ANZCTR search results

Inflammatory bowel disease is a chronic and debilitating condition that affects 1 in 250 Australians. As many as 40% of patients with IBD have a concurrent diagnosis of irritable bowel syndrome with either constipation or diarrhoea as a major symptom. Delineating between inflammatory and functional symptoms can make assessment and management difficult in IBD. Concurrent functional symptoms frequentlyresult in unnecessary invasive investigations and even unnecessary escalation in already powerful immunosuppressive therapy. Constipation is the presence of solid or hard stools in the colon that are difficult to pass without significant exertion. They cause stretch, distension and bloating of the bowel which results in pain that can be difficult to differentiate from underlying inflammatory pain in some patients with concurrent IBD. Ulcerative colitis associated constipation is a phenomenon in which active inflammation results in a slowing of colonic motility and worsening of constipation, predominantly higher up in the colon (proximal constipation). This manifests as pain, bloating and discomfort and not only causes symptoms but can also impact the delivery of medications to the colon that rely on normal colonic movements. Intestinal ultrasound (IUS) has been used successfully across many countries to accurately and safely assess inflammatory bowel disease and allow for real-time decision making as a point of care test. It has been shown in small studies to be able to identify colonic contents such as solid or liquid stool, but this has not been formally defined. The ability of IUS to accurately distinguish between proximal faecal loading versus inflammatory pathology would allow a more safe, cost-effective and tailored approach to managing patients in real-time. Hypotheses: 1. IUS accurately and objectively measures proximal constipation in IBD as validated against CT as the reference standard 2. Unrecognised and frequent proximal constipation is a common cause for symptoms in participants with IBD 3. Proactive management of proximal constipation in IBD leads to an improvement in clinical symptoms and IUS parameters

A significant curriculum redevelopment of the teen Mental Health First Aid for Year 7-9 secondary students (tMHFA 7-9) Edition 2 course has occurred with input from multiple curriculum specialists. The course has been piloted with a class of Year 8 students and responses received to the course from students, MHFA Instructors and supervising teachers used to make further minor revisions. This Uncontrolled Trial will allow for sufficient data to be sure the tMHFA 7-9 Edition 3 program is effective, safe and acceptable to schools, students and instructors prior to it being launched by Mental Health First Aid Australia and subsequently evaluated in a planned Randomised Controlled Trial (ACTRN12621001589875).

Despite a dramatic decline in tobacco smoking prevalence, current smoking rates have plateaued and smoking remains the leading cause of preventable diseases and death in Australia. Smoking rates in ICU patients are higher than the general population, offering an opportunity for intervention, especially as there is good evidence that many smokers do consider cessation following an ICU admission. Thus surviving an ICU admission potentially provides a unique opportunity to promote long-term smoking cessation. Whilst smoking cessation interventions have been evaluated in hospital settings, the optimal intervention remains unclear and no studies looking at combination nicotine replacement therapy (NRT) and counselling have been performed specifically in ICU survivors. Our goal is to conduct a randomized controlled trial comparing standard care (ad hoc advice to patients and NRT) to a formal brief counselling intervention in addition to protocolized NRT. The aim is to improve smoking cessation rates in ICU survivors and thus improve their morbidity and mortality.

A large number of people experience long-COVID Symptoms persisting for weeks and months after overcoming the acute illness. Symptoms include chronic fatigue, breathlessness, muscle pain, persistent cough, loss of sense of smell and/or taste. This study aims to explore underlying disease etiology by a series of blood tests and clinical assessment, followed by a staged treatment approach of 2x 6 weeks. After clinical assessment by a trial doctor, eligible participants will receive intervention-1 for a 6-week period, and allocated to one of three groups of intervention in the 2nd 6-week period. This study is exploratory, and will provide important insights for protocol development for a larger cohort study.

This study is designed to assess whether QIV antigen, administered by HD-MAPs applied to the human skin using an integrated applicator, is safe and well tolerated in healthy adult volunteers. This study represents the first time that HD-MAPs coated with QIV antigen will be applied to humans

This study involves the testing for eight weeks of a regulatory approved acne support supplement The research project is aiming to: • generate evidence-based advertising claims within the regulatory-permitted indications for the Acne Support product. • evaluate the product effectiveness on acne severity will be evaluated in an eight-week real-life direct-to participant setting, in people with mild-to-moderate facial acne. • assess the effectiveness of the treatment on other outcomes related to the condition and participants’ quality of life Patients will be recruited via a consumer panel or through social media or other virtual channels via an online screening survey. This study will be completed taking one oral tablet of the Acne Support product once daily for eight weeks.

The CONSOLE clinical trial aims to compare two schedules of radiotherapy in the treatment of painful cancer that has spread to bones not located in the spine. Who is it for? You may be eligible for this study if you are an adult over the age of 18 who has been diagnosed with cancer that has spread to your bones not located in the spine and is causing you pain. Study details Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In Arm A, called the conventional treatment or current standard of care, participants will be either given in one (1) treatment on a single day or five (5) treatments over a period of a maximum of seven (7) calendar days for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. Each treatment will go for around 15 to 30 minutes. . In Arm B, called Sterotactic Body Radiotherapy (SBRT), participants will be given in two (2) treatments with a minimum of one (1) and a maximum of three (3) days gap between treatments for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. radiotherapy which is given in two treatments. Each treatment will take around 30 to 45 minutes. Questionnaires and pain and medication diary will completed at the initial assessment, last day of treatment, 2 weeks after radiotherapy and at 3 and 6 months following the last treatment.

The aim of this study is to determine whether real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians improves duration on treatment in patients with relapsed multiple myeloma receiving standard of care treatment, when compared to standard of care treatment alone. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of relapsed multiple myeloma, and have or are commencing a lenalidomide, carfilzomib, or daratumumab based treatment regimen. Study details Participants will be randomised (i.e. allocated by chance) to receive standard of care treatment plus real-time feedback of PROMs, or to receive standard of care treatment alone. Participants in the intervention group will be asked to complete a multiple myeloma-specific quality of life questionnaire (myPOS) within the week before each clinical visit using an online PROM collection system. Participants receiving daratumumab or carfilzomib based regimens will also complete additional questions regarding treatment-specific side effects at this time. The questionnaires will take approximately 10 minutes to complete, and will be completed prior to a total of 13 visits over a period of 12 months. A summary of the completed questionnaires with results of concern will be provided to your treating clinician before clinical visits, so that the results may be considered in your care. Participants in the standard of care alone group will not complete the MyPOS questionnaire prior to clinic visits. All participants will be asked to complete a quality of life questionnaire and a treatment satisfaction questionnaire every three months. Participants in the standard of care alone group, receiving daratumumab or carfilzomib based regimens, will also be asked to complete the additional questions regarding treatment-specific side effects every 3 months. After a period of 12 months, all participants will have data collected from their medical records on time to discontinuation of treatment, disease progression, and survival, and will complete questionnaires regarding quality of life, side effects, and treatment satisfaction. It is hoped that this study may show that real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians at clinic visits improves duration on treatment and survival when compared to patients on standard of care alone.

The study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intervention. This trial aims to examine whether intensive prehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia and who have undertaken minimal rehabilitation in the last two years. The feasibility trial will also test whether intensive prehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury.

Derangements of serum phosphate concentrations, specifically hypophosphataemia, are common among ICU patients and our previous work has suggested this may be associated with worse clinical outcomes, including higher mortality and morbidity. Although replacement of phosphate through both intravenous and enteral routes is common in ICUs, the optimum threshold of serum phosphate at which to commence active replacement in critically ill patients is currently unknown, and the benefits have never been confirmed with an RCT. Resultantly, there are no consensus guidelines on phosphate replacement in ICU, with individual ICUs and clinicians self determining thresholds at which to replace phosphate. Such treatment comes at significant cost and there are potential adverse outcomes associated with phosphate replacement including hypocalcaemia (potentially precipitous and life-threatening), nausea, vomiting, diarrhoea and hypotension. Thus, ICU clinicians are left with substantial uncertainty about the optimal threshold at which to replace phosphate. Therefore, a clinical and ethical imperative exists to conduct a high-quality, investigator initiated, RCT to inform clinical practice with regards to phosphate replacement and its impacts on patient centred outcomes in critically ill patients. The PRICE-1 RCT will compare the use of a restrictive phosphate replacement protocol against a liberal phosphate replacement protocol for the management of serum phosphate levels in critically ill patients. The liberal protocol will start replacing phosphate when the serum concentration is below 0.80 mmol/L, whereas the restrictive protocol will start replacement when the serum phosphate concentration is below 0.50 mmol/L. The choice of oral versus intravenous phosphate administration is determined by the functioning of the patient's gastrointestinal tract. All other aspects of patient care will be determined by the treating clinicians as is appropriate for the condition/s with which the patients are admitted to the Intensive Care Unit. We hypothesise that use of a restrictive phosphate replacement protocol, compared to a liberal protocol, will result in reduced amount of phosphate replacement administered to critically ill patients in the Intensive Care Unit. Additionally, we hypothesise that the conduct of an electronic database-integrated cluster randomised trial will be feasible.