ANZCTR search results

This study is a randomised controlled trial, comparing the participation in a Smiling Mind program with a waitlist/control group. Participants will be recruited through facebook and will be given the participation information statement outlining the research. Those agreeing to participate will be redirected to the initial survey (baseline data collection) which will be generated through REDcap survey software. Once the survey is complete participants will be randomised to either the waitlist/control group, or participation in a Smiling Mind program of their choice (sleep, relationships, or stress). Participants allocated to the waitlist group will receive an email with detailing that they will need to wait to join the program. Participants allocated to participate in the program will be sent instructions for joining the program. Participants will be asked to complete the initial survey (minus questions asking about demographics, and their experience with mindfulness practice) at two more time points: two weeks (half way), and four weeks (conclusion of the program). The data collected from the surveys at each time-point will be analysed to assess if there is a difference between the experimental and control groups. As an incentive to complete follow up surveys participants who complete all of the surveys will go in the draw win one $100 Amazon gift voucher. Throughout the study the Smiling Mind team will monitor using participant email addresses provided at baseline whether intervention participants have downloaded the application and are participating. If after 5 days participants have not downloaded the app and started engaging in the program, then the University of Newcastle team will send an email reminder. The email address will also be used to match participant responses between surveys. The data collected from interventions application usage will also be analysed to determine patterns of usage and engagement. It is hypothesised that participants who engage in the Smiling Mind program will have significantly improved well-being in comparison to the control group.

Effect of a combined Krill and Greenshell Mussel (GSM) supplement on joint health and osteoarthritis in an older adult population: A double-blind randomized placebo-controlled parallel study. The aim of this study is to assess the effectiveness of a phospholipid and omega-3 (from krill and GSM) supplement on joint health and osteoarthritis compared to a placebo (glycerol). We will test the hypothesis that supplementation with omega-3 will enhance joint health and quality of life in older adults.

This is a Phase 2 trial to be conducted in a single center in Australia to evaluate the safety and tolerability of CBL-514 Injection on subcutaneous fat of both thighs.

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.