ANZCTR search results

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?

We will conduct a pilot cross-over randomised controlled trial to assess feasibility of delivering mobility training using a gait rehabilitation technology. Upon enrolment, participants will be randomly allocated to the intervention or control group (1:1 ratio), before crossing over to the other arm of the trial. All treatments will be provided at the University of South Australia (UniSA) Health and Medical Clinic through a student led service, supervised by qualified clinicians.

The purpose of this study is to explore the differences in a type of tumour marker, called a carcinoembryonic antigen, in two different blood sample sites. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer of either the colon or appendix. Study details All participants in this study will be asked to provide consent for venous blood samples to be taken as part of your peritonectomy surgery. Five ml of blood will be taken from a vein in your arm as well as another 5 ml of blood from the vein near your appendix or right colon that is located in the right lower side of the abdomen during the initial stages of your peritonectomy surgery. All participants will also give access to medical records to collect the relevant study data such as demographic details, diagnosis, treatment, blood and histopathological results. It is hoped that this research will form part of the eventual outcome where we hope to identify patients at risk of developing liver metastases from their colorectal cancer and develop a suitable drug to prevent these patients from developing liver metastases - Improving their prognosis and disease free survival.

This is a multicentre non-randomized clinical trial looking to examine the benefit of implementing a decision aid named Pregnancy IBD Decision Aid (PIDA). Access to dedicated pre-conception counselling sessions within both metropolitan, regional and rural Australia and Canada however can be limited, given the restricted number of specialised ‘pregnancy in IBD’ clinics. A decision aid, to be utilised in conjunction with outpatient clinical appointments, may provide a method by which to overcome such limitations in access. Each site will have study outcomes collected over a six month period during the implementation of the current standard of care of preconception counselling; in the following six months the intervention (PIDA) will precede this standard of care. Sites will comprise a combination of tertiary centres with dedicated pregnancy in IBD Clinics, in addition to non-tertiary centres which provide non-specialised IBD care. An improvement in the quality of the decision-making process as measured by the Decisional Conflict Scale will be the primary outcome variable. The secondary outcome variables are: 1. Quality of decision-making process (as assessed by PrepDM scale questionnaire) 2. Quality of decision comprising knowledge and congruence of values (as assessed by CCPKnow; SWD questionnaires)