Safety and Immunogenicity of a Recombinant Subunit Herpes Zoster Vaccine in Patients With Rheumatic Diseases Undergoing Immunosuppressive or Biologic/Targeted DMARD Therapies: a Double-blind Randomized Placebo-controlled Trial

A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies

开始日期2025-01-01

申办/合作机构

Tuen Mun Hospital

NCT06472050 / Not yet recruiting临床4期IIT

Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial

The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.

开始日期2024-09-01

申办/合作机构

Tuen Mun Hospital

NCT05731349 / CompletedN/AIIT

Early Sepsis Care With the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the Emergency Department: A Hybrid Type 1 Effectiveness-Implementation Pilot Stepped Wedge Randomised Controlled Trial (NEWS-1 Trial Pilot Study)

The goal of this pilot clinical trial is to determine the feasibility of conducting a fully powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided by early warning score in adult emergency department (ED) patients who have infection. The main questions it aims to answer are:
* Is it feasible to execute the trial procedure and fulfill the progression criteria to a full-scale trial?
* Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of adult ED patients with a clinical diagnosis of infection and a National Early Warning Score 2 (NEWS2) equal to or greater than 5?
* What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle in the ED settings?
Participants will receive the following SSC Hour-1 Bundle care during the intervention period:
* Blood lactate level measurement
* Blood cultures collection before administering antibiotics
* Broad-spectrum antibiotics
* Intravenous fluid
* Vasopressors if the blood pressure remains low during or after fluid replacement to maintain the mean arterial blood pressure equal to or greater than 65 mmHg
Researchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to or greater than 5 and patients who receive standard treatment based on clinical judgement to see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult ED patients with infection.

开始日期2023-04-01

申办/合作机构

香港大学

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项与 Tuen Mun Hospital 相关的文献（医药）

2024-12-01·The American Journal of Emergency Medicine

Factors influencing secondary overtriage in trauma patients undergoing interhospital transfer: A 10-year multi-center study in Hong Kong

Article

作者: Hau, Eunice Siu Shan ; Cheung, Nai Kwong ; Chui, Kenneth Ka Kam ; Leung, Ling Yan ; Hung, Kevin Kei Ching ; Graham, Colin A ; Chan, Yan Yi ; Leung, Chun Yu ; Ha, Pauline Pui Kwan ; Cheng, Chi Hung

BACKGROUNDWith the development of regionalised trauma networks, interhospital transfer of trauma patients is an inevitable component of the trauma system. However, unnecessary transfer is a common phenomenon, and it is not without risk and cost. A better understanding of secondary overtriage would enable emergency physicians to make better decisions about trauma transfers and allow guidelines to be developed to support this decision making. This study aimed to describe the pattern of secondary overtriage in Hong Kong and identify its associated factors.METHODSThis was a retrospective review of 10-years of prospectively collected multi-center data from two trauma registries in the New Territories of Hong Kong (2013-2022). The primary outcome is secondary overtriage, which was defined as early discharge alive within 48 h, Injury Severity Score (ISS) <15, and no surgical operation done. Patient characteristics, physiology, anatomy and investigation variables were compared against secondary overtriage using univariate and multivariable analyses.RESULTSDuring the study period, 3852 patients underwent interhospital transfer from a non-trauma center to a trauma center, and 809 (21 %) of the transfers were considered secondary overtriage. The secondary overtriage rate was higher in pediatric age groups at 34.8 % (97/279). Logistic regression analysis showed secondary overtriage to be associated with blunt trauma and an Abbreviated Injury Scale (AIS) score of <3 for head or neck, thorax, abdomen and extremities.CONCLUSIONInterhospital transfer is an essential component of the trauma system. However, over one-fifth of the transfers were considered unnecessary in Hong Kong, and this could be considered to be an inefficient use of resources as well as cause inconvenience to patients and their families. We have identified related factors including blunt trauma, AIS <3 scores for head or neck, thorax, abdomen and extremities, and opportunities to establish and improve on transfer protocols. Further research should be aimed to safely reduce interhospital transfers in the future to improve the efficiency of the Hong Kong trauma system.

2024-10-01·Supportive Care in Cancer

StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a pilot study

Article

作者: Tran, William ; Kennedy, Samantha K F ; Behroozian, Tara ; Chow, Edward ; Soliman, Hany ; Day, Marley ; Wong, Cindy ; Vesprini, Danny ; Leung, Eric ; Kuszaj, Olivia ; Gallant, Francois ; Lee, Shing Fung ; Szumacher, Ewa ; Carothers, Katherine ; Gojsevic, Milena ; Yewhans, Tiegsti ; Wong, Henry ; Karam, Irene ; Zhang, Liying ; Rajeswaran, Thenugaa ; Rakovitch, Eileen ; Wronski, Matt ; Chen, Hanbo

PURPOSEPrevious literature has produced heterogeneous results on StrataXRT for prevention of acute radiation dermatitis (RD) in breast cancer. This pilot study aimed to assess the feasibility and efficacy of StrataXRT in a cancer center.METHODSThe study consisted of five cohorts: (1) patients with large breasts treated with local radiation therapy (RT) either in the supine position or (2) the prone position, (3) patients receiving locoregional breast RT with any breast size, and (4) patients receiving chest wall RT, either locally or (5) locoregionally. The primary endpoint of the study was RD grade as assessed using the Common Terminology Criteria for Adverse Events. Secondary endpoints included incidence of moist desquamation (MD), patient- and clinician-reported skin assessments, patient quality of life as assessed by the Skindex-16, and patient satisfaction. These outcomes were compared with those from a published trial from the same institution assessing standard of care and Mepitel Film (MF) as prevention of breast RD.RESULTSForty-five patients receiving RT to the breast or chest wall were enrolled. Two withdrew, leaving 43 evaluable patients. Overall, two (4.7%) patients had grade 3 RD, 14 (32.6%) had grade 2 RD, and 27 (62.8%) had grade 1 RD. Ten patients (23.3%) developed MD during/after RT.CONCLUSIONStrataXRT is effective in preventing grade 3 RD in patients, and the most promising results were observed within the prone cohort. Further research includes evaluating the efficacy of StrataXRT against the standard of care for the prophylaxis of RD.TRIAL REGISTRATIONThe study protocol was registered at ClinicalTrials.gov (identifier: NCT05594498) on October 13, 2022.

2024-10-01·Pathology

Cytokeratin 15 is a novel and independent predictor of poor outcome in luminal B HER2-negative breast carcinomas

Article

作者: Tse, Gary M ; Li, Joshua J X ; Lau, Sin Leung ; Loong, Thomson C ; Tam, Fiona ; Tsang, Julia Y ; Lee, Dennis H Y

Cytokeratin 15 (CK15) has been described as a stem cell marker in human organs and its expression is seen in breast tissue. CK15 expression is associated with aggressive features in endometrial and oesophageal cancers, but data on the breast are lacking. This study aims to investigate the clinicopathological associations and prognostic significance of CK15 in breast carcinomas. A multi-institute cohort of breast carcinomas were retrieved. Clinicopathological and outcome data were obtained and compared with immunohistochemical expression CK15 and a panel of biomarkers. In total, 1,476 cases were included, with an expression rate of 3.5%, preferentially expressed in luminal subtypes (p=0.024), with luminal B carcinomas being the highest (4.7%), as opposed to basal-like (1%) and HER2-overexpressed carcinomas (0%). Except for nodal stage (p=0.013) and nodal metastasis (p=0.048), oestrogen (p=0.035) and progesterone receptor (p=0.001) positivity, there were no associations with other clinicopathological parameters. A trend was observed with shorter breast cancer specific survival (BCSS) in CK15-positive luminal B carcinomas (p=0.062). On further subgroup multivariate analysis of luminal B HER2-negative carcinomas, CK15 expression exhibited robust correlation with shorter BCSS (HR=9.004, p=0.001) and disease-free survival (HR=7.085, p<0.001). Restricted to luminal breast carcinomas, specifically luminal B HER2-negative, CK15 is demonstrated to be a robust independent predictor of higher risk of recurrence and shorter survival, with potential as a clinical prognostic marker and an exclusive stem cell marker for this subgroup of carcinomas.

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