ANZCTR search results

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

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31593 results sorted by trial registration date.
  • Lactoferrin Supplementation, Immune Function & Respiratory Virus Infection in healthy, older adults: The LIFE Trial

    Lactoferrin is a well-known anti-viral and anti-bacterial protein that previous research has shown can improve immune function and reduce respiratory tract infections. Lactoferrin is made in the human body as part of our immune system defence and is normally present in saliva and breast milk. Lactoferrin is also naturally present in cow’s milk, allowing it to be purified and used as a dietary supplement. Clinical trials in adults and children show that lactoferrin supplements can reduce respiratory tract infections, though little research has been done to help us understand how lactoferrin improves immune function. The LIFE trial will test a lactoferrin dietary supplement in older adults, as immune function can decrease with older age. The LIFE trial will test whether taking a lactoferrin supplement, daily for 4 weeks can improve immune function and protect against virus infection in older adults. Researchers will do this by looking at changes in immune cells from blood samples taken before and after the 4-week trial.

  • Why does diet effect mood? Investigating the possible roles of psychological beliefs and biological changes that influence mood when undertaking a healthful diet.

    Several studies have now reported that modest improvements in diet (eating more fruit and vegetables) can lead to improvements in mood (Firth et al., 2019; Jacka et al., 2017; Parletta et al., 2019). In our recent study, Francis et al., (2019) demonstrated that a 3-week diet intervention for participants who reported low mood experienced significant improvement after the intervention, compared to controls. The usual explanation for these effects of diet is ‘physiological’. However, an alternative explanation is that positive expectations about a treatment (i.e., a placebo effect) and ‘taking control’ of events in your life (called self-efficacy) can both make you feel better. It is very likely that people believe that fresh food is good for you. It is also very likely that taking charge of ones’ diet is likely to increase feelings of self-efficacy. Together, these psychological effects could improve a person’s mood. Therefore, the aim of our study is to investigate if the beneficial effects of a healthy diet on mood are in part from positive expectations and improved self-efficacy.

  • The effect on residents of a co-designed intervention on Residential Aged Care outdoor access

    Evidence demonstrates that being outdoors and exposed to greenery has a positive impact on our physical and mental health. Numerous studies have explored interventions that support older people living in Residential Aged Care Facilities to participate in outdoor activities such as gardening and walking groups resulting in a variety of benefits such as reductions in depression, stress, falls and vitamin D deficiency. However, Residential Aged Care Facilities often report that outdoor spaces are unused. Common barriers include the design of the outdoor space and the main building (access points and their usability), safety concerns and staffing issues, weather and access to shelter, and lack of social activities. This study aims to reduce these barriers by co-designing with residents, their family/carers and staff an intervention at three Residential Aged Care Facilities in Victoria, Australia to improve safe access to and satisfaction with outdoor spaces. This in turn will increase opportunities for residents to access the benefits that we know time spent outdoors provides.

  • Effects of Chitodex with steroid on patients having sinus surgery for chronic rhinosinusitis

    This research project compares two different absorbable nasal dressings applied directly after functional endoscopic sinus surgery for the treatment of chronic rhinosinusitis. One is chitosan-dextran (Chitodex) gel mixed with a topical steroid added and the other is the current standard of care PureRegen gel. Post-operative adhesion formation to sinus openings and wound-healing will be assessed as well as the participant's subjective and objective symptoms scores.

  • An Observational Prospective Registry of Atrial Fibrillation

    RECORD-AF study will enroll participants with a clinical diagnosis of atrial fibrillation (AF). This study will assess development of stroke and cognitive decline overtime, as well as record mortality rate among patients with AF. The primary objectives of this study are: 1. Assess the interaction of baseline AF health literacy, social determinants of health and biological aging the incidence of long-term outcomes such as: a) heart failure (HF) (HF preserved ejection fraction (EF), HF midrange EF, and HF reduced EF); b) mortality; c) stroke; d) cognitive decline and e) progression of AF Secondary objectives of this study are: 1. Determine the impact of blood pressure variability on long-term outcomes, in particular cognitive impairment, in patients with paroxysmal and non-paroxysmal AF. 2. Determine factors associated with development of tachycardia induced cardiomyopathy in AF patients.

  • Breathing Motion Assessment on the Varian Halcyon Treatment Machine for Patients Receiving Radiation Therapy

    During radiation therapy treatment, some treatment machines have the ability to monitor a patients breathing patterns during treatment using a monitoring camera. A particular benefit of this treatment technique is for left sided breast patients as a deep breath (and hold) allows us to treat the breast cancer with reduced radiation dose to the heart. In this study, we are looking at whether the patient monitoring camera on the end of the Varian Halcyon treatment machine couch (called a Live View System (LVS)) can be used to monitor patients breathing during treatment. This will be compared to the currently used breathing motion camera called the Real-time Position Management (RPM) System. Who is it for? You may be eligible for this study if you are an adult receiving radiation therapy treatment at an Icon Cancer Centre. Study details We are aiming to recruit at least 16 patients (32 patients in total) at each participating site in order to determine the effectiveness of the new camera based system. Data will be collected from patients that are already being treated using the RPM system as well as other patients who are receiving radiation therapy treatment. This study will not impact the patients treatment in any way. For those patients where the RPM system is already being used in their treatment, data will be collected on both the RPM and LVS system during their treatment. The breath-hold-gating devices will collect the data during one daily treatment only and will not take any additional time for the patient. If breath-hold-gating is not required as a part of the patients treatment, they will be asked to participate, in a session separate from their treatment where their breathing can be monitored over a short period of time, providing data from both systems that can then be compared. It is intended that this research will contribute to the outcomes of patients by allowing motion management to be utilised on the Halcyon Linear Accelerator.

  • Reducing the frequency of Autoimmune adverse events in the treatment of Multiple sclerosis with alemtuzumab using B-celL dEpletion (RAMBLE): a phase II, randomised, placebo-controlled clinical trial.

    To reduce the occurrence of autoimmune adverse events from the treatment of multiple sclerosis (MS) with alemtuzumab through the subsequent targeted use of rituximab. The hypothesis to be tested is that rituximab therapy following alemtuzumab treatment for MS will reduce the frequency of autoimmune adverse events. If this strategy proves to be safe and is effective in preventing or significantly reducing the frequency of autoimmune adverse events in the treatment of MS with alemtuzumab, then this approach could be adopted immediately in a large number of pwMS with an immediate reduction in co-morbidity.

  • The effect of resistance training prescription on muscle strength and health.

    The primary purpose of this project is to examine the changes in muscle strength with different prescriptions of RT volume and intensities while equating the overall resistance training ‘dose’ in healthy untrained adults. Resistance training dose is calculated as the number of sets × repetitions × intensity × number of exercises. This investigation will also examine how muscle strength is impacted when an intervention group is prescribed roughly half the dose of RT. In addition, this study looks to determine if RT dose influences changes in health and well-being. Lastly, this study will examine the relationship between objectively determined intensity and perceived intensity of training over multiple sets and exercises. The researchers hypothesize that no significant difference in muscle strength will be observed between the two equated RT dose interventions, with the reduced dose intervention producing significant increases in muscle strength but lower when compared to the other intervention groups.

  • "Pobody's Nerfect": A 5-lesson perfectionism program teaching young adolescents about minimising the impact of perfectionism on well-being.

    This study builds on pilot work testing 2-5 session perfectionism programmes with children (ACTRN12616000981426) and early adolescents (ACTRN12618000444280; ACTRN12621000457842) which found improvements in emotional problems, self-imposed perfectionistic standards (sustained at 4-week follow-up), and well-being, sustained at 3-month follow-up (Vekas & Wade, 2017). The modified programme for the current research expands the pilot programme (ACTRN12618000444280) and subsequent 5-lesson perfectionism intervention (ACTRN12621000457842) to be led by trained psychologists which include an emphasis on the difference in pursuing excellence and pursuing perfection to high school students across Year 7 to Year 12 universally. Research objectives 1. To examine the impact of the Pobody's Nerfect curriculum on primary (perfectionism) and secondary (anxiety, depression, wellbeing, self-compassion) outcomes. 2. To test whether improvements in certain outcome factors (anxiety, depression, well-being, self-compassion) are moderated by the following outcome factors: level of perfectionism, self-compassion and sex. We hypothesize that the intervention group will experience significantly greater decreases in perfectionism, anxiety, and depression, and significantly greater increases in wellbeing and self-compassion at follow-up. We also hypothesize that decreases in perfectionism and increases in self-compassion between baseline and end of treatment will moderate the association between group and follow-up changes in anxiety, depression, and well-being.

  • Switching patients from intravenous to subcutaneous infliximab in inflammatory bowel disease

    Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal system that mainly comprises ulcerative colitis (UC) and Crohn’s disease (CD). Treatment modalities include anti-tumour necrosis factor (TNF) biological agents such as intravenous (IV) infliximab infusions given regularly every 8 weeks, subcutaneous (SC) adalimumab given every 2 weeks and golimumab given every 4 weeks. Anti-TNF drugs are now available as biosimilars, which are identical copies of the originator drug. Remsima® is prescribed for adults 18 years or older at a dose of 120mg infliximab solution SC via pre-filled syringe or pen every 2 weeks. The efficacy of SC infliximab is similar to IV infliximab at one year in an initial open-label study. Another study demonstrated non-inferiority of SC infliximab compared with IV infliximab in terms of pharmacokinetic, efficacy and safety in patients with active Crohn’s disease and ulcerative colitis. Efficacy analysis found no statistically significant differences between both routes of administration. Safety profile was also comparable between both groups. The aim of our study is to determine whether SC infliximab is non-inferior to IV infliximab in the maintenance of clinical and biochemical remission in patients in IBD within Australia.. This study differs from prior studies as we will examine patients in remission (and not those with active disease). We also aim to determine the patient satisfaction of switching from IV infliximab to SC infliximab as determined by a self-administered questionnaire. The hypothesis of this study is that there is no difference in clinical outcomes between the two groups and that patients will be more satisfied with SC infliximab.

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