ANZCTR search results

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

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32826 results sorted by trial registration date.
  • Prospective Clinical Drug-Drug Interaction study between Rifampicin and Fusidic Acid

    For many years, two oral antibiotics, rifampicin (RifadinTM) and fusidic acid (Fucidin TM), have been used effectively in combination in Australia for patients with serious staphylococcal infections. These antibiotics are important as they are one of the few antibiotic combinations available to treat staphylococcal infections resistant to other antibiotics. These antibiotics are known to affect the levels of other drugs that a person might be taking at the same time, however very little is known about how they affect the levels of each other. This study involves taking blood samples from people being treated with rifampicin and fusidic acid and measuring levels of these antibiotics in the blood at different times to see if they affect the levels of each other. Identifying how these antibiotics affect each other could help doctors use these antibiotics in a better way in the future to treat patients and reduce side-effects. Our hypothesis is that there is a drug-drug interaction between rifampicin and fusidic acid but with currently used dosing in Australia, drug levels are appropriate for most patients. We hypothesize that some patients may have elevated or decreased drug levels of one or both drugs and the knowledge of this may be able to help improve treatment for patients in the future.

  • A comparison of the utility of a new cardiac biomarker, cardiac myosin-binding protein C, with the exisiting gold standard cardiac biomarker, troponin, in the early assessment of patients presenting to the Emergency Department with symptoms suspicious for heart attack.

    Acute chest pain is a common reason for patients to present to an Emergency Department (ED). The majority (>75%) of these individuals are at low risk of serious complications, with only a small proportion diagnosed with an acute coronary syndrome (ACS) or other major pathology. The consequences of misdiagnosis are, however, potentially catastrophic. Thus, considerable time and resources are expended to ensure the accurate triage of such patients. Currently, high sensitivity troponin (hsTn) is used to aid in the diagnosis of ACS. However, in patients presenting early (i.e. <2 hrs) after the onset of their symptoms, hsTn may not yet have been released in great enough quantities to be detected. This may result in a treatment delay for some patients. Recently a new biomarker, cardiac myosin-binding protein C (cMyC) has been identified that rises more rapidly than hsTn in patients with ACS. Our aim will be to compare the utility of cMyC with hsTnI in the early assessment of low risk patients presenting to the ED with chest pain. We anticipate that because serum cMyC levels rise more quickly than hsTnI, this new assay will be most useful in patients who present soon after the onset of symptoms.

  • Comparison of three intravenous fluids used in the treatment of children admitted to the paediatric intensive care unit

    Hypothesis: Balanced fluids (Plasma-Lyte and Compound Sodium Lactate) will lower the prevalence of high chloride rise (greater than or equal to 5mmol/L) compared to 0.9 % sodium chloride solution. Study purpose: To demonstrate if balanced solutions are better than 0.9% sodium chloride as fluid therapy in critically ill children in PICU. Study design: Single centre, open label, randomised controlled trial. Intervention: Random assignment of individual patients (less than 16 yrs) into three groups – 0.9% Sodium Chloride solution, Plasma-Lyte 148 (PL) and Compound Sodium Lactate solution (CSL). Outcomes Primary Outcome • Increase in serum chloride level greater than or equal to 5mmol/L from baseline value to the highest chloride level within 48 hours from the time of randomisation Key Secondary Outcomes • Survival free of Acute Kidney Injury (AKI) • Survival free of organ dysfunction • Survival free of new onset AKI • Duration of ICU / Hospital stay

  • Improving wellbeing after acquired brain injury with a group program to enhance participation in valued activities

    Acquired brain injuries (ABIs) such as stroke, traumatic brain injury, and multiple sclerosis are commonly associated with cognitive impairment and emotional distress. These changes significantly impact a range of outcomes, including participation in meaningful and valued activities. Valued living (the extent to which a person lives in accordance with their values) has been associated with improved psychological adjustment and functional outcome in ABI survivors (Pais-Hrit, Wong, Gould & Ponsford, 2019). Therefore, interventions increasing valued living within ABI populations may be effective in improving a range of psychological and functional outcomes. Since 2018 our research team has been evaluating the feasibility and acceptability of a new group program called VaLiANT (Valued Living After Neurological Trauma) that aims to enhance psychological adjustment in acquired brain injury (ABI) populations by combining cognitive rehabilitation and psychological therapy using Acceptance and Commitment Therapy (ACT) principles. The 8-week group program for individuals with ABI-related cognitive impairment and/or emotional distress focusses on helping participants reconnect with what gives their lives meaning while providing strategies for cognitive and emotional barriers. A Phase I study has been completed utilising a single case experimental design (SCED). Preliminary results show that wellbeing and psychological flexibility improved following participation in the VaLiANT program, and trends were evident suggesting increased mood and self-efficacy and reduced subjective memory complaints. This Phase II study aims to build on the findings of the SCED through a pilot randomised controlled trial evaluating the efficacy of the program in enhancing psychological adjustment in people with ABI. Up to four groups will run out of the La Trobe University Psychology clinic per year. Participants who would like to increase their participation in valued activities and are experiencing ABI-related cognitive dysfunction and/or emotional distress (reported by self or other) will be invited to take part. Participation will involve attending eight group sessions (2 hours per week for 8 weeks), as well as attending assessments immediately before, immediately after, and 8-weeks following the group (1.5 hours each).

  • Feasibility of a providing an online personal dementia risk profile to improve dementia risk knowledge - Dementia risk profiling tool pilot trial

    Our team has conducted focus groups with at-risk older adults to co-design an online dementia risk profiling tool. This pilot study aims to examine the feasibility of providing a personal dementia risk profile to help-seeking adults at-risk of developing dementia. The study will provide preliminary evidence on the impact of the personal risk profiles on improving Alzheimer’s disease risk knowledge (personal susceptibility and risk factors). The study will also explore the impact of improving dementia risk knowledge on motivation to engage in behaviour change and psychological effects.

  • Comparison of TAM for two relative motion extension orthotic programs (RME full time v RME during the day and a night resting orthosis) following extensor tendon repair in zones V-VI: A randomised pilot study

    To prevent rupture of any surgically repaired extensor tendon of the fingers, at least 3 to 6 weeks of splint protection is necessary. The RME finger splint positions the injured metacarpophalangeal joint(s) in greater extension than the neighbouring uninjured metacarpophalangeal joint(s). This restricts motion in the repaired finger tendons to a safe range whilst allowing motion in the intact neighbouring fingers. The aim of this study is to compare two relative motion extension (RME) approaches, with the hypothesis that there are no differences between the groups outcomes: (1) RME splint for daywear and a resting splint overnight for the first 4 weeks post repair (RME +), and (2) use of the RME splint only full time for first 4 weeks post repair (RME-only).

  • 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.

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