ANZCTR search results

This study aims to address gaps in the current literature and Australian treatment guidelines for knee osteoarthritis by conducting a high quality randomised control trial to compare the impact of intra-articular botulinum toxin A injections with intra-articular corticosteroid injections on knee pain and function. It is hypothesised that the intra-articular botulinum toxin A injection will significantly reduce knee pain and improve function compared with the intra-articular corticosteroid injection. It is also hypothesised that the intra-articular botulinum toxin A injection group will require less analgesia for knee pain post-injection than the intra-articular corticosteroid injection group. Finally it is hypothesised that there will be no difference in adverse event rate between groups.

SIR2446M is a Receptor-Interacting Protein 1 (RIP1) inhibitor that is under development as a new investigational drug for the treatment of degenerative and inflammatory diseases. SIR2446M will be supplied as API-in-capsule in this study. The primary objectives are to evaluate the safety and tolerability of SIR2446M after single escalating doses, and multiple escalating doses for 10 days, administered orally in healthy participants. In part 1 the secondary objectives are to characterize the PK profile and preliminary food effect of SIR2446M after single escalating oral doses in healthy participants; to compare the PK profile of SIR2446M in capsule and tablet after single dose; and to explore the metabolite identification of SIR2446M in urine after a single dose. In part 2 the secondary objectives are to characterize the PK profile of SIR2446M after escalating multiple oral doses in healthy participants; to characterize the PD profile of SIR2446M after escalating multiple oral doses in healthy participants; and to explore the metabolite identification of SIR2446M in plasma after multiple doses.

This project lays the foundations for an Australian trial to test the usefulness and safety of drug therapies to prevent the development of long-term diabetes among women who develop diabetes in pregnancy, gestational diabetes mellitus (GDM). GDM, previously considered a transient condition, is now an established risk factor for long-term diabetes. Women whose blood sugar levels do not return to normal soon after giving birth are at particularly high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions may help, but they are hard for busy mothers to adopt and sustain. Even with lifestyle interventions, these women still have substantial “residual risk”, warranting investigation of preventive drug therapies. Currently, clinical guidelines do not recommend routine use of medications because of the lack of adequate research. Our proposed research will provide critical information that will form the basis of a substantial Australian contribution to global research efforts in diabetes. Our research will: - Identify all women who were diagnosed with GDM from three (3) Sydney hospitals in the past 3 years and invite them to complete an online questionnaire and, if long-term diabetes has not already developed, to undergo a blood test to evaluate their glucose status. - Invite a sample of women to participate in interviews to understand their perspectives of GDM, long-term risks and willingness to take preventive medications (including willingness to participate in trials of preventive medicines). - Conduct interviews with healthcare providers to understand their views of long-term diabetes risk, screening and preventive strategies for women with GDM. Collectively, this study will provide a contemporary snapshot of post-GDM care and outcomes from a diverse Australian population who receive obstetric care at large urban hospitals. These data will critically inform the design and conduct of a large-scale trial of preventive medications in this and similar populations.

The primary aim of this project is to determine whether a single session intervention is no less effective (i.e., non-inferior) in reducing anxiety and depressive symptoms compared to a multi-session intervention, the Wellbeing Course. The secondary aim of this project is to determine whether the single session intervention is more effective than a waitlist control group. Participants in the SSI will receive access to a single online lesson and will be invited to contact the clinician within the 1-week following the release of the lesson. Participants in the MSI will receive access to the 8-week intervention and contact with the clinician. Participants in the Waitlist Control Group will receive access to the MSI following the 8-week waitlist period. All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks later. The primary endpoint will be 8-weeks after pre-treatment (i.e., Week 9).

This study is a randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus. Subjects who fulfil the International Classification of Headache Disorders, third edition criteria of migraine and status migrainosus and who have failed or are inappropriate to receive triptan and chlorpromazine therapy will be enrolled into this trial. Upon randomisation, forty subjects will be allocated in a 1:1 ratio to receive either eptinezumab 300mg or placebo infusion, and admitted to hospital to receive intravenous lignocaine as standard medical therapy (if they received a placebo infusion on randomisation), or a placebo infusion for up to five days, or until their migraine is successfully treated.

Cognitive Orientation to daily Occupational Performance Approach TM (CO-OP) was developed to support motor skill development of children with motor difficulties. This study is a randomised controlled trial to test the acceptability, feasibility, and efficacy of the CO-OP motor skill intervention program in children with autism and motor difficulties aged 5-10 years (n = 30). Following the initial intake assessment and goal setting (session 1), participants will be randomised to receive either the immediate CO-OP intervention (n = 15) or be waitlisted to receive the CO-OP intervention (n = 15). Families in the immediate CO-OP group will receive the full intervention protocol immediately following the intake session (8*1hr weekly CO-OP sessions – Sessions 2-9), while families in the waitlist group will not receive any active intervention during this first 8 week block, however, they can continue to access any clinical services that they would usually access. After the follow up assessment (session 10 for immediate CO-OP group, session 2 for waitlist group), the waitlist group will complete the CO-OP therapy (sessions 3-10) and attend a follow up assessment session (session 11), It is expected that at the conclusion of the intervention, children undertaking CO-OP will have improvements on the performance and satisfaction of their movement-based goals.

Objectives: To investigate the effectiveness of an online intervention program Learning to Thrive for university students mental health and well-being. Hypotheses: (1) Compared to the control condition, participants in the intervention conditions will show lower levels of anxiety, depression, academic worry, social anxiety, loneliness, trait avoidance, and intolerance of uncertainty, as well as higher life-satisfaction at post-intervention, at three- and six-month follow-ups. (2) The change scores of both behavioural activation, self-compassion and social identification from pre- to post-intervention will mediate the intervention effects on the outcomes at post-intervention, and at three- and six-month follow-ups.

This research project aims to assess the impact of a wound healing technology (NovoSorb® BTM) on the rate of wound healing in participants who need to undergo minor amputation of their foot. A minor amputation is a procedure which is required to be performed when there is infection or damage to the tissue of the foot which is no longer able to be salvaged or healed without surgery. A minor amputation may involve one or more of your toes or a portion of your foot which has become damaged and is not able to be saved or healed without removal (amputation) of the affected tissue. Ischemia is a condition where parts of the body are starved of blood, which provide oxygen and nutrients for survival, in turn resulting in damage to tissue which can result in wounds. Neuro-ischemia is a condition most often suffered by people with diabetes. This condition affects both the large and small blood vessels in your body, which results in ischemia to tissues. In people with diabetes this condition often affects the blood vessels in their feet which can lead to non-healing wounds. This study seeks to test the ability of the NovoSorb® BTM to heal wounds in people with wounds related to neuro-ischemia. NovoSorb® BTM was originally designed for use in healing wounds in burns patients. The technology has proven useful in helping to heal burns wounds for more than 5 years. This technology is a piece of foam which serves as a scaffold for your healing tissue to grow through. The product is applied by a surgeon in a theatre environment and is left in place until your tissue has grown through the foam scaffold. The foam is specially formulated to slowly dissolve as your healing progresses and your tissue gets stronger. The foam is absorbed by your body and is considered safe and non-toxic. We are seeking to assess whether NovoSorb® BTM helps to heal minor amputation wounds faster and with less risk of infection when compared with current practice (standard wound dressings – negative pressure and antimicrobial dressings). Medications, drugs, and devices must be approved for use by the Australian Federal Government. NovoSorb® BTM is approved in Australia to treat wounds.

The study will evaluate the effectiveness of a new interactive online Cognitive Behavioural Therapy program for individuals who experience difficulty with binge eating, named Binge Eating eTherapy or BEeT. BEeT consists of ten, one-hour interactive, multi-media sessions with all core components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring, thought challenging and feared food exposure. The study will examine whether engaging with BEeT results in a significant decrease in individuals' binge eating in those with binge-eating disorder.

Sleep improves the health, well-being and performance of individuals undergoing training, so this study aims to investigate a practical nutritional aid in attempt to improve sleep quality. The impact of diet on sleep is a growing area of research interest, with reports that protein intakes high in tryptophan may benefit sleep, especially for those experiencing sleep complaints. In addition to sleep, the intake of alpha-lactalbumin may improve mood and cognitive performance of an individual. The proposed mechanism by which sleep, mood and cognition are affected is through increases in tryptophan availability to the brain, which can be measured through blood plasma concentrations. The effect of alpha-lactalbumin intake on these measures has not been completed within a trained population with sleep difficulties. Therefore, we are testing the hypotheses that alpha-lactalbumin supplementation in the evening will improve sleep characteristics, mood, and cognitive performance of trained individuals with sleep difficulties.