ANZCTR search results

The purpose of this study is to assess the safety, tolerability of the drug INCB099280 and assess how this drug acts in the body with and without food in increasing doses. You may be eligible for this study if you are a male or female, aged 18 to 55, and you are in good health with no existing conditions. Participants in this study will be randomized (by chance) in each of the 6 cohort. In Cohorts 1-5 all participants will either receive a single dose of the drug or placebo (orally in a fasted condition (no food). In Cohort 6 all participants will be randomly assigned to treatment A or treatment B groups and then crossed over to the other treatment group (A or B) after a washout of 7 days. Participants in treatment A group will be dosed after fasting of 8 hrs. Participants in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. Participants will also provide blood and urine samples. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions, results from the study will affect how patients with cancer use this medication.

Up to 50% of women gain more than the recommended amount of weight during pregnancy. Retention of weight gained during pregnancy contributes to becoming overweight and obese and subsequent chronic disease risk, with the associated personal, financial and public health burdens. This study is a randomised-controlled trial to evaluate a consumer co-created text-message-based intervention to support women to improve diet quality and decrease postpartum weight retention.

The purpose of this study is to determine if a high dose of an anti-nausea drug (called prochlorperazine) is safe to give to patients during chemotherapy treatment, while also seeing if there is a health outcome benefit to patients. Who is it for? You may be eligible for this study if you are an adult who has a confirmed head and neck cancer or triple negative breast cancer or an adenoid cystic cancer of the head and neck region. Study details All patients in this study will receive a high dose of the anti-nausea medication 3 days after the commencement of chemotherapy. After this, all participants will receive the anti-nausea medication weekly, with their chemotherapy. There will be 5 different doses of the chemotherapy given in combination with the anti-nausea medication to participants depending on when the participant joins the study, with the doses increasing over time and only increasing if the doses pass safety reviews. It is hoped that this research will help determine if the anti-nausea drug is safe in combination with chemotherapy to treat patients, while also testing whether this has an effect on improving health outcomes.

Heat tolerance testing is used to establish if a Defence member is fit for return to duty following heat illness. The most frequently utilized heat tolerance test was developed by the Israeli Defence Force in the late 1970s with male participants. To our knowledge, the appropriateness of this protocol for females has not yet been established. Therefore, this study aims to investigate female heat tolerance responses using the current standard heat tolerance test protocol and to develop an alternative protocol if the current protocol is inappropriate.

This study evaluates the efficacy of brain stimulation, i.e. Transcranial Direct Current Stimulation (tDCS) to improve attention skills and working memory in people with traumatic brain injury. The study involves placing electrodes on the scalp and passing a weak direct electrical current through the brain that can increase neuronal excitability. The stimulation is non-invasive and painless with few reported side effects such as skin irritation or a mild headache. Individuals received one active/actual tDCS sessions and one sham or placebo session. During both sessions they also completed two computer-based task in which they responded to symbols appearing on the computer monitor. Participants were fully awake and alert during these sessions. Test sessions were approximately an hour in duration and took place approximately 1 week apart. The order of session (active or sham) was unknown to participants and, indeed, people find it very difficult to guess.

The aim of the study is to test whether a new integrated psychological treatment (INTEGRATE) improves mental health difficulties and decreases the risk of problematic substance use in young people, compared with usual treatment. Young people between the ages of 12 and 25 (inclusive) will be randomised to receive either i) the INTEGRATE therapy, or ii) treatment as usual (TAU), for 16 weeks in a double-blind, randomised controlled trial (RCT), with followup to 12 months. The primary hypothesis is that young people who are randomised to receive the INTEGRATE intervention will decrease their alcohol and other drug use compared to participants in the TAU group.

There is some concern that medications called opioids, which are used to treat pain, may delay the onset of blood thinning medications that are vital to improving patient outcomes after a heart attack. This study seeks to enrol patients suspected of having a heart attack to compare the safety and effectiveness of a different type of painkiller called lignocaine (which does not appear to interact with blood thinners) to fentanyl which is the current standard of care opioid used. We hypothesise that use of lignocaine will be safe and effective for pain related to a heart attack. Ambulance Victoria paramedics will randomise patients with suspected heart attacks to receive either intravenous lignocaine or intravenous fentanyl and assess its effectiveness as pain relief and also side effects (safety) in each group. We will also assess size of the heart attack based on blood testing as well as clinical outcomes during follow-up.

The study aims to examine the rate and type of microbial contamination rate of silver impregnated and non-silver contact lens storage cases. This study is a prospective, randomized, single-masked, crossover clinical trial with five scheduled visits. A total 40 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for three month) along with a multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand. There will be total 5 visits within 6 months (baseline, 1 month, 3 months, 4 month and 6 month). Routine assessment of contact lens fit and anterior eye health will be conducted at each visit and lens cases will be collected for microbial analysis at the 1, 3, 4 and 6 month visits. At each visit, participants will be requested to complete two questionnaires relating to their contact lens use. The contact lens storage cases and multi-purpose disinfecting solutions will be provided free of charge during the duration of the study. Participants will be provided with a $10 vouchers at the end of each study visit to compensate for their costs incurred in attending the study visits.

Mal de Debarquement Syndrome (MdDS) is a rare neurological condition that affects the vestibular system and currently has no cure. Symptoms of MdDS include a continuous swaying, rocking, or motion-like feeling that typically arises following a motion experience such as traveling on sea, which leaves patients with a feeling of chronic “sea legs” or “sea sickness” though they are on stable ground. The underlying cause is currently unknown, and thus treatments for this condition are often ineffective. This project seeks to investigate the efficacy of a combination of Theta Burst Stimulation (a form of Transcranial Magnetic Stimulation) and the Vestibular Ocular Reflex Protocol (a manual therapy) in reducing objective and subjective measures of the condition. It is hypothesized that MdDS patients will report an improvement of symptoms after the combined therapy, which will significantly affect their quality of life, compared to the sham treatment.

This pilot pragmatic open label randomized controlled Trial (RCT) compares the use of Nitric Oxide (NO) treatment blended into the oxygenator of the Extracorporeal Membrane Oxygenation (ECMO) circuit in comparison to standard care defined as no treatment with NO into the ECMO circuit. We hypothesize that in children treated with ECMO, a randomized trial investigating the use of NO during ECMO is feasible. We hypothesize that neonates and children on ECMO exposed to NO on ECMO have a reduced rate of clotting and bleeding complication and reduced inflammatory response measured by various clotting markers as well as serum cytokine levels in comparison to controls, leading to shorter ECMO run duration and reduced health care costs. The findings could have major potential to improve patient-centered outcomes and reduce health care costs.