ANZCTR search results

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

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32814 results sorted by trial registration date.
  • 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.

  • Hypnotherapy for Pain, Itch and Anxiety in Burned Children: A feasibility and effectiveness study

    Hypnotherapy can be effective and superior to distraction techniques in reducing children’s pain and anxiety during painful procedures and may be beneficial in treating itch experienced after procedures. Hypnotherapy can be used in different settings, with different individuals, in varied delivery modes and durations without high technical requirements. Little is known regarding the feasibility of examining hypnotherapy with burned children in an acute setting. This research aims to find out if it is feasible to examine hypnotherapy for pain, itch and anxiety following the use of hypnotic suggestibility tests in burned children.

  • Understanding the Early Natural History of Cerebral Palsy

    This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed in their homes by a trained therapist at regular intervals up to 24 months of age, across a variety of developmental domains (such as movement, thinking skills, language, and more). This will provide, for the first time, comprehensive developmental trajectories of this group. This will contribute to the existing knowledge of CP development, which will assist clinicians and therapists in: 1) accurate diagnosis and prediction of CP, 2) providing targeted early interventions at the 'just-right' challenge, and 3) aiding in the early monitoring and prevention of secondary impairments (for example contracture and hip dislocation). Where indicated, individual participants' results from this study will be used to inform their therapy. A cost analysis of healthcare resources will also be applied as a part of the study. This study is intended to form part of a larger multi-site international study.

  • Cytology-based Circulating Tumour Cell (CTC) Testing in cancer patients and for early detection screening: The ISET-CTC study

    This trial consists of two components recruiting people who have been diagnosed with cancer, and people who may be at high risk of cancer, for example because of family history. Cancer patient study: This study will determine whether there is a difference between the number and type of circulating tumour cells in cancer patients before and after treatment. Who is it for? You may be eligible to join this study if you are aged 18-80 years, diagnosed with any cancer and have received treatment at least 3 weeks ago or will receive treatment within one week. Cancer patient study details The study aims to establish the Circulating Tumour Cell (CTC) detection method using the ISET (Isolation by SizE Of Tumour cells) device (Rarecells, France) in conjunction with cancer therapies including those offered at NIIM. There will be no changes to the participants’ cancer treatment plans. Participants will be required to provide a blood sample at the beginning of their treatment and 3-4 weeks after commencement of treatment. The blood will be processed using the ISET technology to determine the number and types of Circulating Tumour Cells. Early detection screening study: This component of the study aims to determine whether the ISET screening blood test can be used for early detection of cancer. Who is it for? You may be eligible to join this part of the study if you are aged between 18-80 years and have a family history of cancer, or have been diagnosed with chronic disease, or are attending a health check. Early detection screening study details: Participants in this part of the study will undergo a blood test at baseline and at 3-12 months following the baseline test. The ISET test has the potential to detect potentially malignant cells, and other illness causing rare cells. Additional cancer marker testing can tell, whether cancer cells are from the prostate (in men) or breast (in women). In 2023 we introduced viral activation testing using viral markers to test in chronic fatigue patients for reactivation of dormant Epstein-Barr-Virus, Cyto-Megalo-Virus, or Herpes Simplex Virus reactivation, as a high number of Circulating Rare Cells (CRC) may be linked to viral reactivation and a suppressed immune system. It is hoped that this research using a simple blood test will assist in determining both cancer treatment efficacy, and early detection of cancer when used as a cancer screening tool by measuring the presence of cancer-specific cells. Furthermore, additional marker testing on the same patient's blood sample may shed light on the origin of cancer cells, or assess potential reactivation of dormant viruses.

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