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The purpose of this study is to assess the safety, tolerability of the drug INCB099318 and assess how this drug acts in the body with and without food in increasing doses. You may be eligible for this study if you are a male or female, aged 18 to 55, and you are in good health with no existing conditions. Participants in this study will be randomized (by chance) in each of the 6 cohort. In Cohorts 1-5 all participants will either receive a single dose of the drug or placebo (orally in a fasted condition (no food). In Cohort 6 subjects will be randomly assigned to treatment A or treatment B groups. Subjects in treatment A group will be dosed after fasting for 8 hrs. Subjects in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. All cohort 6 participants will receive two single doses of drug. Participants will also provide blood and urine samples. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions, results from the study will affect how patients with cancer use this medication.

Studies have consistently shown that ketamine and dexmedetomidine infusions on their own provide good and safe analgesia, decrease opioid requirements and can increase the pain-free period during the postoperative recovery. A combination of dexmedetomidine and ketamine may prevent adverse events associated with Ketamine use such as tachycardia, hypertension, salivation, as well as reduce anxiety from ketamine, whereas ketamine may prevent the bradycardia and hypotension, which has been reported with dexmedetomidine. What is more, IN is an attractive needle-free sedative option where IV access is unnecessary or may be deferred until sedation is achieved. Both ketamine and dexmedetomidine are efficacious and well tolerated when provided as an IN preparation. To our knowledge, however, very few studies have examined a combined formulation. This study will therefore seek evaluate the sedative, anxiolytic, and analgesic effects of combined dexmedetomidine and ketamine when administered via the nasal route in healthy adults.

Cerebral palsy (CP) is the commonest physical disability in childhood. Respiratory illness is the leading cause of death for children with CP, and is responsible for more multi-day hospital admissions than any other cause. Children with CP admitted to hospital for respiratory illness stay in hospital, on average, 2.5 times longer than other children, and two in five are re-admitted the following year. At present, there is no coordinated approach to preventing respiratory illness in children with CP. Children with respiratory illness are usually not referred for specialized care until their respiratory illness is advanced and often life-threatening. The BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) research team have determined the early risk factors for respiratory illness in children with CP so that they can be treated much earlier. We have also systematically reviewed the research literature to determine the most effective treatments for preventing respiratory disease. However, there is very little research evidence. Treatment studies are urgently needed. We have also asked researchers and clinicians worldwide with expertise in respiratory health in CP what treatment approaches they would recommend, and developed a consensus statement for management of respiratory illness in children with CP. This study will trial this recommended approach to management of respiratory illness in children with CP. Treatments will be individualized for children with CP at risk of respiratory illness to find out whether they are feasible, acceptable, and likely to be effective by comparison with current standard treatment. If the trial is successful, we will apply for funding to do a large-scale trial across several hospitals to improve respiratory health and quality of life for children with CP at risk of respiratory illness and reduce healthcare costs.

Substantial evidence tells us that people with intellectual disability (ID) urgently need accessible and affordable mental healthcare options. Despite electronic mental health (eMH) making mental health more affordable and accessible, Australians with ID cannot access the eMH programs that their peers now take for granted. A specifically designed eMH tool has the potential to close this gap and place crucial mental health services in the hands of thousands of Australians with borderline-to-mild ID. To our knowledge, our purpose-designed eMH health tool (named Healthy Mind) is the first program of its kind designed by and for people with ID. Healthy Mind is the product of considerable research, clinical and life expertise gathered across many individuals and organisations. Our tool is designed to target the most commonly experienced symptoms of psychological distress in people with ID. It is based on empirically effective strategies that have been demonstrated to improve anxiety and depression in previous trials involving people with ID. This project aims to establish if Healthy Mind can help Australians (16yo and over) with borderline-to-mild ID reduce symptoms of anxiety and depression and improve their day-to-day functioning. A secondary aim of this project is to determine if Healthy Mind can help support the mental health of younger Australians with borderline-to-mild ID as they experience a stressful life transition, such as moving into a more independent living arrangement or commencing employment. We hope that individuals who use Healthy Mind will experience reduced anxiety and depression, and increased daily functioning, when compared with individuals in a control group. We also hope that individuals who use Healthy Mind while undertaking a stressful life transition will report better coping and lower stress in response to their life transition than similar individuals in a control condition. The potential benefits of a program like Healthy Mind are wide-ranging. With improved access to mental healthcare, people with ID and their families will likely require fewer support services, experience fewer carer days-out-of-role and increased levels of community participation, including greater employment. Additionally, the specialised nature of Healthy Mind appears to help users feel empowered and included. Initial user testing has revealed not only the feasibility and acceptability of Healthy Mind, but also excitement and gratitude for an eMH program designed by and for people with ID.

Midline Catheters (MCs) and Peripherally Inserted Central Catheters (PICCs) are devices which are inserted peripherally into a vein in the upper arm under ultrasound guidance. These are used to deliver medical treatment, including medicines, fluids, and blood transfusions. The main difference between these two devices is the length of the catheter, and where the tip of the device ends (MC, near the shoulder; PICC, centrally). This randomised controlled trial involves being randomly allocated to one of two arms: • Insertion of a Peripherally Inserted Central Catheter (50-55cms) • Insertion of a Midline Catheter (8-20cms) The aim of the trial is to compare MC with PICC for patients requiring prolonged intravenous therapy (up to or equal to 29 days). The researchers hypothesise there will be no significant difference for all-cause device failure between patients who receive a MC versus a PICC.

Alcohol use ranks among the top five contributors to global disease burden, yet the public has relatively poor awareness of the wide range and seriousness of alcohol-related harms. Following successful use in tobacco control, health warnings on alcohol containers have been proposed as a potential alcohol harm reduction measure. This study aims to investigate the efficacy of alcohol health warning labels on drinking intentions and behaviours among Australian adults who drink alcohol regularly. Additionally, the study aims to investigate the degree to which the format of the warning labels influence health warning efficacy. The five alternative warning label scenarios to be tested via the online experiment include: two control groups that represent the usual situation (A) no warning label; and (B) DrinkWise voluntary warning labels; and systematically developed (C) text-only warning labels; (D) text & pictogram warning labels; and (E) text & photograph warning labels. The findings from this study will contribute to the evidence base available for advocacy and forthcoming policy deliberations on alcohol warning labels.

The IDEAL-EX Project will compare the effect of combined high-intensity interval training (HIIT) and progressive resistance training (PRT) against HIIT alone for improving cardiometabolic risk factors in older adults. Both groups will attend UNSW and receive supervised exercise sessions, 3 non-consecutive days a week over 12 weeks. The HIIT+PRT group will perform 20 minutes of HIIT followed by 4 high-intensity PRT exercises. The HIIT group will perform 20 minutes of HIIT only and be instructed to avoid PRT during the intervention. Study Importance: Investigating whether a novel, combined high-intensity aerobic and resistance training exercise program is safe, feasible and more efficacious at improving muscle strength than HIIT alone in an older adult population with moderate risk of cardiometabolic disease. We aim to build on the emerging literature that high-intensity aerobic and resistance exercise can be safe as well as effective in these individuals. The IDEAL-EX Project may also help to determine whether HIIT+PRT can deliver superior improvements to cardiorespiratory fitness and cardiovascular risk factors (such as blood pressure, cholesterol levels and blood glucose levels) compared to HIIT alone for older adults. The results will aim to guide clinicians and professional organisations on the use of alternate exercise prescription for older adults with cardiometabolic disease risk. With adults reporting less time to exercise, this research aims to determine if a low-moderate volume HIIT exercise program is as effective as HIIT+PRT.

Tibial shaft fractures are commonly treated with intramedullary nailing. Anterior knee pain is an often reported complication after this surgery. The aetiology of anterior knee pain remains unclear, but the surgical approach may play an important role. The central aim of this study is to conduct a pilot randomised controlled trial (RCT) investigating the influence of surgical approach (suprapatellar nailing (SPN) versus infrapatellar nailing (IPN)) on tibial shaft fractures treated with intramedullary nailing, via development of a biomechanically validated methodology for assessing post-operative anterior knee pain and functional patient outcomes. This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital (South Australia). We aim to recruit a total of 60 patients between the ages of 18 – 60 years old, who will be randomly assigned to one of the approaches after a decision has been made for surgical fixation. All nails used in this study will be Stryker T2 Alpha nails. Patients will be followed up to 18 months after surgery, and will complete a number of patient-reported outcome measures and functional movement and gait assessments in the Gait Lab at Clinical Research Facility located in the Adelaide Health and Medical Sciences Building. This study will help to provide clarity on the effect of SPN versus IPN for intramedullary nailing of tibial shaft fractures. We hypothesize that there is a difference in clinical and functional outcomes between patients managed suprapatellar or infrapatellar intramedullary nailing approaches.

This study will determine the pharmacokinetics and safety of the controlled released formulation of Octreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-45, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), all participants in this study will receive one injection of Octreotide acetate. As part of the study, participants will undergo safety assessments, pharmacokinetic, pharmacodynamic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. This new formulation of Octreotide will provide a significant reduction of the volume of administration and deliver an immediate onset of action. Additionally the long-acting release is intended to potentially result in less frequent dosing which could improve treatment compliance and quality of life in patients.

Researchers at the Microbiome Research Centre, UNSW Sydney are inviting healthy and active adults to join in a study to help them discover what is the optimal human microbiome-state. The microbiome is the population of microbes occupying various sites on our bodies, and is already known to have a major impact on human health. If we can determine what the normal microbiome of a the supremely healthy person is made up of, then we have the potential to positively change health outcomes for many future generations by using the microbiome as a target for clinical therapies.