ANZCTR search results

A Phase 1 clinical study in healthy subjects to evaluate the extended-release formulation candidates and assess their associated food effect to select the optimal extended release formulation based on the safety, tolerability, and plasma drug concentration profile of MAXONA Pharmaceuticals MAX-001

An APP has been developed to provide information and guidance to individuals with TBI and RTW/VR providers in ways to prepare for returning to work and to provide strategies to manage potential challenges once back at work. The aim of the project is to compare the effectiveness of the app in improving employment outcomes in a group who access the app prior to and during their return to work as compared with those who don’t. The results will be used to justify use of the app to improve work outcomes for individuals after TBI.

Approximately 150 million people wear contact lenses (CL) globally . Of these, 50% experience discomfort during contact lens wear and 25% of wearers are likely to discontinue wear permanently. The etiology of contact lens discomfort (CLD) is multifactorial and could be due to reduced compatibility between CL and the ocular environment. Intense Pulsed light therapy has been proven to be an effective therapy for improvement of signs and symptoms of dry eye disease, but it has not been fully evaluated as a treatment for contact lens discomfort. This project aims to evaluate the qualitative and quantitative change in signs and symptoms of Contact lens discomfort (CLD) and Meibomian gland dysfunction (MGD) following Intense Pulsed Light (IPL) treatment in Contact lens wearers. The research hypotheses is that Intense pulsed light (IPL) therapy will improve the signs and symptoms of CLD and MGD in contact lens wearers. This study designed as single centre, randomised, double masked trial, and consists of three visits. At the first visit, screening will be performed to determine the eligibility to take part in the study, If eligible, various clinical procedures will be conducted, followed by random allocation to one of the two treatments (Intense pulsed light or sham treatment) with Meibomian gland expression. The primary outcome is an improvement in Contact lens dry eye questionnaire -8 (CLDEQ-8) symptoms score following Intense pulsed light therapy in contact lens wearers. The secondary outcome is an improvement in tear break up time and Meibomian gland expression following intense pulsed light therapy in contact lens wearers .

Deep Transcranial magnetic stimulation (dTMS) is a form of repetitive transcranial magnetic stimulation (rTMS) which has been established as a safe, effective and well-tolerated treatment for depression, especially in patients who do not respond to initial antidepressant medication treatment. Although dTMS, and other forms of rTMS, are effective treatments, only about 50% of patients get a substantial clinical response and for some this can take a considerable period of time. Over recent years we have conducted extensive research developing methods to enhance treatment response to forms of rTMS including exploring whether improving the targeting of treatment into relevant brain areas can improve clinical outcomes. dTMS involves the application of repetitive pulses using a coil that has a deeper and wider area of stimulation of the brain. There are a number of dTMS coils commercially available which allow for stimulation of different areas of the brain. For example, H1 coil is typically used to stimulate a relatively large area of the lateral prefrontal cortex. In contrast, the H7 coil is applied to stimulate medial prefrontal regions. Evidence suggests that meaningful therapeutic benefits in patients with depression can be achieved with stimulation of both lateral and medial prefrontal cortex although there may be differences in the clinical characteristics of patients who respond to treatment at these two locations. The aim of the current research is to explore whether clinical outcomes may be improved using an approach which combines stimulation of these two sites. Specifically, we will compare treatment at the lateral prefrontal cortex with the H1 coil alone (current standard treatment) to a dual approach stimulating both lateral prefrontal cortex with the H1 coil and medial prefrontal cortex with the H7 coil.

Non-ambulant children with cerebral palsy experience more sedentary behaviour, spending up to 96% of their waking day sitting. With limited evidence-based interventions available, this can have a devastating impact on health and well-being. CPMovetime aims to develop wearables and user interface that reduce sedentary behaviour to improve health outcomes.

This research aims to improve outcomes for mothers and babies when a labour is artificially brought on or induced. Inducing the labour can lead to the baby being stressed and make the labour more painful. If the baby is severely stressed this can rarely lead to stillbirth or brain damage to the baby. This research will use lower doses of medications used to bring on labour, aiming to make it safer for mothers and babies. It could also reduce the chances that a woman has a caesarean section

Mycoplasma genitalium and Chlamydia trachomatis are two of the most common sexually transmitted bacteria. Doxycycline is an antibiotic that is very effective for treating C. trachomatis and it is also used for M. genitalium. Doxycycline reduces the bacterial load of M. genitalium and can help to improve M. genitalium cure when taken before a second antibiotic. Current treatment guidelines recommend 7 days of doxycycline before starting the second antibiotic for M. genitalium. However, it is possible that taking the doxycycline for less than 7 days is just as effective. To determine if the duration of doxycycline treatment can be shortened without any impact of overall treatment efficacy, we need to understand how the amount and viability (if the bacteria is alive or dead) of M. genitalium and C. trachomatis changes each day during doxycycline treatment. Therefore, this study aims to determine the impact of doxycycline on the: 1. bacterial load of M. genitalium and C. trachomatis over 7 days in men attending a sexual health service 2. viability of M. genitalium and C. trachomatis over 7 days in men attending a sexual health service 3. urethral microbiota composition

This is a first in human study of a new potential treatment drug HH3806 for patients with relapsed/refractory NHL or advanced solid tumors. This study aims to determine the maximum safest dose of HH3806 that may be administered to cancer patients as a single therapy. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and to determine maximum safest dose of HH3806 that will be administered orally as a single therapy in adult patients with advanced malignancies. Who is it for? You may be eligible for this study if you are an adult aged 18 or older and you have been diagnosed with relapsed/refractory NHL or advanced solid tumors. Study details This study will be conducted for eleven dose levels. Participant will receive HH3806 once daily till disease progression. HH3806 capsule will be administered as an oral capsule once daily for the duration of each 28-day treatment cycle without any study treatment interruption between each cycle. 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 for each participant could be continued until disease progression, unacceptable toxicity, death or withdrawal of consent until the date of the last data collection (1 year post-treatment commencement), whichever occurs first. 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). It is hoped that this research will demonstrate the safety of HH3806 and find the ideal dose for larger-scale studies.

The primary aim of this study is to evaluate the effect of a titrated respiratory physiotherapy treatment protocol on subject quality of life over a 12-month period. Secondary outcomes include rate of lung infections (pulmonary exacerbations), spirometry, patient self-efficacy and the patient experience assessed through qualitative interviewing. Enrolled study participants will be provided a tailored airway clearance program by a trained respiratory physiotherapist to augment clearance of excess secretions from the lungs. The efficacy of this program will be reviewed at regular intervals during the treatment period. If required the subject’s airway clearance regime will be up-titrated to improve effectiveness of the treatment. We hypothesise that this outcome-based customization of airway clearance will improve quality of life, spirometry and self-efficacy in patients with bronchiectasis.

This project aims to investigate whether taking ginger powder as a dietary supplement has any beneficial effect on blood ferritin levels in patients with iron deficiency (ID). The study will recruit 20 participants confirmed with an ID diagnosis attributable to dietary deficiency. Participants will be randomly assigned to either intervention or control groups. Participants in the intervention group will take three capsules of dried ginger powder (525 mg x3) per day in addition to oral iron therapy (standard care) during the trial. The control group will receive standard care only. Outcome measures include serum ferritin, haemoglobin, hepcidin, systemic inflammatory markers and patient-reported fatigue and indigestion scores. Data will be collected at baseline and 2 follow-up sessions 3 months apart.