ANZCTR search results

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

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32752 results sorted by trial registration date.
  • Multi-level interventions to impact incidence and prevalence of sexually transmissible infections (STIs) among First Nations Peoples.

    The RISE study aims to address the long standing disparity of STIs among Aboriginal and Torres Strait Islander people in three regions of Australia; Cairns and outlying Hinterlands; Central Queensland, and the Katherine West region of the Northern Territory. The RISE study core objective is to develop, implement and evaluate the impact of multilevel interventions aimed at reducing STI incidence and prevalence in communities. These interventions are categorised at four broad levels, encompassing: individual, community, health service and structural/system. The study will prioritise interventions for all Aboriginal and Torres Strait Islander people aged 15-44 in the three regions and have discrete efforts focused on three priority population groups: Young people aged 15-24, Women of reproductive age 15-44, Men aged 15-40. The primary outcome is change in STI prevalence, across each region by population group, measured using notification rates and electronic medical record test positivity, comparing the intervention period with baseline and with control regions, reported by priority population groups.

  • A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Chir-110 in Healthy Adult Participants

    This study is testing a new oral form of a medicine called esketamine (Chir-110) in healthy adult volunteers. Esketamine is a medicine that acts on the brain and is already used in some settings to treat depression. This study is investigating a new capsule form taken by mouth to better understand how the body absorbs and processes the drug, and whether it is safe and well tolerated. Participants will receive a single dose of either Chir-110 or a placebo (a capsule with no active medicine). The study will test different dose levels in small groups, starting with a low dose and increasing step-by-step if it is safe to do so. Participants will be closely monitored at the clinical research unit on the day of dosing and will attend follow-up visits over about one week. During the study, researchers will collect blood and urine samples and check participants’ health, including heart activity, vital signs, and any side effects. The main aim of the study is to assess the safety and tolerability of Chir-110, as well as how the drug is processed in the body and its effects on the brain. It is expected that Chir-110 will be safe and well tolerated at the dose levels studied, and that the results will help determine appropriate doses for future clinical studies.

  • INtentional PreOperative WEight loss for patients with obesity diagnosed with Resectable GastroIntestinal cancer (INPOWER-GI)

    Brief description of the study purpose This study is looking at whether intentional weight loss before surgery can be safely achieved in people with obesity who have been diagnosed with resectable gastrointestinal cancer. It will test whether this approach is safe, well tolerated and may help improve outcomes after cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, have resectable gastrointestinal cancer planned for curative treatment, are more than 2 months prior to surgery, and meet the study eligibility criteria for obesity. Study details This study is a randomised controlled trial. Participants will be assigned by chance to receive either tirzepatide (Mounjaro) or a placebo injection once a week before surgery, in addition to their usual cancer care. Participants will attend an initial study visit, monthly review visits while on treatment, a visit before surgery, and follow-up after surgery. They will have measurements taken, be monitored for side effects and progress, and complete questionnaires about their wellbeing and quality of life. Participants will also receive advice from the study team about exercise, nutrition and preparation for surgery. This study is hoped to improve understanding of whether pre-operative weight loss is safe, feasible and beneficial for people preparing for gastrointestinal cancer surgery.

  • A study to see if an educational video will improve the quality of informed consent in patients undergoing coronary angiography

  • Evaluation of Positive End-Expiratory Pressure (PEEP) level changes and its effects on gas exchange, lung mechanics and intracranial pressure in mechanically ventilated patients admitted to the intensive care unit following who have experienced a subarachnoid haemorrhage

    Some patients with subarachnoid haemorrhage (SAH) – a type of bleeding around the brain – need help with breathing. They may be placed on a breathing machine called a ventilator. Ventilators use pressure called PEEP (positive end-expiratory pressure). PEEP helps keep the lungs open so oxygen can move into the blood. Doctors often adjust PEEP levels, but we do not fully understand how these changes affect patients with SAH. This study looks at how different PEEP levels affect oxygen levels, how the lungs move and pressure inside the skull (intracranial pressure). The study will include 20 adults ICU patients at the Austin Hospital who have been diagnosed with SAH, having monitoring for pressure in the brain, have had their aneurysm treated (surgery or a procedure), are on full breathing support from a ventilator and are expected to stay on the ventilator from at least another day. We will record routine breathing information already measured by the ventilator, adjust PEEP levels briefly (commonly 5, 10 or 15 cm H2O), check oxygen levels and how the lungs respond, and collect medical information from the patient’s chart. There is no extra treatment, no added procedures, and no follow-up for patients. The information collected will help improve care for future ICU patients.

  • A Phase Ib/II Study to Evaluate the Safety, Tolerability and Efficacy of IMD303 in Participants With Advanced Malignant Solid Tumors

    Study Purpose This study aims to evaluate IMD303, a new investigational treatment, in combination with another drug known as PD-1 inhibitor to determine a safe and tolerable dose and to characterize how the two agents interact in individuals with advanced solid cancers. Who Can Participate? You may be eligible for this study if you are aged 18 years or older and have selected tumor type expansion like melanoma, renal cell carcinoma and hepatocellular carcinoma and whose cancer has progressed despite standard treatment, who cannot tolerate standard treatment, or who have chosen not to pursue further standard therapy. Study details Those who are eligible will receive IMD303 as an intravenous infusion on Day 1 of each treatment cycle. The IMD303 dose will be given at least minutes after administration of a PD-1 inhibitor. Each group will have about 5 to 10 participants. Because people are enrolled one after another into the next available dose group, the dose they receive depends on when they join the study. Study Duration The anticipated study duration for each participant in Phase 1b/II is at least 8 treatment cycles (each cycle is of 21 days). The Safety Monitoring Committee may assess whether the treatment could continue beyond Cycle 8 based on the emerging evidence of clinical benefit (e.g., partial or complete response). Potential Benefits It is hoped that the study will help determine whether IMD303 when given together with a PD-1 inhibitor is safe and how the combination affects cancer growth. The data may provide important early information to support the future development of new treatment options.

  • HEARTBeats: a pilot study of noise-cancelling headphones playing therapeutic suggestions and pleasant music during open heart surgery to improve post-operative pain, anxiety and delirium.

    Patients recovering from cardiac surgery often experience significant pain, anxiety and distress in the first few days after their operation. Previous studies suggest that playing relaxing music and positive therapeutic suggestions to patients while they are under general anaesthesia may help improve recovery after surgery. This pilot study will investigate whether delivering relaxing music and recorded therapeutic suggestions through noise-cancelling headphones during cardiac surgery is feasible and acceptable for patients and clinical staff. Participants undergoing cardiac surgery will be randomly assigned to receive either standard care or standard care plus the headphone intervention, which will begin after induction of anaesthesia and continue until the breathing tube is removed in the intensive care unit. The main aim of this pilot study is to determine whether the intervention can be successfully delivered and whether patients can be recruited and followed up reliably. Information from this pilot study will be used to plan a larger clinical trial to test whether this intervention improves recovery after cardiac surgery, including pain, quality of recovery, and other postoperative outcomes.

  • COPD OUT- Does dosage of physiotherapy management of acute exacerbation of Chronic Obstructive Pulmonary Disease affect OUTcomes?

    COPD OUT is the first study to see if it is possible to run a clinical study testing two different dosages of physiotherapy treatments that are traditionally provided to adult patients admitted to hospital for treatment of an emphysema or chronic bronchitis flare up. Results of this study are vital to help future researchers design the best study possible to successfully test if physiotherapy is effective in faster resolution of symptoms, improving recovery, and long-term quality of life, in adults admitted to hospital with an acute exacerbation of COPD.

  • ACE Trial: Assessing Cyproheptadine and Endep for treatment of vestibular migraine. A Randomised Controlled Trial

    Vestibular migraine is a syndrome characterised by recurrent episodes of vertigo or other dizziness-related symptoms causing imbalance, nausea, and disruption to daily functioning, There is currently no standard treatment to prevent these episodes. Doctors commonly prescribe medications based on treatments for other types of migraine which have not been specifically studied in people with vestibular migraine, including amitriptyline (often used for migraine and chronic pain) and cyproheptadine (used in children for allergic conditions and sometimes for migraine). Early research suggests both may be helpful, but no direct comparisons exist, This study aims to compare these two medications versus a placebo medication (folic acid) in a randomised controlled trial to better understand which is more effective and better tolerated for reducing the number and severity of vestibular migraine episodes. It is hypothesised that cyproheptadine will have better treatment outcomes and less side effects than amitriptyline for vestibular migraine.

  • The Ora Connect cuff-less blood pressure device compared to standard cuffed non invasive blood pressure (NIBP) in adults undergoing tilt table testing and posture changes and exertion to validate accuracy

    The study aims to collect blood pressure readings via conventional cuffed BP machines and concurrently collect blood pressure readings cuff-lessly via a novel device called Ora Connect that has been developed by the Zaplutus IQ company. Tilt Table Testing and an alternative Posture and Exertion procedure will be used as these procedures commonly induce a change in blood pressure for the participant. By collecting comparative blood pressure readings, the intent is demonstrate that cuff-less blood pressure is as accurate as cuffed blood pressure.

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