ANZCTR search results

Coronary heart disease (CHD) is one of the leading causes of death in both men and women in developed countries. Western diets, which typically contain large amounts of animal and energy-dense processed foods, together with a sedentary and stressful lifestyle, are associated with increased risk of CHD. We aim to investigate the impact of a 1 year intensive lifestyle intervention (involving a 5:2 pesco-vegetarian diet, exercise, and mindfulness training) in 150 individuals with a recent diagnosis of stable CHD detected during a CT scan. Patients will be asked to follow a 5:2 pesco-vegetarian diet which substitutes meat for fish and includes plenty of fruits, vegetables, whole grains, legumes, nuts and seeds while avoiding processed foods, added sugar and supplements. On two non-consecutive fasting days, they will be asked to consume 2 meals a day containing approximately 500-600 kcal in total with a big emphasis on non-starchy raw and/or cooked vegetables. Patients will also be prescribed physical activity and mindfulness training. We will measure the impact of this intensive lifestyle intervention on coronary plaque volume and structure, as well as body composition, blood vessel function, blood pressure, blood lipids, glucose metabolism, and inflammatory markers, all of which are well established risk factors for ChD.

The aim of the project is to examine the underlying biology of 40 people who have been diagnosed with ME/CFS (Myalgic encephalomyelitis / Chronic Fatigue Syndrome) by their general practitioner comparing these symptoms to people who are well (controls) . We have brought together a team of clinicians and researchers to investigate ME/CFS from a multidisciplinary perspective. The diagnosis will be confirmed using the Canadian Consensus ME/CFS definition, interviews and questionnaires. We will aim to take blood samples, urine and faecal samples at times when the sufferer is experiencing what is often referred to as a ‘crash’ (a period of significant worsening of symptoms and accompanying greater impairment). Another set of samples will be taken when the person is feeling relatively well. A series of questionnaires will be used to obtain information about symptoms and experiences. We will examine the differences in the blood, urine and faecal samples across these two times. Samples will be taken as early as possible to allow for fasting i.e. between 8am and 10am to be negotiated with participant. There are no interventions or medications involved in this research. The most invasive aspects of the research is 2 sets of blood samples (51mls occasion 1 and 36mls occasion 2) and some questionnaires. This is an observational study.

This study will assess the feasibility (can it be done?) and acceptability (is it a helpful thing to do?) of short electronic surveys called patient reported outcome measures (PROMS) in the ongoing treatment of Stage III melanoma patients. Who is it for? If you are an adult who has been diagnosed with Stage III melanoma (with lymph node involvement) at least 3 months earlier and you are being treated at the Sydney Melanoma Surgical Oncology clinics at either the Royal Prince Alfred Hospital, or the Melanoma Institute of Australia, you may be eligible to participate in this study. Study details Participants enrolled in this study will be asked to complete a series of 2-5 health-related surveys about their quality of life on an iPad prior to their scheduled clinic appointments. Participants will receive instructions on how to complete the surveys, and will be provided with assistance from a nurse or the research project manager as needed. It is anticipated that completion of the surveys will take no more than 30 minutes before each appointment, and participants will be asked to complete either 2 or 5 surveys before 4-5 clinic visits over a 12 month period. At the end of the 12 months, all participants will be asked to complete a short survey and some will be invited to attend a one-on-one study interview with the research project manager to discuss their involvement in the study, and whether they found the surveys helpful in their discussions with their doctors. It is hoped this research may be used to improve health outcomes for patients with Stage III melanoma by highlighting patient-important outcomes following surgery, including symptoms, and quality of life issues that are central to assessing the value of melanoma care from a patient’s perspective.

Approximately one quarter of Australians suffer from constipation symptoms. Current treatments including fiber supplements, laxatives, and prescription medication are not effective for all people and have been associated with adverse events. There is recent evidence showing that excess methane production which is a gas produced by some people in the stomach or gut may be important in slowing colonic transit or the time it takes for food to travel through your digestive system in some people with constipation. A new treatment that has been shown to be effective in some people with constipation are probiotics. Probiotics are live microorganisms that are intended to have health benefits. Further research however is needed to find out whether different types of probiotics are effective in treating constipation and what are the underlying reasons for their effectiveness including whether they work by reducing methane gas levels. This study aims to test in whether a novel therapy of probiotics is effective in the treatment of constipation symptoms and methane production levels as determined by a breath test and chemical analysis in 90 patients attending a gastroenterology outpatient clinic with constipation.

The purpose of this study is to investigate whether it is possible for blood samples to be used to monitor whether the correct dose of cancer medicines are being provided to patients. Who is it for? You may be eligible for this study if you are an adult who is receiving Fluorouracil (5-FU) or Capecitabine for the treatment of cancer. Study details All participants in this study will need to provide two blood samples and one dried blood spot sample at two visits with a pathologist. Any results from these samples will then be provided to your oncologist. It is hoped that this research will help determine if it is possible to monitor the dose of medication needed per individual using blood samples.

This is an open-label multiple ascending dose study to assess the safety and tolerability of PMR-116, a drug treatment for patients with advanced solid tumours of any cancer type. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with a solid tumour of any cancer type, and you have previously failed treatment with other available therapies indicated for your cancer (including chemotherapy, surgery and radiation therapy). Study details This trial will be conducted across two parts. In the first study part (Dose escalation), up to six participants will receive multiple doses of PMR-116, to be taken at set times throughout a 28-day treatment cycle. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants in a second cohort will receive an increased dose of PMR-116 to be taken at set times throughout a 28-day treatment cycle. Up to 5 increasing doses will be investigated in separate treatment cohorts until the maximum safe dose has been determined. Following Dose Escalation will be Dose Schedule Optimization. Dose Schedule Optimisation will also assess the safety and tolerability of PMR-116 and identify the maximum feasible dose and the dose administration schedule. All participants will undergo the same assessments as listed in the Dose Escalation portion of the study, however 3 dosing schedules of 2-days dosing/5-days off; 3-days dosing/4-days off & 4-days dosing/10-days off will be explored. Dose levels explored will not exceed 1800mg/week. Participants enrolled in the Dose Expansion and Dose Schedule Optimization phases of the study will be asked to provide a sample of their archival tumour before commencing PMR-116 treatment., In the second study part (Dose expansion), a new cohort of participants will receive multiple doses of the maximum safe dose of PMR-116 to be taken at set times throughout a 28-day treatment cycle. All participants will have their vital signs checked and will provide blood and urine samples for testing. Participants enrolled in the dose expansion study will also be asked to provide a sample of their tumour (taken by a biopsy) before starting and again 22 days after starting PMR-116 treatment, It is hoped this research will determine the maximum dose of PMR-116 that can be administered safely without causing severe reactions. Once the dose of PMR-116 has been determined, a larger trial investigating the efficacy of PMR-116 as a treatment for cancer patients with advanced solid tumours may pr

The aim of this study to assess the safety and efficacy of two transperineal prostate biopsy methods Who is it for? You may be eligible to join this study if you are male and have a clinical suspicion of prostate cancer (PCa) and are scheduled to undergo a prostate biopsy. Patients with a previous diagnosis of PCa on active surveillance are included. Study details Participants in this study will be allocated to one of two biopsy groups. Participants will undergo single diagnostic freehand transperineal prostate biopsy performed either under local anaesethetic (intervention) or template grid biopsy under general anaesthetic (control) by a qualified urologist. This will take place in a public hospital. We will assess proportion of patients with prostate cancer positive biopsies, pain score during biopsy procedure and patient satisfaction as well as any complications. The aim of this study is to show that local anaesthetic transperineal prostate biopsy is a safe and just as accurate as prostate biopsy under general anaesethesia. Another aim is to show it is more efficient in terms of health economics therefore can be adopted by more public hospitals and ultimately widen the access to prostate biopsy for patients.

Anxiety is common in adults with advanced life-limiting disease, adversely affecting quality of life, social relationships and daily functioning at a critical time. This current study will assess the feasibility of a larger multi-centre, randomised, double-blind, placebo-controlled Phase III trial of oral lorazepam for symptoms of anxiety in participants with advanced life-limiting disease. Who is it for? You may be eligible to join this study if you are aged 18 and above with advanced life-limiting disease receiving specialist palliative care input and experiencing symptoms of anxiety and meet all the inclusion and none of the exclusion criteria. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Arm 1 will be lorazepam and Arm 2 will be placebo. The study treatment will be commenced at a dose of 0.5mg (1 capsule) at night. If this is tolerated at Day 3, the dose will be increased to 0.5mg twice daily. A dose titration schedule with up to weekly dose review will then be followed. Each week the total daily dose may be increased by 0.5mg based on clinical assessment, adverse events assessment and HADS-A score, up to a maximum dose of 2mg twice daily (4 capsules twice daily). The study treatment will be continued for 12 weeks, unless criteria for discontinuation of treatment are met prior to this.

This is a placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of 3 doses of Nintedanib Solution for Inhalation (AP02) (0.25 mg/mL) administered using the eFlow nebulizer in normal healthy volunteers, patients with idiopathic pulmonary fibrosis and patients with progressive, fibrosing interstitial lung disease. Eligible subjects in the normal healthy volunteer (NHV) cohorts (1 - 3) will be assigned to one of three cohorts, where they will receive a single dose of AP02 (or matching placebo) via inhalation for up to approximately 20 minutes. Cohort 4 (NHV) will receive AP02 at the maximum tolerated dose (MTD) established in the first 3 cohorts and Cohort 5 (NHV) will receive oral nintedanib at 150 mg. Cohort 6 will enroll patients with IPF/PFILD and will receive AP02 at the MTD established in the first 3 cohorts. The primary objective of this study is to evaluate the safety and tolerability of AP02, with this to be evaluated in each cohort by the Safety Review Committee and through review of the adverse events, physical examination, vital signs, laboratory, oximetry and spirometry values prior to and after dosing. The secondary objectives are to determine the maximum tolerated dose (MTD) of AP02, and the nintedanib plasma and bronchoalveolar lavage (BAL) pharmacokinetics (PK) following delivery of a single dose of AP02. Sentinel dosing will be employed in the first three cohorts for this single site study with a total of approximately 24 volunteers (NHV) to be enrolled - up to 8 in each cohort with 2 sentinel subjects dose 24 hours before the remaining 6 subjects. Cohorts 4 – 6 may be run simultaneously and will enroll a total of 8 volunteers (NHV) and 6 IPF/PFILD patients.

Vitamin D deficiency remains a global public health issue, with clinical rates growing. Vitamin D deficiency is well known to be linked to musculoskeletal conditions, however there is also strong epidemiological evidence linking deficiency with diabetes, cardiovascular disease, osteoporosis, osteoarthritis and some cancers. The condition has a significant financial impact on not only individuals, but also the economy, therefore is of public health importance. As majority of vitamin D is synthesised through cutaneous exposure to the sun, it is unlikely that vitamin D deficiency is perceived to be an issue for much of the Australian population. However, vitamin D deficiency is prevalent in Australia, due to the many individual and environmental factors that impact on vitamin D status, such as skin colour, dressing habits, latitude and season. The Australian Health Survey 2011-12 identified that 23% of the population were vitamin D deficient (defined as <50nmol/L), which equivalates to approximately 4 million people (ABS 2014). Our study will look at the vitamin D status of women living in Australia in winter 2020/2021. This study will take place in Wollongong, on the South East Coast of Australia, Latitude 34.42° S, 150.89° E. We will determine which factors such as dietary intake, sun exposure and muscular strength contribute to vitamin D status. The findings of this study will not only fill this gap in the knowledge, but may also contribute to the literature which informs public health policy on vitamin D.