ANZCTR search results

This study is testing a new radiation therapy device, a rotating chair, as an alternative to the normal treatment position (lying down) for patients with either head and neck or lung cancer. The main purpose of this research is to find out if the images we take of patients seated in the radiation therapy chair are suitable for positioning a patient during radiation therapy, which is essential to ensure that the therapy can be delivered to the target area. Who is it for? You may be eligible for this study if you are aged 50 years or older, you have been scheduled to receive radiation therapy for either lung cancer or head and neck cancer, you are able to move into a sitting or a lying position independently and you are willing to have routine radiotherapy in the afternoon. Study details All patients who choose to enrol in this study will be asked to participate in three main sessions, a seated simulation session (30 minutes), a seated imaging session and questionnaire (approximately 60 minutes), and a follow up questionnaire (approximately 15 minutes). These sessions are in addition to a radiation simulation session and multiple radiation treatment sessions which are a part of usual care. During the seated sessions, participants will be asked to sit in the rotating radiation therapy chair. The chair is rotated by a small electric motor, in a similar motion to how an office chair rotates. Study participants will be rotated very slowly – it will take 1-2 minutes to do two full rotations. There will be no extra visits to the hospital if you choose to take part in this study, all additional sessions will be scheduled on days you would be attending hospital for usual care. In the seated simulation session, we will introduce participants to the rotating radiation therapy chair. Our therapists will adjust the chair to a comfortable position and setup equipment to help keep participants still. In the seated imaging session, we will take an image similar to a CT image (CAT scan) by rotating participants in the chair whilst taking a series of x-ray images. This image will be assessed to see if it is suitable for positioning patients for radiation therapy in the future. We will also take x-rays to test if a patient’s body position changes while sitting in the chair, and if we would be able to set a patient up in the same body for multiple treatments in the future. Participants will be interviewed about their experience of both lying down for routine treatment and sitting in the rotating chair. Patients will be interviewed with a follow-up questionnaire, after one of their routine radiation treatments near the end of their treatment course. It is hoped this research will determine whether use of a rotating chair for radiation therapy is possible and whether this method of delivery is comfortable for participants. If this study demonstrates that is possible, a larger study to test treatment with the chair may occur in the future.

This study is a randomised controlled trial (RCT) utilising a single virtual site, the virtual Nurse on Call (NOC) platform. Participants will be recruited by contacting NOC and following the ascertainment of their eligibility by the nurse from NOC, eligible patients will be randomised to either receive advice to attend a physical emergency department or to contact the VVED. 1,142 participants will be included with 571 in each trial arm. Follow-up will continue for one week to observe participants’ health service use but the trial itself will take place over the course of several months until the last patients have been recruited and follow-up is completed. The outcome is patient’s use of either the VVED, physical ED, or admission to hospital and will be used to reflect the acceptability of NOC advice by patients.

PMDD is a common condition that causes significant distress and disruption to daily life. The treatment options for PMDD are limited, however, newer forms of COCPs are becoming available and investigation of its efficacy is urgently needed. Moreover, no study to date has directly compared the efficacy of the first-line treatment options for PMDD. The proposed study aims to investigate whether nomegestrol acetate/17-beta estradiol (Zoely) or sertraline (Zoloft) is more effective in reducing symptoms of PMDD.

Aim: The overall aim of this research is to report on maternal weight status prior to pregnancy and nutrition status (weight gain, oral intake, micronutrient deficiencies) during pregnancy after bariatric surgery and its association with maternal and offspring outcomes.

Children can sometimes have pulsed dye laser procedures for birthmarks and scars without a general anesthetic. Instead of having a general anaesthetic, they instead have pain relief (paracetamol/ibuprofen) before their procedure and have access to additional pain relief during the procedure if required. It is unclear if, in this situation, children might benefit from having a numbing cream (topical anaesthetic) applied to their birthmark or scar before the laser. Any medications have their own risks associated with them, so we want to make sure that if we do start routinely using numbing cream in these situations, that it brings enough of a benefit for children that it would outweigh any associated risks with using numbing cream. We would like to do a study that looks at children's pain scores during and after laser procedures, and whether there is a difference in pain scores of children who have had numbing cream compared to children who receive a placebo (non-active) cream. The first step of doing such a study would be to check that it is feasible to do, and acceptable to everyone who might participate. That is what this feasibility pilot study will aim to do.

To examine the feasibility and acceptability of a 12-week VILPA intervention to increase physical activity (PA) in insufficiently physically active adults who are transitioning to retirement. This study will be a pilot randomised controlled trial with two groups of participants using the adapted Consolidated Standards of Reporting Trials (CONSORT) statement. Eligible participants will be randomised to either a waitlist or intervention group. The intervention group will receive the intervention for 12 weeks. The waitlist group will receive current physical activity recommendation by the World Health Organization until the intervention group has completed their 12-week trial.

FMT has been proven to be a safe and effective treatment for recurrent and refractory C. difficile infection and is now available within Australia for this purpose. There is also significant and growing evidence that FMT can effectively treat gastrointestinal disorders such as ulcerative colitis, Crohn’s disease, irritable bowel syndrome, immune checkpoint inhibitor-associated enterocolitis and functional constipation, and practitioners may now request access to FMT for patients with these conditions under the TGA managed Special Access Scheme-B (SAS-B) or authorised prescriber schemes. However, there is a dearth of evidence on the safety and efficacy of FMT in gastrointestinal disorders in a real-world setting. In this a real-world, prospective, observational study, we aim to track the real-world safety and efficacy of FMT treatment in patients with gastrointestinal disorders within Australia. The results of this study may inform standard clinical care for patients with gastrointestinal disorders.

This study will assess the safety and tolerability of a single dose of Erwinaze, and how this drug acts in the body in healthy volunteers. Erwinaze is indicated for use in patients with acute lymphoblastic leukemia (blood cancer), but a trial of the drug in healthy volunteers is needed to obtain additional information to potentially make Erwinase available in more countries. Who is it for? You may be eligible for this study if you are aged 18 to 40 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will be screened for eligibility within the 28 days prior to being admitted to a clinical research unit for up to 5 days. Eligibility will be confirmed within the 24 hours prior to participants receiving a single intramuscular (injected) dose of Erwinaze. Participants will then be asked to provide a series of blood and urine samples to assess the effect of the drug on their body. After 5 days, participants will be discharged home and will be asked to attend two further study visits to provide blood samples. It is hoped this research will determine whether Erwinaze can be safely administered without causing severe reactions. Once the safety and tolerability of Erwinaze has been determined, further studies to assess the effect of Erwinaze in people with leukemia may proceed.

The current study aimed to demonstrate an acute cortisol response following a single high salt meal. While studies to date show an association between high dietary salt-intake over several days and 24-h urinary cortisol, no studies have investigated the acute relationship between salt-intake and cortisol production. The primary aim of our study was to demonstrate salt-induced cortisol production in an acute setting. Our secondary aim was to demonstrate this cortisol production in the absence of an adrenocorticotropic hormone (ACTH) response. We hypothesized that urinary cortisol but not plasma ACTH will increase following a single high-salt meal. To further characterize the role of high salt intake, we measured salivary cortisol, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and blood glucose.

Peripheral Intravenous Catheters (PIVCs) are the most frequently used vascular access device in Australia, with Queensland Health spending $41 million purchasing over 2.6 million PIVCs in 2016 alone. Currently, peripheral intravenous (IV) device choice consistently defaults to short-PIVCs (<4cms) to meet most patients’ IV treatment needs. This is largely due to the current workforce model in which most PIVC inserters are doctors and nurses (generalist) inserting PIVCs within their existing roles. Over the last decade, PIVC insertion teams made up of Vascular Access Specialists (VAS) have been disbanded in many hospitals due to budgetary constraints. The ‘generalist’ approach has been adopted instead putting pressure on already-stretched frontline clinicians, particularly junior medical officers in the after-hours space. Inherent inefficiencies in the current generalist workforce model are not sustainable. More efficient, innovative service provision is urgently needed. Our research project aims to compare the clinical effectiveness of peripheral intravenous device selection and insertion by (i) VAS compared with (ii) generalist model (standard practice). We will conduct a single-centre, two-arm, parallel, randomised controlled trial recruiting 196 patients who are 18 years of age or older and requiring IV therapy for 24hrs or more. All participants enrolled in this trial will be randomly allocated (by chance) to have their IV device inserted by either a VAS or a generalist inserter. Daily follow up checks will then be carried out by a (blinded) Research Nurse until the time of device removal. We the investigators hypothesise that devices selected and inserted by a VAS, compared to those inserted by a generalist inserter, will result in: • Reduced peripheral IV device failure and complications • Fewer attempts to achieve successful peripheral IV device placement • Fewer devices to complete the prescribed peripheral IV therapy • Improved patient satisfaction and less self-reported pain on insertion