ANZCTR search results

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

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31097 results sorted by trial registration date.
  • Evaluation of integrated online and face-to-face support for complex youth mental health disorders: Piloting of eOrygen.MOST

    This study will pilot a novel model of care integrating face-to-face and online support (Moderated Online Social Therapy) for young people receiving specialist treatment for complex mental health disorders. The primary aims are to assess the feasibility, safety and acceptability of this model of care, with additional aims to assess changes in participants’ psychological and social outcomes and to assess the relationship between these outcomes and usage of eOrygen.MOST.

  • Transvenous Cardiac Implantable Devices and Pulmonary Hypertension: An Echocardiographic Evaluation in a Cohort Study

    Previous case studies have shown that intracardiac lead thrombus can cause pulmonary embolism (PE). However, the incidence of new or worsening pulmonary hypertension after cardiovascular implantable electronic devices (CIED) lead placement has not been well investigated. Pulmonary hypertension after CIED implantation will subsequently result in right heart failure and increase morbidity and mortality. This study is aimed to: I. Determine the incidence and factors associated with development of pulmonary hypertension and right ventricular dysfunction in patients with CIEDs. II. Determine the role of anticoagulation in the prevention of pulmonary hypertension in patients with CIEDs.

  • Intravesical Microdox versus normal saline bladder instillation for recurrent urinary tract infections: A Randomised Controlled Trial.

    The aim of this study is to evaluate the effectiveness of microdox bladder rinse in patients with recurrent UTIs. Efficacy will be assessed by the number of symptomatic UTI’s during the 3 month treatment period and 3 months following completion of Microdox. Women must meet criteria for recurrent UTI i.e. > 2 documented symptomatic UTIs in preceding 12 months. We are aiming to exclude catheterised women. This is a multi-centre, double blinded, randomised trial. Intravesical Microdox treatment is superior to intravesical normal saline wash for the prevention of recurrent UTI’s at 6 months. There is currently no human trials using Microdox in the bladder. Most research on Microdox is based on wound care. There is one recent randomized trial using normal saline wash in catheterised patients and the UTI rate decreased markedly. The cost and suffering resulting from Recurrent UTI’s is significant. Hence better treatments of Recurrent UTI’s is desperately needed, particularly treatment that won’t contribute to the growing antibiotic resistance, and we are hoping that Microdox could be the answer.

  • Younger Women's Wellness Program for Premenstrual Syndrome in University students

    The study aims to explore the feasibility and acceptability of the younger women’s wellness program for PMS in University students .In Phase one, Feasibility will be determined through composite analysis of eligibility, recruitment, retention, protocol adherence, missing data, and sample size estimates. In phase two, participants in group 1 will be contacted after completing the 12-week study for an in-depth semi-structured interview (30-40 minutes). The aim of Phase two qualitative study is to understand in-depth the interventional components that were helpful for women and those that were not. Further information will also be elicited from informants about the content and delivery methods that are likely to yield maximum likelihood of participant retention.

  • Blood stage antimalarial activity of tafenoquine in healthy subjects infected with Plasmodium falciparum

    This is a single-centre, open-label phase 1b study using the P. falciparum induced blood stage malaria (IBSM) model to evaluate the antimalarial activity of a single oral dose of tafenoquine in healthy subjects. The study will be conducted in three parts. Part 1 will be composed of an initial cohort of four subjects followed by up to three cohorts of up to eight subjects per cohort, and will evaluate the potential of different single oral doses of tafenoquine to clear asexual blood stage P. falciparum parasites and inhibit the development of the sexual stage of the parasite (gametocyte) responsible for transmission to mosquitoes. Part 2 will be composed of up to two cohorts of up to eight subjects per cohort, and will evaluate the potential of a single oral dose of tafenoquine administered prior to intravenous inoculation with blood stage P. falciparum to protect against infection. Part 3 will be composed of up to two cohorts of up to eight subjects per cohort and will determine if a single oral dose of tafenoquine is active against mature gametocytes, and is able to block transmission to mosquitoes. Parts 2 and 3 of the study are optional and are dependent on the results obtained in Part 1.

  • Effect of gait training on walking stability in people with Parkinson's disease

    The aim of this program is to reduce the risk of falls in people with Parkinson's disease using non-invasive technology to monitor and improve their walking balance. Falls are a major cause of hospitalisation in people with PD, with 60% of all sufferers experiencing a fall each year. There is strong evidence that fallers walk with greater side to side head movement along with shorter step length and a slower cadence than non-fallers. Improving gait stability by retraining the way these individuals walk may thus have great potential to reduce the risk of falls and consequently reduce fall-related hospitalisations. A cross sectional study involving approximately 30 people with PD with mild to severe disease severity will be conducted. The effect of real-time feedback on walking mechanics will be investigated. Participation in this research will require individuals to visit the school of Exercise Science's Biomechanics Laboratory at the Brisbane campus of the Australian Catholic University on two separate occasions separated by approximately 1 week to complete a series of walking assessments. During these assessments, walking mechanics will be evaluated using a 3-dimensional motion capture system. The protocol will involve each participant receiving real-time biofeedback.

  • Future Health Today: A cluster randomised controlled trial of quality improvement activities in general practice

    The purpose of this study is to determine if a new software (called Future Health Today) can be used by general practices to optimise diagnosis of cancers and management of chronic kidney disease. Who is it for? You may be eligible for this study if you are over the age of 18, have either chronic kidney disease or are considered at high risk for an undiagnosed cancer, and attend one of the practices enrolled in this study. Study details General practices will be randomly assigned to one of two trial arms. One arm will receive the software and educational activities focusing on prevention of cardiovascular conditions in those with chronic kidney disease and the other will receive software and educational activities focusing on identification of patients with potential undiagnosed cancer. Both clinics will receive modules regarding quality improvement. Participants who are patients of the general practice involved in this study will attend their general practice as per usual. Data will then be collected from practices 12 months after enrolment to determine if there have been changes in management of patients and whether this has had an impact on diagnosis of cancers and management of chronic kidney disease. This research will help to understand the role of technology and education activities in facilitating quality improvement in general practice.

  • Double-blind, placebo-controlled, cross-over trial of LivauxTM for the treatment of constipation and microbiome restoration in Parkinson’s disease.

    The aim of this study is to determine the efficacy of Livaux, a prebiotic supplement made from gold kiwifruit, in improving the gut microbiome and symptoms of constipation in patients with diagnosed Parkinson's disease. Approximately 50 patients will be randomised to receive either 2400mg of Livaux or placebo daily for six weeks in a double-blind cross-over study. The study will last for approximately 20 weeks with a 4-week screening period, two 6-week treatment periods with a washout period of 4 weeks in between. Patients will be required to maintain a bowel diary for the duration of the study, provide food and fluid diaries during the screening and treatment periods, and provide faecal and other specimens on four occasions to enable quantification of the microbiome and its metabolites. Colonic transit time will be measured at the end of each treatment period to determine the effect of transit time on constipation. The final study endpoints will be to determine whether Livaux has any impact on transit time and the quality of the microbiome.

  • Investigating the effect of direct current brain stimulation on symptoms associated with obsessive-compulsive disorder.

    The overall aim of this research is to advance the knowledge of transcranial direct current stimulation (tDCS) in the treatment of OCD. A double-blind randomised controlled trial will be conducted involving active tDCS vs sham tDCS over the brain regions that have been implicated in OCD in a group of general OCD patients. We hypothesise that the participants receiving active tDCS will show clinically and statistically significant improvement in their OCD symptoms, their depression and anxiety symptoms, a reduction in obsessive beliefs and an increase in their quality of life compared to those receiving the sham condition. We also anticipate that there will be an improvement in the ability to inhibit impulses and think flexibly in those receiving the active tDCS.

  • Assessment of cognitive function and cerebral blood flow in patients undergoing aortic valve intervention

    Aortic stenosis is a common condition caused by a narrowing of the aortic valve that can be resolved by replacing the valve. Traditionally this has been performed with open-heart surgery, which is effective but may be associated with significant complications. Transcatheter aortic valve intervention (TAVI) is an alternative to surgical replacement that has resulted in improved results for patients at high and intermediate risk for surgery. It is understood that surgical valve replacement may negatively affect cognitive function, though the effect of TAVI on cognitive function is less clear; relieving the narrowing improves blood flow to the brain and may improve cognition, however, the procedure may lead to small blood clots being sent to the brain that limit this improvement. In this study, we are looking to examine whether patients who undergo the different aortic valve procedures may have disturbances in the blood flow in their brain after the procedure and how this affects mental performance. We will use transcranial Doppler ultrasound (TCD) to measure blood flow in the brain during a series of mental tests and compare the results before and after the procedure.

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