ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31134 results sorted by trial registration date.
  • The PEAK Study: Physiotherapy, Exercise and physical Activity for Knee osteoarthritis

    We are conducting a clinical trial to compare the clinical effectiveness and cost-effectiveness of different modes of delivering physiotherapy care to people with knee OA. Participants will undergo five consultations with a physiotherapist over 3 months (30-45 minutes) for prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education, after which participants will be reassessed remotely via paper or web-based questionnaires at 3 months and 9 months after randomisation.

  • Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties of DWN12088 following Oral Administration in Healthy Volunteers

    This first in human (FIH) Phase I study is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and PK of single and multiple oral ascending doses of DWN12088 in healthy subjects. This study will be conducted in two parts. Part 1: SAD & Part 2: MAD

  • Coach-led vs self-directed habit-based interventions for weight loss in adults with overweight and obesity: a randomised controlled trial

    The purpose of this trial is to assess the effectiveness of a coach-supported (Sum Sanos) compared with two self-directed (7SH booklet and app) habit-based interventions on 12-month weight loss outcomes in adults with overweight or obesity. Sum Sanos, is a 12-month, one-on-one coach-led, weight loss program. The methodologies that form the foundation of Sum Sanos are based on evidence of key weight-loss facilitators (i.e., habit-change, self-compassion, mindful eating, emotional management, etc.). (www.sumsanos.com) Seven Savvy Habits (7SH), is a one-off self-guided booklet or smartphone application which the participants will engage in 12-months. 7SH is focused on making simple, evidence-based, weight management behaviours, habitual. We hypothesise that a coach-supported intervention will be superior for weight loss outcomes compared with a self-directed approach

  • The effects of a clinically feasible application of low-level laser therapy on the rate of orthodontic tooth movement: A triple-blinded randomized controlled clinical trial.

    This study will investigate if monthly (4 weekly) applications of low level laser therapy (LLLT) affects the amount of orthodontic tooth movement during canine retraction. The aim of this study is to investigate the effect of 4-weekly applications of LLLT on the rate of tooth movement when 150-gram distalisation forces are applied to maxillary canines over a 12-week period. Patients with mild to moderate crowding who require extraction of maxillary first premolars and canine retraction (with moderate anchorage) as part of their orthodontic treatment are to be recruited from the orthodontic waiting list at Sydney Dental Hospital.

  • Curcumin for the Treatment of Digestive Complaints in Adults

    In this randomised, double-blind, placebo-controlled study, 80 adults who are currently experiencing digestive complaints will be randomly assigned to receive capsules containing either a curcumin extract (500mg a day) or placebo for 60 days. We will assess change in digestive symptoms, intestinal bacteria, general mood, and overall quality of life.

  • Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (SALIENT)

    This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.

  • Use of rotational thromboelastometry (ROTEM) guided blood product utilisation in cirrhotic patients undergoing interventional procedures.

    Routine coagulation studies, such as INR and platelet count, do not accurately reflect the risk of bleeding in chronic liver disease (CLD) patients due to the complex changes in the coagulation system that occurs in CLD. Subsequently, the use of blood products in this setting is resource intensive and not evidence based. It is suggested that rotational thromboelastometry (ROTEM), can predict the risk of thrombosis and bleeding in CLD. The aim of this proposal is to study the effects of a ROTEM-guided blood product protocol in patients with CLD undergoing interventional procedures associated with a moderate to high risk of bleeding. Patients randomized to the ROTEM arm will receive blood products guided by the ROTEM algorithm, developed for the trial, prior to their invasive procedure. Blood products used will be compared to those used in the standard of care arm at each of the participating sites. It is anticipated that the study will show a significant reduction in blood product usage associated with the ROTEM arm. It is hoped that findings from this study will help establish improved evidence based guidelines for patients with CLD undergoing invasive procedures.

  • The use of digital technology to increase school children access to dental services

    Why is this study needed? Despite great improvement in child oral health, some children still suffer from higher levels of tooth decay. Geographic and socioeconomic barriers and the lack of access to dental care services are among common reasons for poor oral health in children. Although dental caries is largely preventable, it is still the most common childhood chronic disease. If dental caries remains untreated, it can have a significant impact not only on children’s teeth but also on their general health, wellbeing and quality of life. Historically in Australia, school dental therapists have been responsible for providing dental care for school children through a State-funded programme called the School Dental Services (SDS). The current SDS has been unable to provide sustainable dental care to all school children due to a reduction in workforce participation and limited resources. Thus, there is a need for an equitable and cost-efficient model of dental care to enhance the opportunity to provide sustainable dental care for school children, particularly, among those living in rural or remote regions. What will we do? We propose a paradigm shift in the current service through the introduction of user-friendly technology to provide a foundation for sustainable SDS. The current project is aimed to take advantage of mobile technologies, using a smartphone camera to acquire dental images from a child’s mouth at his/her school and forwarding images electronically to an offsite dental practitioner to assess and prepare recommendations remotely. Such an approach will enable dental practitioners to assess the teeth of school children without needing to be physically present. This would help to prioritise high-risk children and provide them with a quick treatment pathway and avoid unnecessary referrals or travelling.

  • Effects of a short message service to improve compliance with fasting in patients undergoing elective surgery

    We performed an audit to determine the extent of prolonged and excessive fasting amongst elective surgery patients. We aimed to compare the actual fasting times of elective surgery patients to the recommended fasting times as per our institution’s guidelines. Additionally, we completed a quality improvement project aiming to determine whether notification of fasting times by short message service (SMS) the day before surgery would improve fasting times and reduce excessive fasting. We hypothesised that the usage of an SMS reminder one day prior to surgery would assist patients in adhering to fasting guidelines and thus reduce excessive fasting.

  • The effect of Colchicine on the release of Neutrophil Extra-cellular Traps after Percutaneous Coronary Intervention in Acute Coronary Syndrome Patients..

    Percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients is associated with a higher incidence of peri-procedural myocardial infarction. An increased release of neutrophil-derived inflammatory products is known to contribute to this process. Colchicine is a well-established anti-inflammatory drug, however its role in attenuating post-PCI release of activated neutrophil-mediators is not well known. This pilot study aims to investigate whether peri-procedural colchicine would suppress local release of Neutrophil Extracellular Traps, and its components Human Neutrophil Elastase and Myeloperoxidases, in both ACS and stable angina pectoris patients.

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