ANZCTR search results

This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy participants. The trial is split into three parts, starting with Part 1 (SAD) and then Parts 2 and 3 (MAD). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3 (MAD), participants receive 1 dose every day for 14 days.

TThis study aims to evaluate the efficacy and safety of VGT-309, a tumor-targeted imaging agent, when used intraoperatively in subjects scheduled for surgical resection or biopsy of suspicious or confirmed lung cancer. Who is it for? This study is for adult men and women aged 18 years and older who are scheduled to undergo surgical resection or excisional biopsy (as per standard care) of a lung nodule that is suspicious for, or confirmed to be, lung cancer. Study Details Eligible subjects will receive a single intravenous infusion of VGT-309, administered 36-96 hours preoperatively. Total participation will last approximately 35 days (excluding a 28-day screening period). During this time, subjects will undergo safety monitoring, including blood and urine sample collections, vital sign checks, physical examinations, and ECGs. This research aims to enable doctors to use VGT-309 as an intraoperative fluorescent imaging agent to differentiate lung cancer from surrounding normal tissue in the future.

Nutritional rehabilitation is integral in the treatment of anorexia nervosa (AN) . During nutritional rehabilitation, the provision of adequate nutrition to achieve weight restoration and medical stability must be balanced against managing the risks of refeeding syndrome (RS). Refeeding hypophosphatemia (RH) is commonly used to indicate the risk for the development of RS. The risk of developing RS is the greatest during the initial 72 hours following commencing nutritional rehabilitation. Current guidelines support an aggressive feeding model, however suggest restricting calories from carbohydrates and including foods rich in phosphate during nutritional rehabilitation in order to avoid RS. However, despite this suggestion, there have been few studies that have investigated the effect of nutrition composition, specifically carbohydrate intake, on the incidence of RH in patients with AN. The aim of this study was to compare a standard carbohydrate calorie matched aggressive feeding protocol with a low carbohydrate feeding protocol on the risk of refeeding syndrome (hypophosphatemia) in patients admitted to a child and adolescent eating disorder program. This study was a single centre randomised controlled trial. Consent was obtained from both the child or adolescent and their parent or guardian prior to participation in the study. The Paediatric and Adolescent Inpatient Unit at the Austin Hospital in Melbourne, Australia, provides tertiary level inpatient care for children and adolescents with eating disorders who require medical stabilisation. Whilst the preference is for outpatient treatment of the eating disorder, criteria for admission includes postural instability, bradycardia, dehydration, food refusal, rapid weight loss or being severely underweight (<75% expected body weight). Patients were randomly assigned via concealed allocation to either a low carbohydrate feeding plan which provided <40% of total energy from carbohydrate, as per current practice, or standard carbohydrate feeding plan which provided 50-60% of total energy from carbohydrate as per the Australian Guide to Healthy Eating recommendations. Calorie intake for both feeding plans was matched. Oral feeding was encouraged with oral bolus or enteral nutrition available if required. Patients were not prescribed any prophylactic nutrition supplementation during the admission, including multivitamin supplements. If phosphate levels were low, oral phosphate in the form of Sandoz phosphate was to be administered. The medical team monitored daily for any signs of RS and this was documented in the medical file. To our knowledge, there are limited studies that have investigated the link between carbohydrate intake and RH in orally fed children and adolescents. If carbohydrate intake doesn't need to be restricted in order to minimise the risks of RS, this may promote both an earlier and more normalised approach to eating and weight restoration.

This project aims to find out the impact of social and intrinsic factors that impact and influence the health outcomes of people with diabetic foot ulcers (DFU). We believe that determinants such as comorbidities, blood sugar control, and socioeconomic factors majorly impact host immune and bodily process pathways. We hope to identify markers that identify people who may develop chronic ulcers, infections, and predict poor health outcomes. These markers may allow us to develop targeted therapeutics, target resources, and make individualized treatment plans. The primary focus of the work is to improve patient care, quality of life and reduce the burden on DFUs.

Incorporating patient reported outcome measures (PROMs) into usual care in hospitals can improve safety, quality and patient satisfaction. The aims of this clinical trial are to: (i) understand barriers and enablers to ePROM implementation across nation-wide hospitals and to develop Australian ePROM implementation recommendations (entitled AusPROM); and (ii) test the feasibility and acceptability of the QoR-15 PROM for elective surgery day and overnight patients applying the early versions of the AusPROM implementation recommendations. There are two phases of this project. Phase I will identify barriers and facilitators to recommendations for the implementation of the AusPROM using a Delphi technique with health professional staff and will occur alongside Phase II. The Delphi technique will involve three separate 1 hour focus groups (vis videoconference) where barriers and enablers are discussed, and a consensus process is used to establish the AusPROM implementation recommendations. Following the first focus group, early versions of the implementation recommendations will be embedded into Phase II (feasibility testing) to test the implementation recommendations with feedback provided to the subsequent staff focus groups. Phase II will determine QoR-15 acceptability from an elective surgery patient perspective across 4 pilot hospitals, using the AusPROM implementation recommendations. For Phase II, patients will complete brief surveys, incorporating the QoR-15 and two acceptability questions, in the week prior to surgery, in the week following surgery and 4 weeks post-surgery. The primary endpoint will be 4 weeks post-surgery. The trial protocol has adopted the Guidelines for Inclusion of Patient Reported Outcomes in Clinical Trials Protocols (SPIRIT-PRO). The findings will highlight value of patient (acceptability domains) and health professional (Delphi technique) co-design to inform the AusPROM recommendations for the implementation of patient focused outcome measures. The trial will also illuminate the feasibility and value of using the QoR-15 to understand patient views about elective surgery outcomes.

This is a single-site study of people who are undergoing treatment for Treatment Resistant Depression (TRD). The study aims to understand the quality of life in people with TRD and to understand the clinical characteristics of patients as they present at a single time point (cross-sectional). Patients admitted as an inpatient to Albert Road Clinic will be invited to participate. Following consent participants will complete a quality of life questionnaire (AQoL-8D), participate in a short interview with the research team to complete a depression assessment (HAM-D) and obtain medical and treatment history. Participant hospital medical charts will be reviewed to obtain further information regarding medical and treatment history. The results of this study will be used to improve understanding of the burden of disease for people with TRD and to assess the feasibility for creating a registry of data in the future.

This study seeks to determine the feasibility of Cognitive Processing Therapy for young people with Posttraumatic Stress Disorder (PTSD) receiving care in residential treatment for substance use disorder (SUD). Research has demonstrated symptom reduction for both disorders when treatment for PTSD and comorbid SUD is integrated (Brown, Stout, & Gannon-Rowley, 1998; Najavits, Sullivan, Schmitz, Weiss, & Lee, 2004; Roberts, Roberts, Jones, & Bisson, 2015; Watts et al., 2013). CPT is considered a ‘gold-standard’ treatment for PTSD, and has been shown to be more efficacious than other evidence-based treatments such as exposure-based interventions (Asmundson et al., 2019; Holliday, Holder, & Surís, 2018; Lenz, Bruijn, Serman, & Bailey, 2014; Roberts et al., 2015). Despite this, trials of CPT for PTSD with comorbid SUD has generally been restricted to adult and veteran samples from the U.S. (Kaysen et al., 2014; Pearson, Kaysen, Huh, & Bedard-Gilligan, 2019), which include people with a high proportion of substance misuse, but not individuals with PTSD and concurrent SUD exclusively. Residential treatment for Alcohol and Other Drug (AOD) use may provide a safe environment to deliver PTSD therapy and reduce drop-out rates, as they offer ongoing mental health and AOD recovery support which PTSD and SUD diagnosed individuals may not otherwise have access to (Pearson et al., 2019; Reif et al., 2014). However, the feasibility of integrated PTSD/SUD treatment within the residential AOD environment and the effectiveness of integrated CPT for comorbid PTSD/SUD for young people is not yet established. We plan to determine the preliminary feasibility of CPT for PTSD/SUD in the residential AOD setting through an uncontrolled feasibility trial. Our sample size goal is 50 participants. Mean differences will be examined from pre-to-post baseline and at 3 and 6 month follow-up time points. The study will allow a better understanding of the effectiveness of CPT for PTSD and as a novel intervention for SUD. The findings of this study will additionally inform the mechanisms of change in CPT, and why some individuals with PTSD/SUD (and other comorbidities) may have a better treatment response to CPT .

The perioperative administration of synbiotics (a combination of probiotics and prebiotics) has been associated with a relative risk reduction in postoperative infectious complications of 50% for patients undergoing general surgery. Major foregut surgery includes oesophagectomy, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, and liver resections. These operations have a relatively high incidence of postoperative infections complications. From our locally maintained prospective database at St Vincent’s Hospital, the rate of infectious complications following major foregut surgery is 31%. This patient population will have preoperative dysbiosis due to the underlying pathology, neoadjuvant chemotherapy and radiotherapy, medications including antibiotics, weight loss, stress, and diet. They could gain significantly from interventions aimed at improving their microbiota and clinical outcomes. We propose a randomised, placebo-controlled, double-blinded trial to assess perioperative synbiotic administration's effectiveness on reducing postoperative infections in major foregut surgery patients. Additional clinical outcomes will assess the impact of synbiotics on time to first bowel movement, length of stay in intensive care, length of hospital stay, antibiotic therapy duration, and mortality. We will also perform a scientific examination of faecal microbiota and assess intestinal permeability and systemic inflammation. By examining whether changes in clinical outcomes are correlated with alterations in these measures, we aim to understand the mechanism of action of synbiotics further.

Young children on the autism spectrum often experience difficulties with anxiety and fears about the unknown (also known as intolerance of uncertainty). This study will investigate the efficacy of a parent-mediated group-based programme, (Coping with Uncertainty in Everyday Situations, CUES) to improve children's ability to tolerate uncertainty and reduce anxiety. Participants will be the primary caregivers of young children (4-7 years of age) diagnosed on the autism spectrum, randomised to receive either intervention immediately or to a waitlist condition. The primary hypothesis is that, compared to waitlist group, parents in the intervention group will improve ratings of their child's ability to tolerate uncertain situations. The outcomes from this project will evaluate if this early intervention may help caregivers support their child's ability to manage uncertainty and reduce emerging anxiety in young children on the autism spectrum.

Biofilms are a cause of localised chronic infection and have been demonstrated to be present in wounds. Biofilms are tolerant to many antimicrobial agents, antibiotics and the host immune system. There is limited evidence for the effectiveness of topical agents (antimicrobial and non-antimicrobial) in vivo (humans). Sorbact is approved by the Therapeutic Goods Administration (TGA) in Australia for use in wounds. It does not contain any active antimicrobial agents that kill bacteria, rather the main ingredient (Dialkylcarbamoyl chloride) binds bacteria to the dressing. The bacteria is therefore removed at each dressing change. In this proof of concept study we plan on seeing if the dressing can attract and adhere bacterial biofilm in patients with chronic diabetic foot ulcers. We plan on recruiting 20 participants for a study period of two weeks, and collect pre-and-post treatment tissue samples, soiled dressings and wound swabs.