ANZCTR search results

The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of MRX-I, an orally administered antibiotic. There will be three Parts to the study. Part 1 will assess the safety, tolerability and pharmacokinetics of single dose administrations of MRX-I compared with placebo. Part 2 will assess the safety, tolerability and pharmacokinetics of a 14 day administration of MRX-I compared with placebo. Part 3 will compare the safety and tolerability of a 28 day administration of MRX-I with linezolid an active comparator. (please refer to ACTRN12613001206718)

Eosinophilic oesophagitis (EOE) is a recently discovered condition which involves allergic inflammation in the oesophagus. This research project aims to conduct the first study of a dietary intervention for the treatment of EOE in children. As part of the research we also aim to mechanistic studies into the pathophysiology of this condition. This study is being completed in two stages. In Stage 1, children with suspected EOE undergoing gastroscopy will be invited to take part into the study. Only patients with confirmed EOE will progress to stage 2 of the study. In Stage 2, children with confirmed EOE will be randomly allocated to one of two interventions: four-food elimination diet (avoiding cow's milk, egg, soy and wheat) plus omeprazole, versus omeprazole alone as the control intervention (for 8 -12 weeks in each arm of the study).

At least a third of people with eating disorders bulimia nervosa or binge eating disorder will be overweight. However, therapies for such disorders do not address weight management well. Similarly, treatments for obesity do not address the eating disorder symptoms , and whilst there may be short term reductions in binge eating with weight loss therapy this is not sustained over time. We have developed an approach that integrates standard cognitive behaviour therapy (CBT) for eating disorders with behavioural weight loss management adapted for this group i.e. HAPIFED. The present study is a preliminary controlled trial of HAPIFED versus CBT.

The study is evaluating whether testing for certain types of Human Papillomavirus (HPV) is a more effective cervical cancer screening test than the Pap Smear test. Who is it for? You may be eligible to join this study if you are female, aged between 25 years and 64 years, an Australian resident in Victoria, and attends routine cervical screenings at one of the study’s participating health care practice. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will undergo three-yearly image read cytology screening with reflex HPV triage testing for low grade Possible/Definite Low-Grade Squamous Intraepithelial Lesion (p/d LSIL) smears. Participants in the second group will undergo six-yearly HPV screening with types 16/18 (+/- 45 in pilot study) genotyping and cytology triage of intermediate risk women with other oncogenic HPV infection. Participants in the third group will undergo a six-yearly HPV screening with types 16/18 (+/- 45 in pilot study) genotyping and dual-stained (DS) cytology (with p16/Ki67) triage of intermediate risk women with other oncogenic HPV infection.

The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of MRX-I, an orally administered antibiotic. There will be three Parts to the study. Part 1 will assess the safety, tolerability and pharmacokinetics of single dose administrations of MRX-I compared with placebo. Part 2 will assess the safety, tolerability and pharmacokinetics of a 14 day administration of MRX-I compared with placebo. Part 3 will compare the safety and tolerability of a 28 day administration of MRX-I with linezolid an active comparator.

Frail older people living in residential care are often prescribed unnecessary medications. We want to test whether stopping some of their drugs will improve their life expectancy, quality of life & independence & reduce their risk of falling. We will stop medications thought to cause harm in older people and medications that may not provide any overall benefit. The primary aim is to determine whether deprescribing is safe among older people living in residential aged care facilities (RACF). The secondary aims are to determine whether medication reduction improves physical health, cognitive function, and quality of life.

The study is comparing two techniques to assess heart function in patients referred to the Peter MacCallum Cancer Institute. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been referred to the Peter MacCallum Cancer Institute for assessment of heart function. Why might this test be needed? A "cardiac gated blood pool scan" (CGBS) is a commonly requested to scan to identify problems with your heart function. Impaired heart function can be a serious adverse effect of chemotherapy and other new anti-tumour agents. Depending on the type of treatment you are receiving, it is therefore important to identify any damage to the heart following treatment or to check heart function before starting treatment. If damage is found, the dose of your treatment may be reduced or a different type of treatment may be chosen. How is the standard test performed? The conventional test is a nuclear medicine imaging test which involves labelling blood with a radioactive substance, and then measuring the amount of blood in the heart during different parts of the heart beat. A special camera, called a gamma camera, measures activity in the heart which is matched (also called “gated”) to your heart rhythm. This test is called a “cardiac gated blood pool scan” (CGBS). The amount of blood being pumped out of your heart, called the left ventricular ejection fraction (LVEF), can then be measured. How is the new test for this study performed? The new test is performed by labelling your blood with a different radioactive substance, called gallium-68. This enables images to be obtained on a newer type of camera, called a positron emission tomography (PET) scanner. What are the potential advantages of this new test? The PET scanner produces three-dimensional (3D) images of higher quality and in a shorter amount of time than the conventional test. How might this study contribute to patient care? The knowledge acquired from this study will be used to validate this new test. If we can demonstrate that it is at least as good or better than current technology, it may replace the existing test in the future. Trial details. This study aims to recruit 40 patients. Both the conventional and new CGBS will be performed in each patient, and the results compared. The new test involves an additional scan performed in a positron emission tomography (PET) scanner. Images of you heart will be performed for 5-10 minutes after being positioned on the bed of the PET scanner. The new scan will be performed shortly after the conventional scan.

Sub-groups of the Australian population are considered at risk of zinc deficiency but uncertainty remains in the interpretation of zinc biomarkers. Zinc has no definable, accessible body stores. Our proposal aims to explore the usefulness of zinc transporters, which regulate the movement of zinc into and within-cells, as potential biomarkers of zinc status in humans. We aim to examine the feasibility of using peripheral blood mononuclear cells for the assessment of zinc status. If our approach is successful we will have the potential of investigating zinc status in greater detail.

The aims of the current study are to evaluate the efficacy of a validated internet-based cognitive behavioural therapy (iCBT) program (CRUfAD's Sadness Program) for depression when delivered to individuals who meet criteria for a major depressive episode comorbid with Type 1 or Type 2 diabetes. This study will recruit 100 people with depression and diabetes and randomly allocate them to 1 of 2 conditions: Diabetes treatment as usual (TAU) + iCBT for depression or Diabetes TAU + delayed iCBT for depression (TAU waitlist control). The primary outcomes will be to determine the impact of online CBT for MDD on depression symptoms and remission rates, as well as on diabetes-specific outcomes. We will also measure adherence to the course material and satisfaction with the intervention generally.

Question: Is group work-circuit physiotherapy an effective model for orthopaedic rehabilitation or is individual therapy more beneficial? Design: Randomised control trial, single-blinded. Participants: Twenty-one in-patients with an orthopaedic problem participated in rehabilitation at John Flynn Private Hospital, Tugun, Queensland. Intervention: All participants received physiotherapy twice daily, six days a week for a variable period (one to three weeks) depending on length of stay (LOS). Each participant had an individualised physiotherapy session in the morning for 30 minutes and then were randomly allocated a further 30 minutes of individualised treatment (Group A) or participated in a group work-circuit physiotherapy program (Group B) in the afternoon. Outcome measures: Measures were undertaken at admission/discharge for all patients admitted to the study. Demographics (age, gender, condition, LOS), pain level (Visual Analogue Scale) and the ability to straight leg raise (able/unable) were recorded. Balance and mobility measures included: the Berg Balance Scale, the Modified Elderly Mobility Scale, the 10 metre walk test and the Timed Up and Go test. Results: This pilot study demonstrated that both the individual and group work-circuit interventions are effective treatment options for a mixed group of orthopaedic patients. Participants in individual and group work-circuit interventions improved in all balance and mobility outcome measures (p<0.05), but only the work-circuit group reported less pain (p<0.05). Conclusion: These preliminary results show that both intervention and models are effective for the rehabilitation of people with orthopaedic problems. These results indicated that group work-circuit therapy is a cost-effective model for orthopaedic rehabilitation.