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Patients with inflammatory bowel disease (IBD) are prescribed medications used to treat inflammation. Infliximab is an effective intravenous therapy that is used in the treatment of Crohn’s disease and ulcerative colitis. Conventionally, infliximab is given as an infusion every 8 weeks. The dose of infliximab is calculated according to weight and may differ between patients. Despite initially responding to infliximab, some patients will lose response over time, such that the drug no longer continues to work as well as it once did. Studies have demonstrated that patients on a maintenance treatment are more likely to continue to show positive responses to infliximab therapy when the blood level of infliximab, measured just prior to the next scheduled infusion (referred to as a ‘trough level’), is within an optimal range (referred to as ‘therapeutic range’). Infliximab levels are measured from a blood sample. In the past we measured infliximab levels only occasionally. This is partly because the results took time to be processed and were not available on the same day. In this project a blood test will be taken to measure the infliximab level every time patients are due for your infliximab infusion. The test to be used is able to measure the drug level within an hour at the point of care. We will then be able to modify the infliximab dose immediately, in small increments, according to the infliximab level with the aim of ensuring that infliximab levels remain within the ideal therapeutic range. The infliximab blood test and dose modification, if needed, will occur at each visit for the duration of the study (for 12 months, or 6-7 infusions). At each visit, 10mL (about 2 teaspoons) of blood will be taken from your peripheral access line to measure the level of infliximab in your blood along with other blood tests normally conducted when you have your infusion. The information from the blood tests will be used by the researchers to adjust the infliximab dose and to validate the dosing guide. Participants will be asked to provide faecal samples to measure faecal calprotectin, a protein that is secreted in the intestine of patients with inflammation of the gastrointestinal tract (this is a test we currently perform periodically; during this study we will do this test at the second visit and at the end of the study). Participants will be asked to complete a brief survey that assesses quality of life at the beginning and the end of the study, and to answer some short questions about their Crohn’s disease or ulcerative colitis

PURPOSE The primary purpose of this study is to determine the efficacy and safety of elotuzumab when combined with cyclophosphamide, thalidomide and dexamethasone (E-CTD) when compared to a standard cyclophosphamide, thalidomide and dexamethasone (CTD) triplet for the treatment of relapsed and/or refractory multiple myeloma (RRMM) WHO IS IT FOR? You may be eligible to join this study if you are over 18 years, have been diagnosed with RRMM, have had between 1-3 prior lines of therapy (may include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy), and do not have central nervous system involvement with the disease. STUDY DETAILS Enrolled participants who meet the eligibility criteria at registration will be randomised in a 2:1 ratio with 2 patients randomised to the E-CTD arm for every 1 patient randomised to the CTD arm. Treatment in both arms will include a combination of weekly intravenous infusions, and daily and weekly oral tablets. Patients will receive treatment in 28 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent. Patients will be followed up every 4 weeks for MM response until disease progression, and then every 12 weeks for survival. The trial duration is estimated at approximately 4.75 years. OUTCOMES It is hoped that the findings of this trial will determine whether the addition of elotuzumab to a standard cyclophosphamide, thalidomide and dexamethasone triplet will improve progression free survival in relapsed and/or refractory multiple myeloma patients

Weight cycling (yo-yo dieting) is an ongoing battle for many obese individuals and is commonly believed to impair energy metabolism and promote future weight gain. However, scientific evidence for this idea remains scarce and mechanisms of how this occurs has not been examined in humans. The aim of this study is to investigate whether weight-cyclers have impaired energy metabolism, greater fat deposition and greater circulating and fat tissue inflammation compared to non-cyclers. 100 overweight/obese women undergoing bariatric surgery will be recruited into this study. 60 women (30/group) will be classified as weight-cyclers or non-cyclers using a validated questionnaire. Blood and fat tissue samples will be collected at the time of surgery and markers of inflammation measured in the laboratory. Clinic visits will be performed at baseline prior to surgery and at 6, 12 and 24 months after surgery. Measurements include anthropometry, body composition, resting metabolic rate and circulating markers of cardiometabolic disease (glucose, insulin, HbA1c, lipids, inflammation). Using a rigorous scientific approach and comprehensive clinical phenotyping we will address whether individuals who weight cycle have reduced energy expenditure and greater fat deposition. These results will assist in tailoring personalised weight loss treatment strategies for the over 70% of Australians affected by overweight and obesity.

The aim of the project is to examine the effect of nitrate-rich beet juice on leg blood flow during reactive hyperaemia and passive leg movement. During reactive hyperaemia and passive leg movement, blood flow is known to be highly dependent on the availability of the nitrate derivative, nitric oxide. The results of this study will determine if beet juice can enhance leg blood flow and thereby provide an effective adjunct to therapeutic exercise. The proposed study will use a placebo controlled, cross-over design to determine if beet juice can increase leg blood flow and femoral artery dilation for older adults. Specifically, we will examine leg blood flow and femoral artery diameter during reactive hyperaemia and passive hyperaemia, two tests which are known to be highly dependent on NO availability, thereby demonstrating the mechanism. Participants will attend the laboratory on three occasions: visit 1 will include participant screening, consent, and familiarisation; visits 2 and 3 will involve nitrate-rich beet juice and placebo trials (in random order). During each of the experimental visits, before and after ingestion of the beet juice or placebo, the following will be measured: blood pressure, blood plasma NO3-/NO2-, arterial stiffness, femoral artery dilation capacity, femoral artery blood flow capacity, and blood flow during passive leg movement. The results of this study will determine whether or not nitrate supplementation increases leg blood flow and vessel dilation during a reactive hyperaemia test and during passive leg movement. Ultimately, this experiment will demonstrate whether leg blood flow increases in response to improved NO availability for older adults. These findings will help to guide treatment for individuals with chronic diseases that limit exercise capacity, such as peripheral arterial disease, pulmonary disorders and heart failure. This study will also clarify the mechanism by which a simple dietary intervention may enhance leg blood flow, providing an effective adjunct to therapeutic exercise.

There is significant interest from researchers, general practitioners and the public re: the administration of Vitamin D3 supplements for health maintenance or disease treatments. The aim of this study is to evaluate the absorption characteristics of a selected group of U.S. MARKETED OVER THE COUNTER (OTC) PRO-HORMONE (D3) PRODUCTS. These products are not commercially available in Australia. As such this study proposes to evaluate the absorption characteristics of these products.

Posttraumatic stress disorder (PTSD) is a common and serious mental health problem that can have a profound impact on the person’s functioning and quality of life. Although we have effective treatments for PTSD, there are still many veterans who do not benefit from these approaches. New and innovative treatments are required. Phoenix Australia and the Monash Alfred Psychiatry Research Centre (MAPrc) are conducting a pilot study of a new intervention for PTSD known as Theta Burst Stimulation (TBS). Previous research has shown that people with PTSD may have an imbalance in the excitability, or ‘activity levels’, of cells in the brain. TBS involves the application of magnetic pulses to the head to try and change the activity level of cells in the brain. The aim of TBS treatment in PTSD is to improve the way different parts of the brain that are affected by PTSD communicate with each other, thereby reducing the symptoms of PTSD and leading to improvements in memory and thinking. To be potentially eligible to participate in the study, individuals must be a veteran, have a current diagnosis of PTSD, and be aged 18 years or above. Participation in the study involves a number of interviews, assessments and a course of TBS treatment given Monday to Friday, 15 minutes a day for four weeks at MAPrc in Prahran, Victoria. All eligible veterans will receive active bilateral TBS treatment. Participants will be assessed prior to, following and 3 months after treatment. A total of 15 participants will take part in this pilot project. This study was initiated by Professor David Forbes, Professor Paul Fitzgerald and Ms Jane Nursey and is funded by a Defence Health Foundation Grant for Medical Research.

PURPOSE This study will determine the safety and pharmacokinetics of oral arsenic trioxide (ATO) in consolidation therapy for Acute Promyelocytic Leukaemia (APML) WHO IS IT FOR? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with APML, and are in complete remission following induction with ATRA + ATO, or ATRA + ATO + idarubicin (high risk APML patients). STUDY DETAILS Enrolled participants will have achieved haematological remission following standard induction therapy with ATRA + ATO, or ATRA + ATO + Idarubucin. Patients will then undergo consolidation therapy, which will consist of two phases: Phase (i)- Approximately 8 patients will receive 7 cycles of ATRA (cycle= 7 days/week for 2 weeks; 2 weeks between cycles) + 4 cycles of IV ATO (cycle= 5 days/week, for 4 weeks; 4 weeks between cycles) with the exception of week 1 of ATO cycle #2, and week 1 of ATO cycle #4, when oral ATO will be used. The total time of consolidation treatment will be 28 weeks (7 months). Patients may have their oral doses adjusted throughout phase (i), with adjustments based on blood and urine results. The treatment regimen is designed so that patients will still receive effective doses of ATO, even if the oral ATO is completely unabsorbed by the body. Phase (ii)- The remaining 20 patients will receive 7 cycles of ATRA (cycle= 7 days/week for 2 weeks; 2 weeks between cycles) + 4 cycles of IV ATO (cycle= 5 days/week for 4 weeks; 4 weeks between cycles) with the exception of week one of either ATO cycle #1 or ATO cycle #2, and week one of either ATO cycle #3 or ATO cycle #4, when oral ATO will be used (the sequence will be determined by randomisation). The total time of consolidation treatment will be 28 weeks (7 months); Pharmacokinetics will be assessed by blood samples collected on days 1 to 2 and days 4 to 5, and urine collected on days 4 to 5 of the first week of each cycle of ATO consolidation. Safety will be assessed using Common Terminology Criteria for Adverse Events. Participants will be followed-up annually for a minimum of 3 years following the 4th cycle of ATO consolidation. OUTCOMES This trial is primarily a bioavailability study; however the efficacy and safety will be also evaluated, with the aim to determine the recommended phase 2 dose of oral ATO for use in a subsequent phase 2 trial to study efficacy.

The primary purpose of this trial is to evaluate the safety and tolerability of Metformin (MET) in combination with sodium valproate (VPA) for the treatment of prostate cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with localised or locally advanced prostate cancer for which radical prostatectomy is planned within the next 6-8 weeks. Study details Participants enrolled in this trial will receive a combination of MET and VPA in increasing doses depending on the cohort they are enrolled in. The study drugs will be administered for a total of 4 weeks just prior to the planned surgery for removing the prostate It is hoped that this trial will provide information on the optimal dose of MET plus VPA to administer to prostate cancer patients, which may be an effective treatment which is safe and tolerated by patients.

Post-operative pulmonary complications (PPC) are the most common complication following upper abdominal surgery (UAS).. Recent unpublished data from a large international multi-centre randomised control trial (LIPPSMAck POP; Boden 2015) found that patients who develop a PPC following major upper abdominal surgery had a mean LOS five days longer, cost an additional $AUD18,000 per episode, and have a significantly higher 30-day mortality rate (9% v 1%, p=0.01) compared to those without a PPC. This is in keeping with meta-analysis data of mortality attributable to postoperative acute lung injury (Neto 2014). Previously reported PPC incidence rates following abdominal surgery vary greatly (anywhere between 10 and 80%). This variance is mostly due to two factors; firstly, the patient group being investigated (for example low risk hernia repair compared to higher risk oesophagectomy) and secondly, the diagnostic criteria used to detect a PPC. There is also limited current prospective evidence to estimate the PPC rate in surgical groups other than elective major abdominal surgery. This includes emergency surgery, organ transplant, neurosurgery, cardiac, thoracic, ENT surgery, and minimally invasive abdominal surgery. The combination of non-standardised measurement of PPC incidence and lack of contemporary incidence rates outside of abdominal surgery means that it is not possible to accurately estimate which surgical groups are at highest risk of developing a PPC. It also means that resource allocation of prophylactic interventions like physiotherapy is not based upon robust evidence. Hospitals could be over-treating some surgical groups and most concerning, under-treating others. This is unknown, as the current physiotherapy practice for these surgical groups has also not been measured robustly (audit rather than survey) and what impact this may have on PPC rate, mortality, and LOS. Considering the high morbidity, mortality, and cost impact of a PPC there is an urgent need to measure PPC prevalence using consistent diagnostic criteria, over a range of hospital types and surgical groups, and a need to investigate the current use of physiotherapy interventions to reduce PPC incidence and improve recovery following major non-orthopaedic surgery.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of tremelimumab treatment in combination with durvalumab followed by single durvalumab treatment in patients with advanced cancers and tumours. Who is it for? All participants in this study must have completed screening as part of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437), and been identified as having having no actionable molecular targets. Study details All participants in this study will take the intravenous drugs tremelimumab plus durvalumab once every 28 day cycle. From week 16 of treatment durvalumab will be administered alone once every 28 days. Treatment will continue until progression, unacceptable toxicity or withdrawal. Retreatment will be discussed with you by your doctor. All participants will undergo assessments at 8 weekly intervals or as clinically indicated in order to evaluate tumour response, safety and tolerability of treatment, health related quality of life during treatment, and overall survival. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that palbociclib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.