ANZCTR search results

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.

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.