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NCT ID: NCT05094284 Recruiting - Clinical trials for Coronary Artery Disease

BioFreedom Ultra Registry

Start date: October 11, 2021
Phase:
Study type: Observational [Patient Registry]

Over the past three decades, coronary stent struts have been made progressively thinner. Thin strut drug-eluting stents (DES) performed better than their thicker counterparts in a recent study. Thinner struts discourage abnormal coronary flow after implantation and associated with greater flexibility, deliverability and better clinical outcomes. Lower strut thickness may be particularly advantageous in small target vessels because thicker struts and smaller minimum in-stent lumen diameter are independent predictors of in-stent restenosis. BioFreedom Ultra is a thin strut (84μm), cobalt-chromium, carrier-free drug-coated stent with Biolimus A9 drug. The BioFreedom Ultra stent is intended for percutaneous coronary intervention (PCI) for high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy. BioFreedom Ultra received CE mark in October 2020 supported by the LEADERS FREE III trial which enrolled 400 HBR patients using the same inclusion criteria as the LEADERS FREE randomized trial. LEADERS FREE III is a single-arm trial, with all patients treated using the BioFreedom Ultra stent. The data was compared to the BioFreedom stainless steel drug-coated stent (DCS-StS) and bare-metal stent (BMS) groups from LEADERS FREE. The primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. The study found that the BioFreedom Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at 1 year in this HBR population was only 1%. Recently, the Biofreedom QCA randomized trial compared the Biofreedom Ultra with the stainless steel version (DCS-StS) in an all-comer population. In this prospective, single-blind non-inferiority randomized (1:1) trial, BioFreedom Ultra was non-inferiority for late lumen loss at 9 months in comparison with DCS-StS.

NCT ID: NCT05094219 Recruiting - Parkinson Disease Clinical Trials

Disease Burden and Cost Consequence of Falls Among Individuals With Parkinson's Disease in Hong Kong: A Prospective Cost-utility Analysis

Start date: November 1, 2023
Phase:
Study type: Observational

Objective: Estimate the cost of disease and falls among people with Parkinson's disease living in Hong Kong. Design: Prospective cost-utility analysis (base year 2021) with one baseline and two follow-up assessments at 6 months and 12 months Participants: Community-dwelling participants with Parkinson's disease of both genders of any age. Intervention: Nil Outcome measures: Self-reported questionnaires will be used to obtain information about the healthcare utility. In addition, the number of falls, the severity of Parkinson' disease assessed using the MDS-Unified Parkinson's Disease Rating Scale, level of disability using the Hoehn and Yahr scale, balance using the Mini Balance Evaluation Systems Test and Activities-specific Balance Confidence (ABC) scale, risk of falls using Falls Efficacy Scale International and quality of life using the Short-form Health survey (SF-36) will be assessed. Predictors of cost include fall frequency, balance status, disease severity, level of disability, quality of life, and duration of disease. Analysis: A multiple regression analysis will be conducted to determine which predictor (independent variable) influence the overall cost. The level of statistical significance (α) will be set at p<0.05. A Tornado plot will be constructed for the individual items of both direct and indirect cost having the minimum and maximum range set at the 25th and 75th percentile. Two-way analysis of variance (ANOVA) will assess the differences in healthcare cost among frequent, in-frequent and non-fallers. Spearman's or Pearson correlation coefficient will assess correlations between quality of life and healthcare cost; disease severity and healthcare cost; falls frequency and healthcare cost. Benefits to healthcare and health Cost-estimation highlights information required to enhance the health care service for the target population. Through a similar study among patients with cerebellar ataxia, our team demonstrated specific challenges that need additional support from the policy-makers such as employment following disability, visits to specialists, home-care, and community participation for people with cerebellar ataxia in Hong Kong. This study will highlight the strength and weakness of the current healthcare system to people of Hong Kong with Parkinson's disease, this will inform the challenges for the healthcare requiring additional attention which in turn will have a beneficial impact on the future service.

NCT ID: NCT05084573 Recruiting - Shoulder Fractures Clinical Trials

Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery

CLIP-H
Start date: August 1, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of continuous interscalene block (CISB) using standard bupivacaine versus a single interscalene injection of liposomal bupivacaine (LB) on pain control following surgical fixation of proximal humerus fractures.

NCT ID: NCT05078424 Recruiting - Depressive Symptoms Clinical Trials

Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong

Start date: September 29, 2021
Phase: N/A
Study type: Interventional

The proposed study is a randomized controlled trial (RCT) that aims to examine the effectiveness of cognitive behavioural therapy in reducing depressive and anxiety symptoms for youths in Hong Kong. It is to be carried out with 120 youths aged 12 - 24 recruited from a series of community-based LevelMind@JC hubs, funded by the Hong Kong Jockey Club Charities Trust. It is designed to improve the youths' abilities/ skills in handling moods to have better emotional management. A written informed consent will be signed by participants. Researchers will perform cognitive behavioural therapy on youths who agree to join the study.

NCT ID: NCT05072340 Recruiting - Clinical trials for Resilience, Psychological

Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students

Start date: October 8, 2021
Phase: N/A
Study type: Interventional

Background University students experience high levels of stress and this may negatively impact their mental health, coping and academic outcomes. Building resilience has been described as an ability to maintain mental well-being. Aims This study aims to (1) assess the feasibility of the Resilience Skills Enhancement (RISE) program, (2) evaluate the effects of RISE on undergraduate students' resilience, coping, emotion regulation, positive emotions and stress and (3) explore students' perception of RISE. Methods This study will be operationalized in three phases. Phase 1 - Feasibility A single-arm pre-post study will be used. 10 students will be recruited to explore their acceptability, perception, and suggestions for improving RISE. RISE comprises of six weekly sessions delivered via LumiNUS and Zoom. The Wilcoxon signed rank test will be used to analyse the data. Phase 2 - Randomized controlled trial A prospective, double blind randomized controlled trial and repeated post-tests will be used. A total of 122 students will be recruited from LumiNUS and social media platforms. Participants will receive a series of six, weekly online sessions in both groups. The primary outcome is resilience. The secondary outcomes include, coping, emotion relation, positive emotions, stress. Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three time points through Wilks's lambda test. The data will be analysed according to the intention-to-treat principle. Phase 3 - Process evaluation A qualitative study using an individual, semi-structured interviews will be used to explore students' perception of RISE. Approximately 20 students will be recruited, and the final sample size will be determined based on data saturation. Thematic analyses will be used to analyse the data. Potential contributions This study will contribute by evaluating evidence-based user-friendly RISE that may be effective for enhancing university students' resilience.

NCT ID: NCT05072314 Recruiting - Breast Cancer Clinical Trials

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

LOLIPOP
Start date: July 27, 2022
Phase: Phase 4
Study type: Interventional

The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.

NCT ID: NCT05071066 Recruiting - ADHD Clinical Trials

New Service Protocol for Attention Deficit/Hyperactivity Disorder With Comorbidity: A Randomized Waitlist-controlled

ADHD+
Start date: December 20, 2021
Phase: N/A
Study type: Interventional

The proposed study is to be carried out in 2021 - 2024 with youths aged 6 - 15 in Hong Kong. This is a randomized waitlist-controlled trial that aims to examine the effectiveness of the ADHD+ new service protocol. This ADHD+ new service protocol intervention will be delivered for 6 months in the format of groups by frontline social workers trained by professional clinicians including clinical psychologists and psychiatrists. It is designed to reduce ADHD and related symptoms in individuals aged between 6 and 15 years. Core treatment components include internet use/addiction intervention, cognitive training, emotion management, social skills training, occupational training, emotion support/befriending, parenting training, and career guidance. It is hypothesized that youths receiving the intervention will have reduced ADHD and related symptoms when compared with controls. Findings will allow the investigators to better understand the effectiveness of the new ADHD+ service; and in the long run, the service model can be generalized to community based early interventions for other uncomplicated mental disorders.

NCT ID: NCT05056948 Recruiting - Dental Prosthesis Clinical Trials

Artificial Intelligence Designed Single Tooth Dental Prostheses

Start date: September 1, 2021
Phase:
Study type: Observational

Tooth loss is common and as consequence deteriorate patient's health and quality-of-life. Dental prostheses aim to restore patients' appearance and functions by replacement of missing teeth. The occlusal morphology and 3D position of the healthy natural teeth should be adopted by the dental prostheses (biomimetic). Despite computer-assisted design (CAD) software are available for designing dental prostheses, considerable clinical time are still required to fit the dental prostheses into patients' occlusion (teeth-to-teeth relationship). Teeth of an individual subjects are genetically controlled and exposed to mostly identical oral environment, therefore the occlusal morphology and 3D position of teeth are inter-related. It is hypothesized that artificial intelligence (AI) can automated designing the single-tooth dental prostheses from the features of remaining dentition.

NCT ID: NCT05056623 Recruiting - Chronic Pain Clinical Trials

Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults With Chronic Pain

Start date: July 14, 2022
Phase: N/A
Study type: Interventional

Objective: To evaluate the effectiveness of a dyadic pain management program (DPM) in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function in older adults. Hypothesis: DPM is more effective in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function among older adults than the usual care, upon completion of the DPM (week 8) and over time (week 16). Design and subjects: Clustered randomized controlled trial with neighborhood elderly centers (NEC) as cluster; 150 dyads (one older adults and his/her caregiver as one dyad) will be recruited from 22 NEC clusters. Each NEC will be randomly allocated to experimental group (receive DPM), control group (receive usual care and pain management pamphlet). Study instruments: Brief Pain Inventory; Pain Self-Efficacy Questionnaire; Short Form Health Survey-12; Depression, anxiety & stress; Caregiver Burden Inventory; 6-minute walk test and process evaluation. Intervention: DPM, each session includes exercise, interactive pain management education, practices on non-drug techniques and using a WhatsApp (WhatsApp Messenger) group to encourage home-based exercise and practice of non-drug methods. Outcome measures: Pain intensity, pain self-efficacy, perceived health-related quality of life and experience in participating DPM, to be collected at baseline (T0), week 8 (T1), and week 16 (T2). Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for within-group and between- group comparisons.

NCT ID: NCT05056467 Recruiting - Pre-Eclampsia Clinical Trials

Labor Induction in Preeclampsia High-risk Women

FORECAST-IOL
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Preeclampsia (PE) is one of the leading causes of maternal and perinatal morbidity and mortality. This pregnancy-specific disorder poses to both pregnant women and their offspring an increased risk of immediate and long-term health problems. The study team is conducting a study entitled "FORECAST" (Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial) and established the infrastructure for the first-trimester "screen and prevent" program for preterm PE. However, there is no established evidence regarding the benefit of scheduled labor induction versus expectant management among women identified as high-risk for PE with uncomplicated pregnancy at term. The investigators postulate that induction of labor at 39 weeks' gestation may possibly be an effective intervention to reduce placental complications in women with uncomplicated pregnancy by 39 weeks at high-risk PE women.