ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31382 results sorted by trial registration date.
  • A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers

    The study will include a Screening Period, a Treatment Period, and a Follow-up Period. Sequential groups of fasted participants will receive a single dose of inhalation administered APR002 at 6 increasing dose levels or placebo. Staggered dosing will be employed with approximately 24 hours between dosing cohorts. After all participants in a dose group have completed study procedures to Day 3 (48 hours after dosing), a decision on dose escalation and enrolment of the next dose group will be made based upon all available data, including the incidence and severity of reported AEs and safety laboratory test results collected after administration of APR002/placebo. Escalation to the next dose level will occur in the absence of dose-limiting toxicity or other significant safety findings after agreement between the Sponsor, an independent Medical Monitor, and the Investigator. Follow-up assessments will occur approximately 14 days after the dosing to inquire for any ongoing AEs or serious adverse events (SAEs), worsening of AEs or SAEs, or development of new AEs or SAEs, and concomitant medications taken since final dose. Follow-up will occur by telephone unless abnormal, clinically significant findings are observed upon discharge or at the Investigator’s discretion. Participants should then be brought back to the clinic for re-evaluation.

  • A Phase 1 Single Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EARLI-001

    The purpose of this study is to determine the assess the safety, tolerability, pharmacodynamics and pharmacokinetics of EARLI-001, a product developed to asses with the detection of cancer. Who is it for? You may be eligible for this study if you are a healthy adult under the age of 55. Study details Participants will receive the study drug via an infusion in the vein and be required to stay at the testing clinic for 24 hours for observation. They will then be required to attend follow-up assessments on days 3,5,7, 14 and 28. As part of this study, we will be collecting blood samples for both safety and research purposes. During the study, the estimated total blood volume to be collected will be approximately 140 mL (approximately 0.6 cups or 7 tablespoons). As a reference, a standard blood donation is 470 mL in any 12-week period. At follow-up visits, participants will also undergo physical examinations, vital sign assessments (blood pressure, pulse rate, breathing rate and temperature) and electrocardiograms for the assessment of safety. It is hoped that this research will help determine if this product is safe for use, to then be used further in future studies to determine whether this product can be used to assist cancer detection.

  • Postoperative pain and outcomes using spinal analgesia in hepatobiliary-pancreatic surgery

    The purpose of this study is to identify whether spinal analgesia with intrathecal morphine alone is superior to spinal analgesia with intrathecal morphine combined with intrathecal clonidine and bupivacaine for patients undergoing major abdominal surgery. Who is it for? The study will include adult patients undergoing liver and pancreatic resection surgery. This is a retrospective study to test the hypothesis that the intrathecal morphine combined with clonidine and bupivacaine results in reduced postoperative opioid use and enhanced postoperative analgesia and recovery in patients undergoing major liver and pancreatic resections using a standardized enhanced recovery after surgery (ERAS) protocol. Study details The aim of this study is to quantify the cumulative oral morphine equivalent daily dose in milligrams (oMEDD) in the postoperative period and evaluate maximum pain scores at rest and on movement after surgery. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of intrathecal morphine in patients undergoing major liver and pancreatic surgery.

  • Effect of a novel exercise and behavioural support tele-health program for participants with peripheral artery disease related walking impairment.

  • Assessment of the impact of a telehealth program for the control of modifiable risk factors in people at risk of Diabetes-related Foot Disease

  • Feasibility of hybrid-technology upper limb rehabilitation for people with neurological impairments in hospital.

    With improving developments in technology rehabilitation, use of technology devices and modalities are becoming more integrated into clinical practice. While there is good evidence for robotics and virtual reality in rehabilitation for improvement of sensorimotor outcomes (e.g. strength, range of motion) of the arm, evidence gaps persist for translation to functional outcomes which continue to be poor. Further, majority of research to date has focused on single-technology modality use (e.g. stand-alone robotics or virtual reality focus only) with little comparative research on sensor-based therapy as an emerging technology enabler for upper limb rehabilitation. This randomized controlled trial will test efficacy of a combination of robotics, virtual reality and sensor-based therapy used for upper limb rehabilitation for inpatients with neurological deficits compared to usual care and will explore feasibility in a hospital setting. It is hypothesized that hybrid technology-enabled upper limb rehabilitation is feasible within a hospital setting, will lead to better therapy intensity and functional outcomes for the upper limb compared to usual care and that participants will show satisfaction for this novel therapy.

  • Investigating the feasibility of home-based, remotely-supervised transcranial direct current stimulation (tDCS) during attention training in children with acquired brain injury

    This study is an open-label, Phase I safety and feasibility trial, named 'hrtDCS-Attention'. We aim to evaluate whether 10 weekdays of home-based, remotely supervised transcranial direct current stimulation (tDCS) for 20 minutes during attention training is feasible and tolerable in children aged 8-18 years with acquired brain injury. tDCS will be applied once daily on the scalp, over the left and right prefrontal cortex. Participants will be randomised to one of two trial arms, to receive either (1) 1 mA of tDCS or (2) 2 mA of tDCS. Participants will be blinded to which dose they have been assigned to. 15 participants will be assigned to each group, for a total of 30 participants in hrtDCS-Attention. The first hrtDCS-Attention session will take place in the clinic to ensure initial tolerability, provide information about the home sessions and training to conduct them, and answer any questions from participants. HD-EEG and other baseline neurocognitive outcomes will be recorded. After the first session, participants will conduct hrtDCS-Attention sessions at home using remote supervision (i.e. through video call) to ensure correct use of the device, adherence to the protocol, safety and support. As well as receiving prior training by tDCS personnel, participants will be given an information guide to use tDCS from home. hrtDCS-Attention will occur from Monday to Friday for two consecutive weeks for a total of 10 sessions. Participants will return to the clinic on tDCS Day 10, where the final (10th) session will take place in clinic, together with an EEG and neurocognitive outcomes. Follow up assessment at 1- and 4-weeks post-tDCS will be conducted remotely. The primary outcome is feasibility and tolerability, measured by sensations recorded during tDCS sessions, compliance to tDCS sessions, and the participant/family's views or comments about the sessions. We will also assess preliminary efficacy, according to changes in reaction time across the 10 days of tDCS and change in functional brain connectivity between baseline and day 10 of tDCS.

  • Resistance exercise effects on self-efficacy and psychological health in people diagnosed with cancer.

    This study aims to investigate the effects of a resistance exercise program on the self-esteem, mental health and self-efficacy of people living with cancer. Who is it for? You may be eligible for this study if you are an adult ages 18 years or older, you have been diagnosed with any type of cancer, including metastatic or widespread cancers and you have received approval from your primary care doctor to complete an exercise program. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three treatment groups. Participants who are allocated to the first treatment group will start the exercise program within 1 week of enrolling in the study. The exercise program will involve attending 3x 1 hour sessions per week for 6 weeks (Monday, Tuesday & Friday). These sessions will be delivered one-on-one between participants and an accredited exercise physiologist who will create a personalised exercise regime for each participant and supervise them during each session. Exercises may involve repeated muscular contractions using weights, resistance bands, exercise machines, or participants' own body weight. Participants who are allocated to the second treatment group will not start their exercise program until 6 weeks after enrolling in the study. Participants who are allocated to the third treatment group will not start their exercise program until 12 weeks after enrolling in the study. During the waiting period, participants in both of these groups will be able to continue with their current exercise routines (if they have one). The exercise program will then be delivered to both of these groups in the same manner as for participants in the first treatment group. It is hoped this research will determine whether a resistance exercise program has a positive impact on the mental health, self-esteem and physical wellbeing of people living with cancer. If this study shows a positive impact on participants' wellbeing, it may be expanded to a larger number of hospital locations so that a greater number of people living with cancer may undertake this program as part of their usual care.

  • EndoCannED – The effect of Medicinal Cannabis on emergency department presentations in people with endometriosis: a randomised, controlled feasibility study

    Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 9 women and those assigned female at birth in Australia (~830,000 people) and has no cure. My research has shown that patients often have to make impossible choices between being in pain, and the worry of dependence, addiction and impairment due to the current drug choices. Effective pain relief with a low to negligible risk of addiction is the holy grail for people with endometriosis. Various phytochemicals (mainly cannabinoids) from Cannabis spp have well described analgesic, anti-inflammatory, anxiolytic, anti-depressant and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, by cannabis. Our previous research has shown that women with endometriosis in Australia and New Zealand are using cannabis, mostly from illicit sources, to manage their pain and other symptoms. We hypothesise that usage of either CBD isolate alone or in combination with THC containing canabis flower will reduce pelvic pain severity, and presentations to the emergency department. The primary aim of this project is to determine the feasibility, safety and acceptability of two different medicinal cannabis interventions in people with endometriosis

  • Investigating Imagery Rescripting as a Treatment for Unipolar Depression

    The primary aim of this study is to investigate the benefits of three sessions of imagery rescripting (ImR) compared to a waitlist control for depression. The secondary aim is to investigate the proposed mechanisms of action (i.e., negative interpretations of intrusive memories, depressive rumination, early maladaptive schemas and schema modes) that underpin ImR for depression. Participants in the treatment group will begin the intervention immediately, and their results will be compared with a waitlist control condition who will receive the same intervention after a three-week wait period.. Outcome measures will be administered at baseline, post treatment and 1-month follow-up. Based on existing studies of ImR for depression, and ImR for other disorders, it is hypothesised that: 1) ImR will be more effective in reducing symptoms of depression than waitlist control at post-treatment and follow up; and 2) ImR will yield greater improvements in negative interpretations of intrusive memories, depressive rumination, early maladaptive schemas and schema modes, compared to waitlist control.

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