ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 90 women aged 18 to 50 years experiencing psychological and physical symptoms associated with menstruation will be randomly assigned to receive a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark Khapregesic (3 grams daily) or a placebo for one menstrual cycle. Pain, mood, and physical wellbeing changes will be assessed before, during, and after the intake of the investigational product. Moreover, changes in the intake of pain-relieving medication will be examined, along with changes in blood measures of C-reactive protein, liver function, renal function, and complete blood count.

This study will rigorously test the effectiveness and cost-effectiveness of an action-oriented discharge intervention. This intervention aims to increase the number of days elderly hip fracture patients spend living well in the community during the first 30 days post-discharge. It will overcome barriers to best practice by promoting active involvement of patients and their support persons in discharge planning, as well as collaboration with hospital and community care providers.

The posterior cerebral artery (PCA) is an important artery which supplies the visual cortex in the occipital lobe and is key to visual function in the contralateral hemifield (loss of half visual field on side opposite to the stroke). Preservation of vision is essential in reading, return to work and driving post-stroke (deficit less than quarter of visual field). Unfortunately, spontaneous complete recovery of visual field occurs in 18.4% of cases and visual rehabilitation does not reduce hemifield deficit. The aim of this trial is to determine if clot extraction versus best medical therapy is the optimal treatment.

This study is intended to study the safety and tolerability of a new investigational medication, MTX-474 in healthy adults. The study is "randomized", meaning that the study drug will be compared against a placebo comparator. MTX-474 as well as Placebo will be administered intravenously to study volunteers over the course of 1 hour, and safety assessments (Clinical Labs, ECG, Physical Examinations) will be performed at various timepoints throughout the study.

Falls are a major health issue for people aged 65+. Participating in regular physical activity which focuses on balance and strength training can reduce the risk of falling, however existing fall prevention exercise programs are not always popular. Tailored dance programs designed for wellbeing and fall prevention are well attended and highly engaging, but as yet there is no evidence that dance prevents falls. We will conduct a pilot RCT of tailored dance classes for people aged 65+, with a waitlist control group, to assess the acceptability, feasibility and impact of a tailored dance intervention. The results will inform the design and methods for a planned large trial of tailored dance classes for older people, with falls as the primary outcome.

This study aims to further understand the difference in teaching formal and informal mindfulness practices, and the effect on dose of formal and informal practices on wellbeing outcomes. Additionally, this project aims to further examine dose-response in mindfulness programs, by in particular focusing on instructions of formal and informal practice, and whether participants follow guidance of formal and informal practice in different ways, and/or develop their own informal practices from being given instructions on different types of practice.

Social anxiety is prevalent among university students. As a result, a sizeable proportion of the student body is left under-prepared for their future careers. To offer effective and scalable support in building these essential skills, we will evaluate a cognitive behaviour therapy (CBT) program for social anxiety called ASTUTE (Anxiety Skills Training in UniversiTy Education). The program will be implemented in two forms: (1) in-person, clinician-facilitated groups (ASTUTE) and (2) online, guided self-help (ASTUTE-Digital). The latter provides a highly scalable means of supporting students overcome social anxiety, which is important given the high prevalence of social anxiety in the university setting. To evaluate the impact and acceptability of these programs, participants will complete questionnaires assessing their psychological functioning at baseline, end-of-program (two months later) and follow-up (four months later). To provide input regarding the ongoing design of the programs, participants will also be asked to take part in focus groups at the four-month time point.

The purpose of this study is to assess safety, reactogenicity (reactions that occur to the body soon after vaccination), and immunogenicity (the ability of a vaccine to provoke an immune reaction in the body) of a COVID-19 vaccine, HN-0001. The HN-0001 vaccine will be administered via intramuscular injection. This study will be conducted in healthy men or women, 18-65 years of age. This study will compare effects seen in participants receiving the study drug at the moderate dose (30mcg) with effects seen in participants who receive an equivalent dose of the comparator COMIRNATY Omicron XBB.1.5 vaccine. 20 participants will be enrolled in the trial.

This study is designed as a 3-part study in healthy participants to test the drug-to –drug interaction of experimental drug, JNT-517 with itraconazole, midazolam and pravastatin, respectively. JNT-517 is believed to reduce levels of phenylalanine in the by increasing its removal with urine and reducing uptake of phenylalanine in the gut.

Previous trials have treated individuals with migraine associated neck pain as homogenous. However our research identified cervical musculoskeletal dysfunction in about 40% and pain hypersensitivity in about 50% of participants with migraine. This indicates the presence of four subgroups in this population: i) with cervical musculoskeletal dysfunction and pain hypersensitivity, ii) only cervical musculoskeletal dysfunction, iii) only pain hypersensitivity, iv) neither. We hypothesise that physiotherapy intervention should therefore be individualised according to these subgroups but such individualisation of management is novel in this population. Therefore the primary aim of this study is to establish the feasibility of conducting an efficacy trial on individualised physiotherapy management of patients with migraine and neck pain, including patient perspectives on preferred primary outcomes and meaningful effect sizes. The secondary aims are to describe this novel individualised treatment program and explore the effects and possible underlying mechanisms.