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The underlying principle of trials evaluating the effectiveness of pharmacological treatments is to compare a drug against a placebo. The difference in effectiveness is then attributed to the active ingredient of the drug. Typically, placebos are designed to resemble the drug as much as possible, but conventional placebos that only contain lactose fibres do not elicit side effects and therefore do not fully resemble all features of the drug. The primary aim of this study is to evaluate if side effects increase the effectiveness of an otherwise inactive placebo treatment. We therefore developed an active placebo that will elicit side effects, but otherwise has no effect on sleep. We hypothesise that active placebos eliciting side effects demonstrate a larger placebo effect for sleep compared with conventional placebos that only contain lactose fibres.

The purpose of this study is to determine whether an online psychological intervention is feasible for women with advanced breast cancer. Who is it for? You may be eligible for this study if you are a female adult who has been diagnosed with advanced breast cancer. Study details Participants in this study will be randomly allocated to one of two groups: Group 1: Participants in this group will be provided with an online intervention consisting of 6 modules which focus on improving the psychological well-being and quality of life of women diagnosed with advanced breast cancer. Topics addressed by the modules include (1) Diagnosis and working with my medical team; (2) Managing physical symptoms (particularly fatigue and pain); (3) Managing emotional distress; (4) Managing identity and role-changes; (5) Social support: receiving support and supporting family; and (6) Living well with a progressing illness: Managing fear of progression and coping with uncertainty. Modules are released at a rate of one per week for six weeks, and participants will be able to access modules as much as needed during the intervention. Group 2: Participants in this group will receive a print-based resource provided by the Breast Cancer Network Australia. Participants in both groups will be followed up by researchers after completing the six week program, and asked to complete an online questionnaire assessing psychological well-being and quality of life. It is hoped that this research will help inform future, larger scale studies on the feasibility of an online intervention for women with advanced breast cancer.

Keeping a baby’s head and face uncovered during sleep is an important part of safe sleeping for babies to prevent Sudden Unexpected Death in Infancy (SUDI). It is also important to not to let babies become overheated while they sleep. Increasingly infant sleep bags are being used to keep babies sleeping safely. Sleeping babies in a safe baby sleeping bag, one designed especially for baby, with fitted neck and armholes and no hood, has a number of features that help baby sleep safely. Research has shown that sleeping bag use reduces the risk of bedclothes covering the baby’s face, and delays the baby rolling onto the tummy during sleep until baby is past the age of peak risk of SUDI. Supine sleep is also promoted when the zipper is opened to the front. In this study we will validate a new SmartSnugg infant sleeping bag which records and displays the temperature inside the sleeping bag so that parents can easily monitor this. Infants will be studied during sleep in two different thicknesses of SmartSnugg to assess if the SmartSnugg accurately records baby temperature. The company SmartSnugg are funding the Hudson Research Institute to conduct this study.

The purpose of this study is to assess whether a new combination of therapies, with stem cell transplant, will prolong remission and hold off recurrence of myeloma in patients who have been diagnosed with multiple myeloma and have not responded to standard treatment (currently Bortezomib). Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with multiple myeloma and have had a minimal or no response to bortezomib based induction therapy. Study details If participants consent to take part in this study, they will receive the following: - Four cycles of daratumumab, lenalidomide and dexamethasone. These medications will be used to alter the immune system response to myeloma cells. - A transplant of their own, non-cancerous cells. - This will be followed 12 cycles of the same medications given initially (daratumumab, lenalidomide and dexamethasone) to ‘consolidate’ treatment. - After the completion of the 12 cycles, all participant will commence ‘maintenance’ phase of this study while involves daily doses of lenalidomide. Patients will also undergo routine blood assessments as per standard of care It is hoped that this treatment will provide an alternative treatment to those who have been diagnosed with multiple myeloma and have not responded to standard treatment.

:This study was initiated to clarify the confusing response to heparin and the difficulty in obtaining adequate heparinisation during catheter ablation for atrial fibrillation (CA-AF). The initial pilot study enabled a more rational approach to heparin management, and after recruiting 500 patients into the study, analysis is progressing with a view to demonstrating a method that enables: o accurate prediction of the heparin dose required to achieve an ACT with the desired range o maintenance of the ACT within the desired range during the procedure o a simple method for reversing the active heparin with protamine.

Daytime tooth clenching can cause broken teeth, headaches and face pain. This study is examining a way of managing awake bruxism by using a thin tooth cover to create awareness of the behaviour. Does this reduce tooth clenching and therefore reduce broken teeth, headache and face pain? Hypothesis: Wearing a thin tooth cover will create awareness of tooth clenching leading to a reduction in the behaviour and therefore a reduction in the effects of the behaviour.

The “Let’s CHAT (Community Health Approaches To) Dementia in Aboriginal and Torres Strait Islander communities” project will work with Aboriginal communities and service providers to develop, implement and evaluate a model of care centred within Aboriginal Community Controlled Primary Care Services. The project aims to improve the timely detection and ongoing management of older Aboriginal people with dementia or cognitive impairment not dementia (CIND). This project will engage with community members, Aboriginal Health Professionals and local Health Practitioners to enhance the overall health outcomes and quality of life of older people who have cognitive impairment or dementia, their families and communities.

It is frustrating for families of children with chronic, non-life threatening health problems to have to wait a long time to see a paediatrician. This project tests an online program called eADVICE (electronic Advice and Diagnosis Via the Internet following Computerised Evaluation) that provides treatment advice to patients while they are waiting for an appointment. The program, which can be used repeatedly by families, asks questions about the sick child, and then gives personalised treatment advice to address the health problem (through a virtual character that talks to the child). The program is linked directly to the GP, who supervises the child’s treatment. We will conduct a randomised controlled trial to compare two groups of families: those given immediate access to eADVICE-continence at the time their GP refers the child to the specialist and those given access 6 months after their referral. We will follow up each participant for 12 months and assess whether the program can reduce the need to see the specialist. We will also look at the effect of the program on the child’s health, the families’ experience of the health system and cost implications.

The purpose of this study is to assess the effect of delivering all anti-cancer medications during initial systemic therapy on outcomes in those undergoing treatment for metastatic colorectal cancer. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic colorectal cancer. Study details Participants will be randomly allocated to receive one of two treatments: 1. Alternating schedule of 2 cycles of oxaliplatin based chemotherapy and 2 cycles of irinotecan based chemotherapy 2. Clinician’s choice of chemotherapy. Participants will receive combination chemotherapy for 4-6 months followed by a maintenance period where participants will continue to receive 'maintenance' chemotherapy until disease progression, toxicity or patient/treating clinician request. It is hoped that combining the two effective chemotherapy drugs in first line treatment, but in an alternating pattern, will be beneficial to the patient's outcome and that this alternating use of them will reduce the higher toxicity that occurs when these drugs are used together.

The antioxidants acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and a-lipoic acid (ALA) are shown to be involved in protecting cells from oxidative damage. Recently, a study performed in the mouse model and in smaller human studies showed a clear benefit of using the combination of the three antioxidants on embryo development as well as implantation potential and foetal growth. We therefore want to study the possible advantage of using a medium containing these three known antioxidants compared with the standard medium currently being used in our IVF laboratories. Mainly we want to investigate whether the combination of these three antioxidants may favour embryo development in human IVF.