ANZCTR search results

This clinical trial aims to compare the safety and efficacy of Cannabinoid Nasal Spray Micelle as an adjunct therapy for the treatment of chemotherapy induced nausea and vomiting in chemotherapy-naive oncology patients. Who is it for? All chemotherapy-naive patients receiving moderate-high emetogenicity chemotherapy aged 18 years or over. Study details: All participants in this study are randomly allocated to one of the two groups. Participants in one group will use a cannabinoid derived nasal spray in addition to standard nausea and vomiting treatment for five chemotherapy days. Participants in the second group will use a nasal placebo spray in addition to standard nausea and vomiting treatment for five chemotherapy days. There is a 50% chance of being assigned to one of the two groups. Participants are expected to have routine blood tests as standard of care provided by the medical oncologists. In addition, participants are expected to complete multiple questionnaires provided by the study investigators. The questionnaires will include 1) One RINV questionnaire per day (one on the day of chemotherapy, and one each of the 4 days post chemotherapy. 2) Two FACT-G/FACIT-F questionnaires per cycle. 3) One FLIE-5DR questionnaire per cycle. 4) Two ESAS questionnaires per cycle. 5) One Adherence Questionnaire for each day the participant receives the study medication. This study aims to see a 'complete response', where 'complete response' is defined as no vomiting and no use of rescue medication.

This study aims to improve sleep and pain post operatively after total knee replacement. It will compare 3 well known medications used for pain and sleep management post operatively.

Selective Decontamination of the Digestive Tract (SDD) is a treatment designed to reduce the risk of infection and improve survival for critically ill patients. SDD is the application of antibiotics and antifungal drugs to the throat and their instillation into the stomach, combined with a short course of intravenous antibiotics. Although many trials suggest that SDD works, the research results have not been convincing enough to lead to the widespread uptake of SDD around the world. Additionally clinicians are concerned that SDD will increase antibiotic resistance amongst endemic bacteria. As a result, SDD is not currently widely practiced. This trial aims to resolve this uncertainty. We will be conducting the definitive randomised study examining the effect of implementing SDD. For 24 months, ICUs in Australia will be randomly assigned to either deliver SDD in the first 12-month period and be a control ICU in the second 12-month period, or to be a control ICU first and deliver SDD in the second period. 8000 critically ill mechanically ventilated patients will be enrolled. Mortality rates will be compared between the SDD and control groups antibiotic resistance rates will be evaluated in samples from all patients prior to, during and after the trial to determine the effect of SDD on the microbial ecology. The SuDDICU trial will provide definitive answer to a fundamental question in intensive care medicine - does SDD reduce critically ill patients’ risk of dying without increasing antibiotic resistance rates? If SDD is found to be effective without increasing antibiotic resistance, the study will have a global impact, leading to improved survival and reduced infection rates in critically ill patients. The results of this study will change practice and be of immense value to clinicians, policy makers and regulators.

Venous cannulation via peripheral intravenous catheters (PIVC) is the simplest and most frequently used method for drug, fluid and blood product administration. Researchers estimate that up to 70% of patients in acute care hospitals require a PIVC. However, PIVC are associated with inherent complications which can be mechanical or infectious. Failure rates of these devices is unacceptably high, affecting up to 40% of patients receiving this therapy. Of these, 30% failed due to occlusion and infiltration (fluids into surrounding tissues) meaning patients had to have the PIVC replaced, which has implications for patient comfort, therapy and health care costs.There have been a range of strategies developed to prevent or reduce PIVC related complications including flushing regimes to maintain PIVC patency. However, current flushing practice is widely varied, with poor outcomes. There is little evidence that flushing of PIVC is actually happening in practice. To achieve best and evidence based practice it imperative that trial research is conducted to establish the best regime for maintaining PIVC patency. The study aims to establish the feasibility of conducting a four arm, factorial, randomized trial evaluating the efficacy and cost effectiveness of different flushing frequencies and volumes in a paediatric population.

This study aims to evaluate the safety and effectiveness of a combination of veliparib with radiotherapy, followed by a combination of veliparib with temozolomide (a chemotherapy), to treat patients with newly diagnosed glioblastoma multiforme (a type of brain tumour). Who is it for? You can join this study if you are a person who is recently diagnosed with glioblastoma multiforme (brain tumour), underwent surgery (or have been scheduled to undergo surgery) for this diagnosis and are considered for further treatment with radiotherapy plus temozolomide treatment. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive veliparib together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with a combination of temozolomide and veliparib. Group 2 will receive receive temozolomide together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with temozolomide. Your chance to receive the group 1 treatment is twice as high as to receive the group 2 treatment. Participants will be asked to attend clinic visits every 2-4 weeks during the treatment period and then two times more (1 month and 3 months after having received the last treatment). During these visits the specialist will assess the status of your glioblastoma and your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, urine testing, scans, and questionnaire completion and to give tissue samples for laboratory research.

This is an open label study designed to assess the long term retention on treatment and long-term safety and tolerability of Triheptanoin in participants with drug-resistant epilepsy.

The primary purpose of the study is to evaluate the safety and performance of a novel, biodegradable dermal matrix for the treatment of patients with deep burns (deep-dermal/full-thickness injuries) involving 10-70% total body surface area (TBSA) requiring burn excision and significant skin grafting. Current standard of care for deep partial or full-thickness burns includes early excision of necrotic tissue and prompt coverage. This attenuates the postburn hypermetabolic response, decreases fluid loss, and ultimately improves survival. A full thickness autograft (skin transplant) is used to cover the debrided wound. However, if the extent of the burns is very severe, then this approach becomes impracticable, there is not enough healthy skin left to harvest and the patient is already too unwell to cope with another large wound. For moderate to large burn injuries in subjects, grafting at a second operation allows significant physiological recovery of the subject prior to graft harvest and application. Reducing the early surgical ‘insult’ to major burn injury sufferers is important in assisting patient survival and reduces the risk of loss of resources (such as harvested applied skin grafts and skin graft donor sites) secondary to physiological insufficiency or deterioration. The Biodegradable Temporising Matrix (BTM), manufactured and assembled by PolyNovo Biomaterials Pty Ltd has been designed specifically for use in extensive full thickness burn injuries, but its structure and properties make it suitable for other full thickness wounds where dermal reconstruction is necessary or desirable.

This project aims to determine the feasibility and acceptability of a brief, individualized and supervised exercise intervention to improve symptoms of depression, anxiety and stress among medical students. The project will also evaluate the effect of the intervention on key measures of physical health including weight, waist circumference, aerobic exercise capacity (fitness), muscle strength and sleep behavior. The project will randomly allocate participants to either one of three experimental groups aerobic exercise, resistance exercise or an active control condition where participants will receive a ‘Jawbone’ or similar physical activity monitor for a period of eight weeks.

Escherichia coli (“E. coli”) and Klebsiella are bacteria which are common causes of infections in your blood stream. Patients with bloodstream infections due to either E. coli or Klebsiella, can commonly be treated with antibiotics called third generation cephalosporins, such as the antibiotic ceftriaxone. When the blood stream infection is resistant to these antibiotics, the antibiotics meropenem and piperacillin/tazobactam have been shown to be effective alternatives for treatment. The purpose of this study is to work out whether these two other antibiotics, meropenem and piperacillin/tazobactam, are equally effective in the treatment of these antibiotic resistant bloodstream infections. These antibiotics have never been compared “head to head” in order to establish the best available treatment for these serious infections. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.

Researchers in allied health and primary care are partnering with Northern Sydney Medicare Local and the NSW State Falls Program (Clinical Excellence Commission) to establish a multi-disciplinary pathway model for fall prevention. The aim is to establish integrated processes and pathways at the levels of practitioner, practice, and program to identify older people at risk of falls and engage a whole of primary care approach to fall prevention. Few older people are asked by their general practitioner (GP) about falls or are offered interventions to prevent falls. For those that do, few base their falls prevention practice on recognised clinical guidelines. Primary care physicians report a number of barriers including time and educational materials. A major problem for evidence uptake is that studies which test fall interventions provided within a research context have much better outcomes than trials reflecting usual practice which rely on referral to usual health care providers. Studies have consistently shown that referral alone is not effective. This is because in reality few community-based organisations regularly offer evidence-based falls prevention services. We aim to form collaborative, information rich, working arrangements with GPs and allied health service providers. Our model aims to: improve access to appropriate fall prevention interventions for older people, ensure ongoing knowledge acquisition and sustainable action by healthcare professionals and organisations, using a multidisciplinary team approach to fall prevention that is integrated and translatable nationally. This cluster randomised trial is part of a hybrid translational project. The trial will evaluate if the intervention can change GP referral and management practices for falls prevention and if this will result in reducing falls for their older patients.