ANZCTR search results

The study is intended to assess the relative bioavailability of the analytes BH4 and sepiapterin following a single oral dose of 2 formulations of PTC923 (PTC923 Phase 3 powder for oral use in water [Formulation B] vs. PTC923 Phase 1/2 powder for oral suspension in Medisca oral mix [Formulation A]) under fed conditions in male and female adult healthy volunteers. Medisca oral mix is used for Formulation A to be consistent with the way in which the Phase 1 and Phase 2 studies were conducted previously. The current powder for oral use PTC923 formulation has been used in the Phase 1/2 studies in healthy volunteers and PKU and/or PBD patients.

Melasma is a common disorder of hyperpigmentation, primarily affecting the face. It can affect all racial types but predominately affects women with darker skin types. The exact cause of melasma is unknown, but it is thought to be due to many things including pregnancy, hormonal contraception, and sunlight. Melasma can be very difficult to treat and often frustrating for the patient and doctor with evidence showing that it may adversely affect quality of life. The standard topical treatment for melasma that has been used since the 1970’s, is a combination agent including hydroquinone 5%, retinoic acid 0.1% and dexamethasone acetate 0.1% (commonly called “Kligman’s Trio”). Although this treatment is effective, it frequently causes skin irritation, and the hydroquinone is largely responsible for this. Hydroquinone also carries a risk of causing skin discolouration with long-term use. Thiamidol, like hydroquinone, is a depigmentation agent. Recent studies showed that thiamidol was better than hydroquinone in treating melasma while causing fewer side effects (Arrowitz et al, Journal of Investigative Dermatology, 2019). Replacing hydroquinone with thiamidol in this readily prescribed depigmentation formula has never been studied. Therefore, this study aims to determine if topical thiamidol + retinoic acid + dexamethasone acetate combination treats melasma as well as the standard Kligman's Trio.

In this pilot study, NexoBrid will be administered and its effectiveness will be assessed compared to the current surgical standard of care (SOC). This study will recruit 10 patients with upper limb burns treated with NexoBrid compared to 10 patients with upper limb burns receiving the SOC. It is hypothesised that the use of NexoBrid on acute thermal upper limb burns will reduce the patient length of stay in hospital.

Patients with rheumatoid arthritis (RA) have a substantially reduced quality of life owing to debilitating reductions in functional capacity. One of the most effective and potent treatments for addressing these issues is with prescriptions of exercise, as recommended by the American College of Sports Medicine guidelines. Previous research has demonstrated that engagement, mastery and physical activity intention were associated with increases in physical activity in arthritis sufferers. The aim of this pilot prospective trial is to determine the effect of an all-inclusive education, exercise and psychological intervention on motivations and intentions to exercise along with physical function outcomes. Understanding each individuals intentions and then addressing them on an individualised basis by educational psychology in conjunction with an individualised exercise program may elucidate positive changes to a rheumatoid arthritis suffers motivation towards physical activity.

Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. While the mechanisms for adaptations can be varied and can include increased energy expenditure, reduced catabolism, and increased protein synthesis, the intended outcome is an increase in the intended adaptations to training. Pycnogenol, a herbal dietary supplement extracted from French maritime pine bark, is widely marketed for its antioxidant effects. Health benefits purported for Pycnogenol include improved cognitive function, endothelial function, and blood pressure regulation. However, the effect of Pycnogenol on exercise performance, or exercise-induced oxidative stress and inflammatory responses is less clear. Consumption of Pycnogenol has been shown to increase serum NAD+ levels and more recently a study demonstrated that French maritime pine bark extract reduced markers of oxidative stress 48 hours post exercise. Substantially more investigation into the influence of Pycnogenol on exercise performance is required to confirm these results, to examine the optimal timing and dose amount of this supplement, as well as to establish the physiological mechanisms that explain the increased time to exhaustion during intense endurance exercise. Therefore, we hypothesize that Pycnogenol, could be a supplement that increases endurance and with greater adaptations when consumed in addition to training. Here we propose a study designed to establish whether Pycnogenol can improve endurance in highly trained Cyclists

To evaluate the impact of a persona-based text-messaging service “Nellie” post-discharge on pain management and opioid use following surgery compared to standard care. The null hypothesis is that the use of Nellie does not reduce the use of opioids post-operatively in opioid-naïve patients undergoing surgery. The primary objective of this study is to evaluate the impact of a persona-based text-messaging service “Nellie” on the patient reported outcomes (PROMs) and opioid use after surgery compared to standard care. Patients are invited to take part in a research project to understand if SMS text messages could be helpful to them after surgery in understanding and managing their pain. This is because they maybe prescribed strong pain medication(s) to manage pain after surgery. Patients will receive SMS messages about managing pain once they have returned home from hospital. These messages can be about general pain information or to check-in with a choice for them to reply. The questions will ask about their pain after surgery their pain medication use and if any unused pain medications were returned to the local pharmacy. The messages will stop at day 30 after returning home. There will be two groups in the project; each group will be sent SMS messages at different time points. Patients will randomly be assigned to one of the two groups.

The slow build-up of two toxic proteins called amyloid and tau, are believed to be the cause of Alzheimer’s disease (AD). Recently, there have been global breakthroughs in the ability of new blood-tests to detect a toxic form of the tau protein implicated in AD pathology (pTau181). It is suggested that a blood-test targeting this protein will improve diagnostic accuracy, particularly in early-disease stages, allowing for the earlier start of treatments. To date, we have yet to determine whether providing such a test result to the treating clinicians of people attending a memory clinic influences clinician diagnostic confidence and management. We aim to address this gap for people attending a Memory Clinic where there is diagnostic uncertainty or mild cognitive impairment.

This is a retrospective multi-centre observational study that aims to determine the effect of environmental and occupational exposures on clinical phenotypes and incidences of ANCA positive renal vasculitis in Queensland.

This is first in human study of a new treatment drug, GQ1007 for patients with cancer that involves HER2-expression in solid tumors. This study aims to determine the maximum safest dose of GQ1007 that may be administered to cancer patients, firstly as a single therapy and secondly in combination with envafolimab therapy. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with any breast cancer, gastric cancer, gastroesophageal junction cancer, urothelial cancer, salivary gland carcinoma, gallbladder carcinoma, cholangiocarcinoma, or non-small cell lung cancer that involves solid tumours with HER2 gene expression. Additional heart and cognitive function tests will be conducted to determine suitability for enrolment. Study details This study will be conducted as four substudies (Parts 1-4), participants who choose to enrol in this study will only participate in one of the substudies. Participants enrolled into Parts 1 and 2 will receive subcutaneous injections (into the skin rather than a vein or muscle) of GQ1007 every 2 weeks for 2 years. Participants enrolled into Parts 3 and 4 will also receive subcutaneous injections of GQ1007 every 2 weeks for 2 years, and will also receive subcutaneous injections of envafolimab every 4 weeks for 2 years. All participants will undergo additional tests (including blood tests, echocardiograms and imaging) to assess the effect of the treatment on their cancer, and to monitor for side effects. Study participation is anticipated to be a maximum of approximately 26 months (up to 28 days for screening, up to 2 years of study treatment, and a Safety follow up Visit at 30 (+7) days after the last dose of any study treatment) plus long-term follow-up for subsequent anticancer therapy and overall survival. It is hoped this research will determine whether GQ1007 is safe and tolerable for patients with various cancer types. If GQ1007 is found to be safe, larger studies can then be conducted to determine the efficacy of this treatment which may then lead to improved quality of life and overall survival for future cancer patients. A Safety Review Committee (SRC) consisting of the Investigators and the Sponsor’s designated representatives will monitor safety throughout the study and make dose escalation decisions (including any decisions to explore intermediate, higher, or lower doses and/or alternative dosing schedules).

The purpose of this study is to determine the feasibility of conducting a longitudinal cohort study at Sir Charles Gairdner Hospital (SCGH) to assess functional outcomes of persons with above-knee amputation with different prosthesis types. Each participant will undergo one assessment which will include a functional gait assessment, completion of questionnaires to measure balance confidence and quality of life, and a balance assessment using the SMART EquiTest system. It is hypothesised that it will be feasible to conduct a longitudinal cohort study at SCGH.