Surfers Paradise

Researchers are evaluating the safety and appropriate dose of increasing levels of the radioactive drug 131I-TLX101, given by intravenous infusion, combined with the best standard care in adults newly diagnosed with glioblastoma, a type of brain cancer. This open-label, single-arm study is conducted across multiple centers and aims to understand how patients tolerate this treatment alongside standard therapies. Participants receive escalating doses of 131I-TLX101 through an intravenous infusion along with the standard chemoradiation therapy known as the Stupp regimen, beginning 3 to 6 weeks after surgical removal of the tumor. The study includes a dose-finding phase to establish the recommended dose, with safety monitored throughout. The radioactive drug is administered in ascending doses, and the study observes participants for up to 62 weeks. During the study, participants will undergo regular safety assessments including laboratory tests of liver and kidney function, monitoring for adverse events, and evaluations of treatment-related toxicities for up to 62 weeks. Researchers will track the incidence and severity of dose-limiting toxicities and treatment-emergent adverse events. Participants must comply with radiation safety guidelines and attend scheduled visits for monitoring. The total study duration from screening until the end is about 62 weeks.

Researchers are evaluating the safety and tolerability of HRS-7525 tablets in men with advanced prostate cancer. The study aims to identify dose limiting toxicity DLT, the maximum tolerated dose MTD, and the recommended Phase II dose RP2D of this drug. This Phase I trial focuses on patients with metastatic adenocarcinoma of the prostate, excluding neuroendocrine or small cell carcinoma types. Participants will receive HRS-7525 tablets during a single-group treatment period. The study includes a single-dose run-in period lasting 2 days, followed by 21 days after the first dose to assess dose limiting toxicity. The overall safety follow-up for each participant extends to about 13 months from informed consent to evaluate the maximum tolerated dose and recommended Phase II dose. During the study, participants will be monitored through clinical assessments to track safety, tolerability, and dosing effects. Researchers will evaluate adverse events, laboratory tests, and imaging to confirm metastatic lesions. Men with female partners of childbearing potential must use contraception during and for three months after treatment. The total participation duration includes the treatment period plus safety follow-up lasting approximately 13 months.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

This research aims to evaluate treatments for patients who arrive at the emergency department with acute ischemic stroke caused by basilar artery occlusion within 24 hours of symptom onset. The study compares the use of tenecteplase, a clot-busting drug, against standard care which may include alteplase or no thrombolytic treatment, with the goal of improving functional outcomes at 90 days after stroke. It is a multi-arm, multi-stage, randomized trial designed to adaptively assess treatment effects and proceed seamlessly from phase 2b to phase 3 based on early results. Participants are randomly assigned to one of two groups one receiving intravenous tenecteplase at a dose of 0.25 mgkg given as a quick bolus, and the other receiving standard care that may include intravenous alteplase at 0.9 mgkg or no thrombolytic treatment. Both groups may undergo mechanical thrombectomy if deemed necessary by their treating doctors. The study uses a computer-based randomization process and will monitor patients through an adaptive sample size plan, with a minimum of 320 and up to 688 patients over about five years. During the trial, participants will be followed for 12 months. Researchers will assess stroke recovery using the modified Rankin Scale at 90 days as the primary outcome, along with other measures like quality of life, early clinical improvement, and safety outcomes such as bleeding in the brain. Assessments include angiography, brain imaging, and clinical evaluations at multiple time points. This ongoing monitoring will help determine which treatment offers better functional recovery and safety for stroke patients with basilar artery occlusion.

Severe trauma can cause heavy bleeding and changes in blood clotting that make it hard for injured patients to stop bleeding effectively. This trial focuses on adults with severe trauma who experience low fibrinogen levels, a key clotting factor, to compare two ways of replacing fibrinogen during major bleeding. The study aims to evaluate the safety, effectiveness, and cost of fibrinogen concentrate versus cryoprecipitate, which is the current standard treatment made from donated blood. Participants will be randomly assigned to one of two groups one will receive fibrinogen concentrate, a dry powder that can be quickly prepared and given at the bedside, and the other will receive cryoprecipitate, which requires thawing before use and contains multiple clotting factors. Dosing is guided by specific clotting tests measuring fibrinogen levels. The study includes 850 patients from trauma centers in Australia and New Zealand and follows them for outcomes after treatment. During the study, researchers will monitor participants days alive and out of hospital up to 90 days after injury, along with other measures like blood transfusion amounts, mortality rates, organ failure, and quality of life over 12 months. Safety is assessed by tracking blood clot-related events and other complications. This phase III randomized trial uses blinded methods to ensure reliable results and includes careful follow-up to understand the impact of fibrinogen replacement in traumatic bleeding.

Mycobacterium abscessus MABS is a group of rapidly growing bacteria resistant to many drugs, causing lung infections that can lead to serious health problems, decreased lung function, and higher risk during lung transplants. The prevalence of MABS infections is increasing globally despite the relatively small number of affected people. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment FORMaT trial aims to identify the best treatment combinations to improve health outcomes while reducing side effects and treatment burden. It also seeks to develop biomarkers to guide treatment decisions and assess disease severity in patients with MABS pulmonary disease MABS-PD. The trial is an ongoing, adaptive study designed to test and improve combinations of therapies for both children and adults with MABS-PD. Participants receive various drug treatments including intravenous therapies such as amikacin, tigecycline, cefoxitin or imipenem combined with oral antibiotics like azithromycin, clarithromycin, and clofazimine. The study includes phases of intensive intravenous therapy followed by consolidation therapy with oral andor inhaled antibiotics. Treatments can be adjusted based on tolerance and microbiological response, with new therapies added or removed as evidence evolves. Participants are involved in screening, treatment, and follow-up visits extending up to 62 weeks. The study monitors microbiological clearance of infection alongside treatment tolerance. Assessments include lung function tests, chest CT scans, quality of life questionnaires, six-minute walk tests, and evaluation of treatment safety and resistance. Researchers also study health costs and reasons for early withdrawal. This comprehensive monitoring helps understand how treatments affect disease control, lung health, and patient well-being over time.

This research aims to evaluate whether early use of enteral fludrocortisone can reduce death and dependency six months after aneurysmal subarachnoid haemorrhage aSAH, a severe type of stroke that mainly affects adults aged 45 to 64 and more often women. The condition has a high mortality rate and many survivors face lasting neurological and cognitive problems, impacting their quality of life and ability to work. The study will address the need for better treatment options given the high healthcare costs and poor outcomes associated with aSAH. Participants will be randomly assigned to receive either fludrocortisone or a matched placebo tablet every six hours by mouth for 14 days. Fludrocortisone is a synthetic steroid that helps retain sodium and fluids, potentially preventing hyponatraemia, a common and serious complication of aSAH that can worsen brain swelling and increase the risk of further brain injury. This trial is blinded and controlled to compare the effects of fludrocortisone against placebo in critically ill patients. During the study, participants will be monitored in a critical care setting with regular assessments including neurological evaluations and laboratory tests. The main outcome measured will be the level of disability or recovery at six months using the Modified Rankin Scale. Additional assessments will include quality of life tools specific to subarachnoid haemorrhage. Safety and side effects will be closely observed throughout the study. The total duration of participation includes treatment and follow-up assessments up to six months after randomization.

Researchers are studying patients with stage II primary invasive cutaneous melanoma to compare the effects of two different surgical excision margins 1cm versus 2cm. The goal is to determine if narrower margins are as safe as wider margins in preventing melanoma recurrence and if they can improve patients quality of life. This trial also looks at the impact of these excision sizes on health services and society. Participants will be randomly assigned to receive either a 1cm or 2cm wide local excision margin around the primary melanoma lesion. Both groups will undergo sentinel lymph node biopsy and may have reconstruction surgery if needed. The surgery must be done within 120 days of diagnosis and within 28 days of randomization. During the study, participants will be followed for up to 60 months to measure disease-free survival as the primary outcome. Additional assessments include local recurrence, distant disease-free survival, melanoma-specific and overall survival, quality of life questionnaires, neuropathic pain evaluations, adverse event monitoring, and health economic analysis. Follow-up questionnaires and safety checks will occur at multiple time points up to 24 months after surgery, with longer-term monitoring continuing up to 120 months.

Researchers are evaluating different ways to increase the use of antimicrobial stewardship AMS resources by doctors treating adults with respiratory tract infections in Australian general practices. The study compares two methods of delivering AMS education and support face-to-face activities Integrated Network versus virtual or online activities Virtual Network. The goal is to see which approach leads to more frequent use of AMS interventions to guide antibiotic prescribing. Doctors in the trial receive about 7 hours of AMS education and support through either online self-paced modules, guided self-audits, and podcasts Virtual Network, or live interactive webinars, peer-group audits, and online forums Integrated Network. Participating doctors use an online AMS Toolbox when treating patients to record intervention use and antibiotic prescribing. A subgroup of doctors and patients also take part in interviews and use point-of-care tests to help identify the cause of infections. Participants provide data through online surveys, where doctors log their AMS intervention use and patient numbers, and patients report their experience of care. Interviews with selected doctors, staff, and patients explore their views on the interventions. The primary outcome is the change in AMS intervention use per 100 consultations over two 5-month winter periods, before and after the implementation activities. The study runs from baseline data collection, through the implementation phase, and into post-intervention follow-up.

Researchers are evaluating the use of intra-arterial tenecteplase given at the end of mechanical thrombectomy in adults with acute ischemic stroke caused by a blockage in a large artery in the brain. This randomized, placebo-controlled trial compares tenecteplase to standard care with a saline placebo to study its safety and effectiveness within 24 hours of stroke symptom onset. The study is a phase 2b3 trial designed to test early neurological improvement and longer-term functional independence in participants. Participants receive either an intra-arterial bolus of tenecteplase dosed by weight maximum 6.25 mg or a placebo saline bolus administered directly at the site of the original artery blockage after thrombectomy. The trial includes two groups with equal chance of assignment and uses a double-blind design. The intervention occurs immediately after thrombectomy, targeting residual clots that may cause ongoing blood flow issues. During the study, participants are monitored for neurological improvement within 24 to 36 hours and functional independence at three months. Additional assessments include brain imaging to measure infarct growth and no-reflow, safety monitoring for bleeding events, mortality rates, and quality of life evaluation. The trial lasts at least three months from randomization, with multiple visits and tests to track outcomes and side effects.