ANZCTR search results

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.

Meibomian Glands (MGs) in the eyelids play a significant role in tear production by contributing lipids (oils) to the superficial tear film. Meibomian Gland Dysfunction (MGD) affects up to 70% of the population and is a multifactorial disease characterised by abnormal MG structure with characteristic changes in the quality or quantity of MG secretions (meibum). Meibum secretions play a crucial role in ocular surface health. Lipids secreted by MGs have an essential role in reducing the evaporation of the tears from the ocular surface. However, while treatments such as Intense Pulsed Light (IPL) therapy have been shown to improve ocular symptoms and signs including dryness, grittiness and burning sensations , any associated changes in gland structure and function are not known. Therefore, it is important to understand the effect of such treatments on the morphology (structure) of these glands and the composition of meibum secretions to better understand the disease process. This project aims to evaluate the changes in meibomian gland structure and function in a symptomatic dry eye population with evidence of MGD, following intense pulsed light therapy. The research question/hypothesis that this study seeks to address is: Whether there is any measurable change in the structure and function of meibomian glands following IPL therapy?

Cognitive training ("brain training") programs are now mainstream among the community, education and health systems, promising to improve cognitive functioning. The potential of cognitive training to improve core cognitive abilities, such as working memory, has been acknowledged by many education and health experts, however these programs are designed based on common untested assumptions of training methods that are conventions in the field. A common assumption is that working memory training should comprise variations of the training activities. This is assumed to provide the trainee with opportunities to practice the skill in different conditions, resulting in improved cognitive performance. However, this assumption has only been tested in adults. The assumed benefit of variations of the training activities has not been systematically evaluated in children. This trial aims to test the common assumption that cognitive training in children should comprise variations of the training activities. It will compare the outcomes of working memory training using one, two or three variations of the training activities, to an active control. Given the lack of research evaluating common assumptions of cognitive training, our aim is exploratory. Training outcome will be evaluated immediately and 6-months post-intervention using: 1) working memory measures similar in structure to the training activities (near transfer), 2) working memory measures different in structure to the training activities (intermediate transfer), and 3) measures of non-verbal reasoning, inattention and hyperactivity-impulsivity behaviours (far transfer).

Monitoring acute changes in symptoms (perceptual wellness) during chemotherapy is essential for determining when to implement or optimise exercise training for cancer patients. This study aims to assess whether a selection of outcome measures is able to provide reliable information regarding cancer patients' perceptual wellness whilst they are actively receiving chemotherapy. Who is it for? You may be eligible for this study if you are aged between 18-85, have a confirmed cancer diagnosis, are scheduled to begin chemotherapy immediately or within one month, and are not currently meeting the optimal physical activity guidelines for cancer. patients. Study details All participants who choose to enrol in this study will be asked to attend up to 7 sessions at the Olivia Newton-John Cancer Wellness and Research Centre in Melbourne (VIC). Each session is anticipated to take 30 minutes. Participants will be asked to complete a series of physical tasks and complete a set of questionnaires regarding their current symptoms and physical and mental well-being. All sessions will be supervised by an accredited exercise physiologist with specialist expertise in cancer and will be scheduled at 2-3 weekly interval (single cycle of chemotherapy only) to align with your standard care exercise regime. It is hoped this research will determine whether the selected outcome measures are able to provide reliable information regarding cancer patients' perceptual wellness whilst they are actively receiving chemotherapy. Suppose the results of this study are positive. In that case, they may be used to guide exercise training schedules for future cancer patients, to ensure that they are receiving the best care without over-exerting themselves.

Observational multicentre cohort study on the long term outcomes of ulcerative colitis patients on ustekimumab therapy (post UNIFI study, NCT02407236), including time to flare, need for escalation and co-therapy for disease control. Time on treatment will be assessed from the first dose of ustekinumab, and 'survival' analysis performed with time on medication (with resutls censored at any loss to follow up. The primary outcome is proportion of patients who relapsed on ustekinumab, defined as a recurrence of flare/colitis symptoms with commensurate biochemical, endoscopic, histological, and/or radiological evidence of disease activity that led to commencement or dose escalation of medical therapy

In this waitlist-controlled pilot study we want to find out if the application of an innovative new adhesive light patch can reduce pain and improve movement in people with knee osteoarthritis (KOA). In this study, we will see whether the light device has any benefit compared to no treatment. Although only half of the participants will receive the light treatment, all participants will be seen at home at pre-determined times by the researchers to assess their progress. Today, the usual approach to pain relief and improved movement is a combination of pain-relief drugs (analgesics that include opioids that may be addictive or have side effects) and exercise rehabilitation. These strategies can work well, but the new light treatment may result in good outcomes without the side effects of drugs, and may promote greater activity in people who have KOA. Almost 70% of all drug-related health disorders are related to opioid use, so reducing the intake of these medicines by using alternative forms of pain relief is a desirable aim. We have previously carried out a small feasibility study (Vassão and Laakso, 2022; not registered) to work out the protocol details for this research study. In the feasibility study, we found that patients who were planned for knee replacement surgery due to severe KOA accepted and tolerated the light device, that it was easy for patients to apply at home, and the device provided good pain relief. Based on this previous research, we expect that using a low dose of light therapy daily for two weeks may decrease pain and improve function. The device we are testing is called CareWear. CareWear is a novel, 3-D printed self-adhesive patch with hundreds of micro-diodes (light emitting diodes are found in many home appliances) that emit specific light frequencies that have been found in other research to reduce inflammation and pain. The CareWear patch is registered in the USA and with the Australian Therapeutic Goods Administration (TGA) for applying light to areas of pain and inflammation. [Vassão PG, Laakso E-L. ‘Photobiomodulation therapy (PBMT) is feasible and acceptable in preconditioning and post-operative recovery of patients after total knee arthroplasty (TKA): A clinical case series’. OBM Integrative and Complementary Medicine 2022; 7(1) doi:10.21926/obm.icm.2201012.]