ANZCTR search results

Standard treatment of gestational diabetes mellitus (GDM) involves a moderately reduced carbohydrate intake spread evenly across the day to reduce glucose spikes, regular moderate physical activity, finger prick glucose monitoring four times daily and where necessary insulin to control maternal glucose levels. Although improving lifestyle is the first-line treatment for GDM, there is no agreement for the best diet. This 21-day pilot randomised control crossover study will see if a low glycaemic load breakfast can improve daily glucose control, reduce the need for insulin and is safe and acceptable in women with GDM. The primary outcomes include measures of glycaemic variability including time in range, time below the range and time above the range, Secondary outcomes include maternal metabolic parameters (fasting lipids and beta-hydroxybutyrate).

Approximately 5 million people are affected by bone marrow failure syndromes (BMFS) worldwide each year, but individually many of the BMFS are rare. In Australia there are 160 new diagnoses each year, of which 50% do not survive. The rarity of these conditions and the absence of coordinated data and sample collection present barriers to research into biology and optimal treatment of BMFS. In Australia, Maddie Riewoldt's Vision (MRV) has supported a national comprehensive clinical data set on newly diagnosed patients with BMFS through strategic funding of the Aplastic Anaemia Registry and Other Bone Marrow Failure Syndromes Registry (AAR). MRV seeks to build on this initiative by establishing a matched research sample set that will allow new research questions to be asked, provide a feasible and ready-to-go sample set that will support BMFS research. The purpose of the AMFB is to establish a national repository of samples from patients with BMFS to serve as a community resource for clinicians and researchers. Promote nationally consistent, comprehensive diagnostic (including molecular) testing for patients with BMFS. It is hoped that the research from this biobank will provide valuable information to improve the diagnosis, treatment, or care of people with BMFS.

Lucid-201 is a psychedelic compound that is expected to impact mood, thinking, and behaviour. The growing evidence of psychedelic compounds for a variety of mental health conditions inspired the investigation of Lucid-201 in humans. This study aims to determine the safety, tolerability, and pharmacokinetics (amount of drug in your body) of Lucid-201 in healthy volunteers and patients with symptoms of depression on certain antidepressant medications. This study also aims to determine the intensity, duration, and types of effects of Lucid-201. The maximum study duration for participants in this study would be approximately 9 weeks. This includes a 6-week screening period, a 3-day and 2-night dosing period, and a follow-up appointment two-weeks later.

Peripheral artery disease (PAD) involves blockages in the leg arteries, leading to exertional lower-limb pain and reduced physical capacity and quality of life. Supervised exercise therapy is an effective treatment for impaired walking due to peripheral artery disease. However, availability and uptake of supervised exercise therapy is limited, perhaps due to the requirement to attend a central facility. The SHAPE trial is a multi-centre, prospective, parallel-group, randomized controlled and assessor-blinded trial. 130 eligible participants with peripheral artery disease will be recruited and consented to the study. In this randomised controlled trial (RCT) the effectiveness and acceptability of SHAPE is compared to current standard of care (centre-based supervised exercise). Participants will be randomly allocated to one of these programs. SHAPE is evidence-based and was designed in partnership with patients, GPs, vascular surgeons and AEPs. This exercise program is done entirely within the participants’ home, supervised by AEPs using telehealth and uses behavioural monitoring via a worn accelerometer. The tertiary facility centre-based supervised exercise program is a exercise program run at a tertiary facility in line with current guidelines. Both programs provide supervised exercise three times per week for 12 weeks. The primary outcome is to test the non-inferiority of SHAPE compared to the centre-based exercise program through a difference of less than 20m during a six minute walk test. Secondary outcomes include health-related quality of life (HRQOL), cardiovascular risk factors, engagement with the program, and participant satisfaction assessed by a survey and, in a sub-set of participants, through interviews.

Loading doses of methotrexate (where high dose methotrexate injection is given once weekly for three weeks at the start to control the disease activity of rheumatoid arthritis, followed by lower dose of oral methotrexate as maintenance) have been used sporadically by rheumatologists in practice, but the research evidence for the loading dose of methotrexate is limited. This study is aimed to investigate how the concentration of methotrexate and its active metabolites differ compared to the standard dose regimen. Also, this study is also aimed to assess the feasibility to implement this loading dose regimen in real life, and the patient's attitude towards this new dosing regimen.

SDC-1801 is a small molecule tyrosine kinase 2 (TYK2)/janus kinase 1 (JAK1) inhibitor entering clinical development for the treatment of participants with inflammatory diseases such as psoriasis. The nonclinical good laboratory practice (GLP) toxicology and safety pharmacology studies indicate that it is appropriate to cautiously assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SDC-1801 in the context of a well-designed, first-in-human (FIH) study. It is reasonable to say that the risk of adverse events (AEs) for JAK inhibitors are broadly similar to those for other biological disease modifying antirheumatic drug (bDMARD) classes. However, concealed within this, there are also important differences between JAK inhibitors and bDMARDs. Tofacitinib and baricitinib have AE profile characteristics that distinguish them from the other bDMARD classes, with signals including an increased risk of herpes zoster reactivation, elevation in lipids, and decreases in haemoglobin and lymphocytes (including natural killer cells). Based on available nonclinical data, SDC-1801 is a potent and selective small molecule TYK2/JAK1 inhibitor currently in development for inflammatory and autoimmune indications, and it has the potential to have an improved safety profile and similar efficacy profile compared with other JAK inhibitors and specific TYK2 inhibitors. A randomised, placebo controlled, dose-escalation, sequential group design is regarded as an appropriate standard design to initiate the cautious assessment of safety, tolerability, and PK of a new investigational product in healthy volunteers. The chosen sample sizes will provide sufficient data to make an initial assessment of the safety, tolerability, and PK of SDC-1801. In addition, the effect of food on SDC-1801 PK will be evaluated to characterise the PK of SDC-1801 in fasted and fed conditions and to guide the selection of a dosing regimen for use in further studies.

Our First trial (ACTRN12609000905268) examined if giving babies the pertussis vaccine (Pa vaccine) earlier than 6 weeks old means that they are better protected. Children on this original trial are now being followed up to compare the pertussis immune responses and safety of a booster dose of either DTPa or low dose dTpa vaccine when given between 18-36 months old. we are hoping to find out if a lower dose diphtheria, tetanus and pertussis booster vaccine (dTpa) may provide comparable immune responses to the currently recommended DTPa vaccine however with a more favourable safety profile.

SDC-1801 is a small molecule tyrosine kinase 2 (TYK2)/janus kinase 1 (JAK1) inhibitor entering clinical development for the treatment of participants with inflammatory diseases such as psoriasis. The nonclinical good laboratory practice (GLP) toxicology and safety pharmacology studies indicate that it is appropriate to cautiously assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SDC-1801 in the context of a well-designed, first-in-human (FIH) study. It is reasonable to say that the risk of adverse events (AEs) for JAK inhibitors are broadly similar to those for other biological disease modifying antirheumatic drug (bDMARD) classes. However, concealed within this, there are also important differences between JAK inhibitors and bDMARDs. Tofacitinib and baricitinib have AE profile characteristics that distinguish them from the other bDMARD classes, with signals including an increased risk of herpes zoster reactivation, elevation in lipids, and decreases in haemoglobin and lymphocytes (including natural killer cells). Based on available nonclinical data, SDC-1801 is a potent and selective small molecule TYK2/JAK1 inhibitor currently in development for inflammatory and autoimmune indications, and it has the potential to have an improved safety profile and similar efficacy profile compared with other JAK inhibitors and specific TYK2 inhibitors. The chosen sample sizes will provide sufficient data to make an initial assessment of the safety, tolerability, and PK of SDC-1801. in both healthy volunteers and participants with plaque psoriasis.

SDC-1801 is a small molecule tyrosine kinase 2 (TYK2)/janus kinase 1 (JAK1) inhibitor entering clinical development for the treatment of participants with inflammatory diseases such as psoriasis. The nonclinical good laboratory practice (GLP) toxicology and safety pharmacology studies indicate that it is appropriate to cautiously assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SDC-1801 in the context of a well-designed, first-in-human (FIH) study. It is reasonable to say that the risk of adverse events (AEs) for JAK inhibitors are broadly similar to those for other biological disease modifying antirheumatic drug (bDMARD) classes. However, concealed within this, there are also important differences between JAK inhibitors and bDMARDs. Tofacitinib and baricitinib have AE profile characteristics that distinguish them from the other bDMARD classes, with signals including an increased risk of herpes zoster reactivation, elevation in lipids, and decreases in haemoglobin and lymphocytes (including natural killer cells). Based on available nonclinical data, SDC-1801 is a potent and selective small molecule TYK2/JAK1 inhibitor currently in development for inflammatory and autoimmune indications, and it has the potential to have an improved safety profile and similar efficacy profile compared with other JAK inhibitors and specific TYK2 inhibitors. A randomised, placebo controlled, dose-escalation, sequential group design is regarded as an appropriate standard design to initiate the cautious assessment of safety, tolerability, and PK of a new investigational product in healthy volunteers. The chosen sample sizes will provide sufficient data to make an initial assessment of the safety, tolerability, and PK of SDC-1801.

Wildfires are natural phenomena that affect people living in many parts of the world including: Australia, Europe, Asia, and North and South America (Bowman et al., 2017; Mcrae & Sharples, 2015; Strauss et al.,1989; Williams, 2013). Bushfires result in injury and loss of human lives, disruption to community cohesion, people’s sense of belonging, safety and wellbeing, and displacements of entire communities (Berry et al., 2010; Guha-Sapir et al., 2015). Bushfires also lead to an increased prevalence of mental health disorders such as depression, anxiety, post-traumatic stress disorder (PTSD), and sleep disturbances (Agyapong et al., 2019; Lowe et al., 2018; Willis, 2020). The presence of sleep disturbances in those who experience trauma, exacerbates and/or maintains PTSD severity (Babson & Feldner, 2010). Moreover, chronic sleep disturbances can lead to poor physical and psychological health, poor quality of life, impaired social relations and suicidal ideation (Morgan et al., 2015; Nadorff et al., 2011; Roth & Ancoli-Isreal, 1999; Simon & VonKorff, 1997; Uchmanowicz et al., 2019). However, despite the negative impact of sleep disturbances on quality of life and their consequences on the development of trauma symptomology, research in this area is limited (Babson & Feldner, 2010). Studies suggest that treating sleep disturbances in those presenting with PTSD leads to better outcomes in terms of both improved sleep and also reduced trauma symptoms (Colvonen et al., 2018). In a meta-analysis of 11 randomised controlled trials that assessed the effectiveness of cognitive behavioural therapy for insomnia (CBT-I), imagery rehearsal therapy (IRT), and exposure, relaxation and rescripting therapy (ERRT), found that these treatments significantly improved sleep quality and also reduced PTSD symptoms, with a moderate effect size of ES = 0.6, for the treatment group in comparison to waitlist groups (Ho et al., 2016). The COVID-19 pandemic changed the way we live. It has also changed the way we receive and provide health care (Isaac et al., 2022). Digital therapies are becoming more popular and are in high demand given the shortage of well-trained counsellors/ psychologists particularly in regional and remote locations. Better and more successful treatment methods for those exposed to bushfires will inform policy makers in navigating where investments in health care should be targeted, such as the provision and timing of treatments designed to improve sleep and reduce trauma symptoms (Siegel et al., 2004; Van Kamp et al., 2006). This will reduce both the burden of sleep disturbances and the subsequent development of serious psychopathology in communities (Babson & Feldner, 2010; Colvonen et al., 2018). Key research question: How effective is Sleep Best-i in reducing symptoms of insomnia and nightmares in bushfire survivors?