ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33036 results sorted by trial registration date.
  • Enhancing the clinical effectiveness of deep TMS treatment of depression

    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.

  • CPMovetime - A wearable sensor and user interface on physical activity and sedentary behaviours in non-ambulant children and youth with cerebral palsy.

    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.

  • Easing Oxytocin in Early Labour (EASE-OUT) Trial

    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

  • Doxy Decay: The impact of doxycycline on the organism load and viability of urethral Mycoplasma genitalium and Chlamydia trachomatis

    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

  • A First-in-Human Study to Evaluate the Safety and Tolerability of HH3806 in Patients With Advanced Tumors

    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 effectiveness of airway clearance in bronchiectasis: A prospective cohort study and review of the patient experience

    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.

  • The Potential Benefits of Ginger Supplementation in Individuals With Iron Deficiency: a Randomised Controlled Pilot Study.

    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.

  • Changes in the structure and function of oil-producing glands of the eyelids following Intense Pulsed Light therapy

    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?

  • COMmon assumptions of cognitivE Training (COMET) Project: A trial evaluating the assumption that working memory training should comprise variations of the training activities in children aged 7-11 years

    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).

  • A multi-faceted assessment model for monitoring performance and perceptual pre-exercise readiness in individuals undergoing cancer treatment

    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.

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