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The effectiveness of Transcendental Meditation on the quality of life, perceived stress and mood of women affected by domestic violence
Almost one in three women worldwide will be exposed to domestic and family violence at some time in their life. Such violence can contribute to physical, social, economic and psychological harm. This pilot randomised controlled trial will compare the effectiveness of two different approaches to improving stress, mood and quality of life in women affected by domestic violence. Women assigned to the first group will complete training in Transcendental Meditation® (TM; an effortless relaxation technique), which will be delivered by qualified and experienced instructors of TM. Women in the second group will participate in weekly group support sessions facilitated by a qualified social worker. During the eight-week intervention/control period, and eight-week follow-up period, participants will complete a series of questionnaires asking about their quality of life, and their perceived levels of stress, anxiety and depression. The study will be conducted in the Southern suburbs of Adelaide, South Australia; however, if the findings show promise, they will help inform the development of related, larger-scale projects not only in South Australia, but nationwide.
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Registry-based Study of Enzalutamide vs Abiraterone assessing cognitive function in ELderly patients with Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to see if there is a difference in cognitive decline between elderly patients treated with two common prostate cancer medications (enzalutamide and abiraterone acetate). Who is it for? You may be eligible for this study if you are a male aged 75 or over, and have a diagnosis of metastatic prostate cancer (cancer that has spread outside the prostate). Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. Both groups will receive one of two standard treatments. One group will receive Abiraterone acetate and a steroid as tablets and the other group will receive Enzalutamide as tablets. Both groups will have their treatment daily until their doctor decides they should stop. As part of this study, participants will answer questionnaires about their ability to think, learn and memorise (cognition), their mood status and their risk of falling. They will also consent to researchers accessing their medical records for information about their cancer. It is hoped this research will clarify if one of these medications has less of an impact on cognitive decline, mood or falls risk, which may help doctors in the decision of what medication to use for elderly patients in the future.
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A Randomised, Open-label, Cross-over Study to Evaluate the Pharmacokinetics of a Single Dose of two Formulations of Orally Administered Tetrahydrocannabinol/Cannabidiol Combination in Fed Healthy Volunteers.
This Phase I study will be the first evaluation of the pharmacokinetics of the THC/CBD products from AusCann Group Holdings Ltd, specifically their 2.5 mg:2.5 mg and 10 mg: 10 mg capsule presentations, when administered to healthy volunteers. The pharmacokinetic data will aid clinical prescribing decisions for use under the existing regulatory pathways for medicinal cannabis, namely the Authorised Prescriber and Special Access Scheme and future clinical trials.
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A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FlecIH-104 in Healthy Volunteers
This research project is being conducted to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single 35, 70, and 90 mg doses of FlecIH-104 when administered in healthy adult subjects via oral inhalation.
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Assessing the glycemic lowering potential of kombucha when consumed with a high glycemic index meal by healthy volunteers with normoglycemia.
The primary goal of this study is to assess if a 330ml kombucha drink will reduce the glycemic response to a meal.
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Australian MRI-Linac Patient Imaging Trial
The purpose of this study is to try out a new imaging machine, called Integrated Magnetic Resonance Imaging Linear Accelerators (MRI-Linacs) Who is it for? You may be eligible for this study if you are aged 18 years or older and are undergoing radiation therapy for cancer at Liverpool or Macarthur Cancer Therapy Centres in Sydney. Study details All participants in this study will have two MRI-Linacs scans. The scans will be about a week apart, and involve lying still on on different positions depending on site of treatment within a confined doughnut like machine. In addition to the scans, participants will also answer questionnaires, consent to access medical records, You may require a dye injected through your viens to enhance image quality depending on the area you are having treatment to. It is hoped this research will provide information to develop new imaging procedures on the Australian MRI-Linac. The data collected will be critical in developing future MRI Linac treatments on this device.
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A Randomised, Double-Blind, Vehicle-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Two Dosage Forms of BTX 1801 Applied Twice Daily for Five Days to the Anterior Nares of Healthy Adults Nasally Colonised with Staphylococcus aureus
The purpose of this study is to demonstrate the effectiveness of BTX 1801 presented as two different dosage forms to eradicate carriage of Staph. aureus on Day 12 in the anterior nares of individuals who are persistent carriers of Staph. aureus. The study will look to see whether there is a difference in the percent of anterior nares culture that are negative for Staph. aureus at Day 12 between active BTX 1801 formulations and the combined Vehicle formulations applied twice daily for 5 days.
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Akynzeo for post-operative nausea and vomiting after bariatric surgery.
Postoperative nausea and vomiting (PONV) is common in the setting of bariatric surgery and can be detrimental to patient recovery. Multimodal antiemetic strategies have been shown to be more effective than monotherapy to target the high incidence of PONV after laparoscopic surgery. The proposed randomised controlled trial will evaluate the efficacy of Akynzeo® (netupitant/palonosetron) to prevent PONV in patients with morbid obesity following bariatric surgery.
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Can intravenous high dose zinc improve clinical outcomes in patients with COVID-19 infection?
An outbreak of a new virus called novel coronavirus (COVID-19 or 2019-CoV) infection has posed significant threats to the health of people worldwide and the global economy. There are no vaccines for this virus, and there is no specific treatment for people infected with the virus. In severe cases, COVID-19 virus can spread to the lungs and cause extreme difficulty with their breathing. We call this acute respiratory distress syndrome (ARDS). Zinc is a naturally occurring essential metal required for the normal function of the body. Numerous studies have been done showing the potential of zinc to inhibit viral infections (including the common cold) in clinical trials and experiments. It is our study hypothesis that zinc will reduce the severity of COVID-19 infection and improve the clinical outcomes of patients with COVID-19 infection. Therefore, we plan to perform a study to test whether zinc (given as Zn chloride) is effective and safe in subjects with COVID-19 infection and to work out whether giving zinc to patients can make them get better quicker.
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Effects of time restricted eating compared to diet modification in people with type 2 diabetes
The proposed study will be the first to compare the benefits of TRE for improving glycaemic control compared with standard dietetic advice, in individuals with T2D in a chronic (6 months) randomised controlled trial. Evidence-based findings for the improvement of blood glucose control and longer term outcomes need to be developed in order for this information to be available for the design of larger studies, prior to being incorporated into current dietary guidelines and inform best practice. The combination of physiological and psychosocial measures will allow us to demonstrate the efficacy and safety of using TRE in a real-world setting to reduce the psychological burden of dietary modifications, whilst improving glycaemic control, for individuals with type 2 diabetes.