ANZCTR search results

This is a single-center study. The study will investigate five ascending doses of XG005 and the approximate molar equivalent doses of Naproxen and Pregabalin for clinical relevant doses of XG005. Five XG005 treatment groups of with 10 subjects/group will be enrolled sequentially. Period 1 will be single-dose, randomized, placebo-controlled, double-blind portion of the study and designed to meet the primary study objective. Period 2 will be the single-dose, open-label portion of the study designed to meet the secondary objective of the study. The four planned dose levels of XG005 are 50, 100, 250, 500, and 1000 mg. Period 1 will be double-blind and randomized with 8 subjects (1:1 allocation ratio by gender) assigned to XG005 and 2 subjects (1:1 allocation ratio by gender) assigned to placebo. Safety Monitoring Committee (SMC; consisting of three members: Investigator, Sponsor Representative, and Independent Medical Monitor) will review available safety and tolerability data from Period 1 of the current dose level before proceeding to the subsequent dose. All subjects in the dose levels of 250, 500 and 1000 mg of XG005 in Period 1 will receive Naproxen and Pregabalin in Period 2 after a washout period. In Period 2, subjects will receive the combination of approximate molar equivalents of Naproxen and Pregabalin for their corresponding XG005 doses in Period 1. Sentinel dose participants (1 for XG005 and 1 for placebo) will be included as the first dose administered at each dose level in Period 1. Safety data and available PK data will be reviewed prior to the SMC meeting. The SMC must communicate and provide approval to dose escalate prior to dosing the next dose group. The following safety data should be reviewed at each safety meeting: vital signs, ECGs, AEs, physical examination observations, safety lab data (chemistry, hematology & urinalysis) and available PK data. Based upon the data presented, a decision will be made whether to continue with dose escalation as scheduled, to alter the next dose level, or repeat the current dose level if indicated or recommend to terminate the study for safety reasons. Meeting minutes will be documented, particularly the decision to dose escalate. This document will be signed off by the Investigator and filed in the Investigator Site File. Due to the study timelines, all safety data will be reviewed in an un-monitored state, although some of the data may have been monitored by the time of the SMC meeting. Pharmacokinetic assessments will include blood (26 collection time points with 13 timepoints/Period) samples over the course of the study. A total of approximately 200 mL of blood (130 mL for PK and 70 mL for clinical labs) will be drawn from each subject during the study. The expected duration of participation for each subject following enrollment will be approximately 15 days.

The primary purpose of this project is to explore the efficacy of the Pain Course in a regional hospital clinical setting for managing symptoms of pain interference, anxiety, and depression in adults (aged 18+) living in North Queensland with chronic pain. A second purpose is to examine the acceptability of the Pain Course in a self-guided format to adults living in North Queensland with chronic pain. A third purpose is to explore the maintenance of clinical improvements at 3month followup timepoint.

This study aims to determine if a combined noradrenergic/antimuscarinic intervention changes sleep apnoea severity compared to placebo and the effects on pharyngeal muscle activity and other key sleep parameters.

This study aims to find out if the combination of trastuzumab (anti-HER2 therapy) with durvalumab (PD-L1 inhibitor) and tremelimumab (CTLA4 inhibitor) will reactivate anti-tumour immune response and improve clinical outcomes in trastuzumab-resistant, advanced HER2-positive breast cancer. Who is it for? You may be eligible for this study if you are 18 years or older, male or female, and have HER2-positive metastatic or incurable breast cancer that has progressed on previous trastuzumab treatment. Trial Details. Up to 4 weeks before starting study treatment, all participants will have either a CT Scan, MRI, or PET with dedicated CT Scan, provide a research tumour biopsy of the cancer (taken within 1 year of starting the study) and research blood tests. TREMELIMUMAB 75 mg DOSE ER-POSITIVE AND ER-NEGATIVE COHORTS: Study treatment takes place in 2 phases: 1) Induction Phase (weeks 1-16); and 2) Treatment Phase (weeks 17-52). Induction Phase During the Induction Phase, participants will receive: 1) 4 doses of durvalumab (1 dose every 4 weeks), administered intravenously; 2) 4 doses of tremelimumab (1 dose every 4 weeks), administered intravenously; 3) 16 doses of trastuzumab (1 dose every week), administered intravenously. Treatment Phase Participants will receive durvalumab and trastuzumab every 3 weeks for 12 doses (total 36 weeks). Tremelimumab will not be given. A research blood sample will be taken every 9 weeks, before each dose of study treatment. TREMELIMUMAB SINGLE 300 mg PRIMING DOSE COHORT One cycle is 3 weeks (maximum of 18 cycles). 1) Tremelimumab 300 mg Day 1, Cycle 1 only (1 dose only) 2) Durvalumab 1120 mg Day 1, Cycle 1 then every 3 weeks for up to 1 year (18 doses) PLUS 3) Trastuzumab: * 6 mg/kg Day 1, Cycle 1 then every 3 weeks for up to 1 year (18 doses) * Loading dose of 8 mg/kg Cycle 1 Day 1 if > 6 weeks since the last trastuzumab or TDM-1 dose. Research blood samples will be collected at Week 10 and Week 16. For all cohorts: Oestrogen-receptor-positive patients will also start or continue endocrine therapy (aromatase inhibitor and/or GnRH agonist). Two core biopsies, if feasible, will be taken from the same site as the initial biopsy about 3 weeks after starting study treatment. During the study heart function tests (ECHO or MUGA) will be performed every 3 months as per standard of care, or as clinically indicated. Participants will be clinically assessed before each study treatment. The full length of treatment is 52 weeks (1 year). After completing study treatment, patients will be followed every 3 months by either clinic visits or via telephone.

This is a parallel, single-blinded, randomised clinical trial evaluating the effectiveness and cost-effectiveness of 8 weeks of treatment with a vaporised nicotine product (VNP) and liquid nicotine compared to traditional oral nicotine replacement therapy (NRT; gum or lozenge) for smoking cessation among low-socioeconomic smokers. We hypothesize a higher 6-month cessation rate among the VNP, compared with the NRT group.

Recurrent headache is a common, disabling condition affecting millions of Australians. TTH has a lifetime prevalence in the general population ranging between 30 and 78%. It affects approximately 1.4 billion people globally or 20.8% of the population. Headaches are a leading cause of lost work productivity, with reduced performance rather than absence from work being the main cause of lost productive time. Therefore, there would be considerable value in a simple, highly tolerable preventive therapy for the large number of people suffering from frequent TTH. This trial aims to assess a novel low-dose BP lowering combination in this regard.

This study will investigate the effectiveness of group-based Acceptance and Commitment Therapy (ACT) intervention in improving quality of life following treatment for early breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above and have completed primary treatment for early breast cancer within the last two years. What does this study involve? In this study, all participants will receive the ACT intervention condition in random order. Participant will be randomly allocated to one of the following combination of study conditions: 1) Group A will first receive the ACT intervention program, then receive a breast cancer education (BCE) control program; 2) Group B will first receive the BCE control program, then cross-over to receive the ACT intervention program; or 3) Group W will first be on a 6-week wait-list during which participants receive neither programs, then they will receive the ACT intervention. As each study condition will be conducted weekly and will run for a 6-week period, with no allocated time interruption in between each condition, study duration is expected to be 12 weeks. In addition to attending group sessions, participation will also involve completing an ACT workbook. The workbook will guide participants through regular individual ACT practice outside group sessions. The ACT program will be delivered by an ACT-trained psychologist and will focus on providing participants with strategies based on the six core processes of ACT (Acceptance, Defusion, Self as Context, Values, Contact with the Present Moment, and Committed Action) aimed at enhancing participants' psychological flexibility and wellbeing. The BCE program will be facilitated by a trained breast care nurse and delivered by experts who will provide education relating to diet, physical activity, sexuality concerns, cancer biology, clinical physiology, relaxation techniques and sleep hygiene. At the beginning and end of each 6-week study condition period, questionnaires will be administered, blood and saliva samples will be collected, and blood pressure and resting heart rate will be measured. Participants will be followed-up at 6 and 12 months after the final session. Benefits of this study? Participating in this research has the potential to improve the quality of life of project participants and help them better manage anxieties related to fear of cancer recurrence. This study has been approved by the Human Research Ethics Committees of the Darling Downs Hospital and Health Services (DDHHS) and the University of Southern Queensland (USQ).

Many patients who require surgery on the shoulder experience significant post operative pain, particularly after their nerve block wears off. Despite the use of conventional analgesia many patients remain uncomfortable during this period. The aim of this project is to determine whether giving magnesium prior to surgery can improve this pain experience. The study proposes to give a single dose of magnesium to patients immediately prior to surgery and to assess their level of pain after surgery. This will involve the use of a subjective pain rating scale (1-10), and documentation of analgesic requirement. Patients will be randomly selected to receive either magnesium or placebo saline solution in order to assess the benefits of magnesium. Magnesium itself is a safe drug commonly used in clinical medicine for a number of different conditions.

A multicentre randomised controlled trial comparing outcomes for humeral shaft fractures (arm fractures) treated with and without an operation to 'fix' the bone (with a metal plate and screws or a rod versus treating with an arm brace). 200 patients will be randomised over 14 hospitals (100 to each treatment type) and followed up over one year to determine if there is any difference in outcome. The hypothesis is that those treated with surgery will have better outcomes. The primary outcomes is the difference between the groups for scores on the Disabilities of hand and shoulder survey at one year post injury. Other outcome measure will be fracture healing, pain and quality of life scores, complication rates and return to activity levels as well as a cost analysis of both treatment types.

The primary purpose of this trial is to evaluate the comparative accuracy of different scans and biopsy diagnostic techniques for low risk prostate cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 75 years and have been diagnosed with low risk prostate cancer, and with a life expectancy of at least 10 years. Study details All participants enrolled in this trial will receive a 68Ga-HBED-CC PSMA PET/MRI of the prostate and pelvis, which involves injection of a radioactive substance (68Ga-HBED-CC PSMA) following by lying in the scanner for 1-2 hours. All participants will then receive a transperineal biopsy of the prostate. Participants who have lesions identified on the 68Ga-HBED-CC PSMA PET/MRI scan will receive a biopsy procedure targeting those lesions when they have transperineal biopsy of the prostate. Researchers will then complete genetic analysis on the previous biopsy sample. The results of the scanning techniques, the biopsy result and the genetic testing score will all be compared to determine the most accurate technique for reclassifying men previously diagnosed with low risk prostate cancer into higher risk categories.