[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"older-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:older-patients":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,52,71,101,130,160,188,216,247],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100638808","phase-4-long-term-follow-up-of-dexmedetomidine-esketamine-and-tdcs-for-neurocognitive-complications-after-surgery-100638808",false,"NCT07576543","Long-term Follow-up of Dexmedetomidine-esketamine and tDCS for Neurocognitive Complications After Surgery","Long-term Follow-up of Perioperative Dexmedetomidine-esketamine Combination and Transcranial Direct Current Stimulation for Prevention of Neurocognitive Complications in Older Patients After Non-cardiac Surgery","Inclusion Criteria:\n\n* Aged 65 to 90 years;\n* Preoperative Mini-Mental State Examination (MMSE) score \\\u003C 27 points, indicating possible cognitive impairment ranging from mild to moderate;\n* Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \\> 1 hour;\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Preoperative inability to communicate due to coma, severe dementia, endstage disease, or language impairment;\n* History of schizophrenia, epilepsy, Parkinson's disease, brain trauma\u002Fsurgery, or myasthenia gravis;\n* Presence of metal implants in the intracranial or cervical region (such as cochlear implants, aneurysm clips, deep brain stimulation electrodes), or skin damage or severe skin disease on the head;\n* Severe cardiac dysfunction (left ventricular ejection fraction \\\u003C 30%), comorbid with sick sinus syndrome, severe bradycardia (heart rate \\\u003C 50 bpm), or second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker;\n* Uncontrolled hyperthyroidism or pheochromocytoma;\n* Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis), or ASA classification ≥ IV;\n* Allergy to dexmedetomidine or esketamine;\n* Participation in other clinical studies within the past 3 months;\n* Other conditions that are deemed unsuitable for study participation.",true,"ALL","65 Years","90 Years",{"count":21,"type":22},1160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse long-term outcomes. An ongoing 2×2 factorial trial conducted by the investigators plan to test the effects of perioperative dexmedetomidine-esketamine combination and transcranial direct current stimulation (tDCS) on postoperative neurocognitive complications in older patients. This long-term follow-up of the ongoing trial aims to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on long-term outcomes in older patients after noncardiac surgery.",[28,29,30,31,32,33,34],"Older Patients","Surgery","Dexmedetomidine","Esketamine","Transcranial Direct Current Stimulation","Cognitive Function","Survival",[36,29,30,31,37,38,34],"Older patients","Transcranial direct current stimulation","Cognitive function","NOT_YET_RECRUITING","2026-05-07",{"date":42,"type":43},"2026-05-12","ACTUAL",{"date":45,"type":22},"2026-06",{"date":47,"type":22},"2031-06",{"name":49,"class":50},"Peking University First Hospital","OTHER",6,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":51},"100637701","phase-4-dexmedetomidine-esketamine-and-tdcs-for-prevention-of-neurocognitive-complications-after-surgery-100637701","NCT07576517","Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery","Perioperative Use of Dexmedetomidine-esketamine Combination and Transcranial Direct Current Stimulation for Prevention of Neurocognitive Complications in Older Patients After Non-cardiac Surgery: a 2×2 Factorial Trial","Inclusion Criteria:\n\n* Aged 65 to 90 years;\n* Preoperative Mini-Mental State Examination (MMSE) score \\\u003C 27 points, indicating possible cognitive impairment ranging from mild to moderate;\n* Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \\> 1 hour;\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Preoperative inability to communicate due to coma, severe dementia, end-stage disease, or language impairment;\n* History of schizophrenia, epilepsy, Parkinson's disease, brain trauma\u002Fsurgery, or myasthenia gravis;\n* Presence of metal implants in the intracranial or cervical region (such as cochlear implants, aneurysm clips, deep brain stimulation electrodes), or skin damage or severe skin disease on the head;\n* Severe cardiac dysfunction (left ventricular ejection fraction \\\u003C 30%), comorbid with sick sinus syndrome, severe bradycardia (heart rate \\\u003C 50 bpm), or second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker;\n* Uncontrolled hyperthyroidism or pheochromocytoma;\n* Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis), or ASA classification ≥ IV;\n* Allergy to dexmedetomidine or esketamine;\n* Participation in other clinical studies within the past 3 months;\n* Other conditions that are deemed unsuitable for study participation.",{"count":21,"type":22},[25],"Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse outcomes. In previous studies, perioperative use of dexmedetomidine-esketamine combination improved analgesia and sleep quality after surgery. Perioperative use of transcranial direct current stimulation (tDCS) also improved sleep quality and reduced delirium occurrence early after surgery. This 2×2 factorial trial is designed to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on early postoperative neurocognitive recovery and delirium occurrence in older patients.",[28,29,30,31,32,63],"Perioperative Neurocognitive Disorders",[36,29,30,31,37,65],"Perioperative neurocognitive disorders",{"date":42,"type":43},{"date":45,"type":22},{"date":69,"type":22},"2030-06",{"name":49,"class":50},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100508997","medical-treatment-with-or-without-transcatheter-patent-foramen-ovale-closure-100508997","NCT05907694","Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure","Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial","STOP","Inclusion Criteria:\n\n* Cryptogenic stroke\n* Age \\>60 years\n* Right-to-left shunt as evaluated by echocardiography (TEE).\n\nExclusion Criteria:\n\n-≤60 year-old\n\n* Lacunar (small vessel) stroke.\n* Permanent or paroxysmal atrial fibrillation\u002Fflutter (clinically apparent or detected by continuous ECG monitoring).\n* Need for chronic anticoagulation therapy.\n* Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).\n* Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia.\n* Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE.\n* Presence of intracardiac thrombus as evaluated by TEE.\n* Uncontrolled hypertension (systemic pressure values \\>160\u002F90 mmHg despite optimal medical treatment).\n* History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass graft).\n* History of prior valve surgery or transcatheter valve repair.\n* Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography.\n* Left ventricular ejection fraction \\\u003C50% as evaluated by TTE.\n* Significant (moderate or severe) valvular disease as evaluated by echocardiography.\n* History of congestive heart failure.\n* Severe chronic kidney dysfunction defined an estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002Fm2 or need for dialysis.\n* Isolated ASD or ASD associated with PFO but with a hemodynamically significant left-to-right shunt requiring closure.\n* Other specific cause of stroke identified (eg, arteritis, dissection, migraine\u002Fvasospasm, and drug abuse).\n* Prior surgical or endovascular treatments of PFO or ASD.\n* Rheumatic heart disease.\n* Left atrial enlargement defined as a left atrial diameter \\>41 mm in men and ≥39 mm in women.\n* Presence of high burden of premature atrial contractions (\\>500 per 24 hrs) as evaluated by continuous ECG monitoring.\n* Follow-up impossible or expected poor compliance.\n* Active cancer.\n* Presence of an inferior vena cava filter.\n* Severe pulmonary artery hypertension (systolic pulmonary pressure \\>60 mmHg).\n* Functional dependency as measured by a modified Rankin Scale score \\>3 (unable to attend to own bodily needs without assistance and unable to walk unassisted).\n* Any medical condition determining a life expectancy \\\u003C2 years.\n* Participation in another randomized study.\n* Failure to provide signed informed consent.","18 Years",{"count":81,"type":22},714,[83],"NA","Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.",[86,87,28,88,89],"Patent Foramen Ovale","Cryptogenic Stroke","Medical Treatment","Recurrent Stroke","RECRUITING","2026-03-23",{"date":93,"type":43},"2026-03-27",{"date":95,"type":43},"2024-06-18",{"date":97,"type":22},"2037-10-01",{"name":99,"class":50},"Josep Rodes-Cabau",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100553181","repetitive-transcranial-magnetic-stimulation-and-postoperative-neurocognitive-recovery-100553181","NCT06482749","Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery","Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial","Inclusion Criteria:\n\n1. Aged ≥65 years;\n2. Patients with preoperative mild to moderate cognitive impairment, defined as 9\\\u003CMontreal Cognitive Assessment (MoCA)\\\u003C26;\n3. Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of \\>2 hours;\n4. Expected to stay in hospital for at least 5 days after surgery.\n\nExclusion Criteria:\n\n1. Left-handed;\n2. Primary school education level or below;\n3. Comorbid diseases including mental illness, intellectual disability, auditory and visual dysfunction, language impairment, severe neurological disorders, or other diseases that impede the completion of evaluation;\n4. Neurosurgery;\n5. Presence of contraindications to rTMS treatment, including epilepsy, pregnant or lactating women, or with a metal or electric implanted device (e.g., deep brain stimulator, ventriculoperitoneal shunt, aneurysm clip, pacemaker, cochlear implant, or surgical staples on the scalp);\n6. Other situations that are deemed unsuitable for inclusion in the study.",{"count":109,"type":22},568,[83],"Patients with preoperative cognitive impairment are at increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Repetitive transcranial magnetic stimulation (rTMS) has been used to improve cognitive function in patients with cognitive impairement. This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.",[28,113,114,115,116],"Cognitive Impairment","Repetitive Transcranial Magnetic Stimulation","Delayed Neurocognitive Recovery","Postoperative Neurocognitive Disorder",[36,118,119,120,121],"Cognitive impairment","Repetitive transcranial magnetic stimulation","Delayed neurocognitive recovery","Postoperative neurocognitive disorder","2025-07-28",{"date":124,"type":43},"2025-07-31",{"date":122,"type":43},{"date":127,"type":22},"2029-02",{"name":49,"class":50},3,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":139,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100450803","prospective-observational-study-based-on-a-cohort-of-geriatric-patients-with-hip-fracture-treated-in-the-centers-belonging-to-the-giog-group-100450803","NCT05150249","Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group","GIOG","Inclusion Criteria:\n\n* Fracture of the femur, regardless of the cause\n* Age ≥ 65 years\n* Willingness to participate in the study by the patient or a relative \u002F caregiver, if the patient is unable to understand and is not \"competent\" at the time of the evaluation.\n* Able to speak the Italian language\n\nExclusion Criteria:\n\n* none",{"count":138,"type":22},7000,"5 Years","OBSERVATIONAL","The study aims to collect the clinical activity and management data of the Orthogeriatrics and Orthopedics Units participating in the study on a continuous and long-term basis. By collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.",[143,28,144],"Hip Fractures","Comprehensive Geriatric Assessment",[146,147,148,149],"GIOG ( Italian Society of Anesthesiology);","geriatric","orthogeriatric","co-management","2025-07-24",{"date":152,"type":43},"2025-07-25",{"date":154,"type":43},"2019-07-15",{"date":156,"type":22},"2025-12-31",{"name":158,"class":50},"University of Milano Bicocca",11,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100596972","phase-2-vendacbu2flu4-vs-bu2flu5-conditioning-regimen-for-elderly-myeloid-malignancies-undergoing-allo-hsct-100596972","NCT07052422","VEN+DAC+Bu2Flu4 vs Bu2Flu5 Conditioning Regimen for Elderly Myeloid Malignancies Undergoing Allo-HSCT","Venetoclax+Decitabine+Busulfan+Fludarabine (VEN+DAC+Bu2Flu4) vs Busulfan+Fludarabine Conditioning Regimen (Bu2Flu5 ) for Older Patients With Myeloid Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)","Inclusion Criteria:\n\n* 60-75 years\n* Acute myeloid leukaemia in first complete remission or myelodysplastic syndrome\n* Willing to undergo the first allo-HSCT\n* Eastern Cooperative Oncology Group performance status of 0-2\n\nExclusion Criteria:\n\n* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)\n* Patients with any conditions not suitable for the trial (investigators' decision)","60 Years","75 Years",{"count":170,"type":22},160,[172,173],"PHASE2","PHASE3","The purpose of this study is to compare the efficacy and safety of venetoclax+decitabine+busulfan+fludarabine (VEN+DAC+Bu2Flu4) regimen with busulfan+fludarabine (Bu2Flu5) regimen in older patients with myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[28,176,177,178],"Myeloid Malignancies","Conditioning","Hematopoietic Stem Cell Transplantation (HSCT)","2025-07-01",{"date":181,"type":43},"2025-07-04",{"date":183,"type":22},"2025-07-15",{"date":185,"type":22},"2029-12-31",{"name":187,"class":50},"Nanfang Hospital, Southern Medical University",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":196,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100519521","phase-3-implementing-geriatric-assessment-for-dose-optimization-of-cyclin-dependent-kinase-cdk-46-inhibitors-in-older-breast-cancer-patients-100519521","NCT06044623","Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4\u002F6-inhibitors in Older Breast Cancer Patients","Implementing Geriatric Assessment for Dose Optimization of CDK 4\u002F6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)","IMPORTANT","Inclusion Criteria:\n\nThe following inclusion criteria will be applied:\n\n1. Patients male or female aged at least 70 years old at the time of informed consent.\n2. Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory.\n3. Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.\n4. No prior systemic treatment for advanced disease (recurrence during neo-\u002Fadjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4\u002F6-inhibitor initiation is allowed.\n5. Adjuvant treatment with CDK 4\u002F6-inhibitors is allowed provided a disease-free interval from treatment end \\>12 months.\n6. Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1.\n7. Written informed consent prior to any study-specific procedures.\n8. Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4\u002F6-inhibitors that is planned to be used.\n9. Able to swallow capsules.\n10. Able to understand and consent in English language or in native language for each participating country.\n\nExclusion Criteria:\n\nEligible patients will be excluded if they have one of the following criteria:\n\n1. Patients considered from treating physician as non-suitable for treatment with CDK 4\u002F6-inhibitors.\n2. Contraindications according to SmPC for the CDK 4\u002F6-inhibitors that is planned to be used.\n3. Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.\n4. History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.\n5. Participating in other interventional trial.","70 Years",{"count":198,"type":22},495,[173],"IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive\u002Fhuman epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4\u002F6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4\u002F6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4\u002F6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.\n\nOn the basis of baseline CGA assessment, patients will either receive full dose of CDK 4\u002F6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4\u002F6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.\n\nThis project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.",[202,203,204,205,28],"Metastatic Breast Cancer","Advanced Breast Cancer","Quality of Life","Toxicity","2024-11-15",{"date":208,"type":43},"2024-11-19",{"date":210,"type":43},"2024-04-01",{"date":212,"type":22},"2029-05-31",{"name":214,"class":50},"Region Örebro County",12,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":196,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":232,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100537294","phase-3-dosage-study-upfront-dose-reduced-chemotherapy-in-older-patients-with-metastatic-colorectal-cancer-100537294","NCT06275958","DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer","DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients","DOSAGE","Inclusion Criteria:\n\n* Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options.\n* Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist\n* Being able to understand the Dutch language\n* Adequate bone marrow and organ function: Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9 mmol\u002FL, Hemoglobin (Hb) \\> 6.0 mmol\u002FL, Platelets \\>100 x 109 \u002F L, Serum bilirubin ≤ 2 x upper limit of normal (ULN), serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases.\n\nExclusion Criteria:\n\n* Patients who received prior palliative chemotherapy\n* Patients in whom local treatment of metastases is scheduled (i.e. liver surgery or stereotactic radiotherapy)\n* Candidates for triple chemotherapy\n* Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed)\n* Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency\n* Patients with Microsatellite instable (MSI)-high colorectal cancer\n* Patients with HIV or active hepatitis\n* Patients with severe kidney failure (defined as GFR ≤30ml\u002Fmin)\n* Patients with severe cognitive deficits making informed consent not possible",{"count":225,"type":22},587,[173],"The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.\n\nPrimary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness.",[28,229,230,231],"Colorectal Cancer","Metastatic Cancer","Candidates for Palliative Chemotherapy",[233,234,235,236],"Dose-reduced Chemotherapy","Upfront Reduction","Palliative Chemotherapy","Non-inferiority","2024-10-14",{"date":239,"type":43},"2024-10-16",{"date":241,"type":43},"2024-07-01",{"date":243,"type":22},"2028-12",{"name":245,"class":50},"Leiden University Medical Center",36,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":277},"100498062","ldl-cholesterol-targets-in-older-patients-age75-years-with-ascvd-target-old-100498062","NCT05765370","LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)","LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With Atherosclerotic Cardiovascular Disease (TARGET OLD)","Inclusion Criteria:\n\n1. Men or women ≥75 years of age\n2. Diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) with one or more of the following:\n\n   1. Diagnosis of coronary heart disease (one or more of the following criteria must be satisfied):\n\n      * Hospitalization for acute coronary syndrome\n      * Treatment or hospitalization for stable angina pectoris with documented ischemia on invasive or noninvasive testing\n      * History of myocardial infarction\n      * History of coronary revascularization procedure (eg, percutaneous coronary intervention \\[PCI\\] or coronary artery bypass graft surgery \\[CABG\\])\n      * Invasive diagnostic coronary angiography indicating \\>50% stenosis in at least one major epicardial coronary artery or CT-imaging (eg, CCTA\u002FMDCT) evidence of coronary atherosclerosis (\\>50% stenosis in at least two major epicardial coronary artery)\n   2. Diagnosis of atherosclerotic cerebrovascular or carotid disease (one or more of the following criteria must be satisfied):\n\n      * History of ischemic stroke or transient ischemic attack (TIA) confirmed by symptoms with a documented ischemic lesion on CT or MRI in the cerebral regions corresponding to the symptoms;\n      * Documented intracranial atherosclerotic stenosis on the basis of conventional cerebral angiography, magnetic resonance angiography, CT angiography, transcranial doppler ultrasound, and high-resolution MRI;\n      * Symptomatic carotid artery disease with ≥50% carotid arterial stenosis;\n      * Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis per angiography or duplex ultrasound;\n      * History of carotid revascularization (catheter-based or surgical).\n   3. Diagnosis of atherosclerotic peripheral artery disease (one or more of the following criteria must be satisfied):\n\n      * History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).\n      * Prior non-traumatic amputation of a lower extremity due to peripheral artery disease\n      * History of intermittent claudication and one or more of the following:\n\n        1. An ankle\u002Farm blood pressure (BP) ratio \\\u003C 0.90, or\n        2. Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound\n3. Baseline LDL-C level should be satisfied:\n\n   * Patients were required to have a baseline LDL-C level ≥100mg\u002FdL (2.6mmol\u002FL) if they were taking a regimen of lipid-lowering therapy \\\u003C4 weeks or they had not previously received lipid-lowering therapy.\n   * Patients were required to have a baseline LDL-C level ≥70mg\u002FdL (1.8mmol\u002FL) if they were on stable treatment with lipid-lowering therapy ≥4 weeks\n4. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Subject was clinically unstable:\n\n   1. Hypotension, defined as sustained systolic blood pressure of \\\u003C90 mmHg due to cardiac failure with associated symptoms;\n   2. Unstable or severe pulmonary edema\u002Fdecompensated congestive heart failure;\n   3. Acute mitral regurgitation or acute ventricular septal defect;\n   4. Cardiogenic shock and\u002For need for mechanical\u002Fpharmacologic hemodynamic support\n   5. Ongoing Non-STEMI with biomarkers (cardiac troponin) still rising\n   6. Recent STEMI (≤7 days prior to randomization)\n   7. Recurrent symptoms of cardiac ischemia\n2. Moderate to severe heart failure (New York Heart Association \\[NYHA\\] Functional Classification III or IV) or last known left ventricular ejection farction (LVEF) \\\u003C40%.\n3. Severe renal dysfunction, defined as creatinine clearance \\\u003C30 mL\u002Fmin or estimated glomerular filtration (eGFR) rate less than 30 ml\u002Fmin\u002F1.73 m2, or requirement for peritoneal dialysis or hemodialysis for renal insufficiency.\n4. History of hemorrhagic stroke or unknown classified stroke.\n5. Uncontrolled or recurrent ventricular tachycardia (such as ventricular fibrillation, recurrent and highly symptomatic ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications).\n6. Uncontrolled hypertension (greater than 180 mm Hg systolic and\u002For greater than 110 mm Hg diastolic at randomization visit).\n7. History or clinical evidence of active liver disease or hepatic dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN), or total bilirubin \\> 2 × ULN.\n8. Unexplained elevated creatine kinase (CK) concentration \\>5 × ULN or elevation due to known muscle disease.\n9. Planned or expected cardiac surgery, PCI or carotid stenting, or planned major noncardiac surgery during the study period. If angiography or revascularization is planned, patients may be screened and enrolled after all such planned procedures are completed.\n10. Active Malignancy (except nonmelanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) including those patients requiring surgery, chemotherapy, and\u002For radiation in the past 3 years.\n11. Drug or alcohol abuse, and inability\u002Funwillingness to abstain from drug abuse and excessive alcohol consumption during the study.\n12. Severe, concomitant noncardiovascular disease that is expected to reduce life expectancy to \\\u003C3 years\n13. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies), or receiving other investigational agent(s)\n14. Subject has received drugs via a systemic route that have known major interactions with background statin therapy (eg, itraconazole, ketoconazole, and other antifungal azoles, erythromycin, clarithromycin, or cyclosporine nefazodone) within 1 month prior to randomization or is likely to require such treatment during the study period.\n15. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)\n16. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n17. Any uncontrolled or serious disease, or any medical or surgical condition (such as known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction, or a chronic disease or infection \\[eg, HIV\\]), that may either interfere with participation in the clinical study and is not currently stable and appropriately managed in the judgment of the investigator, and\u002For put the subject at significant risk (according to investigator's judgment) if he\u002Fshe participates in the clinical study.\n18. Mental\u002Fpsychological impairment\u002Fneurocognitive disorder, or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study",{"count":255,"type":22},4200,[83],"To determine whether treating to an LDL-C target of 25 to \\\u003C70 mg\u002FdL is superior to an LDL-C target of 70 to \\\u003C100 mg\u002FdL with respect to major cardiovascular events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) in patients aged ≥75 years with atherosclerotic cardiovascular disease (ASCVD).\n\nTo determine whether treating to an LDL-C target of 25 to \\\u003C70 mg\u002FdL is non-inferior to an LDL-C target of 70 to \\\u003C100 mg\u002FdL with respect to major safety events (hemorrhagic stroke, new-onset diabetes, muscle-related events, neurocognitive adverse events, new or recurrent cancer, cataract, or hepatic disorder \\[Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) \\>3× ULN, or total bilirubin \\>2× ULN\\]) in patients aged ≥75 years with ASCVD.",[259,28,260],"Atherosclerotic Cardiovascular Disease","LDL Cholesterol",[262,259,36,263,264,265,266],"LDL-C target","Age≥75 years","Lipid-lowering therapy","Stain","PCSK9 inhibitor","2023-04-07",{"date":269,"type":43},"2023-04-10",{"date":271,"type":43},"2023-03-24",{"date":273,"type":22},"2026-12-24",{"name":275,"class":276},"China National Center for Cardiovascular Diseases","OTHER_GOV",1]