Invasive Bladder Cancer",[167,168,169,170,171,172],"MIBC","sparing","cystectomy","muscle invasive bladder cancer","gemcitabine","cisplatine","2024-10-02",{"date":175,"type":40},"2024-10-04",{"date":177,"type":21},"2024-12",{"date":179,"type":21},"2027-12",{"name":46,"class":47},""]