Clinical Research Directory

Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery

Along with aging population, cancer incidence and mortality are increasing. However, despite advances in oncology and surgery, long-term survival of cancer patients is far from optimal. Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative, analgesic, and anxiolytic effects. Studies showed that perioperative use of dexmedetomidine reduces delirium and some non-delirium complications after surgery. In long-term follow-up studies of older patients who, for other reasons, were randomized to receive either dexmedetomidine or placebo during intra- or postoperative period, dexmedetomidine use was associated with improved long-term survival. This multicenter randomized trial aims to investigate the effect of perioperative dexmedetomidine on long-term outcomes in older patients undergoing cancer surgery.

GOT VOICE Feasibility With In-Person Group Singing

Unlike traditional physical exercise, the impact of singing on cardiovascular health has not been extensively studied. Endothelial dysfunction predicts cardiovascular events, and physical exercise improves vascular endothelial function. In a rigorously conducted randomized, cross-over control study, this study team is the first to demonstrate that 30 minutes of solo singing improves endothelial function acutely, regardless of singing expertise. Changes were more robust in subjects with baseline endothelial dysfunction (i.e., those with established coronary artery disease). The improvements occurred in microvascular, but not macrovascular, endothelial function. The observed change in microvascular function translates into a \~25% reduction in cardiovascular disease (CVD) risk, which is comparable to traditional cardiac rehabilitation program participation. Based on the investigator's prior research, the overall objective of the planned future RCT is to test the central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering CVD risk. The overall objective of this project, titled "GrOup singing or solo singing To improve Vascular health in Older adults wIth Coronary artery disEase (GOT VOICE): A Feasibility Study", is to refine and protocolize the singing interventions and test the feasibility of future trial design.

Effects of Positive Psychology on Hope, Gratitude, and Well-Being

This randomized controlled study aims to evaluate the effects of an eight-week, group-based positive psychology program on hope, gratitude, and mental well-being among adults aged 65 years and older living in nursing homes in Gaziantep, Türkiye. Approximately 60 participants will be assigned to an intervention group or a control group, with 30 participants planned for each group. The intervention group will receive eight weekly positive psychology sessions, each lasting 40-45 minutes, based on the PERMA model and adapted to older adults. The program will address positive emotions, engagement, relationships, meaning in life, accomplishment, hope, gratitude, and psychological well-being. The control group will receive no intervention during the study period and will be provided with an educational guide about the program after study completion. Hope, gratitude, and mental well-being will be assessed using the Herth Hope Scale, Gratitude Scale, and Warwick-Edinburgh Mental Well-Being Scale, respectively. Assessments will be conducted before the intervention, immediately after the eight-week program, and at a two-month follow-up. The study aims to determine whether the positive psychology program improves these outcomes among older adults living in nursing homes.

Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature

Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.

Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure. The study compares two established treatment strategies: 1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and 2. Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care). Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time. The study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months: 1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and 2. patient-reported health-related quality of life (HRQoL), measured by the RAND-36 "General Health" domain. ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.

Sensory Interaction and Balance Control During Standing and Walking in Healthy Young and Older Adults

This project is designed to: a) develop a new test called Sensory Integration in Walking (SensIWalk) Test which would allow us to evaluate sensory interaction process in locomotion assess whether Locomotor CTSIB and to investigate whether SensIWalk is a reliable test to evaluate sensory interaction in both young and older adults, b) evaluate the difference in sensory interaction and balance performance between standing and walking between both young and older adults, c) examine the changes in sensory interaction process under challenging conditions such as perturbations, dual-task, and when both are present between both young and older adults, d) examine the association between overall fall risk defined by the single-large perturbations and sensory interaction processes used during all the trials in both age groups. In order to achieve these aims, 10 trials will be conducted: Trial 1- Single-Large Perturbation in Standing Trial 2- Single-Large Perturbation in Walking Trial 3- Instrumented CTSIB Trial 4- Locomotor CTSIB Trial 5- Instrumented CTSIB + Perturbations Trial 6- Locomotor CTSIB + Perturbations Trial 7- Instrumented CTSIB + Auditory Stroop Test Trial 8- Locomotor CTSIB + Auditory Stroop Test Trial 9- Instrumented CTSIB + Perturbations + Auditory Stroop Test Trial 10- Locomotor CTSIB + Perturbations + Auditory Stroop Test Two different treadmill perturbations will be applied in addition to the Instrumented CTSIB and SensIWalk: a) slip perturbations, b) continuous perturbations. An auditory stroop task will be applied in relevant trials. All of the trials will be performed either in CAREN High-End Systems or GRAIL (Motek Medical BV, Amsterdam, The Netherlands) which are motion capture systems that are equipped with a treadmill, virtual reality (VR) screen, and a marker-based movement analysis system.

Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT

This comprehensive, multidimensional evaluation assesses patient-related factors, disease-related factors, donor-related factors, and treatment-related factors. The study aims to identify potential risk factors influencing transplant outcomes in elderly patients and enhance the outcomes of allo-HSCT.

Citalopram and the Risk of Serious Adverse Events

This population-based cohort study aims to evaluate the safety of initiating a new outpatient prescription of citalopram at 20 mg/day (higher dose) compared to 10 mg/day (lower dose) in adults aged 65 years and older with reduced kidney function. The primary research question is whether initiating a higher dose of citalopram (20 mg/day) versus a lower dose (10 mg/day) in older adults with low kidney function (defined as an estimated glomerular filtration rate \[eGFR\] less than 45 mL/min per 1.73 m2, without dialysis or a history of kidney transplantation) is associated with an increased 30-day risk of a composite outcome comprising all-cause hospitalization, all-cause emergency department visits, or all-cause mortality.

Conditioning Regimen in Elderly AML Patients Receiving Haplo-HSCT.

Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Studies suggest Bu/Flu/Cy/ATG are safer and more effective for elderly AML haplo-HSCT, lowering TRM. However, prospective randomized trials are lacking. This study aims to compare Bu/Flu/Cy/ATG vs. Bu/Cy/ATG to determine if TRM can be reduced in elderly AML undergoing haplo-HSCT.

Escitalopram and the Risk of Serious Adverse Events

The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 10mg/day of Escitalopram (higher dose) compared to 5 mg/day (lower dose) in adults over the age of 65 with low kidney function. Primary question Whether initiating a new outpatient prescription of a higher dose of Escitalopram (10mg/day) compared to a lower dose (5 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk of a composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality?

Sertraline and the Risk of Serious Adverse Events

The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney function. The primary question is whether initiating a new outpatient prescription of a higher dose of Sertraline (50mg/day) compared to a lower dose (25 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2, but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk. The outcome measured will be a composite of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.

Oral Hygiene Assistance Training Program

This is an oral health study with a nursing home staff training program and product intervention.

Innovative and Cooperative Pathway Integrating Oncogeriatric, Pharmaceutical and Pharmacological Follow-up in Elderly Patients.

The incidence of cancer among older adults is increasing as a result of longer life expectancy. Therapeutic advances have led oncologists to propose new available treatments for these patients, particularly oral therapies, whether targeted therapies or hormone therapies. However, these patients are more vulnerable and have an increased risk of treatment-related toxicity or inefficacy. Indeed, they more frequently suffer from comorbidities (renal, cardiac, hepatic insufficiency, etc.) and present risk factors (polypharmacy, cognitive disorders, etc.) known to reduce the effectiveness or increase the toxicity of oral therapies due to variations in plasma drug concentrations. For several years, various international recommendations (ASCO, ESMO, etc.) have suggested that specialized geriatatric oncology care is indicated for these patients. Similarly, some studies have shown that pharmacist involvement may have an impact by reducing drug-drug interaction issues or non-adherence. Finally, the introduction of oral therapies in oncology has raised pharmacological challenges: regular pharmacokinetic monitoring could allow dose adjustments in cases of disease progression in undertreated patients or toxicity in overexposed patients. Our hypothesis is that implementing an integrative care pathway in this population could demonstrate a benefit by improving quality of care, reducing toxicity, optimizing efficacy, and maintaining an acceptable cost. This approach could help prevent early treatment discontinuation due to disease progression related to insufficient drug concentrations, as well as certain toxicities related to overdosing (e.g., drug-drug interactions), leading to improved quality of life and a reduction in rehospitalization rates.

Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly

Agility comprised of cognitive and physical functions, which influences whole-body movement with change of speed and direction. Agility training is widely used in athletes, and recent studies have begun to apply it into the elderly. Agility training is multidimensional and highly functional, which makes it possible to provide more efficient training in limited time. In elderly, the decrement of cognitive function, muscle strength in the upper and lower limbs, the percentage of body fat, body flexibility and endurance caused by aging will make it difficult for the elderly to perform movements. Therefore, it is essential to explore whether agility training can achieve the improvement of the physical function and cognitive function in elderly, and to find the relationship between the two functions and brain activity. Method: This study will recruit 60 participants, and randomly allocate to control group and agility training. The training groups will have 8 weeks of training, 2 times a week, 45 minutes of training each time. Assessment will be performed before and after intervention in 1-week, and with 1-month follow-up. Assessment including agility ability, physical function, cognitive function, brain activity, and functional assessment scales.

Effectiveness of Implementing a Reablement Model in Community-Based Long-Term Care Centers

This study will examine whether a reablement approach can help people receiving community-based long-term care maintain or improve their independence, daily functioning, and quality of life. Approximately 300 adults from eight long-term care facilities across Taiwan will participate. The 12-week reablement program includes group and individualized activities designed to support mobility, cognitive function, daily activities, and social participation. Participants' physical and cognitive function, daily living abilities, emotional well-being, quality of life, and personal goals will be assessed before and after the program. The study will also include observations and interviews with care providers, participants, and family members to understand their experiences with the program and identify factors that support successful implementation. The findings are expected to help develop a practical reablement model for community-based long-term care in Taiwan and provide guidance for improving care quality, independence, and healthy aging.

FICB for Hip Fracture Pain in Elderly

Hip fracture is a common injury in elderly patients, often requiring surgical treatment. However, these patients frequently experience severe postoperative pain, which can delay mobility and recovery, and increase the risk of complications such as delirium, pneumonia, and prolonged hospital stay. The fascia iliaca compartment block (FICB) is a regional anesthesia technique that has been shown to provide effective pain relief for hip fracture patients. This study aims to investigate whether early administration of FICB, performed upon hospital admission before surgery, can improve postoperative rehabilitation outcomes in elderly patients with hip fracture. This is a prospective, randomized, controlled study. A total of 144 elderly patients with hip fracture will be randomly assigned to either the FICB group or the control group. The FICB group will receive ultrasound-guided FICB after being admitted to the orthopaedic ward, while the control group will receive standard analgesic care once inside the operating room. The primary outcome measure is Quality of Recovery-15 score (QoR-15 score) 24 hours post-surgery. Secondary outcomes include: QoR-15 score at 48 hours postoperatively, NRS scores and sleep duration and quality scores at preoperative and various postoperative time points, total perioperative consumption of opioids and other analgesic drugs, extubation time and emergence agitation during anesthesia recovery period, incidence of delirium from postoperative period to before discharge, length of hospital stay, and overall satisfaction score with pain management. The hypothesis of this study is that early FICB intervention, compared to standard care, will lead to better pain control, earlier mobilization, shorter hospital stay, and improved overall postoperative recovery in elderly patients with hip fracture.

Iron Status Assessment in Geriatric Elderly

In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status. The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays. The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein \[CRP\] \> 50 mg/L). In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled. Research-specific laboratory analyses will be performed on blood samples collected at 4 times: * the day after admission; * when CRP \< 20 mg/L (pilot phase only); * when CRP \< 10 mg/L; * five days after a CRP \< 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.

Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery

A majority of the elderly patients undergo surgery for malignant tumors. For these patients, postoperative tumor recurrence and metastasis are main factors that worsen long-term outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in elderly patients after cancer surgery may help to maintain immune function and improve long-term outcomes, possibly by relieving stress and inflammatory response, improving analgesic efficacy and sleep quality, and reducing delirium incidence.

AI-Based Risk Factor Analysis and Prediction Model of MACE in Elderly Hip Fracture Patients Postoperatively

This is a multicenter ambispective observational cohort study led by Beijing Anzhen Hospital, Capital Medical University, with China-Japan Friendship Hospital serving as the external validation center. Major adverse cardiovascular events (MACE) occurring after surgery are common complications among older adults undergoing hip fracture surgery and are associated with poor long-term outcomes, including increased one-year mortality. Previous studies have not systematically evaluated perioperative risk factors or developed prediction models specifically for this population. In addition, conventional statistical approaches may have limited ability to account for complex interactions and nonlinear associations among multiple perioperative variables. Therefore, this study aims to identify risk factors for postoperative MACE and to develop and externally validate a machine learning-based prediction model. Patients aged 60 years or older who undergo surgical treatment for hip fracture will be included. The derivation cohort, established at Beijing Anzhen Hospital, will be used for model development and internal validation, whereas the independent external validation cohort, established at China-Japan Friendship Hospital, will be used to evaluate the generalizability and predictive performance of the developed model. The study will adopt a bidirectional cohort design: one portion of the study population will be identified retrospectively from electronic medical records, and the remaining participants will be consecutively enrolled prospectively following ethics committee approval. Postoperative outcomes will be ascertained from the end of surgery until the earliest occurrence of hospital discharge, death, or postoperative day 30. Standardized, de-identified data will be collected, including demographic characteristics, comorbidities, laboratory findings, surgical and anesthetic information, perioperative medications, and postoperative MACE outcomes. No study-specific intervention will be assigned, and all patients will receive routine clinical care. Data will be managed in accordance with institutional privacy policies and applicable data protection requirements. Candidate predictors will be evaluated using univariable analyses, least absolute shrinkage and selection operator regression, and random forest-based feature selection. Prediction models, including logistic regression, XGBoost, and LightGBM, will be developed in the derivation cohort. Internal validation will be performed using resampling methods, and external validation will be conducted using data from the independent validation center. Model performance will be assessed in terms of discrimination, calibration, and clinical utility using the area under the receiver operating characteristic curve, calibration plots, and other appropriate performance measures.

Hybrid Group Singing

The overall objective of the planned future clinical trial is to test the investigator's central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering cardiovascular disease (CVD) risk. The overall objective of this study is to refine and protocolize the singing interventions and test the feasibility of the future trial design. The investigative team has previously studied solo singing. Collective singing, as in a choir or small group, is associated with a positive sense of social inclusion, well-being, and improved mood, including in older adults.

Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement Among Elderly Trauma Patients

This randomized controlled trial aims to compare the effectiveness of the AnchorFast™ endotracheal tube (ETT) securement device with conventional adhesive tape and gauze fixation in preventing oral mucosal pressure injuries and endotracheal tube dislodgement among mechanically ventilated elderly trauma patients admitted to the intensive care unit. A total of 90 patients aged 65 years and older requiring oral endotracheal intubation will be randomly allocated to one of the three securement methods. The primary outcomes are the incidence and severity of oral mucosal pressure injuries, assessed using the Beck Oral Assessment Scale (BOAS), and ETT displacement measured using the Endotracheal Tube Slippage Scale. Secondary outcomes include unplanned extubation, ease and time of fixation, need for assistance during application, and time to the development of pressure injury. The findings are expected to provide high-quality evidence to guide the selection of optimal ETT securement methods, improve patient safety, reduce device-related complications, and enhance the quality of critical care nursing practice in elderly trauma patients.

The Effect of Laughter Therapy on the Mental Health of Elderly Living in a Nursing Home

This study was designed and conducted as a randomized controlled experimental research with a pre-test and post-test control group to evaluate the effect of laughter therapy on psychological well-being, life satisfaction, and mental health of elderly individuals living in a nursing home.

Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly

Benzodiazepines or related drug (BZDR) are consumed for hypnotic or anxiolytic purposes in most cases. The consequences of BZDR are multiple with an increased risk of daytime sedation, balance disorders leading to falls and fractures, cognitive disorders, road accidents and dementia. Given their comorbidities, physiological changes, and multiple medications, the elderly are more at risk of suffering from BZDR adverse events. Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively. Morever, motivational interviews (MI) may reduce the extent of substance abuse compared to no intervention.

Effectiveness of a Physical Activity Program

study with multicomponent exercise