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Multiple sclerosis (MS) is a potentially devastating disease of the central nervous system and progressive MS, which occurs in up to two-thirds is the most severe form. Current therapies for MS have limited effect in the progressive stage. Recent studies have confirmed that the primary cause of MS is latent infection with Epstein-Barr virus (EBV). We have conducted a systematic review of existing drugs with potential anti-EBV effects. Through an internationally peer reviewed process we have selected two promising agents with known acceptable safety profiles and proven efficacy against EBV. In order to maximise efficiency to find the best such treatment we have partnered with experts in the UK in designing a state of the art trial to test these agents in progressive MS. We propose to run an innovative adaptive phase III clinical trial to evaluate the effectiveness of promising anti-EBV therapies for progressive MS by repurposing old drugs (Spironolactone and Famciclovir) for a new indication. In stage 1 we will compare the effect of the two agents against dummy-treatment (placebo) in their ability to reduce antibodies to EBV and the amount of EBV shed in saliva in relatively small numbers (total 150) over 6 months. The agent that produces the largest reduction in these measures will then progress to state 2, where the clinical effectiveness of this treatment will be compared to placebo over a period of 3 years in a larger group (total 300). This study will facilitate the participation of Australians with progressive MS in a novel trial of anti-EBV therapies. If the outcomes of this study are positive then the impacts would be immense. It has been noted that the lack of treatment for progressive forms of MS is the single greatest unmet need for people with MS. The advent of an effective therapy to prevent further progression or even improvement would be a huge step forward. There would be similar implications for the wider MS community.

More than 20,000 heart operations are carried out each year in Australia. While most patients survive their surgery, many spend a long period of time in hospital recovering. Delayed recovery may happen as a result of the complexity of the surgery, or due to medical problems that occur after the operation such as irregular heart rhythms, stroke or kidney failure. These medical problems following surgery are known as postoperative complications. Postoperative complications can lead to long-term ill health and loss of independence, as well as prolonging hospital stay. In addition, a longer stay in hospital may expose patients to risks such as infection and predispose to physical deconditioning. Reducing length of stay in hospital is associated with improved recovery from surgery, in addition to reduced healthcare costs. Previous studies have suggested that a new drug called ‘angiotensin II’ can successfully be used to treat low blood pressure in critically unwell patients. Drugs to preserve blood pressure are also often needed in heart surgery, however there are no large studies that have assessed the effectiveness of angiotensin II in patients during and after heart surgery. We previously carried out a small study that showed that using the drug angiotensin II during and after cardiac surgery is possible (ACTRN12621000195853). This knowledge has allowed us to design a new study to compare the use of angiotensin II to the current standard drug used to treat low blood pressure after heart surgery, called noradrenaline. In our previous research, patients who were given angiotensin II had fewer postoperative complications (although this difference wasn't statistically significant) and shorter lengths of stay in hospital. However, before we can recommend that angiotensin II is better for treatment of low blood pressure during cardiac surgery, we need to confirm these findings in a much larger study to make sure that our previous study findings were not simply the result of chance. In this study we will assess whether the administration of angiotensin II reduces length of hospital stay compared to noradrenaline.

Neck pain is disabling and characterised by recurrent pain episodes. Treatment is often delivered by health practitioners. This study aims to enhance proprioception for people with neck pain to enable self-recognition of potential contributing factors to the perpetuation of their condition; reduced pain and disability; and, improved internal locus of control. The intervention consists of x5 1-hour physiotherapist-guided group exercise and education sessions; a daily home exercise program (under 30-minutes); and journaling. The program will be assessed by collecting information regarding pain, disability, locus of control, and participant experience of the intervention.

This is a randomised controlled, parallel design, single-blinded trial to examine the efficacy of a novel EEG neurofeedback intervention in comparison with the control condition for individuals with neuropathic pain after SCI. Participants will be randomised to receive EEG neurofeedback (Treatment condition) or ‘treatment as usual’ (Control condition). Participants in the treatment condition will complete a session of EEG neurofeedback once a day for 20 days over a 4-week period. Each session will comprise 5x2.5-minute blocks of EEG neurofeedback with a break of up to 30 seconds between each block. Participants in the control condition can continue with all the treatment options that they would normally have access to in the community. We hypothesise that 1) EEG neurofeedback intervention will show greater reduction in self-reported pain intensity for people with neuropathic pain after SCI following the intervention compared to the control condition. 2) Completion of the EEG neurofeedback intervention may be associated with pre- to post-intervention improvement in psychosocial factors.

Cognitive ability, including memory and problem solving, declines with normal aging. For some people, this decline is more rapid, resulting in a condition known as mild cognitive impairment (MCI). MCI is a precursor for neurological conditions including dementia and Alzheimer’s disease. Despite considerable biotechnology and pharmaceutical investment, current pharmacological treatments for these conditions only temporarily alleviate symptoms with some 50% of people diagnosed showing no benefit with treatment. A growing body of research suggests alternative therapies such as photobiomodulation (PBM) and hyperbaric oxygen therapy (HBOT) may offer benefits to both the symptoms and progression of neurodegenerative diseases. This research will assess whether PBM, also called red light therapy, is an effective treatment for mild to moderate cognitive impairment and whether this effect is heightened by the combined treatment of HBOT. Treatment involves PBM therapy either alone or with HBOT for 8 or 16 weeks depending on treatment arm. Trial participants will undergo MRIs, cognitive tests and a series of blood tests at various time points over a 6-month period to assess immediate and long-term effects of PBM and HBOT on brain structure, function, and cognition. This study is exploratory and will provide important insights for future studies.

Crohn's disease (CD) is a chronic inflammatory disorder with increasing prevalence worldwide. Of note, Australia has one of the highest rates in the world with over 40,000 Australians affected. Ustekinumab (UST) is a monoclonal antibody targeting IL-12 and IL-23 through their shared p40 subunit. UST was approved for the treatment of moderate to severe CD in Australia in September 2017. Currently, there is a paucity of studies into the use of UST in bio-naive patients, and knowledge regarding the predictors of response to UST therapy are limited. Data investigating the utility of UST in real-world clinical practice is also lacking. As there are no Australian prospective studies to date, this prospective national multicentre observational cohort study will explore clinical factors and biomarkers in Australian cohort that may aid in clinical decision making to indicate which patients are likely to respond to therapy - a key answered question in the field of inflammatory bowel disease management.

This study aims to establish the efficacy of ambroxol and doxycycline, administered individually or in combination for 48 weeks, in slowing the progression of motor symptoms of moderate severity PD and in maintaining this effect for 12 weeks after the IP is discontinued. Who is it for? You may be eligible for this study if you aged between 25 and 80 years old. Please note that this study will be enrolling patients with Parkinson’s Disease. Study details Participation will involve 48 weeks of treatment and a 12 follow up period. Patients will be randomized to one of the 2 IPs (Ambroxol or Doxcycycline), placebo or combination (Ambroxol and Doxycycline) arm. The 2 IPs will be administered with matching placebos for blinding purposes. All patients will received 5 oral pills per day according to the following schedule: -Twice daily (BID) Ambroxol pills will be taken at breakfast time and dinner time and 1 Doxycycline placebo pill will be taken once daily (QD) at breakfast time -Twice daily (BID) Ambroxol placebo pills will be taken at breakfast time and dinner time and 1 Doxycycline pill will be taken once daily (QD) at breakfast time -Twice daily (BID) Ambroxol placebo pills will be taken at breakfast time and dinner time and 1 Doxycycline placebo pill will be taken once daily (QD) at breakfast time -Twice daily (BID) Ambroxol pills will be taken at breakfast time and dinner time and 1 Doxycycline pill will be taken once daily (QD) at breakfast time It is hoped this research will determine the efficacy of ambroxol and doxycycline for motor symptoms in moderate severity Parkinson's disease.

Reducing tobacco usage has been identified as an urgent national health priority, being the leading cause of preventable death and disability in Australia. The Incentive to Quit (I2Q) pilot aims to reduce the harms associated with smoking and vaping by training health professionals on delivering brief smoking cessation advice, providing smokers/vapers willing to make a genuine quit attempt with financial incentives, use of the Quitline counselling service, and pocket-sized resources with content tailored to help smokers/vapers make a quit attempt or support successful quitters at different stages of their journey. An evaluation of the I2Q intervention will be undertaken via one-on-one interviews with a subset of health professionals and participants (smokers/vapers) of the I2Q program throughout the program period to identify how the service can be improved.

An Open-Label Phase 1b Study Evaluating the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. The study population allows for the inclusion of subjects with all possible HBV genotypes Study details This is a Phase 1b, open-label, multicenter, multiple-dose study of Intramuscular (IM) administration of CLB-3000 in noncirrhotic subjects with chronic hepatitis B (CHB) on stable doses of NUCs at study. This study is designed to assess the safety, tolerability, immunogenicity, and antiviral activity of repeated administration of multiple dose levels of CLB-3000 in adults with Chronic Hepatitis B taking stable doses of standard of care nucleoside/nucleotide analogues (NUCs) for viral suppression. Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-3000 on Days 1, 30, 60, 90, and 120. The end of the study is defined as the last subject last visit at Day 300. The estimated duration of the study is approximately 11 months (28-day Screening period, 150-day Treatment period, and 150-day Safety follow-up period).

Smoking imposes a wide range of impacts on women of reproductive age, beginning with its effect on fertility and extending throughout pregnancy and beyond. A comprehensive, and culturally appropriate smoking cessation interventions are needed to achieve a healthy generation. 44% of Aboriginal women continue to smoke during the first 20 weeks of pregnancy. Only one in ten Aboriginal women who smoke manage to quit successfully during pregnancy. This statistic is largely attributed to the lack of culturally relevant support, leaving many Aboriginal women longing for assistance to overcome the health risk posed to their babies and their own well-being. Over the past 4 years the Which Way? project has worked in partnership with Aboriginal and Torres Strait Islander women and communities to develop an Indigenous-led evidence base for smoking cessation care. Our goal is to provide Aboriginal and Torres Strait Islander women access to high quality, evidence based and meaningful smoking cessation care to empower smoke-free generations. This program has been built based on requests from Aboriginal and Torres Strait Islander women for group-based supports. This program was developed using a co-designed approach in partnership with Birra-Li Aboriginal Maternal Infant Health Service and Waminda South Coast Women’s Health and Welfare Aboriginal Corporation and the University of Newcastle. This program has been designed to provide communities with key information, resources, and strategies to support their smoking cessation journey in a group-based setting.