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The primary objective of this trial is to determine the feasibility of a pivotal clinical trial of intravenous iron and erythropoietin in adult survivors of critical illness requiring treatment in the intensive care unit. The hypothesis of the pilot phase of the trial is that a clinical trial of intravenous iron and erythropoietin is feasible based on the capacity of the study investigators to enrol sufficient eligible participants and deliver the study medications and follow up the patients appropriately. Demonstrating this would provide evidence that a trial with a much larger number of patients should be undertaken to assess safety and efficacy. The primary objective of the clinical phase of this trial is to determine the safety and efficacy of intravenous iron and erythropoietin in adult survivors of critical illness requiring treatment in the intensive care unit. In both phases the trial is parallel group, placebo-controlled, blinded, randomised trial that will allocate patients who are recovering in an ICU after an episode of critical illness and who are anaemic, in a 1:1 ratio, to intravenous iron and intravenous erythropoietin alfa in addition to standard care, or placebo in addition to standard care. The pilot phase was conducted at a single centre, the larger clinical trial is planned to be multicentre.

The TeleClinical Care-STOKE trial is a multicentre, prospective, randomised, blinded endpoint study. Patients discharged from hospital following an acute stroke/TIA will be randomised to management with the TCC-STROKE system or the standard of care for 6 months. The overall study aim is to demonstrate that a smartphone app-based system of transitional care following discharge from an acute stroke treatment centre can decrease hospital re-admission rates within six months. The primary hypothesis is that the TCC-STROKE system of transitional care will reduce the all cause hospital re-admission rate by 10%, relative to standard care, within six months of discharge following the index stroke event.

This project will compare the change in colour or concealment of unsightly white spots (early decay) on human tooth enamel and closure of open microscopic holes (tubules) in human tooth roots (dentine), which can relieve tooth root sensitivity, after application of either: 1) gel containing the major milk protein casein, calcium and tin fluoride; 2) gel containing casein and calcium without fluoride; 3) solution containing tin fluoride; 4) no gel or solution, to the surfaces of enamel white spots and open dentine tubules. To test these treatments, pieces of pre-sterilized human enamel with white spots and root dentine with open tubules will be attached to custom-made removable denture-like appliances that will be worn by four human participants for 24 hours a day for each of four 14-consecutive day treatment periods, with a different treatment allocated to each period. Each treatment period will be separated by a one-week washout period when the participants will rest from the study while new pieces of enamel and dentine are attached to their appliances before they cross-over to another treatment. For three treatment periods, a different gel or the solution will be painted on the pieces of enamel and dentine, with the appliance out of the mouth, by the research team once daily on weekdays and by the participants once daily on weekends. Participants will only wear their appliance for the fourth treatment. The order of treatments will be random. The hypothesis is that the gel containing casein and calcium with or without tin fluoride will change the colour of or conceal the white spots and close the dentine tubules more effectively than the other treatments.

The purpose of this study is to determine if a nurse-led, distance-delivered intervention called ‘Re-engage’ can be used in childhood brain cancer survivors to increase health-related self-efficacy, improve their long-term physical and mental health, and quality of life. Who is it for? Survivors are eligible if they were diagnosed with a brain cancer (any nervous system tumour) prior to the age of 18 years, and were diagnosed more than 5 years prior to participation in the study. At the time of study participation, survivors may be of any age, however if aged 14 years or younger, parents participate on their behalf. Survivors must have completed active treatment, be in remission and have not received any specialist survivorship care in the past 18 months. Study details: This project will offer young ‘disengaged’ survivors of childhood brain cancer who currently access no cancer follow-up care a novel, free, and low burden intervention to identify their risk factors and improve their physical and mental health. All participants in this study will receive two live, online consultations with a clinical nurse consultant, and a medical case review with a multi-disciplinary team. The purpose of these consultations and reviews is to triage and provide referral pathways to appropriate follow-up services. The primary outcome for the trial will be survivors’ self-reported health-related self-efficacy and quality of life. Participants will also need to complete four questionnaires at 1, 6, 12, and 24 months post-intervention. Despite recommendations for regular medical follow-up, many young survivors do not access any regular cancer-specific follow-up care to address health concerns. Without early intervention, late effects can shorten survivors’ lives and can severely impact quality of life. Critically, many of the health and psychosocial problems childhood brain cancer survivors experience can be prevented or managed better with effective survivorship care. Summation: It is hoped that this research will determine whether a novel nurse-led intervention is acceptable to, and enables re-engagement of childhood brain cancer survivors which may lead to improved health outcomes in the longer term.

We propose a double-blinded prospective randomised placebo-controlled clinical trial. We aim to investigate the effect of perioperative intravenous lignocaine in women with chronic pelvic pain (CPP) undergoing operative gynaecological laparoscopy at the Monash Endosurgery unit at Moorabbin Hospital in Melbourne Victoria. CPP is a common cause of physical, emotional and socio-economical dysfunction in women which is often complex and challenging to manage. Operative laparoscopy is frequently a component of multidisciplinary management, however the benefits of surgery are often reduced or counteracted by central sensitization pathognomonic to CPP. Pre-existing pain and inadequate pain management in the perioperative period are strong predictors of persisting pain and dissatisfaction with surgery postoperatively. Intravenous lignocaine (IVL) has anti-inflammatory, analgesic and anti-hyperalgesic properties impacting the peripheral and central nervous system. IVL infusions improve pain scores in patients with non-gynaecological chronic pain conditions. Perioperative IVL improves postoperative pain, analgesia requirements, nausea and vomiting and recovery of bowel function in a variety of surgical fields with minimal adverse effects and a good safety profile. Whilst previous studies of perioperative IVL have largely excluded patients with chronic pain, this patient group is likely to benefit most from the use of IVL in the perioperative period. We hypothesis that IVL compared to placebo will significantly improve visual analogue scale (VAS) pain scores in the perioperative period for women with CPP undergoing operative gynaecological laparoscopy.

This trial aims to determine the safety, feasibility, and efficacy of a combination of chemotherapy, immunotherapy, and chest radiation therapy in extensive stage small cell lung cancer. Who is it for? You may be eligible for this study if you are 18 or above and have untreated extensive stage small cell lung cancer. Study details Participants will be given durvalumab (an immunotherapy drug) concurrently with 4 cycles of cisplatin/carboplatin and etoposide chemotherapy, which is given as in injection every three weeks over approx. 12 weeks. Maintenance treatment with durvalumab alone will continue every 4 weeks after the completion of the chemotherapy cycles until there is evidence of disease progression. Participants will also receive 10 chest radiotherapy sessions, which will take approx. 2 weeks to complete (given either concurrently with cycle 3 or 4 of chemotherapy (called concurrent radiotherapy) or within 6 weeks of finishing chemotherapy (called consolidation radiotherapy). Fractions are expected to be delivered daily. When RT is to start depends on the location and size of the area to be treated). Throughout the study, participants will be monitored regularly for any adverse effects, and for progression of disease using a number of imaging techniques. It is hoped that this study may demonstrate that chest radiation is safe and beneficial when given in combination with chemotherapy and immunotherapy for the treatment of extensive stage small cell lung cancer.

This study aims to assess the efficacy of Restorabite, a trismus treatment device, as an early intervention for trismus and its impact on quality of life for patients with head and neck cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a diagnosis of head and neck cancer, and you are experiencing trouble opening your jaw wider than 35mm. Study details Participants will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10 week study period. Data on changes in jaw opening distance and quality of life will be collected over a 12 month period. It is hoped that this study will demonstrate that the Restorabite device is effective in treating trismus in patients with head and neck cancer, which could lead to an improvement in quality of life for these patients.

Our study hypothesis is that 20mL of bupivacaine 0.5% infiltrated via paracervical block after induction of general anaesthesia and prior to the initial surgical incision will improve patients’ quality of recovery at 24-36 hours following total laparoscopic hysterectomy.

This project aims to improve GP use of CVD prevention guidelines. This will involve implementing and evaluating a new online format for the guidelines (www.auscvdrisk.com.au), using a national stepped wedge cluster randomised trial. The intervention comprises three evidence-based behaviour change strategies that improve guidelines use and doctor-patient communication: 1) an interactive CVD risk calculator that automatically applies assessment and management algorithms to the patient; 2) self-directed audit and feedback exercise with example cases for GPs; and 3) personalised decision aid for patients. We hypothesise this will increase: 1) complete absolute CVD risk assessment data for patients in the target age range; 2) lifestyle referral for high risk patients; and 3) risk-appropriate prescribing of blood pressure and cholesterol-lowering medication to high risk and not low risk patients.

Although verbal education has been found to be ineffective in preventing inpatient falls for patients with cognitive impairment, educational videos seem promising. Literature suggests that visual stimuli is better retained than words in patients with cognitive impairment. Quasi-experimental (pre- and post-intervention) studies inclusive of patients with cognitive impairment have shown reductions in falls rate following the addition of an educational video to existing falls prevention programmes. However, randomized controlled trials evaluating educational videos have excluded cognitively impaired individuals. We conducted a randomized trial to test if our falls prevention educational video is better retained by individuals with cognitive impairment when compared with the standard practice of verbal falls education. We hypothesize that the educational video will be better remembered.