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NCT ID: NCT06390033 Enrolling by invitation - Amputation Clinical Trials

Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities

Start date: June 30, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are: 1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities? 2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market? Participants will be asked to do 1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot. 2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests. 3. Participants will be required to perform the Berg Balance Test. 4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz. 5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis. 6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing. 7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively. 8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire.

NCT ID: NCT06222632 Enrolling by invitation - Clinical trials for Elevated LDL Cholesterol

Cardioprotective and Mental Health Benefits of the MIND Diet Combined With Forest Bathing

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to study the effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet combined with forest bathing (FB) on reducing cardiovascular disease (CVD) risk factors in Chinese adults aged 50-75 years at increased risk of CVDs. The study will assess the impact of the intervention on obesity, higher cholesterol, higher blood pressure, higher triglycerides and glucose levels, stress, and negative emotional state. The investigators hypothesize that the MIND diet combined with FB will have increased cardiac and mental health benefits in Chinese adults with elevated LDL-C compared to the MIND diet alone and routine care. The main questions it aims to answer are: - What are the effects of the MIND diet plus FB, the MIND diet alone, and routine care on various cardiovascular risk factors and mental health indicators at 4 weeks? - What is the sustained effect of the MIND diet plus FB, the MIND diet alone, and routine care on these cardiovascular risk factors at 12 weeks? - How do the effects of the MIND diet plus FB, the MIND diet alone, and routine care differ when considering other individual characteristics such as demographic and lifestyle factors? This twelve-week study will involve screening participants, obtaining their consent, and measuring various parameters such as blood pressure, lipid panel, glucose levels, waist circumference, body mass index, and dietary intake. Participants will also complete two psychometric questionnaires. Measurements will be taken at three time points: before the intervention, immediately after four weeks of intervention, and at the end of the twelve-week intervention period. Each measurement session is expected to last around 20 minutes. Participants assigned to the MIND group will attend nutrition group counseling classes and adopt the MIND diet for twelve weeks. Participants in the MIND plus FB group will attend nutrition group counseling classes and participate in forest bathing sessions. Participants in the routine-care group will continue their usual activities and receive health talks and pamphlets about cardiovascular diseases. The investigators will examine and compare the effects of the interventions on cardiovascular risk factors and mental health at 4 weeks and 12 weeks to determine if there are combined and sustained effects.

NCT ID: NCT06152120 Enrolling by invitation - Dementia Clinical Trials

Preparing Surrogates of Dementia Patients Through an Advance Care Planning Intervention

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effects of a nurse-facilitated post-discharge advance care planning intervention with family surrogates of dementia patients on outcomes that reflect the preparedness of surrogates in decision-making. The main question it aims to answer is, whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months. Participants will be randomized to ACP intervention vs. usual care. 1. patients of the Intervention group will be assessed on palliative care needs, and surrogates of the Intervention group will participate in 2-3 nurse-led ACP consultations; 2. surrogates of both intervention and control groups will complete 3 surveys at different time points during their participation of the study. Researchers will compare the intervention group and control group to see any differences in: 1. surrogate preparedness for decision-making, 2. distress of surrogate and satisfaction with the care of loved one with dementia at the end-of-life, 3. enrolment in Community Geriatric Assessment Team end-of-life care program, 4. advanced care program documentation in medical record, 5. patient comfort at end-of-life, 6. hospitalizations in the last 6 months of life.

NCT ID: NCT06117761 Enrolling by invitation - Delirium Clinical Trials

Combined Activity and Cognitive Intervention for ICU Survivors

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

This mixed-methods study comprising a 3-arm pilot RCT and a qualitative study aims to investigate the preliminary effects and feasibility of a home-based combined activity and cognitive intervention for ICU survivors (COMBAT-ICU). Adopting a 3-arm design with COMBAT-ICU, exercise and attention placebo study arms will enable us to evaluate the added effects, if any, of the novel combined intervention compared with the standard exercise-only rehabilitation strategy and attention placebo. Data triangulation from quantitative and qualitative aspects can facilitate result interpretation. The study's objectives are: 1. To evaluate the preliminary effects of the COMBAT-ICU intervention for ICU survivors on PICS, physical, mental and cognitive outcomes, HRQoL, unplanned re-hospitalisation rate, and mortality. 2. To explore the feasibility and acceptability of the COMBAT-ICU intervention and ICU survivors' intervention engagement experience. The hypothesis of the first objective is that upon completion of the COMBAT-ICU intervention, ICU survivors will have reduced PICS, improved physical function, mental health, cognition and HRQoL, and reduced unplanned readmissions and mortality compared with the exercise and attention placebo groups at post-intervention and 3 months thereafter. While the hypothesis of the second objective is that the COMBAT-ICU intervention is feasible and acceptable for ICU survivors.

NCT ID: NCT05694494 Enrolling by invitation - Fall Clinical Trials

Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Falls are the second leading cause of unintentional injury and death around the globe. About one in every three older adults falls each year worldwide. With the aging population, the cost of treating fall-related injuries is increasing exponentially. There is a pressing need for a cost-effective fall prevention program. Ample evidence has shown the substantial standalone effectiveness of well-designed physical exercises in preventing falls. However, continuous exercise adherence is required for a long-lasting fall prevention effect. Unfortunately, adherence to an exercise program was generally only 21%. Building up the habit of doing regular exercise is thus crucial in preventing falls. Lifestyle integrated Functional Exercise program (LiFE) has been shown to be able to reduce the fall rate by 31% and maintain 64% of the participants exercising at 12 months follow-up. This proposed randomized controlled trial aims at comparing the effectiveness of an internet-based LiFE in reducing subsequent falls and promoting exercise adherence in community-dwelling older adults.

NCT ID: NCT05613400 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

Statin and Bone Health

Start date: April 13, 2022
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the impact of simvastatin on the bone density of postmenopausal women with type 2 diabetes over a duration of 18 months, using a randomized controlled trial design. Aiming to recruit 240 patients, half of them will be randomly assigned to receive simvastatin treatment, while the other half will receive ezetimibe, also a lipid-lowering agent with no known effect on bone. Bone density will be measured at the baseline and the end of the study for comparison of the changes between the simvastatin and the ezetimibe groups. This is an investigator-initiated study. The principal investigator and the study team will be responsible for ensuring that the study is conducted in compliance with this protocol and the study data collected are verified against the relevant source documents. All participants will undergo clinical and biochemical assessments at baseline of the trial. Participants will be seen by an endocrinologist at baseline and subsequent follow-up visits at 3, 6, 12 and 18 months respectively.

NCT ID: NCT05583513 Enrolling by invitation - Heart Failure Clinical Trials

Heart Failure Evaluation Study

Start date: October 1, 2022
Phase:
Study type: Observational [Patient Registry]

Heart failure (HF) is a highly prevalent conditions that impose a significant burden to the patients, the hospital and the healthcare system. In Hong Kong, HF was one of the commonest causes of hospitalization and death. While HF with reduced ejection fraction (HFrEF) infer high mortality, HF with preserved ejection fraction (HFpEF) can be equally debilitating with similar hospital readmission rate and decline in functional status. Despite recent advancement and approval of novel pharmacologic agents and device therapies to treat HF, HF remains difficult to manage, with increased mortality and frequent hospitalization. HF is characterized by a gradual progression with intervals of exacerbation that often necessitating frequent re-admission. These readmissions are common with up to 1 quarter of patients readmitting within 30 days and half within 6 months8. An ambulatory HF centre can serve both as a transition of care from inpatients to community setting and as a point-of-care for early HF exacerbation (HFE) to prevent recurrent HF hospitalization. This is a registry study aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the ambulatory HF clinic.

NCT ID: NCT05583305 Enrolling by invitation - Stenosis Clinical Trials

Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome

ICAS_APS
Start date: October 12, 2022
Phase:
Study type: Observational

Antiphospholipid syndrome (APS) is an important cause of young stroke which could result in major disability. Cohort studies suggested that 17% of young ischemic stroke were accountable by APS (1). Although warfarin has been the mainstay of treatment in APS for the past decades, recurrent thromboembolism occurred up to 10% of warfarinized patients with APS (2, 3). These observations call for an in-depth understanding of disease mechanisms secondary to antiphospholipid antibodies (aPL). Contrary to traditional understanding, recent evidence suggested mechanisms of cerebrovascular ischemia in APS are far more complex than hypercoagulability alone. In the proposed cross-sectional study, we aim to determine the prevalence of intracranial stenosis, and to explore the correlations between the neuroimaging findings and the immunological as well as clinical features in patients with APS. In the proposed cross-sectional study, we aim to determine the prevalence of intracranial stenosis, and to explore the correlations between the neuroimaging findings and the immunological as well as clinical features in patients with APS.

NCT ID: NCT05560204 Enrolling by invitation - Clinical trials for Combined Pulsed-field Ablation (PFA)

Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet

COMPAWA
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation. Oral anticoagulant (OAC) therapy is currently the standard therapy before and after successful ablation. Percutaneous LAA Occlusion (LAAO) has been emerged as an alternative to oral anticoagulants for stroke prophylaxis in patients who refused or contraindicated to OAC. As both AF ablation and percutaneous LAAO require transseptal access from to left atrium, combining the two procedures into one single procedure may provide a straightforward strategy aiming at concomitant rhythm control as well as stroke prevention, without the additional risk of multiple procedures. It is showed in previous studies that this approach is feasible and safe. Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses high amplitude pulsed electrical fields to ablate tissues through the mechanism of irreversible electroporation. Irreversible electroporation is the application of high electric field to a cell with a resultant increased permeability of the membrane and downstream cell death. Success with PFA depends upon the proximity of the electrode to the target tissue, but not necessarily upon contact. Therefore, with PFA the transseptal access for successful AF ablation is less demanding. Moreover, PFA would induce less pulmonary ridge edema compared to conventional ablation techniques and could potentially causes less PDL. Watchman Flx (Boston Scientific) and Amulet (Abbott) are the two most commonly used LAAO devices. The two devices have different designs, deployment requirements and occlusion results. Both devices have been used in combined procedure. However, there is no data of combined AF ablation and LAAO using the PFA technique, and of combined AF ablation comparing the use of Watchman Flx versus Amulet device. In this randomized controlled study, we aim to assess the feasibility and compare the peri-procedural outcomes and LAA occlusion result of combined AF ablation (using the PFA technique), and LAAO using either the Watchman Flx or the Amulet device.

NCT ID: NCT05551065 Enrolling by invitation - Clinical trials for ST Elevation Myocardial Infarction

Post STEMI Echo Registry

Start date: July 22, 2022
Phase:
Study type: Observational [Patient Registry]

This is a prospective observational study of consecutive patients presenting with STEMI to the Prince of Wales Hospital over a 12-month period. All patients will receive standard of care including reperfusion and GDMT irrespective of study enrolment. Patient will be followed for 9 months after enrolled in this study. Point-of-care ultrasound (POCUS) using a hand-held ultrasound (Vscan, GE Healthcare) will be performed to assess baseline LVEF within 48 hours of admission. Patients with baseline moderate-to-severe LV dysfunction by visual POCUS assessment (i.e. LVEF <40%) will be recruited for follow-up LVEF assessment at 3 months. Patients with persistent LVEF <40% by POCUS will undergo formal echocardiography to confirm LVEF by either 2D area (Simpson's rule) and 3D volumetric measurements. In 9 month visit, patient's clinical data will be collected and no echo is needed during this visit.