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A Phase 1 Study of Deflexifol in patients with advanced malignancy after failure of standard treatment
Expand descriptionThis study will determine the pharmacokinetic properties of Deflexifol, as well as test the safety and efficacy of Deflexifol when given as a bolus followed by infusion to patients that have failed standard of care Who is it for? You may be eligible to join this study if you are aged 18 and above and have metastatic or locally advanced malignancy for which standard of care treatment has failed. Study details Participants in this study are allocated to one of 4 dose levels of Deflexifol, administered to participants in a combined bolus and infusion. Patients will receive 6 cycles of one dose level, with one treatment occurring every 2 weeks. Pharmacokinetics will be measured during the first 2 cycles, and safety will be assessed every 2 weeks over the 6 cycles of treatment. A follow up visit will be conducted 30 days after the last dose of trial treatment. It is hoped this trial will determine a suitable dose for further study of Deflexifol in a phase II trial.
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The Walter and Eliza Hall (WEHI) Stafford Fox Rare Cancer Program (SFRCP) will use blood , eyebrow hairs and tumour tissue samples from patients with rare cancers to study these types of cancers in detail.
Expand descriptionThe purpose of the Walter and Eliza Hall Institute Stafford Fox Rare Cancer Program is to use blood, tumour tissue and eyebrow hair samples from patients with rare cancers to study these types of cancers in detail. Who is it for? You may be eligible for this study if you have cancer that is considered rare, occurring in less than 6 people for every 100,000 diagnosed per year. There are literally hundreds of different types of rare or less common cancers. In fact most cancers, except breast, prostate, bowel, lung and skin melanoma, can be considered rare or less common. Examples are soft tissue cancers (sarcomas), brain tumours, cervical cancers, thyroid cancers, liver cancers, testicular cancers and many more. The researchers are also interested if a person has had three or more different types of cancers in their lifetime. Study details By consenting to this study, all participants may choose to donate suitable tissue (blood, tumour tissue and eyebrow hairs) for analysis which will help us to better understand the biology driving the development of their rare cancer/s. Participants in this study will then be contacted by their research doctor on a regular basis (every six-twelve months) to ask about their general health for up to 5 years. We hope that in doing these analyses, novel regulatory mechanisms could be discovered which will allow more effective treatments to be developed.
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A clinical trial exploring the administration of intravenous antibiotics and fluids via intravenous pole and pump versus portable CADD pump to improve mobility in patients diagnosed with cancer (The Active Trial)
Expand descriptionThe purpose of this study is to compare the currently used IV pole and pump to a smaller, portable IV pump, called a CADD pump, for the administration of IV antibiotics and IV fluids. You may be eligible for this study if you are aged 18 years or over and are a cancer inpatient who has been prescribed intravenous antibiotics or fluids. Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will use the CADD pump to receive their IV antibiotics/fluids, and the other group will use the existing IV pole and pump system. All participants will wear a step-counter, called an accelerometer, on their wrist. Patients will be asked to consent to the study by a research nurse and will be required to answer some brief questionnaires during their involvement in the study. It is hoped this research will show that the CADD pump helps inpatients to be more mobile in hospital, and that this will lead to improved patient outcomes and reduced hospital-acquired complications.
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The effect of treatment of obstructive sleep apnoea on the development of gestational diabetes in pregnancy (POSA).
Expand descriptionTo determine if treatment of OSA during pregnancy, with CPAP or positional therapy, leads to improvement in clinical outcomes, particularly gestational diabetes. Pregnant women with any OSA, will be eligible to participate in the randomised trial, and will be randomized into three groups to be treated with Continuous Positive Airway Pressure (CPAP), Positional therapy and usual care. The primary outcome for this study is the incident gestational diabetes mellitus on oral glucose tolerance test (OGTT) performed at or prior to 28 weeks gestation
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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB099280 in healthy adult participants, and the effect of food on pharmacokinetics
Expand descriptionThe 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.
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mater4newmums: A pilot randomised controlled trial investigating the effect of a mobile phone (m-health) intervention on healthy eating, physical activity and postnatal weight retention in women of prepregnancy BMI of 25 or greater
Expand descriptionUp 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.
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Testing whether prochlorperazine can be safely used to move anti-cancer therapy targets temporarily to tumour cell surfaces with combination dose increases of cetuximab anti-EGFR antibody.
Expand descriptionThe 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.
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Investigating heat tolerance in females
Expand descriptionHeat 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.
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Effects of transcranial direct current stimulation for improving attention after traumatic brain injury
Expand descriptionThis 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.
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INTEGRATE: An integrated treatment for young people with psychological distress.
Expand descriptionThe 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.