ANZCTR search results

This study will examine the efficacy of delivering an electronic just in time nudge to reduce glucose levels at home in individuals with type 2 diabetes. Delivering an pictographic behavioural nudge by smartphone app (Intui Research) with a SMS reminder proximal to the anticipated time of snacking, compared to non-nudge delivery, will lead to a reduction in the glucose area under the curve after dinner measured by continuous glucose monitors and improved sleep health.

The purpose of this study is to investigate whether treating a neurological immunological disorder with an Autologous Haematopoietic Stem Cell Transplant (AHSCT) will suppress or stop their immune system attacking their nervous system. This procedure could enable their body to develop a new immune system by treating their disease. All patients referred for AHSCT by their treating neurologist will be assessed by a transplant neurologist and haematologist prior to having their cases discussed at a meeting involving all centres in Australia running a clinical trial of AHSCT for neurological diseases (all patient data will be de-identified). The meeting will be comprised of MS-specialised neurologists with a special interest in AHSCT for NID and transplant haematologists again with expertise in AID. The AHSCT procedure involves two stages: collecting and then giving back the patients stem cells. In the first stage, the patients blood stem cells are collected by initially giving high dose of intravenous chemotherapy called cyclophosphamide followed by subcutaneous injections of granulocyte stimulating factor to stimulate the stem cells to 'grow in number'. Once the required number of stem cells are dected through blood tests, the patient undergoes undergo daily leukapheresis until minimium number of stem cells are collected. Once this is done, the patient returns after a period of time, the patient is hospitalised for the transplantation procedure. Chemotherapy is given to knock out the current immune system using Cyclophosphamide, Rituximab and Anti-Thymocyte Globulin (ATG) and then reinfusing their own stem cells to ‘grow’ a new immune system. Patients are chosen to participate in this study because they have an aggressive neuroimmunological condition which is not responding to routine therapy. The study will investigate whether their disease can be controlled by AHSCT. This study will also investigate how their body develops a new immune system after using these different types of chemotherapy. We hypothesize that HSCT will continue to be safe and beneficial (as measured by resolution of disease characteristics) to patients with severe treatment-resistant neuroinflammatory disease whilst using a variation in conditioning regimen

In this randomised, double-blind, placebo-controlled study, 80 adults experiencing stress-induced exhaustion will be randomly assigned to receive capsules containing either a curcumin extract (Curcugen) (250mg once daily) or a placebo for 8 weeks. We will assess changes in cognitive performance, stress, fatigue, and sleep using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor – a and C-reactive protein), free radical damage (Malondialdehyde and Total Antioxidant Capacity), and Brain-derived neurotrophic factor (important for the survival of brain cells) will be assessed over time. Using hair samples collected at the beginning and end of the study, we will also measure changes in the stress hormone cortisol It is hypothesised that, compared to the placebo, curcumin supplementation will be associated with greater improvements in mood, cognitive performance, energy, and markers of stress, inflammation, and oxidative stress.

In this randomised, double-blind, placebo-controlled study, 80 working adults experiencing high stress and fatigue will be randomly assigned to receive tablets containing either a saffron extract (affron) (14mg twice daily) or a placebo for 8 weeks. We will assess changes in stress, anxiety, sleep, and energy using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor – a and interleukin-4), and salivary concentrations of hormones associated with stress and sleep (cortisol and melatonin) will be assessed over time. Changes in heart rate variability, which provides a measure of overall health, will also be assessed over time.

Myopia, also known as short-sightedness, is the most common eye disorder of school-aged children globally, but current methods for controlling myopia progression have limitations for the global control of myopia. Based on our previous findings on the protective effects of increased light intensity of outdoor time, we are proposing an innovative solution, which enables relatively higher energies of light to be delivered on the fundus at much shorter durations of exposure to induce the myopia control effect. This trial is a single-centre, multi-ethnic, single-blind, parallel-group RCT with a 1:1 allocation of intervention (RLRL+SVS) and control subjects (SVS), aiming at providing evidence to evaluate this innovative treatment as a novel solution for myopia control in multi-ethnic children. We hypothesize that RLRL would significantly slow the progression of axial elongation and refraction in multi-ethnic children.

We do not understand very clearly what causes Functional Seizures (FS; also known as Non-Epileptic Seizures, or Psychogenic Non-epileptic Seizures) or how to treat them. Previous research suggests that rapid breathing (called hyperventilating) can provoke an episode in some people who have FS. We think that if these people could learn to control their breathing so that they didn’t breathe too quickly this might stop them having seizures. We have tested this on a few people with FS by teaching them something called Breathing Control Training (or ‘BCT’ for short) and found that most of their seizures either stopped or became much less frequent. BCT is a treatment provided by physiotherapists for people with asthma so they can manage their hyperventilation symptoms, but we want to see if it works for people who experience Functional Seizures (FS). In this research project, we will provide BCT, or a comparison treatment known as 'Befriending', to 220 people with FS so we can determine how many people BCT works for, and which people it does help (so we know who to recommend the treatment to in future). We will also assess if BCT is safe for FS (i.e. does it cause any side effects); if it is acceptable (i.e. do people like it, and find it easy to implement); and if it is an affordable treatment option for people with FS.

Participants were asked to test themselves using two HIV self-tests (oral and blood-based), in a randomised order in a private space at the participating sexual health clinics clinics, using manufacturer-supplied instructions for use. A study nurse observed the participants while performing self-testing to note if they performed all the necessary steps correctly as per a pre-designed checklist. Participants were asked to complete an online self-administered questionnaire on a hand held electronic device which captured socio-demographic characteristics, HIV and sexually transmitted infection (STI) testing history, sexual behaviour and ease of use overall and for different steps involved in self-testing (responses and their preferred HIVST. The primary outcome of the study is the ease in performing HIV self-test. Secondary outcomes are preference (the proportion of participant who preferred one type of HIV self-test) and difficulties when performing the HIV self-test.

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.