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ALLG AMLM30: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study.
The primary aim of this study is to assess the effectiveness and safety of Bleximenib with standard of care induction and consolidation therapy, as well as a maintenance therapy. Who is it for: Adult patients, over 18 years of age, with newly diagnosed acute myeloid leukemia (AML) who have NPM1 mutations or KMT2A rearrangements and are eligible for intensive chemotherapy. Study details: This is a randomised, phase 3 trial to determine if adding a new drug, Bleximenib, to the standard of care induction, consolidation, and as a maintenance therapy will improve patient outcomes. Participants will be randomly divided into three groups that will receive: 1) Bleximenib with standard induction chemotherapy and consolidation therapy (intermediate-dose cytarabine) followed by maintenance therapy with Bleximenib, 2) Bleximenib in combination with standard induction chemotherapy and consolidation therapy followed by maintenance therapy with placebo, or 3) Placebo in combination with standard induction chemotherapy and consolidation therapy (intermediate-dose cytarabine or allogeneic stem cell transplant) followed by maintenance therapy with placebo. The study will involve multiple cycles of treatment, with each cycle lasting 28 days. After each cycle, a response will be assessed to evaluate the continuation of treatment. It is hoped that this research will determine if the addition of a new drug, Bleximenib, can improve survival rates and patient outcomes in this AML patient population.
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ALLG AMLM28/A2 (ADAPT): Achieving Durable remissions via Adaptive Pro-survival Targeting in acute myeloid leukaemia (AML)) – VEN/AZA/Pelcitoclax. A therapeutic arm of the ALLG AMLM28 ADAPT Study-Master Protocol.
AMLM28/A2 is part of the ADAPT platform trial (ACTRN12623000900617), which is testing new ways to treat acute myeloid leukaemia (AML). The study is looking at whether adding a new drug called Pelcitoclax to usual treatment is safe and more effective. Who is it for? Patients enrolled on the ADAPT platform trial who are stratified to: · Domain 1) TP53 mutated acute myeloid leukaemia (AML), and · Domain 2) Minimal residual disease (MRD) persistence after 3 cycles of Azacitidine and Venetoclax (AZA-Ven) treatment with less than <5% blasts, will be enrolled into the A2 treatment arm. Study Details. This is a phase 1b/2, open label study to investigate the feasibility and efficacy of adaptive therapeutic intervention. Patients will receive Pelcitoclax, a dual BCL-2/BCL-XL inhibitor, in addition to their AZA-VEN treatment. The trial will begin with a dose-finding phase (n=12) to assess the safety of adding Pelcitoclax to AZA-VEN treatment, and to determine the recommended Phase 2 dose. This will be followed by an expansion phase, recruiting a total of 50 patients. This study aims to determine if the addition of Pelcitoclax to standard of care AZA-VEN treatment is a safe and more effective strategy for the treatment in newly diagnosed AML patients unfit for intensive chemotherapy.
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Iron Infusion Post Cardiac Surgery - A Randomised Controlled Trial (Iron Heart)
The Iron Heart Study will evaluate patient reported quality of life measures after administration of intravenous iron supplement in post-operative, anaemic, cardiac surgery patients. Post cardiac surgery patients (n = 80) who have a hemoglobin of less the 100mg/L on day 4 post-operative are eligible for this trial. Once consented, participants will be randomised to receive either an intravenous iron supplement infusion (ferric carboxymaltose 1000mg) or intravenous placebo (normal saline 0.9%) on Day 4 post cardiac surgery. Participants will be asked to complete an EQ-5D-5L Questionnaire on day 4 postoperatively prior to the infusion, and week 6 post-operatively. Participants will also be asked to have blood collected at weeks 2, 4 and 6 post-operatively. Blood results and questionnaire responses will be compared between the two groups to assess quality of life measures.
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A randomised controlled trial comparing effectiveness of rough and smooth dental implants on jaw function after jaw reconstruction for cancer.
The purpose of this project is to determine the effectiveness of two types of dental implants. We have two types of dental implants that are used routinely. The two types of dental implants differ in the amount of smooth area. The research project is testing which type of dental implant is better to keep the bone and soft tissue around the dental implants healthy so the dental implants can survive for a long time. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo Osseous free flap reconstruction of the jaw requiring dental rehabilitation with endosteal dental implants. Study Details: You will receive both types of dental implants (if you need more than one dental implant). Your dental implants will be randomly chosen for implant location in your mouth and type at each location. You will have head and neck reconstructive surgery as planned and dental implants will be placed. Following your surgery, bone loss and soft tissue assessments will be conducted every 3 months for 1 year after your operation as routine standard of care. However, these appointments are longer to assess bone loss (15 to 30 minutes) and soft tissue health (15 to 30 minutes) around dental implants for trial purpose. Quality-of-life patient reported data will also be collected using the FACE-Q Head and Neck Module questionnaire and the European Quality of Life-5 Dimensions (EQ-5D-5L) at the first appointment and 3,6,9,12 months post-op. Participation in this clinical trial is voluntary. It is hoped this research will generate new information about dental implants and therefore improve the outcomes of future patients undergoing head and neck reconstructive surgery.
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Traditional Chinese Medicine style acupuncture for the treatment of endometriosis: a randomized controlled trial
Endometriosis is a condition where endometrial-like tissue grows outside the uterus. The direct consequences of endometriosis usually include different chronic pain symptoms, but also other symptoms beyond pain, such as fatigue, bloating, and gastrointestinal disturbances. The typically complex range of symptoms affects the quality of life of women with endometriosis. Endometriosis has also been consistently associated with mental health issues such as anxiety and depression. Unfortunately, many of the pharmaceutical medications for endometriosis have bothersome side effects or should only be used for a short period of time due to concerns related to dependence and addiction. Therefore, it is important to define other treatment options that are safe, effective, and associated with minor side effects. Acupuncture has shown promising results in previous research for the management of endometriosis. In addition, it is also considered a safe treatment. Acupuncture is the insertion of fine needles into specific body points. It is part of Traditional Chinese medicine (TCM) and aims to restore the balance, which is believed to be impaired in pathological conditions such as endometriosis. Each needle addresses the entire network, reflecting TCM’s holistic approach. We will test whether two types of acupuncture can improve endometriosis symptoms. We will also examine the safety of the treatment by monitoring any adverse events participants might experience.
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Registry assessing heart outcomes in patients with cancer (CORIS-1)
The purpose of this study is to collect data for cancer patients with heart risks and compare this data to other people without cancer. Who is it for? You may be eligible for this study if you are an adult who has either been diagnosed with cancer or has never been diagnosed with cancer. Study details Participants with cancer will take part in blood tests, echocardiogram, ECG, and vital sign assessments as part of their standard care and questionnaires, while participants without cancer will take the same asssessments of which results will be availabe through medical record or your treating team in many cases. All participants will also be asked to complete an interview at baseline and be followed up for 6 months, 12 months and 24 months which includes vital signs, blood tests, ECG, echocardiongram,and questonnaires. If the test results are available, we'll collect data through medical records, however it these are not available, participants are asked to do the tests. It is hoped that this study will help provide data that will be able to be used to reduce risk of side effects including the heart, while also reducing interruptions to cancer treatment.
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Examining the Feasibility of Integrating Measurement Based Care into Group Therapy for Alcohol and Other Drug use using the 'Collect Share Act' Framework.
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Dance2Kinnect: What is the impact of a cultural dance program on the social and emotional wellbeing of Aboriginal and Torres Strait Islander children?
The Guunu-maana (Heal) Aboriginal and Torres Strait Islander Health Program at The George Institute has been awarded a grant over three years to develop a new approach to reducing early life preventable disease risk and improve the health and wellbeing among Aboriginal and Torres Strait Islander children. The funding - part of the Australian Government’s Medical Research Future Fund Indigenous Health Research round - will support a contemporary cultural dance pilot program to enhance cultural identity, cultural connectedness, self-esteem and physical fitness of children on the Central Coast and in Moree, a remote community of NSW. The program will be led by the Guunu-maana (Heal) Aboriginal and Torres Strait Islander Health Program in partnership with Aboriginal youth, Elders and communities. It will be offered to children between the ages of 8 and 15 yrs and families experiencing economic disadvantage to address modifiable risk factors for non-communicable diseases including cardiovascular and mental health conditions. To ensure ongoing community involvement and that communities’ priorities are met, our partners Barang Regional Alliance, Yulugi Marumali (Moree) NAISDA dance college, Yerin Eleanor Duncan Aboriginal Health services, Darkinjung Aboriginal Land council and Moree SHAE Academy will support the dance project. We also will have a youth group to ensure cultural safety for the kids. NAISDA and Barang Regional Alliance will be holding youth meetings that the children participants will be attending.
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18F-Fluorodopa (18F-FDOPA) PET/CT for the localisation of prolactinomas.
Tumours of the pituitary gland (located beneath the brain) are common, affecting 1/1000 people. Prolactinomas (defined by hypersecretion of prolactin hormone) are the most frequent pituitary tumour subtype. Currently, no functional imaging tests are routinely available in for the diagnosis of prolactinomas. In this study, we will assess the ability of a radiotracer, 18F-FDOPA, to provide functional information about these tumours and aid in their diagnosis. 18F-FDOPA is currently used to assess Parkinson’s disease and is therefore an established, safe radiotracer. Here, we will assess its ability to diagnose prolactinomas and inform management decisions e.g., surgical planning and responsiveness to medications.
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Using a handheld ultrasound to check for collapsed lung (pneumothorax) after lung biopsy procedures
This study looked at whether a small handheld ultrasound device can accurately detect collapsed lung (pneumothorax) after a lung biopsy. Currently, patients are usually checked with a chest X-ray, but this takes time and requires special equipment. We believed that handheld ultrasound would provide faster results at the bedside without radiation exposure. The study compared ultrasound findings with chest X-ray results to see how accurate the device is, particularly for clinically important cases that need treatment. We will also look at how quickly each test provides answers and compare their overall costs.