ANZCTR search results

The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are: 1. Is the digital health program usable? 2. Is the digital health program acceptable? 3. Do patients adhere to the digital health program? Researchers will compare a group using the digital prehabilitation program with standard care to see if the program is feasible and explore any differences in health outcomes. Participants will * Use a digital health mobile phone application to guide you through exercise, nutrition and preparation for surgery. * Engage in telehealth consultations. * Complete questionnaires * Complete exercise testing

This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.

A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled 3 Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PROT-001, and the Effect of Food and Age on the Pharmacokinetics of PROT-001 in Healthy Adult Participants

The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.

Hip fractures are common, especially in older adults, and they can have a big impact on health and quality of life. In Australia, hip fractures are a significant healthcare challenge. After surgery, patients often need rehabilitation to regain mobility, but this usually involves long hospital stays. The RITH4Hips trial will determine if a program where patients receive rehabilitation at home (instead of in the hospital) is similar to conventional inpatient rehabilitation. Objectives: The main goal of this study is to find out if rehabilitation at home after surgery for a hip fracture works as well as rehabilitation in the hospital. The investigators also want to see if the home rehabilitation program can reduce the time spent in a hospital bed and improve other aspects like quality of life, mobility, and pain management. Methods: This study will involve older adults who have had surgery due to a low-trauma hip fracture. Participants will be randomly assigned to either the usual care inpatient rehabilitation or the Rehabilitation in the Home (RITH) program. The investigators will measure outcomes such as how well patients can move, how much pain they experience, how their quality of life improves, and how much time they spend in the hospital. Expected Outcomes: The investigators expect that the home rehabilitation program will be just similar to inpatient rehabilitation in helping patients recover mobility. The investigators also hope to find that it will reduce the time patients spend in a hospital bed, improve their quality of life, reduce fear of falling, and lessen the burden on carers. Additionally, the investigators aim to show that the home program is more cost-effective than hospital-based rehabilitation.

This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.

Objectives: The primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal cancer surgery, compared to usual care alone. The secondary aims will be to obtain data on the likely difference in key outcomes including: (i) Quality of life (EORTC QLQ-C30 and QLQ-CR29) (ii) Number of days at home within 30, 90 and 365 days after surgery (DAH-30, 90, 365) (iii) Quality of recovery (QoR-15) (iv) Cost-effectiveness (v) Implementation metrics (RE-AIM) Our hypothesis is that the PRIORITY-CONNECT 2 intervention will be more effective in reducing postoperative complications and more cost-effective than usual care. Study design: Pragmatic Randomised Type I Hybrid Effectiveness-Implementation Trial. Planned sample size: To achieve the primary aim, 564 participants will provide 90% power to detect a 15% difference in 30-day postoperative complication rates between the intervention and control groups. The sample size calculation accounts for up to 10% loss to follow-up, 5% non-compliance and a two-side alpha of 0.05. Selection criteria: A sample of 564 participants undergoing colorectal cancer surgery including open, laparoscopic or robotic-assisted surgery (mostly, anterior resection, sigmoid colectomy, hemicolectomy, total proctocolectomy, subtotal colectomy, total colectomy) at sites throughout Australia will be included. These are common colorectal cancer surgeries performed at the participating centres. All the surgeons involved in this study have clinical appointments in their respective hospitals. Inclusion: Adults aged =18 years undergoing elective major surgery for colon or rectal cancer with curative intent; and consulting a colorectal surgeon at least 1 week prior to scheduled surgery. Exclusion: Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease; or cognitive impairment such that they are unable to provide informed consent. Study Procedure: Participant's treating team will screen and provide an information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). The intervention will include the delivery of usual care and evidence-based exercise, nutritional, psychological and nursing interventions, and / or group-delivered peer support. All interventions will be conducted before and after surgery. Duration of the Study: Approximately 60 months. Funding: Medical Research Future Fund (MRFF) 2023 Early and Mid-Career Researchers (Application ID: 2031563). Sponsor: The University of Sydney.

This study is intended to test a new treatment for a condition called adhesive capsulitis, also known as frozen shoulder. The treatment being tested is called bevacizumab. Participants will receive a single dose of bevacizumab (50mg, 100mg, 150mg, or 200mg) via injection into their shoulder joint. After the injection, participants will return to site 6 times over the course of a year for safety assessments, questionnaires to track pain levels, and range of movement tests conducted by a physiotherapist. The main goal of this study is to: 1. Evaluate the safety and effectiveness of bevacizumab when it is injected into the frozen shoulder joint. 2. Determine the maximum dose of bevacizumab that can be given without side effects. This is an investigator initiated clinical trial sponsored by Macquarie University. There will be a maximum of 28 participants enrolled and the only site involved in recruitment is Macquarie University.

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease