[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"elderly-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:elderly-patients":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,51,76,106,131,160,188,222,247,271,294,321,344,372,395,426,446,475,502,523,551,578,606],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641106","targeted-temperature-management-on-delayed-neurocognitive-recovery-in-older-patients-after-major-cancer-surgery-100641106",false,"NCT07655687","Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery","Intraoperative Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery: a Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.\n\nExclusion Criteria:\n\n1. Preoperative fever (tympanic temperature ≥ 38℃).\n2. Known or suspected preoperative infection.\n3. Previous schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or preexisting delirium.\n4. Inability to communicate due to coma, severe dementia, or hearing or speech impairment.\n5. Critically ill patients, defined as NYHA functional class \\> III or LVEF \\\u003C 30%, Child-Pugh class C, preoperative dialysis dependence, ASA physical status \\> IV, or expected survival \\\u003C 24 hours.\n6. Surgery for breast cancer, intracranial tumors, or rare cancers.\n7. Planned to undergo therapeutic hypothermia.\n8. Body mass index \\> 30 kg\u002Fm² (to facilitate temperature management).\n9. Previous enrollment in this study.\n10. Other conditions deemed unsuitable for study participation.",true,"ALL","65 Years",{"count":20,"type":21},1512,"ESTIMATED","INTERVENTIONAL",[24],"NA","With aging population, more older patients will receive major surgery for cancer. Older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which is associated with prolonged hospital stay, raised complications, and impaired quality of life. Intraoperative hypothermia occurs in 57.1%-78.6% of patients undergoing major cancer surgery, especially in the elderly. Studies show that intraoperative hypothermia suppresses immune function, interferes with anesthetic metabolism, and delays anesthesia emergence. All these may be correlated with the occurrence of early postoperative dNCR. This study aims to verify whether intraoperative targeted temperature management (target core temperature: 36.8°C) compared with conventional temperature management (core temperature: 35.5°C) can reduce the incidence of dNCR in older patients undergoing major cancer surgery.",[27,28,29,30,31],"Elderly Patients","Cancer Surgery","Hypothermia, Accidental","Targeted Temperature Management","Delayed Neurocognitive Recovery",[33,34,35,36,37],"elderly patient","major cancer surgery","intraoperativ hypothermia","targeted temperature management","delayed neurocognitive recovery","NOT_YET_RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-23","ACTUAL",{"date":44,"type":21},"2026-06",{"date":46,"type":21},"2028-11",{"name":48,"class":49},"Peking University First Hospital","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100642290","transnasal-microstream-etco2-reduces-hypoxemia-during-emergence-in-aged-post-abdomen-surgery-100642290","NCT07652385","Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery","Effect of Transnasal Microstream Capnography on Incidence of Hypoxemia During Emergence From General Anesthesia in Elderly Patients After Abdominal Surgery: A Prospective Randomised Controlled Trial","Inclusion Criteria:\n\n* Age 65-80 years;\n* ASA physical status I-III;\n* BMI 18-30 kg\u002Fm²;\n* Participants scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation;\n* Willing to participate in the study and provide written informed consent\n\nExclusion Criteria:\n\n* Patients with nasal bleeding, nasal mucosal injury, nasal cavity occupancy, or other conditions that preclude transnasal carbon dioxide monitoring;\n* Patients undergoing emergency surgery;\n* Participants requiring postoperative assisted ventilation via endotracheal intubation or tracheostomy;\n* Presence of any disease or condition that may cause abnormal end-tidal carbon dioxide waveforms or abnormal baseline pulse oximetry (e.g., congenital heart disease or chronic lung disease);\n* Severe cardiac insufficiency (≤4 Metabolic Equivalents \\[MetS\\]);\n* Severe renal insufficiency (acute kidney injury \\[AKI\\] or chronic kidney disease \\[CKD\\] stage 4 or higher);\n* Severe hepatic insufficiency (Child-Pugh class C or worse);\n* Allergy to study medications;\n* Daily alcohol intake ≥60 grams;\n* History of psychiatric disorders such as depression, severe central nervous system depression, Parkinson's disease, basal ganglion lesions, schizophrenia, epilepsy, Alzheimer's disease;\n* Participation in another related clinical study within the past 3 months.","80 Years",{"count":60,"type":21},324,[24],"This prospective, randomized controlled study aims to investigate whether transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the post-anesthesia care unit (PACU) reduces the incidence of postoperative hypoxemia in elderly patients (65-80 years, ASA I-III, BMI 18-30 kg\u002Fm²) undergoing elective laparoscopic surgery under general anesthesia with endotracheal intubation. A total of 324 patients will be randomized 1:1 to either the control group (standard SpO₂ monitoring and clinical observation with oxygen delivery at 2 L\u002Fmin via sampling line) or the experimental group (same oxygen delivery plus continuous real-time transnasal microstream EtCO₂ monitoring). The primary outcome is the incidence of hypoxemia (SpO₂ \\\u003C 90% for \\>15 seconds) after extubation in the PACU. Secondary outcomes include severe hypoxemia (SpO₂ \\\u003C 85%), lowest SpO₂ during PACU stay, vital signs at specified time points, PACU length of stay, and other adverse events. Statistical analysis will use chi-square or Fisher's exact test for the primary outcome, with a sample size calculated to detect a reduction in hypoxemia from 33% (control) to 18% (experimental group) (α=0.05, power=80%, plus 20% dropout).",[27,64,65,66],"Laparoscopic Surgery","Postoperative Hypoxemia","Capnography","2026-06-16",{"date":69,"type":42},"2026-06-17",{"date":71,"type":21},"2026-07-01",{"date":73,"type":21},"2028-10-01",{"name":75,"class":49},"Jianbo Wu",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100632534","phase-2-venetoclax-azacitidine-in-combination-with-chidamide-and-cag-in-fit-older-patients-with-acute-myeloid-leukaemia-100632534","NCT07514936","Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia","Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;\n2. Age between 60-75 years at the time of screening, with no gender restrictions;\n3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;\n4. No severe allergic constitution;\n5. Liver function: ALT and AST \\\u003C= 2.5 times the upper limit of normal values, bilirubin \\\u003C= 2 times the upper limit of normal values;\n6. Renal function: creatinine \\\u003C= upper limit of normal values;\n7. No uncontrollable infections or severe mental illnesses;\n8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study medication or have contraindications to it;\n2. Pregnant or breastfeeding women;\n3. Patients with active infections;\n4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;\n5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;\n6. Patients who have undergone major organ surgery within the last 6 weeks;\n7. Abnormal liver function, with total bilirubin \\> 1.5 times the upper limit of normal, ALT\u002FAST \\> 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT\u002FAST \\> 5 times the upper limit of normal; abnormal renal function, with serum creatinine \\> 1.5 times the upper limit of normal;\n8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).","60 Years","75 Years",{"count":86,"type":21},120,[88],"PHASE2","This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard \"3+7\" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.",[91,27],"Newly Diagnosed Acute Myeloid Leukemia (AML)",[27,93,94],"newly diagnosed","Acute Myeloid Leukemia","RECRUITING","2026-06-11",{"date":98,"type":42},"2026-06-15",{"date":100,"type":42},"2024-11-18",{"date":102,"type":21},"2027-12-31",{"name":104,"class":49},"Chinese PLA General Hospital",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":129,"locationsCount":105},"100634198","sublingual-caffeine-on-reducing-recovery-time-and-postoperative-agitation-in-elderly-patients-undergoing-general-anesthesia-100634198","NCT07536568","Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia","Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 65 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status II.\n* Scheduled for elective ophthalmology surgery under general anesthesia.\n\nExclusion Criteria:\n\n* History of severe cardiac arrhythmias or uncontrolled hypertension.\n* ASA III patients were excluded to reduce the risk of adverse events in elderly patients with severe systemic diseases.\n* Known allergy or hypersensitivity to caffeine.\n* Pre-existing cognitive impairment or dementia (All patients will undergo preoperative cognitive screening using the online Mini-Cog test or Montreal Cognitive Assessment \\[MoCA\\]).\n* History of seizures or epilepsy.\n* History of alcohol or drug abuse.\n* Chronic use of CNS stimulants or sedatives.\n* Emergency surgeries.\n* Prolonged procedures for more than 3 hours.",{"count":114,"type":21},50,[24],"This study aims to evaluate the efficacy of sublingual caffeine in reducing recovery time and incidence of postoperative agitation in elderly patients undergoing general anesthesia.",[118,119,120,121,27,122],"Sublingual","Caffeine","Recovery Time","Postoperative Agitation","General Anesthesia","2026-04-18",{"date":125,"type":42},"2026-04-21",{"date":123,"type":42},{"date":128,"type":21},"2026-08-30",{"name":130,"class":49},"Cairo University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":105},"100608374","the-role-of-neuroinflammation-on-neurocognitive-outcome-in-cardiac-surgery-100608374","NCT07200726","The Role of Neuroinflammation on Neurocognitive Outcome in Cardiac Surgery","The Role of Neuroinflammation on Neurocognitive Outcome in Cardiac Surgery: INOCS Study","INOCS","Inclusion Criteria:\n\n* aged 60 years or older;\n* scheduled for cardiac surgery.\n\nExclusion Criteria:\n\n* dementia, as diagnosed by a specialist, since this would make detection of PNCD impossible;\n* urgent, not elective surgery.",{"count":140,"type":21},80,"OBSERVATIONAL","RATIONALE: Postoperative cognitive changes are common after cardiac surgery and can be categorised into three main types: postoperative delirium (POD), delayed neurocognitive recovery (DNCR) and postoperative neurocognitive disorder (PNCD). DNCR is diagnosed until postoperative day 30 and PNCD is diagnosed at least 30 days after the operation. Both conditions can be mild or major, and can affect the quality of life of these patients.\n\nThe incidence of PNCD in cardiac surgery is around 40%. Despite this high incidence, screening for PNCD is absent in current postoperative care since the diagnosis of PNCD is difficult and very time intensive. Furthermore, the underlying pathogenesis is incompletely understood.\n\nThe identification of a biomarker and\u002For validated short diagnostic instrument would be of paramount importance to easily identify patients at risk, or to diagnose patients with PNCD in order to identify therapeutical pathways for this disease.\n\nOBJECTIVES: The main objective of this prospective clinical trial is to evaluate the performance of the short NPA and\u002For biochemical markers for the diagnosis of DNCR and PNCD in cardiac surgery patients aged 60 years or older.\n\nSTUDY DESIGN: Single-centre interventional observational study\n\nSTUDY INTERVENTIONS: Patients will undergo a neurophysiological assessment (NPA) pre-operatively and at two timepoints post-operatively, namely 6 (+\u002F-1) days and 40 (+\u002F- 10) days after surgery. During the stay at the intensive care unit, they will be screened daily for delirium, using the CAM-ICU and 3D-CAM.\n\nTo evaluate whether the development of DNCR or POD has an important effect on quality of recovery , the quality of recovery scale 15 (QOR-15), muscle strength (handgrip strength) and the Chalder fatigue score will be scored post-operative (postop day 1, 3 and 5). To evaluate whether PNCD has an effect on quality of live the EQ5D5L score will be measured at 40 (+\u002F- 10) days after surgery, compared to preoperative values.\n\nOn several time points, blood samples will be drawn to measure markers of neuroinflammation. The time points will be preoperatively, at the moment of arrival on ICU, postoperative day 1, 2 and 3, if still on ICU. Two repeat blood sample will be taken at the moment of NPA performed after 6 (+\u002F- 1) days and 40 (+\u002F- 10) days after surgery, if the patient is willing (not obligatory).\n\nSTUDY POPULATION:\n\nPatients aged 60 years or older who are scheduled for cardiac surgery.\n\nInclusion criteria:\n\n* aged 60 years or older;\n* scheduled for cardiac surgery.\n\nExclusion criteria:\n\n* dementia, as diagnosed by a neurologist;\n* urgent, not elective surgery.\n\nMAIN STUDY ENDPOINTS:\n\nPrimary outcome PNCD defined as a decline of \\> 1 SD on \\> 2 tests in one or more cognitive domains or a decline of \\> 1 SD on total cognitive domain score.\n\nSecondary outcomes Postoperative delirium - CAM-ICU will be evaluated twice daily (morning and evening) on every day when the patient is awake (not intubated) on the ICU. This is standard of care and is part of the routine clinical care in the hospital. Furthermore, once daily a 3D-CAM will be performed on day 1, 3 and 5.\n\nQuality of recovery\n\n* QOR-15, a validated measurement of quality of recovery in the short term postoperative recovery, will be evaluated pre-operatively and postoperatively day 1, 3 and 5.\n* EQ5D5L, a validated measurement of quality of recovery in the long term postoperative recovery, will be evaluated preoperatively and at the moment of the third NPA measurement.\n* Postoperative muscle function (upper extremity, by hand grip strength) on day 1, 3 and 5 after surgery and at the moment of the second and third NPA measurement (being day 6 (+\u002F-1) and day 40 (+\u002F-10) postoperatively), as compared to preoperative values.\n* Chalder Fatigue questionnaire on day 1, 3 and day 5 and on the second and third NPA measurement, as compared to preoperative.\n\nBiochemical analysis\n\n\\- Blood samples will be drawn for analysis before induction of anaesthesia (preoperatively), at the end of the operation (immediately postoperatively on arrival in ICU), on day 1, 2 and 3 postoperatively (if still at the ICU) and at the time of the postoperative follow-up visits with the NPA testing (day 6 (+\u002F-1) and day 40 (+\u002F-10) days post-surgery).\n\nAt each time point, markers of neuroinflammation and -degeneration will be determined.\n\nTertiary outcomes\n\n* Length of CPB\n* Duration of mechanical ventilation\n* Administered anaesthetic drugs during surgery\n* Transfusion need\n* Length of ICU stay (days)\n* Length of in-hospital stay (days)\n* Readmission to ICU or hospital within 28 days after surgery\n* Cardiovascular outcome: atrial fibrillation, , thrombo-embolic events, myocardial injury, myocardial infarction, cardiac arrest, cardiac death\n* Pulmonary outcome: postoperative pulmonary complications, postoperative pneumonia, postoperative respiratory failure\n* Postoperative infection within 28 days after surgery",[144,145,146,147,148,149,27,150],"Postoperative Neurocognitive Dysfunction","Postoperative Neurocognitive Disorder","Cardiac Surgery","Major Surgery Under General Anesthesia","Major Surgery in Adult Patients","Postoperative Fatigue","Quality of Recovery","2026-04-07",{"date":153,"type":42},"2026-04-08",{"date":155,"type":42},"2025-10-21",{"date":157,"type":21},"2026-10",{"name":159,"class":49},"Ziekenhuis Oost-Limburg",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":166,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":105},"100632314","phase-2-a-dose-optimization-study-of-enzalutamide-in-elderly-patients-with-advanced-prostate-cancer-100632314","NCT07512076","A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\nMain Cohort:\n\n1. Male aged 75 years or older.\n2. Signed Informed Consent Form\n3. Advanced prostate cancer with a Health Canada approved indication for enzalutamide amongst the following:\n\n   1. High-risk biochemical recurrent hormone sensitive prostate cancer (high risk definition: PSA doubling time of ≤9 months and a PSA level of ≥2 ng per milliliter above nadir after radiation therapy or ≥1 ng per milliliter after radical prostatectomy with or without postoperative radiation therapy).\n   2. Metastatic castration-sensitive prostate cancer.\n   3. Non-metastatic castration-resistant prostate cancer (M0CRPC) with a PSA doubling time of ≤9 months\n4. Participants must receive concomitant androgen deprivation therapy with either a Luteinizing hormone-releasing hormone (LHRH) antagonist or agonist, or have had bilateral orchiectomy.\n5. Participant is capable, in the opinion of the investigator, of completing all study assessments and procedures, including blood draws for PK sampling according to the required schedule as per the study protocol as well as PROs.\n\n   1. Note, for patients who speak a language other than English, PROs may be completed with the help of an interpreter, or translated PROs may be substituted, if available in the patient's primary language.\n\nControl Cohort:\n\n1. Age \\\u003C 70 years\n2. Receiving enzalutamide for advanced prostate, for any indication as per Product Monograph\n3. Receiving the same dose of enzalutamide taken daily and fully compliant for ≥ 29 days\n4. Signed Informed Consent Form\n\nExclusion Criteria:\n\nMain Cohort:\n\n1. Metastatic castration-resistant prostate cancer\n2. Pain related to bone metastasis requiring the use of opioid analgesics\n3. Impending spinal cord compression related to metastasis to vertebral column\n4. Painful femoral neck or any other metastasis judged to be at risk of short-term pathological fracture in the investigator's opinion\n5. Co-administration of medications which are moderate to strong CYP2C8 inducers or inhibitors\n6. Co-administration of medications which are moderate to strong CYP3A4 inducers or inhibitors\n7. History of seizure disorder\n8. History of moderate-severe dementia\n9. Performance status \\> ECOG 2\n10. Uncontrolled hypertension (defined as sustained systolic blood pressure above 160 and\u002For diastolic above 100 despite the adequate use of antihypertensive medication)\n11. Participants with a known history of dementia, seizure disorder, intracranial lesions, moderate to severe hepatic impairment, stage ≥ 3 chronic renal failure or stroke will also be excluded\n\nControl Cohort:\n\n1. Unable to provide written informed consent\n2. Receiving a medication which is a moderate-strong CYP2C8 or CYP3A4 inducer or inhibitor","FEMALE","18 Years",{"count":169,"type":21},26,[88],"This is a phase II, single-centre, pragmatic, non-randomized, dose escalation study to evaluate optimal dose levels of enzalutamide in elderly patients using pharmacokinetic blood sampling concentrations.",[173,27,174],"Prostate Cancer Patients","Pharmacokinetic Study",[176,177,178],"prostate cancer","enzalutamide","elderly patients","2026-03-31",{"date":181,"type":42},"2026-04-06",{"date":183,"type":21},"2026-04",{"date":185,"type":21},"2027-12",{"name":187,"class":49},"Sunnybrook Health Sciences Centre",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":204,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":105},"100623756","hope-theory-based-nursing-intervention-after-hip-fracture-surgery-100623756","NCT07400770","Hope Theory-Based Nursing Intervention After Hip Fracture Surgery","Effect of a Snyder Hope Theory-Based Nursing Intervention on Psychological Status, Pain, and Functional Recovery in Elderly Patients After Hip Fracture Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 60 years.\n* Patients with hip fracture requiring surgical intervention.\n* Patients who have undergone hip fracture surgery within the past 2 weeks.\n* Patients who are able to communicate and provide informed consent.\n* Patients and\u002For their family members who are willing to participate in the study.\n\nExclusion Criteria:\n\n* Patients with other lower limb fractures or history of lower limb thrombosis.\n* Patients with multiple fractures.\n* Patients with severe damage to major organs (heart, lungs, brain) or malignant tumors.\n* Patients who have undergone hip replacement surgery in the past.\n* Patients with infectious diseases or immune system disorders.\n* Patients with chronic diseases or neurological disorders.",{"count":196,"type":21},112,[24],"This is a randomized controlled trial to evaluate the effectiveness of a Snyder Hope Theory-based nursing intervention on elderly patients following hip fracture surgery. The study aims to improve the patient's psychological well-being, reduce pain, and enhance their functional recovery. Participants will be randomly assigned to either the intervention group or the control group. The intervention involves individualized counseling, goal setting, and rehabilitation training based on the Snyder Hope Theory. The trial will assess changes in hope levels, anxiety, pain, hip joint function, and quality of life before and after the intervention.",[200,27,201,202,203],"Hip Fracture","Postoperative Recovery","Nursing Interventions","Snyder Hope Theory",[205,206,207,208,209,210,211],"Hope Theory","Elderly Hip Fracture Surgery","Postoperative Nursing","Psychological Counseling","Rehabilitation Training","Pain Management, Anxiety","Quality of Life","2026-02-03",{"date":214,"type":42},"2026-02-10",{"date":216,"type":42},"2024-05-01",{"date":218,"type":21},"2026-11-30",{"name":220,"class":221},"Institute of Orthopaedic Surgery, Taizhou No.3 People's Hospital","OTHER_GOV",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":245,"locationsCount":50},"100531598","phase-2-efficacy-of-adapted-physical-activity-on-a-walking-platform-in-elderly-patients-hospitalized-for-cancer-surgery-100531598","NCT06201884","Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery","APPAHOCA-2","Inclusion Criteria:\n\n* Men or women aged 65 or over\n* Candidate for scheduled major oncological surgery and\u002For surgery with high morbidity\n* Patient able to walk for 10 minutes on the walking platform at the time of the test\n* Patient affiliated to a social security system\n* Signature of informed consent prior to any specific study-related procedure\n\nExclusion Criteria:\n\n* Patient with severe undernutrition (BMI\\\u003C18, and\u002For weight loss \\>15% in 6 months or \\>10% in 1 month)\n* Emergency surgery\n* Physical contraindications preventing use of the platform\n* Simultaneous participation in another clinical study that could compromise the conduct of this study\n* Patients deprived of their liberty, under guardianship or subject to a legal protection measure, or unable to express their consent.\n* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.",{"count":230,"type":21},60,[88],"The aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.",[234,27,235],"Oncology","Surgery",[237,238],"Adapted physical activity","walking platform","2026-01-08",{"date":241,"type":42},"2026-01-12",{"date":243,"type":42},"2024-03-15",{"date":185,"type":21},{"name":246,"class":49},"Centre Francois Baclesse",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":254,"targetDuration":255,"studyType":141,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":4},"100611338","efficacy-and-safety-of-endovenous-ablation-for-relief-of-knee-pain-in-elderly-patients-with-lower-extremity-varicose-veins-a-prospective-observational-study-100611338","NCT07239284","Efficacy and Safety of Endovenous Ablation for Relief of Knee Pain in Elderly Patients With Lower Extremity Varicose Veins: A Prospective Observational Study","EVA-Knee-Elder","Inclusion Criteria:\n\nAdults aged ≥80 years. Clinical diagnosis of lower limb varicose veins with documented venous reflux on duplex ultrasound (CEAP C2-C4).\n\nPresence of knee pain lasting ≥4 weeks prior to enrollment, confirmed by patient-reported VAS\u002FNRS ≥3 at baseline.\n\nPlanned to undergo standard endovenous treatment (radiofrequency ablation, endovenous laser ablation, or equivalent).\n\nAbility to provide informed consent and complete study questionnaires.\n\nExclusion Criteria:\n\nPrior surgery or endovenous ablation for varicose veins in the same limb. History of inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic rheumatologic disease.\n\nRecent acute knee injury (ligament, meniscus, fracture) within 6 months. Prior knee replacement or major knee surgery. Recent intra-articular injection or arthroscopy (\\\u003C3 months). Known deep vein thrombosis or history of pulmonary embolism within the past 6 months.\n\nSevere peripheral arterial disease (ABI \\\u003C0.8). Pregnancy or breastfeeding. Inability to comply with follow-up schedule or complete questionnaires.",{"count":114,"type":21},"6 Months","Lower extremity varicose veins (LEVV) are common among elderly patients and can cause leg heaviness, pain, and swelling. In some older adults, venous congestion may contribute to knee or peri-knee pain, which is often misattributed to degenerative joint disease alone. Evidence on whether varicose vein treatment can relieve knee pain in very elderly patients (aged 80 years or older) is limited.\n\nThis prospective cohort study aims to evaluate the effectiveness and safety of endovenous ablation (EVA) for improving knee pain in elderly patients with symptomatic varicose veins. The study will include participants aged 80 years or older who present with both lower extremity varicose veins and knee joint pain. Eligible patients will undergo endovenous thermal ablation (radiofrequency or endovenous laser ablation) as the primary intervention.\n\nParticipants will be assessed at baseline, 1 month, 3 months, 6 months, and 12 months after treatment. The primary outcome is the change in knee pain intensity measured by the Visual Analog Scale (VAS) from baseline to 6 months. Secondary outcomes include changes in knee joint function (assessed by the Western Ontario and McMaster Universities Osteoarthritis Index \\[WOMAC\\] or Knee Injury and Osteoarthritis Outcome Score \\[KOOS\\]), venous clinical severity score (VCSS), limb heaviness, quality of life (assessed by EQ-5D), and procedure-related complications.\n\nSafety will be evaluated by recording peri-procedural adverse events, including deep vein thrombosis, skin burns, nerve injury, and postoperative infection. The study will also analyze whether preexisting osteoarthritis, venous reflux severity, or body mass index (BMI) affect the magnitude of pain improvement.\n\nThe hypothesis is that endovenous ablation improves knee pain in elderly patients by reducing venous congestion around the knee and improving venous return. This study will help clarify whether treating varicose veins can provide additional benefits for knee pain and mobility in patients aged 80 years and older.",[258,259,260,261,27],"Varicose Veins of Lower Limb","Chronic Venous Insufficiency, CVI","Knee Pain","Knee Osteoarthritis","2025-11-16",{"date":264,"type":42},"2025-11-20",{"date":266,"type":21},"2025-12-10",{"date":268,"type":21},"2027-07-10",{"name":270,"class":49},"Chengdu University of Traditional Chinese Medicine",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":292,"locationsCount":105},"100511456","effects-of-flumazenil-on-recovery-after-total-intravenous-anesthesia-with-remimazolam-100511456","NCT05939674","Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam","Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.","Inclusion Criteria:\n\n* Patients over 65 years old scheduled for hip joint surgery\n\nExclusion Criteria:\n\n* Patients with impaired consciousness or delirium before surgery\n* Patients who are hemodynamically unstable before surgery\n* Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function\n* Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours\n* Patients with known allergy to benzodiazepine, flumazenil\n* Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption\n* Patients with hypersensitivity to Dextran40\n* Patients who have been taking benzodiazepine for long term\n* Patients with end stage renal disease requiring hemodialysis\n* Patients with history of acute angle glaucoma\n* Patients with alcohol or substance dependence\n* ASA classification 4 or 5",{"count":279,"type":21},24,[24],"Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.",[283,284,285,27],"Flumazenil Adverse Reaction","Remimazolam","Hip Joint","2025-09-07",{"date":288,"type":42},"2025-09-12",{"date":290,"type":42},"2023-09-19",{"date":44,"type":21},{"name":293,"class":49},"Pusan National University Yangsan Hospital",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":105},"100601305","intraoperative-infusion-of-either-lidocaine-or-dexmedetomidine-on-regional-cerebral-oxygen-saturation-and-postoperative-delirium-in-elderly-patients-undergoing-abdominal-surgeries-100601305","NCT07108764","Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries","Effect of Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries","Inclusion Criteria:\n\n* Age ≥ 65years old.\n* Both sexes.\n* Physical status classification of II - III according to the American Society of Anesthesiologists (ASA).\n* Undergo elective non-cardiac surgeries.\n\nExclusion Criteria:\n\n* History of mental illness, neurological illness, or scoring less than 8 using the abbreviated mental test (AMT) before operation.\n* Severe hearing or visual impairment that may interfere with communication.\n* Severe renal or hepatic dysfunction.\n* Patients on central nervous system (CNS) medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).\n* Contraindications to lidocaine or dexmedetomidine \\[e.g., allergy, severe bradycardia, atrioventricular (AV) block\\].",{"count":302,"type":21},100,[24],"This study aims to compare the effect of intraoperative infusion of either lidocaine or dexmedetomidine on the incidence of postoperative delirium (POD) in elderly patients undergoing major surgeries. It also aims to evaluate the impact of both medications on intraoperative regional cerebral oxygen saturation (rSO₂).",[306,307,308,309,310,27,311],"Intraoperative Infusion","Lidocaine","Dexmedetomidine","Cerebral Oxygen Saturation","Postoperative Delirium","Abdominal Surgeries","2025-07-31",{"date":314,"type":42},"2025-08-07",{"date":316,"type":42},"2025-04-17",{"date":318,"type":21},"2027-04-01",{"name":320,"class":49},"Tanta University",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":16,"sex":17,"minAge":328,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":50},"100594952","blended-learning-to-enhance-elderly-communication-skills-in-nursing-students-and-new-nurses-100594952","NCT07026136","Blended Learning to Enhance Elderly Communication Skills in Nursing Students and New Nurses","Application of Blended Learning Model to Improve the Communication Skills of Nursing Students and New Nurses With the Elderly: Development and Effectiveness Verification","Inclusion Criteria:\n\n* At least 20 years old\n* Graduated from a nursing school\n* Full-time employee\n* Less than six months of nursing work experience\n* Working in a medical ward\n\nExclusion Criteria:\n\n* Job nature does not involve direct patient contact, such as working in the supply room.\n* Not engaged in clinical nursing work, such as a research assistant.","20 Years",{"count":330,"type":21},70,[24],"The study will recruit new nurses from the hospital to evaluate the effectiveness of learning communicating skills in elderly care through a hybrid learning model. Participants will be randomly assigned to either an experimental group receiving hybrid method course or a control group using written materials, with both groups participating in a 60-minute educational session. The research will employ a multi-stage assessment approach, beginning with a pre-test to measure baseline knowledge of aging, attitudes toward older adults, willingness to serve the elderly, and communication skills. Immediately following the intervention, participants will complete a post-test, with a follow-up delayed assessment conducted three months later to evaluate knowledge retention. Clinical preceptors will systematically assess the nurses' elderly communication skills using a standardized rating scale. To gain deeper insights, selected nurses will also participate in qualitative interviews, sharing their learning experiences, reflections, and recommendations for improving the teaching materials, thereby providing a comprehensive understanding of the training's effectiveness and potential areas of enhancement.",[334,27],"Communication","2025-06-10",{"date":337,"type":42},"2025-06-18",{"date":339,"type":21},"2025-07-01",{"date":341,"type":21},"2025-12-31",{"name":343,"class":49},"China Medical University Hospital",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100568163","evaluation-of-medical-and-social-care-for-elderly-patients-between-hospital-and-home-temporary-accommodation-out-of-hospitalization-by-nursing-home-and-long-term-care-units-in-ile-de-france-region-100568163","NCT06677645","Evaluation of Medical and Social Care for Elderly Patients, Between Hospital and Home: TEMPORARY ACCOMMODATION Out of Hospitalization by Nursing Home and Long-Term Care Units in Ile-de-France Region","HTSH","* Inclusion Criteria:\n\n  1. Patient selection criteria\n\n     * Patient male or female at least 60 years of age, as initially defined with the Regional Health Agency, discharged from hospital,\n     * Oral expression of non opposition to participation in the study, documented in the medical record by the physician,\n     * Presenting a defined and feasible plan for returning home,\n     * Whose social\u002Fmedical situation (stabilized) does not allow an immediate return home after hospitalization.\n  2. Caregiver selection criteria\n\n     * Person with an unpaid caregiving activity for their relative in HTSH,\n     * Person verbally expressing their non-opposition to participating in the study, and documented in the medical record of the patient they are helping,\n     * A person who is able to understand the study questionnaires and evaluations, and is able to answer them without the help of a third party.\n  3. Professional selection criteria\n\n     * Salaried professional, nursing or not, regularly and directly involved in the HTSH circuit, whether in hospital or in nursing home \u002F long term care units, for at least 6 months,\n     * Oral expression of non opposition to participation in the study, documented by the establishment.\n* Non-inclusion Criteria:\n\n  * Be already included in another clinical study,\n  * Benefit from a legal protection measure or be unable to express their consent, in accordance with article L1121-8 of the French Public Health Code.",{"count":352,"type":21},258,"Prospective, observational, non-interventional, comparative, multicenter RIPH3 study to investigate the impact of HTSH on length of hospital stay in referring services.",[355,356,27],"Social Care","Medical Care",[358,359,360,361,362],"social care","Tempory hospitalization","Elderly people","Medical care","medical-economic study",{"date":364,"type":42},"2025-06-13",{"date":366,"type":42},"2024-11-20",{"date":368,"type":21},"2027-11-20",{"name":370,"class":49},"Gérond'if",10,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":105},"100575153","effect-of-oral-melatonin-versus-intraoperative-lidocaine-infusion-on-incidence-of-postoperative-delirium-in-elderly-patients-undergoing-total-hip-arthroplasty-100575153","NCT06768580","Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty","Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty: Prospective Randomized Controlled Blinded Study","Inclusion Criteria:\n\n* Elderly patients aged \\>65 years old undergoing unilateral total hip arthroplasty.\n* Patients with body mass index (BMI) (18-30) kg\u002Fm2.\n* American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.\n\nExclusion Criteria:\n\n* History of mental illness or scoring less than 8 using abbreviated mental test (AMT) before operation.\n* Obvious sinus bradycardia (heart rate of \\\u003C50 beats per minute) or other serious cardiovascular diseases.\n* Symptomatic cerebrovascular disease (such as previous stroke).\n* History of liver and kidney dysfunction.\n* Allergy to lidocaine or melatonin.\n* Metabolic disorders and fluid, electrolytes disturbances.\n* Alcohol dependence or drug abuse.\n* Redo surgery or infectious complications.\n* CNS medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).\n* History of deep vein thrombosis.",{"count":380,"type":21},135,[24],"The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.",[384,385,310,27,386],"Oral Melatonin","Lidocaine Infusion","Total Hip Arthroplasty","2025-04-12",{"date":389,"type":42},"2025-04-15",{"date":391,"type":42},"2025-01-15",{"date":393,"type":21},"2026-10-01",{"name":320,"class":49},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":410,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":4},"100581100","personalized-digital-remote-monitoring-for-elderly-patients-100581100","NCT06845917","Personalized Digital Remote Monitoring for Elderly Patients","Personalized Digital Remote Monitoring for Elderly Patients: Multicentric RCT Study","EPOCARE","Inclusion Criteria:\n\n* Age ≥ 75 years,\n* Three or more chronic pathologies (e.g., diabetes, heart disease, depression, cancer, respiratory failure, renal failure, dementia),\n* Hospitalization or fall at least once in the previous year (Y-1),\n* Recently discharged from the emergency department (within 24 hours),\n* Patients, with or without caregivers, who accepted to participate and provided informed consent.\n\nExclusion Criteria:\n\n* Patients discharged to or having been institutionalized in nursing homes (EHPAD),\n* Patients enrolled in another clinical trial\n* Suicidal or hetero-aggressive risk in a patient alone at home,\n* Homeless patients,\n* Patients protected by the following French legal measure: \"sauvegarde de justice\"",{"count":404,"type":21},700,[24],"Objective This clinical investigation aims to evaluate whether the EPOCA Remote Monitoring System (RMS) enhances care for elderly patients with multiple chronic conditions and reduces unplanned hospitalizations.\n\nKey Research Questions\n\nThis study will assess:\n\n* Unplanned Hospitalizations: Does EPOCA RMS reduce the total number of unplanned hospital days over 12 months?\n* Quality of Life \\& Costs: What is the impact of EPOCA RMS on patients' quality of life and overall healthcare costs?\n* Survival Rates: Does EPOCA RMS improve survival rates compared to standard care?\n\nParticipant Criteria\n\nParticipants must:\n\n* Be 75 years or older with at least three chronic conditions.\n* Have experienced a hospitalization or fall in the past year.\n* Be randomly assigned to either the EPOCA RMS group or a control group receiving standard care.\n* Be monitored for 12 months, with data collected at multiple time points.\n\nStudy Design\n\n* Type: Multicenter, randomized controlled trial (RCT).\n* Sites: Conducted across 8 hospitals in France.\n* Duration: 12-month follow-up.\n* Sample Size: 700 participants (350 per group).\n* Intervention Group: Remote monitoring through the EPOCA RMS, integrating connected devices and medical coordination.\n* Control Group: Standard care follow-up.\n\nExpected Outcomes\n\n* Reduced unplanned hospital stays and emergency visits.\n* Improved quality of life and patient satisfaction.\n* Comprehensive cost-effectiveness analysis and economic impact assessment.",[27,408,409],"Polypathology","Multiple Chronic Conditions",[411,412,413,414,415],"Elderly","Hospitalization","Decompensation","Multiple chronic conditions","Remote monitoring","2025-02-20",{"date":418,"type":42},"2025-02-25",{"date":420,"type":21},"2025-06-15",{"date":422,"type":21},"2027-10",{"name":424,"class":425},"EPOCA U&I","INDUSTRY",{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":4},"100570752","effect-of-new-oropharyngeal-airway-on-incidence-of-hypoxia-during-painless-gastroenteroscopy-in-elderly-patients-100570752","NCT06711328","Effect of New Oropharyngeal Airway on Incidence of Hypoxia During Painless Gastroenteroscopy in Elderly Patients","Inclusion Criteria:\n\n* Age 65-80 years old\n* written informed consent of patient or family member\n* painless stomach + colonoscopy\n* ASA grade I-II\n\nExclusion Criteria:\n\n* Patients with clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who could not perform oropharyngeal airway ventilation;\n* Upper respiratory tract infections such as mouth, nose or throat;\n* Fever (core body temperature ≥37.5℃);\n* a confirmed diagnosis of pregnancy or breastfeeding;\n* Allergic to sedatives such as propofol or equipment such as tape;\n* Emergency surgery;\n* Multiple trauma;\n* SpO2 \\\u003C 95% before operation;\n* A history of drug and\u002For alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);\n* Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;\n* Currently participating in other clinical trials;\n* Patients who are deemed unfit by the investigator to participate in the trial;\n* Patients with a history of smoking should not participate in this study.",{"count":433,"type":21},164,[24],"With the aging of Chinese population, the early screening of gastrointestinal diseases and the promotion and implementation of comfortable medical treatment, more and more elderly patients choose painless gastroenteroscopy for diagnosis and treatment.However, the incidence of anesthesia-related adverse reactions and complications is high in elderly patients.Hypoxemia caused by anesthetic-induced respiratory depression and airway obstruction is a serious complication in painless gastroenteroscopy.Severe hypoxemia not only requires emergency airway intervention, such as mask ventilation or even tracheal intubation, but also leads to the interruption of endoscopic diagnosis and treatment.Advanced age was an independent risk factor for hypoxemia during painless gastroenteroscopy,This study observed the effect of a new type of oropharyngeal ventilation in improving the elderly painless gastroenteroscopy anesthesia hypoxemia and reducing intraoperative airway intervention, so as to evaluate the safety and effectiveness of a new type of nasopharyngeal ventilation in the elderly painless gastrointestinal diagnosis and treatment, and provide clinical reference.",[437,27],"Airway Management","2024-11-26",{"date":440,"type":42},"2024-12-02",{"date":442,"type":21},"2025-02-01",{"date":444,"type":21},"2025-12-30",{"name":75,"class":49},{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":460,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":50},"100562739","preoperative-risk-evaluation-and-per-eras-intervention-in-the-chinese-elderly-patients-underwent-spinal-fusion-surgery-100562739","NCT06607081","Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery","The Preoperative Risk Evaluation and Perioperative ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery","Inclusion Criteria:\n\n* 1.Age ≥75 years old;\n* 2.Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;\n* 3.With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;\n* 4.No serious cognitive impairment (MoCA score ≥8);\n* 5.No surgical contraindications;\n* 6.Anesthesia assessment patients can safely undergo surgery;\n* 7.Patients who voluntarily participate in and sign informed consent, can independently complete effective questionnaires, and are willing to follow up according to clinical requirements.\n\nExclusion Criteria:\n\n* 1.Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;\n* 2.Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;\n* 3.Patients with cerebrovascular accidents in the last 30 days;\n* 4.Patients with hepatic encephalopathy or acute active hepatitis;\n* 5.Patients with severe renal insufficiency with creatinine\\>2.5mg\u002FdL or undergoing hemodialysis;\n* 6.Patients with severe lung and cardiovascular diseases, coagulation disorders, and anesthesia contraindications;\n* 7.Patients with poorly controlled diabetes (HBAlc\\>8.0%);\n* 8.Patients who are participating in clinical trials of other drugs or medical devices;\n* 9.Patients requiring emergency surgery;\n* 10.Patients who are considered by the investigator to be unable to participate in this clinical trial due to other circumstances.",{"count":454,"type":21},5000,[24],"This study aims to evaluate the value of preoperative risk factor evaulation combined with perioperative ERAS measures in improving the clinical prognosis of elderly patients undergo the spinal fusion.",[458,27,459],"Degenerative Spinal Disease","Spinal Fusion Acquired",[461,462,463,464,465],"Elderly patients","ERAS","Spinal disease","Surgical intervention","Risk factors","2024-09-19",{"date":468,"type":42},"2024-09-23",{"date":470,"type":21},"2024-10-15",{"date":472,"type":21},"2027-10-31",{"name":474,"class":49},"Xijing Hospital",{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":17,"minAge":482,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":105},"100547851","phase-2-sintilimab-after-concurrent-chemoradiotherapy-in-elderly-patients-with-esophageal-squamous-cell-carcinoma-100547851","NCT06413342","Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma","Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Randomized, Multi-center Phase II Clinical Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, clinically staged before treatment (8th edition of the UICC\u002FAJCC TNM staging system for esophageal squamous cell carcinoma) as stage II-IVb (cT1N2-3M0-1, cT2-4bN0-3M0-1, M1 limited to supraclavicular lymph node metastasis).\n2. Candidates for curative esophageal cancer surgery who are unable to tolerate surgery or refuse surgery.\n3. Age 70 to 85 years.\n4. ECOG performance status of 0-1.\n5. The minimum technical standard for radiotherapy is intensity-modulated radiotherapy (IMRT). The total dose of radiotherapy is 54Gy ± 10%.\n\n   Note: It is recommended that study centers conduct screening within 14 days after subjects complete synchronous chemoradiotherapy.\n6. Concurrent chemotherapy regimen: Single-agent S-1 70mg\u002Fm2, days 1-14 and 29-42, synchronized with radiotherapy for 14 days or longer.\n7. The last cycle of chemotherapy must end before or concurrently with the last session of radiotherapy. Consolidation chemotherapy after radiotherapy is not allowed, and chemotherapy before chemoradiotherapy is not accepted. Patients who have not progressed after chemoradiotherapy, including complete response (CR), partial response (PR), and stable disease (SD), can be enrolled in this study.\n8. Except for hearing loss, hair loss, and fatigue, all toxicities from previous anti-tumor treatments must have recovered to grade ≤1 (according to the National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE\\] v5.0) or baseline level before enrollment.\n9. The first dose of study medication must be administered within 42 days after completion of chemoradiotherapy.\n10. No esophageal perforation or active esophageal bleeding, no significant invasion of the trachea or major blood vessels in the chest. No interstitial pneumonia or history of interstitial pneumonia. FEV1 ≥ 0.8L.\n11. Expected survival ≥ 3 months.\n12. Laboratory criteria:\n\n    1. Serum hemoglobin ≥ 90g\u002FL, platelets ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL.\n    2. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 mL\u002Fmin.\n    3. Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.\n    4. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with an INR within the expected therapeutic range for anticoagulant therapy can be screened).\n13. Patients must sign formal informed consent forms indicating their understanding that this study complies with hospital policies and ethical requirements.\n\nExclusion Criteria:\n\n* 1\\. Patients who underwent surgical resection for esophageal cancer prior to the start of this trial or have previously received treatment with immune checkpoint inhibitors such as anti-PD-1\u002FPD-L1 or CTLA-4 inhibitors.\n\n  2\\. Patients staged as cT1-3N1-2M0, deemed suitable for surgical resection, and requiring surgery.\n\n  3\\. Experience disease progression after chemoradiotherapy. 4. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.\n\n  5\\. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary conditions.\n\n  6\\. Poor nutritional status, with a BMI less than 18.5kg\u002Fm2, or PG-SGA score ≥9. 7. Inability to comprehend trial requirements or likelihood of non-compliance with trial requirements.\n\n  8\\. Presence of hematogenous metastases. 9. Presence of other malignant lesions, excluding curable non-melanoma skin cancer, cervical carcinoma in situ, or malignancies with a cure ≥5 years.\n\n  10\\. Known grade 3 to 4 allergic reactions to any treatment component. 11. Participation in other clinical trials within the past 30 days. 12. Active autoimmune diseases or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); exceptions include vitiligo or resolved atopic asthma without the need for intervention in adulthood; patients with stable doses of thyroid replacement hormone therapy for autoimmune-mediated hypothyroidism and patients with stable doses of insulin for type I diabetes can be included.\n\n  13\\. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.\n\n  14\\. Uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA class II or higher heart failure (2) Unstable angina (3) Myocardial infarction within the past year (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n\n  15\\. Active pulmonary tuberculosis infection detected by history or CT examination, or history of active pulmonary tuberculosis infection within the past year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago without proper treatment.\n\n  16\\. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 1× 104 copies\u002FmL), hepatitis C (positive HCV antibodies, and HCV-RNA higher than the detection limit of the assay).\n\n  17\\. According to the investigator's judgment, concurrent diseases that pose a serious risk to patient safety or may interfere with patient completion of the study, or other reasons deemed unsuitable for enrollment by the investigator.","70 Years","85 Years",{"count":485,"type":21},191,[88],"This trial is a prospective, randomized, controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy.\n\nPatients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status (positive vs negative) and randomized in a 1:1 ratio into two groups: the treatment group receiving sintilimab (for patients with a weight \\\u003C60 kg: 3 mg\u002Fkg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) and the observation group receiving regular follow-up. Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression, intolerable toxicity, loss to follow-up, death, or other circumstances where the investigator determines treatment should be discontinued, whichever occurs first. The maximum duration of sintilimab treatment is 12 months (from the start of treatment), while the observation group will be followed up every 3 months for at least one year. No other anti-tumor treatments are allowed during the study period. The study aims to compare the effects of the two treatment modalities on progression-free survival, overall survival, tumor response, toxicity reactions, and quality of life in elderly patients with esophageal cancer.",[489,490,491,492,27],"Esophageal Cancer","Chemoradiotherapy","Sintilimab","Immunotherapy","2024-07-12",{"date":495,"type":42},"2024-07-16",{"date":497,"type":42},"2024-06-01",{"date":499,"type":21},"2028-06-01",{"name":501,"class":49},"Zhejiang Cancer Hospital",{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":105},"100518554","phase-2-single-drug-chemotherapy-plus-immunotherapy-in-metastatic-non-small-cell-lung-cancer-elderly-patients-100518554","NCT06032052","Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients","Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients","Inclusion Criteria:\n\n1. Regardless of sex, age ≥ 65, PS 0-2.\n2. metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.\n3. No mutation or fusion of common driving genes, such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS-1).\n\n   (adenocarcinoma requires genetic testing).\n4. Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).\n5. First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).\n6. Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.\n7. The estimated survival time is not less than 6 months.\n8. The clinical laboratory criteria within 2 weeks before treatment are as follows: hemoglobin ≥ 110g \u002F L, leukocytes ≥ 4x109 \u002F L, platelet ≥ 100x109 \u002F L, liver and kidney function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, urea nitrogen, creatinine) were all within 1.25 times of the upper limit of the normal value.\n9. Informed understanding and voluntary participation in this study, and informed consent has been signed.\n\nExclusion Criteria:\n\n1. Mutation or fusion of common driving genes (EGFR,ALK or ROS1).\n2. Have received systemic treatment before.\n3. Previous suffering from other malignant tumors (except stage I non-melanotic skin cancer or cervical carcinoma in situ) or other malignant tumors at the same time.\n4. Other drugs are being tested.\n5. Patients with positive HIV and are receiving antiviral therapy .\n6. Active pulmonary tuberculosis.",{"count":510,"type":21},49,[88],"Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The proportion of elderly lung cancer patients in the global lung cancer population is steadily increasing, at the same time, it is also the age group with the highest lung cancer mortality, but there is little evidence for treatment of elderly lung cancer patients. In this study, the investigators set the definition of the elderly to 65 years and older.\n\nThe progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy were higher than those of chemotherapy alone, which established the dominant position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly patients benefit from immunotherapy.\n\nIt is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can not significantly prolong OS, and can not improve the overall health status of patients. Based on the results of this study, single drug chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era of immunotherapy, it is not clear whether single-drug chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.",[27,514],"Metastatic Lung Cancer","2024-03-13",{"date":243,"type":42},{"date":518,"type":42},"2024-02-01",{"date":520,"type":21},"2027-09",{"name":522,"class":49},"Hubei Cancer Hospital",{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":4},"100535451","phase-4-efficacy-and-safety-of-fospropofol-for-same-day-bidirectional-endoscopy-in-elderly-patients-100535451","NCT06251999","Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients","Efficacy and Safety of Fospropofol Disodium Sedation for Same-day Bidirectional Endoscopy in Elderly Patients: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Trial","Inclusion Criteria:\n\n* 65 years or older\n* American Society of Anesthesiologists (ASA) physical status I to III\n* Body mass index (BMI) 18-30 kg\u002Fm2\n* Scheduled for same-day bidirectional endoscopy under sedation\n\nExclusion Criteria:\n\n* Severe cardiovascular, pulmonary, renal, or liver diseases\n* Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate \\\u003C50 beats\u002Fmin), or hypoxemia (SpO2 \\\u003C90%)\n* Neurocognitive or psychiatric disorders\n* Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.)\n* Hypersensitivity to study medications\n* Drug or alcohol misuse\n* Definite upper respiratory tract infection\n* Refusal for participation",{"count":531,"type":21},256,[533],"PHASE4","Introduction: Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.\n\nMethods and analysis: This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated, in a 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg\u002Fkg or 1.5 mg\u002Fkg propofol and supplemental doses of fospropofol 1.6 mg\u002Fkg or 0.5 mg\u002Fkg propofol will be titrated as needed to the target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events (AEs) concerning cough reflex, gag reflexes, body movement, muscular tremor, pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 \\\u003C 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia, will be also recorded. Data will be analyzed on the intention-to-treat basis.\n\nDiscussion: The investigators hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients.",[27],[537,538,539,540,541],"fospropofol","propofol","sedation","elderly","bidirectional endoscopy","2024-02-08",{"date":544,"type":42},"2024-02-09",{"date":546,"type":21},"2024-08-01",{"date":548,"type":21},"2028-08-31",{"name":550,"class":49},"Shanghai 6th People's Hospital",{"id":552,"slug":553,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":105},"100265461","phase-1-chemoradiotherapy-in-elderly-patients-with-oesophagus-cancer-100265461","NCT02735057","Chemoradiotherapy in Elderly Patients With Oesophagus Cancer","Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer","OSAGE","Inclusion Criteria:\n\n* Esophageal cancer, squamous and adenocarcinoma types, T1-3, N0-1, M1a (TNM 6th),\n* age \\> 75 years,\n* WHO status \\\u003C 2, Balducci 1, adequate bone marrow reserve, normal renal and hepatic function.\n\nExclusion Criteria:\n\n* age \\\u003C 75 years","100 Years",{"count":561,"type":21},54,[563,88],"PHASE1","Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.\n\nChemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.",[566,27],"Oesophagus Cancer",[568],"oesophagus cancer","2024-01-17",{"date":571,"type":42},"2024-01-18",{"date":573,"type":42},"2016-04-04",{"date":575,"type":21},"2029-05-16",{"name":577,"class":49},"Centre Hospitalier Universitaire de Besancon",{"id":579,"slug":580,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":510},"100396462","phase-3-prephase-treatment-with-prednisone---vitamin-d-supplementation-followed-by-immunochemotherapy-100396462","NCT04442412","Prephase Treatment With Prednisone +\u002F- Vitamin D Supplementation Followed by Immunochemotherapy","Prephase Treatment With Prednisone +\u002F- Vitamin D Supplementation Followed by Immunochemotherapy in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi.","FIL_PREVID","Inclusion criteria\n\n1. Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO) classification.\n2. Age ≥ 65 years\n3. Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.\n4. Eastern Cooperative Oncology Group performance status (PS) ≤3\n5. Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)\n6. No previous treatment for DLBCL or Follicular grade IIIb lymphoma\n7. Ann Arbor stage I-IV\n8. At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan ; or one metabolic active site of disease at baseline FDG-PET scan\n9. Serum basic levels of Vitamin D \\[25 (OH) VitD\\] ≤ 40 ng \u002F ml;\n10. Adequate hematological counts defined as follows:\n\n    * Absolute Neutrophil count \\> 1.5 x 109\u002FL unless due to bone marrow involvement by lymphoma\n    * Platelet count ≥ 80.000\u002Fmm3 unless due to bone marrow involvement by lymphoma\n11. Adequate renal function defined as follows:\n\n    \\- Creatinine ≤ 2 mg\u002FdL, unless secondary to lymphoma\n12. Adequate hepatic function defined as follows:\n\n    \\- Bilirubin ≤ 2 mg\u002FdL unless secondary to lymphoma\n13. LVEF \\> 50% at bidimensionally echocardiogram\n14. Life expectancy ≥ 6 months\n15. Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee , prior to the initiation of any screening or study-specific procedures\n16. Subject must be able to adhere to the study visit schedule and other protocol requirements\n17. Men must agree to use one of the below reported acceptable method of contraception for the duration of the study and for 3 months after receiving the last dose of immunochemotherapy, and to not donate sperm while on study.\n\nExclusion criteria\n\n1. Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with rearrangement of MYC, BCL2 and\u002For BCL6 (double-hit)\n2. Use of VitD supplementation as standard of care at dose higher than 10,000 U\u002Fweek\n3. Suspect or clinical evidence of CNS involvement by lymphoma\n4. Contraindication to the use of rituximab\n5. Contraindication to the use of VitD supplementation (Hypercalcemia\u002FHyperphosphatemia)\n6. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug\n7. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n8. Any history of other active malignancies within 2 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin or limited stage surgically removed breast cancer or adequately treated with radiation therapy or limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy or previous malignancy confined and surgically resected with curative intent\n9. Evidence of other clinically significant uncontrolled condition including, but not limited to:\n\n   * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   * Chronic hepatitis B virus or hepatitis C requiring treatment.",{"count":587,"type":21},430,[589],"PHASE3","This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).\n\nAll patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.",[592,27],"Diffuse Large B-Cell Lymphoma",[594,595,596],"Vitamin D","prednisone +\u002F- Vitamin D supplementation","randomized, open label, phase III","2022-08-23",{"date":599,"type":42},"2022-08-26",{"date":601,"type":42},"2021-03-23",{"date":603,"type":21},"2030-09-01",{"name":605,"class":49},"Fondazione Italiana Linfomi - ETS",{"id":607,"slug":608,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":11,"sex":17,"minAge":613,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":4},"100414519","phase-2-neoadjuvant-chemotherapy-plus-surgery-versus-surgery-first-for-elderly-gastric-cancer-patients-100414519","NCT04677673","Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients","RJGC-Senile","Inclusion Criteria:\n\n* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.\n* Clinical stage: cTNM: stage III\n* Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)\n* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia\n* Distant metastases (including retroperitoneal lymph node)\n* Locally advanced inoperable disease (Clinical assessment)\n* Relapse of gastric cancer\n* Malignant secondary disease\n* Prior chemo or radiotherapy\n* Inclusion in another clinical trial\n* Known contraindications or hypersensitivity for planned chemotherapy","76 Years",{"count":615,"type":21},232,[88,589],"The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.",[619,620,27,235],"Gastric Cancer","Chemotherapy Effect","2020-12-17",{"date":623,"type":42},"2020-12-21",{"date":625,"type":21},"2021-01",{"date":627,"type":21},"2027-01",{"name":629,"class":49},"BIRENDRA KUMAR SAH"]