Clinical Research Directory

Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients

Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing oncologic surgery. Early identification of patients at risk for hemodynamic instability remains a major challenge in perioperative management. Skin conductance reflects sympathetic nervous system activity and may provide a noninvasive indicator of autonomic responses. This prospective observational study aims to evaluate whether skin conductance measurements can predict the development of hypotension following spinal anesthesia in geriatric oncology patients undergoing urologic surgery. The findings may contribute to improved perioperative monitoring and early risk stratification in this vulnerable patient population.

G8 Screening Tool Validation in Older Adults With Cancer in Portugal

The G8 screening tool is widely recommended for the identification of frailty in older adults with cancer. However, prospective validation data in the Portuguese population are currently lacking. This prospective observational study aims to evaluate the diagnostic performance of the G8 screening tool compared with a Comprehensive Geriatric Assessment (CGA) in older adults with cancer. Patients aged ≥70 years with solid tumors will be assessed using both the G8 screening tool and a multidimensional CGA. Frailty will be defined as impairment in at least one CGA domain. The performance of the G8 will be evaluated in terms of sensitivity, specificity, and area under the receiver operating characteristic curve. This study aims to provide the first prospective validation of the G8 screening tool in Portuguese older adults with cancer and to support its implementation in clinical practice.

Home-based Acute Care for Older Persons Initiated by the Emergency Medical and Ambulance Services - a Retrospective Observation of Effects on Healthcare Utilisation and Mortality

This observational study aims to examine outcomes of home-based acute care delivered by a mobile healthcare team in persons aged 75 years and older following an episode of acute illness. The study will assess whether home-based acute care initiated by the emergency medical dispatch centre or ambulance services is non-inferior to emergency department care with regard to care needs and mortality.

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Application of Device-based Training to Improve Postural Control in Older Adults With CCI

The goal of this clinical trial is to improve comprehensive rehabilitation programs for elderly patients with chronic cerebral ischemia by incorporating training methods with biofeedback for postural control training. The main objectives of the study are as follows: To evaluate the effectiveness of incorporating stabilometric training with biofeedback using the Huber system (LPG Systems, France) and treadmill-based biofeedback training using the C-Mill system (Physiomed Elektromedizin AG, Germany) into comprehensive rehabilitation programs, with respect to postural and cognitive functions in elderly patients with chronic cerebral ischemia. To conduct a comparative analysis of the effectiveness of training programs performed using the Huber (LPG Systems, France) and C-Mill (Physiomed Elektromedizin AG, Germany) biofeedback systems, based on outcomes related to gait pattern recovery, postural parameters, and cognitive performance. The investigators will compare training sessions using the Huber and C-Mill biofeedback systems with a control group (patients receiving conventional therapeutic exercise) in order to determine whether these devices are effective in improving postural control and reducing the risk of falls in patients with chronic cerebral ischemia. Participants are required to: Complete a course consisting of 8 procedures, performed once daily. Report any adverse events occurring during or after the procedures, should they arise.

Complications of Surgical Geriatrics Hospitalized in the Orinoco Region

The life expectancy of the Colombian population is increasing. Older patients are frequently hospitalized and treated in surgical wards, and are treated as the general surgical population. However, geriatric patients are frequently found with additional comorbidities, besides the primary surgical diagnosis. Some diseases, like hip fractures, diverticulitis, and cancer, are common in this age range. The preoperative, intraoperative, and postoperative period requires a special care and planning to avoid complications related to the physical status, medications, and comorbidities. Studies about the geriatric surgical population are limited in the Orinoco region. The implementation of a comprehensive geriatric assesment in surgical services requires follow-up of outcomes.

Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm

The aim of this project is to evaluate the effect of a dynamic light in order to improve the circadian rhythm, provide a better sleep and well-being, and in the long run an improved recovery. The primary question is whether dynamic artificial light with circadian stimulus can affect the circadian rhythm. The secondary question is whether this also provides better sleep and well-being. The group that is particularly interesting to study is a geriatric population that is more sensitive to circadian rhythm disorders, sleep disorders and confusion in connection with hospitalization and that can be of particular benefit from this intervention.

Exercise Program for Colorectal Older Patients

The Exercise for COlorectal OLder patients (ECOOL program) is randomized controlled trial to assess the effects of an exercise program on physical function and health-related quality of life of patients 75 years and older with colorectal cancer undergoing surgery. ECOOL is a multicomponent home-based exercise intervention focused on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. The investigators expect that ECOOL program will improve physical function and health-related quality of life of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Smoking Cessation Program for the Older Smokers

This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK).

Remimazolam vs Midazolam to Reduce Delirium in Adults ≥65 Undergoing CPB Valve Surgery

"Postoperative delirium is a common and serious complication following cardiac surgery, particularly among older adults who require intensive care. Its incidence is reported to range between 20% and 70% after cardiopulmonary bypass (CPB), and has been associated with prolonged hospitalization, increased medical costs, higher morbidity and mortality, and long-term cognitive decline. Benzodiazepines are frequently used during anesthetic induction in cardiac surgery due to favorable hemodynamic stability, although multiple clinical guidelines have recommended limitation of benzodiazepine exposure because of concerns for delirium. However, robust clinical evidence in cardiac surgery remains limited. Midazolam is currently the most commonly administered benzodiazepine in this setting, though metabolism through hepatic pathways and accumulation of active metabolites may increase the risk of postoperative delirium, especially in older patients and those with organ dysfunction. Remimazolam, a recently approved benzodiazepine, undergoes rapid hydrolysis by plasma esterases and demonstrates predictable pharmacokinetic properties with a markedly shorter context-sensitive half-time compared to midazolam. These pharmacologic features suggest a potentially reduced impact on postoperative delirium risk. Despite this rationale, no randomized controlled trial has evaluated the effect of remimazolam versus midazolam on delirium after CPB-assisted valve surgery. This randomized double-blind controlled trial aims to determine whether remimazolam reduces the incidence of postoperative delirium compared with midazolam in patients aged ≥65 years undergoing valve surgery with CPB. Eligible participants will be randomized in a 1:1 ratio to receive either remimazolam or midazolam for anesthetic induction according to a computer-generated allocation sequence. All other anesthetic management will follow standardized institutional protocols, including depth of anesthesia monitoring. Delirium assessment will be performed three times daily in the intensive care unit using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC) and twice daily on the ward using 3-Minute Diagnostic Interview for CAM (3D-CAM) for four postoperative days. The primary endpoint is the incidence of delirium within four postoperative days. Key secondary outcomes include in-hospital or 30-day mortality and a composite of major postoperative complications. A total of 300 patients (150 per group) will be enrolled to provide 90% statistical power to detect the hypothesized difference in delirium risk between groups, accounting for a 10% dropout rate. Findings from this study are expected to provide high-quality evidence regarding the comparative impact of remimazolam and midazolam on postoperative delirium and may inform anesthetic strategy selection in high-risk cardiac surgical populations."

WhatsApp Intervention for Seniors' Digital and Cognitive Management (WISDOM)

The goal of this clinical trial is to learn if a digital health literacy program using mobile phone chat-based application called WISDOM (WhatsApp Intervention for Seniors' Digital and cOgnitive Management) can help older adults in Singapore with fewer resources improve their digital health skills and support brain health. The main questions it aims to answer are: * Is it feasible to run WISDOM in senior centres, and will participants join and stay in the program? * Does WISDOM help older adults find and use online health information? * Does WISDOM help older adults make health decisions and impact brain functions? * What do participants think about WISDOM, and how can it be improved? Researchers will compare two groups: * WISDOM group: Participants will join a 6-week program with face-to-face learning sessions and WhatsApp activities about digital health skills. Extra support will be given if needed. * Control group: Participants will continue with their usual activities at the senior centres. Participants in the WISDOM group will: * Join weekly face-to-face sessions for 6 weeks * Use WhatsApp to complete learning activities

Online Access to Clinical Treatment Notes for Outpatients

This study investigates the feasibility and impact of patient access to clinical notes written by their healthcare providers-a concept known as Open Notes. While international research has already demonstrated positive effects of Open Notes on patient empowerment and treatment outcomes, there is a lack of corresponding evidence for the German healthcare context. The quasi-experimental study therefore combines quantitative and qualitative methods to evaluate the effects of Open Notes on patient-reported outcomes as well as clinical practice. The study is structured into five modules, each addressing specific research questions: Module A - Summative Outcome Evaluation in Patients: Does the use of Open Notes lead to a significant increase in patient-reported outcomes such as empowerment and self-efficacy? Module B - Formative Process Evaluation with Stakeholders: What experiences do patients, relatives and clinicians have with Open Notes and what challenges and barriers arise in their use? Module C - Changes in Clinical Documentation: How do language style and content of clinical notes change when they are shared with patients as Open Notes? Module D - Optimization through Artificial Intelligence: Can clinical notes be processed using artificial intelligence in a way that makes them easier for patients to understand compared to conventional medical documentation? Module E - Integration into National Data Infrastructure: What technical, organizational and legal requirements must be met to successfully integrate Open Notes into the national telematics infrastructure and the electronic health record or routine care? The overall goal is to identify both patient-related outcomes and structural conditions for the sustainable implementation of Open Notes in the German healthcare system. The use of artificial intelligence is intended to further enhance patient-centeredness while reducing the burden on clinical staff.

Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures

The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are: * which peripheral nerve block is the best regarding analgesia * which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia? * which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous? * which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy? * what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery? * what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution. All respondents will, in addition to obligatory intraoperative monitoring,: * be thoroughly examined by anesthesiologists before surgery * be closely monitored after surgery, until their hospital discharge.

Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients

Patients with mechanical ventilation in the intensive care unit (ICU) often develop anxiety and agitation, sleep distuebances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery.

Care Pathways and Disparities in Care for Older Patients With Cancer: Typology, Determinants and Effect on Prognosis ( PASSAGE )

More than half of new cases of cancer in Europe in 2022 occurred in people aged over 70. In addition to cancer, the majority of older people have one or more illnesses that may interact with the treatment decision, cancer progression, tolerance and efficacy of treatments, quality of life, care pathway and survival. Furthermore, cancer treatments are most often evaluated in middle-aged subjects without severe disease, so the real-life management of older patients is often empirical. The general objective of the PASSAGE project is to assess the hospital care pathways of older patients with cancer treated at AP-HP by evaluating key elements of these pathways from both geriatric and therapeutic perspectives. Characterizing these care trajectories will help identify the most vulnerable patient profiles and potential disparities in access to care, with the goal of optimizing the management of elderly patients with cancer. The aims of this research are 1) to provide a better description of trends in the management of older cancer patients in routine clinical practice, and 2) to assess the impact of frailty, multimorbidity and the management of these patients on the prognosis of the disease.

Community Beauty and Health Program for Older Adults: An Experiential Learning Trial

This study develops and evaluates a "Senior Beauty and Health Care" course designed to improve students' awareness, attitudes, and skills in caring for older adults' appearance and well-being. Using experiential learning and community practice, the course aims to reduce negative stereotypes and boost students' motivation and competence. A mixed-methods approach, including pretest-posttest surveys and focus group interviews, will assess the course's effectiveness and provide insights for future geriatric care education.

Development of a Pharmacodynamic Model for Propofol in Older Adults

The goal of this pharmacodynamic study is to develop a model for Propofol administration for older adults (\>65 years). The main objective is to create a model based on a new pharmacodynamic parameter, derived from frontal electroencephalogram (EEG), to admininster Propofol in older adults. With this new model, the investigators aim to: * Evaluate the relationship between the plasmatic concentration, described by the Eleveld pharmacokinetic model, versus the effect of the drug represented with a new parameter derived from the intraoperative frontal EEG. * To validate the predictive ability of Eleveld's pharmacokinetic-pharmacodynamic model, based on the bispectral index (BIS), compared to the new model based on a parameter derived from intraoperative frontal EEG. Participants will be asked to answer preoperative questionnaires, receive a Propofol intravenous infusion concomitantly with continuous BIS and EEG monitoring, and to be evaluated for clinical sings of loss and return of consciousness.

Robotic-Assisted System in Enhancing Balance, Postural Stability, Functional Gait and Fall Efficacy in Older Adults

Our study aims to investigate the effectiveness of a more individualized and personalized feedback-oriented approach using the Hunova Robotic Systems. This system is tailored to specific needs of individuals and is dynamically adjustable relative to patients' balance and functional demands. It will be compared to Traditional Balance and Mobility Exercise which are more generalized. Given the generalized nature of Traditional approaches, we aim to compare it with the Hunova Robotic Systems in the enhancement of Balance, Postural Stability, Functional Gait and Fall Efficacy in older adults.

Evaluation of a Residential In-Reach Program in Regional and Rural Australia

Residential In-Reach (RIR) programs are designed to provide responsive care for residents in residential aged care homes (RACH) with the aim of avoiding unnecessary hospital transfers. The evidence for their clinical and cost-effectiveness and implementation has been established in urban settings, but there is a small amount of low-quality evidence for rural and regional settings. The Grampians Region Health Service Partnership Resi-In-Reach Redesign Committee will be implementing a new RIR program to be offered to all RACHs in the Grampians region, this project aims to evaluate the clinical and cost-effectiveness of this program, and its implementation in the rural and regional setting. A stepped-wedge trial will be conducted so that as the RIR program is gradually rolled-out across the region, outcomes can be compared in the same facilities across time and between different facilities. The primary outcome measure will be presentation to emergency departments and urgent care centres, and data will also be collected on other clinical outcomes and barriers and enablers of implementing the program. It is anticipated that there will be a reduction in hospital presentations, and a range of barriers and enablers unique to the rural and regional setting will emerge.

Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults

The goal of this randomized controlled trial is to assess the effectiveness of a pharmacist-led medication review using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP), an explicit criteria in hospitalized older adults. The main questions it aims to answer are: 1. The effectiveness of the intervention in reducing the number of PIMs and chronic medications after discharge 2. The impact of the intervention on quality of life, falls events, emergency department visits, readmissions and survivals Researchers will compare the control group to see if there is corresponding changes to the outcomes specified above.

Aging, Geriatric Syndromes and Clonal Hematopoiesis

In this study the investigators will incorporate a wide range of clinical variables associated with aging and cardiovascular disease to determine whether they are associated with mutation status independent of chronologic age. Clinically, aging can be operationalized using geriatric assessment, which entails a comprehensive multi-dimensional assessment of the health of an older adult, including measures of comorbidity, polypharmacy, functional status, cognition, depression, falls, social activities and social support. Given that aging is heterogeneous, geriatric assessment allows greater specificity for aging than chronological age alone.

Effect of Otago Exercise Program in Comparison With Dual Task Training on Balance and Postural Control in Elderly Population

Balance and postural control are major concerns in reduction of risk of fall among older adults. Otago Exercise Program and dual task training program are commonly used approaches to improve balance, functional mobility and postural control. However, limited studies have compared the efficacy of Otago Exercise Program and dual task training program in improving balance and functional mobility. One-third to one-half of the population over age 60 reports injuries due to fall because of the high incidence of balance and mobility disorders in older adults, interventions are necessary that optimize the performance of balance- and mobility-related activities among older adults. The aim of the current study to find out better intervention which will benefit the clinicians and physiotherapists in clinical decision making of managing the geriatric population, suffering fear of fall, going to effect on their daily livings, with evidence.

Aquatic Exercise and Reactive Balance

The present clinical trial aims to identify if skills acquired during aquatic exercise are more effectively transferred to a reactive balance task than land exercise. This study is designed as a double-blinded, randomized controlled clinical trial. Forty-four older adults aged 60 years or above who meet the eligibility criteria will be recruited and randomized into an aquatic exercise group or land exercise group. Each group will participate in the same balance training exercise during a single session that includes a ball throwing and catching task. A modified lean-and-release test will be implemented on land immediately before, after, and one week after the training session. The outcomes will include reaction time, rapid response accuracy, and mini-BESTest scores obtained from stepping and grasping reactions.

SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients

Elders living with multiple chronic conditions often take many drugs (polypharmacy); some of the drugs may not benefit them or may be harmful. The Canadian Institute for Health Information has reported that about one-quarter of Canadian seniors are prescribed ten or more different drugs each year. Polypharmacy can result in poorer health, reduced quality of life and high healthcare costs. Choosing Wisely Canada and the Canadian Deprescribing Network have suggested wiser uses for the following four Potentially Inappropriate Prescriptions (PIPs): drugs that reduce stomach acid; reduce anxiety and induce sleep; treat agitation; and treat type 2 diabetes but have a high risk of low blood sugar. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Using quality improvement (QI) and supported by Electronic Medical Record (EMR) data, SPIDER will invite family doctors, nurses, pharmacists and front desk staff to participate in Learning Collaboratives and learn from each other. The practice teams will work with a QI Coach to identify areas to improve, develop strategies and implement changes tailored to the local practice context. The objective of this study is to determine whether SPIDER will reduce PIPs for patients 65 years or older who are on ten or more different drugs. The study will also explore patient experience and provider satisfaction with SPIDER and assess the cost of running SPIDER. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a Randomized Controlled Trial (RCT) in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.