ANZCTR search results

Lab studies suggest that sugammadex can reduce plasma oestrogen and progesterone concentrations to the equivalent effect of 1 missed dose of the pill. However, there has been no investigations of this in real life patients.

The main objective of this study is to determine whether transanal irrigation is quicker than standard bowel care for adults who have a spinal cord disorder. Another important outcome is to see whether transanal irrigation can reduce the amount of bowel accidents and constipation that people with spinal cord disorder experience. Finally, the study wishes to know if people report an improvement in their quality of life if they use transanal irrigation.

‘Food is medicine’ programs incorporate provision of healthy foods into the medical system to help improve population diets and complement pharmacologic treatment of non-communicable diseases. Healthy ‘Food Farmacy’ is one such approach, which allows physicians and other health professionals to prescribe healthy food for lower-income or food-insecure patients, in combination with nutrition education and related social support to synergistically improve health behaviour. This is a pilot healthy Food Farmacy trial that will recruit food-insecure patients with poorly-controlled type 2 diabetes (T2D) via physician consultations at hospital sites in Sydney. Participants will be prescribed food boxes comprising of healthy foods such as whole grains, fruits, vegetables, nuts/nut butters, and low-fat unsweetened dairy products; which will be provided to them weekly over 3 months. In addition, participants will be provided simple recipes as well as fortnightly dietary consultations on nutrition education and cooking tips. The primary outcome of interest in this pilot study is to understand the effects of the Food Farmacy intervention on dietary behaviour in patients. In addition, this trial will assess the feasibility and acceptability of the intervention by collecting feedback from key stakeholders. Finally, effects of the Food Farmacy on food security, clinical risk factors and household behaviours will be explored before and after the intervention.

The ageing population is growing at a fast pace, and is associated with increased rates of common health issues such as cardiovascular disease, diabetes and obesity, however, optimal dietary intake can have a positive effect on these health issues most common in older age. Limited amounts of certain amino acids – namely branched-chain amino acid (BCAA: isoleucine, leucine and valine), tryptophan, methionine – have been linked with poor health outcomes in older age. In this study we aim to determine the effects of branched chain amino acids (BCAA) supplementation by itself, combined with tryptophan, or combined with methionine on appetite and short-term metabolic outcomes in individuals aged 65-80. We expect that that compared to the control diet, those on a diet supplemented with BCAA will have an increased appetite and energy intake, whereas those on a diet supplemented with BCAA and tryptophan will not show this increase in appetite. Supplementation of BCAA + methionine will have similar effect to BCAA on its own.

SIR1-365 is a potent and selective allosteric kinase inhibitor of RIP1 with favorable drug-like properties in vitro and in vivo. RIP1 inhibitors may be beneficial for the treatments of degenerative diseases including neurodegenerative and systemic inflammatory diseases. In vitro work has shown weak inhibition of SIR1-365 on the activity of CYP450 isoform 3A4. Thus, the objective of this study is to evaluate the effects of SIR1-365 after a single oral dose of 300 mg on the activities of CYP450 isoform 3A by comparing the PK profiles of midazolam (the sensitive index substrate for CYP450 isoform 3A) when administered alone or together with SIR1-365.

This trial aims to determine feasibility and preliminary efficacy of a 12-week online yoga program in women with breast cancer-related lymphoedema, and to evaluate its impact on coping skills and quality of life. Who is it for? You may be eligible for this study if you are 18 or above, have completed chemotherapy or radiotherapy for breast cancer, and have breast cancer-related lymphoedema. Study details Participants will attend one 60-minute yoga session per week via Zoom. The first session will be one-on-one, followed by 11 group sessions with a maximum of 6 participants. Participants will also be given pre-recorded sequences that can be practised for 15 minutes every day of the 12-week program. A number of questionnaires will be given for completion before and after the 12-week program, as well as arm measurements and range of motion tests to assess for improvements in lymphoedema symptoms. It is hoped that this study may demonstrate that yoga classes delivered online can improve arm volume (circumference), range of motion, self-efficacy, coping and quality of life in individuals with breast cancer-related lymphoedema.

The purpose of this pre-post comparison study is to provide preliminary evidence for any effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on a range of intermediary cardiovascular risk markers in sleep clinic patients with OSA. Intermediary cardiovascular risk markers (peripheral and central blood pressure, arterial stiffness, endothelial function, autonomic function, and blood biomarkers) will be assessed at 3 and 6 months post OAT implementation. Efficacy of OAT in controlling OSA at the end of the study and adherence to OAT over the study period will be assessed via usage data downloaded from embedded adherence chip. Analysis will be performed to assess the influence of baseline cardiovascular risk status (hypertension, Framingham risk score) and treatment effectiveness (efficacy and usage) on changes in cardiovascular risk markers over the treatment period. The recruitment target (including allowance for drop outs) will be 105 participants. This is to ensure sufficient complete responders to OAT are recruited in the sample. There are known variations in OAT efficacy. Previous research suggests that <40% of OSA patients are complete responders to treatment, 30% have minimal clinical response and the remainder have some clinical benefit. We aim to have a minimum of 30 complete responders in the sample. Data from this observational study will be used to inform future trials of OSA therapy for cardiovascular disease prevention.

Botulinum A Toxin is currently used to treat refractory urinary urgency. This research uses a part existing retrospective and part (with regard to concept)- prospectively collected dataset that is very detailed, and which documents the care of real-world treatment-seeking women in the community. Existing patient records will be used to compile a large study data set that in turn will be used to create a predictive model for Botox treatment outcome. This will be internally and if promising, externally validated, and finally, clinically trialed for its usefulness as a predictive model to guide initial and also subsequent Botox use. Additionally, any negative effects for those receiving Botox and other treatments over time such as deterioration in bladder function will be tracked. The aim is to achieve more effective, efficient treatment of storage symptoms that is relevant to real-world treatment-seeking women. Such a model does not currently exist.

This trial aims to determine the acceptability, appropriateness, and feasibility of a 7-week online mindfulness course on individuals with a cancer diagnosis, and to evaluate its impact on coping and empowerment skills, cancer symptoms, and emotional wellbeing. Who is it for? You may be eligible for this study if you are 18 or above and have been diagnosed with cancer. Study details Participants will attend one 90-minute Zoom session per week, which will cover various mindfulness techniques and practices. Participants will also be given access to online course materials in the form of videos, text, and audio accessed online to support the content of the mindfulness course. A number of questionnaires will be given for completion before the course and at the end of the 7-week course as part of the study. It is hoped that this study may help to ascertain the main symptoms of cancer patients and whether mindfulness training is an acceptable, appropriate, and feasible way of effectively improving these symptoms.

Project Aims - This project aims to assess the feasibility of conducting a study to determine a patient’s individual taste status prior to receiving cancer treatment, and how these radiotherapy and chemotherapy treatments impact on their taste and dietary behaviour after treatment completion. Who is it for? - You may be eligible for this study if you are aged 18 years or older and you are undergoing radiotherapy or chemoradiotherapy treatment for head and neck squamous cell cancer. Study Details - Participants who enrol in this study will be asked to complete a series of questionnaires about their diet and taste perceptions prior to starting treatment, and again at 1 month, 3 months and 6 months after treatment completion. It is anticipated that participants will be able to complete these questionnaires & assessments via a telehealth appointment of approximately 45 minutes, and an additional 30 minutes completing an online survey, at each of the timepoints described. Study Outcomes - It is hoped this research will provide valuable data on the effect cancer treatments may have on the taste and smell perceptions of patients with head and neck cancer and how this impacts on their ability to eat. This data will also be used to inform a larger study to identify possible genetic markers for these individual variations.