ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Prospective trial assessing the additive diagnostic value of 68Ga-PSMA positron emission tomography (PSMA-PET) in men scheduled to undergo diagnostic biopsy for suspicion of prostate cancer.

    The purpose of this study is to examine the diagnostic accuracy of a non-invasive PET scan in the context of prostate cancer. Who is it for? You may be eligible for this study if you are over 18, have an elevated PSA or abnormal DRE, are scheduled to or have undergone a prostate MRI and are considering a prostate biopsy. Study details All participants in this study will undergo an additional PET scan prior to their scheduled biopsy. If prostate lesions are identified on this scan, they will be targeted at the time of biopsy. It is hoped this research will help to reduce unnecessary prostate biopsies in men being investigated for prostate cancer, by identifying situations where a biopsy is required more precisely.

  • In extremely preterm infants less than 28 weeks gestation who are receiving invasive mechanical ventilation, does extubation to a higher level of continuous positive airway pressure compared to standard practice prevent deterioration and return to mechanical ventilation.

    Does extubation to a higher CPAP pressure decrease risk of extubation failure following the first extubation attempt within the first 3 weeks of birth compared with CPAP pressure currently used? This study will explore the effects of higher nCPAP pressure versus standard CPAP pressure on the need for re-intubation through a randomised clinical trial. This study will involve 200 extremely preterm infants born less than 28 weeks’ gestation who are being extubated. They will be extubated to either the high group of CPAP (10 cm H2O) compared with a standard practice. The hypothesis is that higher levels of nCPAP will reduce extubation failure in the extreme preterm infant.

  • The effects of palmitoylethanolamide (PEA) on pain and brain activity.

    This study entails understanding the effects of palmitoylethanolamide on pain and brain activity. We hope to learn whether palmitoylethanolamide (a natural compound found in certain foods) reduces on-going pain in the face and how this is reflected in changes in brain anatomy and function. Participants will undergo initial screening which involves questionnaires and a 2 ml blood sample, then scanned using an MRI. Participants will then be assigned either the active drug or a placebo for a total of six weeks and asked to rate their pain daily for the entire period. After six weeks, participants will redo the questionnaires, provide another 2 ml of blood and be scanned using an MRI. We believe that after six weeks of treatment, patients will experience a decrease in pain intensity and MRI scans will show changes in anatomy and function that reflect the decreases in pain.

  • Optimal supplementation dosing strategy for Ursolic Acid in healthy men

    Muscle wasting, or atrophy, is a widespread problem in elderly human populations, and greatly increases the chances of falls and metabolic diseases such as type 2 diabetes. Ursolic acid (UA) is a natural food-derived nutrient (found in many herbs such as Rosmarinus officinalis (rosemary), Origanum vulgare (oregano), and the peel of fruits such as apples) has been shown in rodents to prevent muscle atrophy and promote muscle growth. However, the bioavailability, safety and tolerability of orally ingested ursolic acid in humans is not fully known. Therefore, our aims for this study are: To determine the bio-availability, safety and tolerability of orally ingested Ursolic Acid in healthy men. We hypothesise that Ursolic Acid will be adequately absorbed to elicit a measurable appearance in the blood in a dose response fashion. We expect to see the greatest bioavailability in the blood from the 1500mg dose with no substantial increase in Adverse Events at this dose.

  • CONNECT: Telecare health coaching management of low back pain in primary care to improve disability

    The aim of the study is to examine the effect of a telecare health coaching intervention on function in people with subacute and chronic low back pain. We hypothesise that the addition of health coaching to GP usual care will be more effective in improving function than usual GP care alone. The intervention will involve health coaching directed towards 4 core components: (2 Mandatory components) Physical activity and specific exercises; pain coping strategies; (2 Optional components) weight management; and sleep hygeine. There will be a 4 month intensive phase with regular health coaching sessions followed by a 2 month maintenance phase involving a minimum of 1 session. Exercise and physical activity pain symptoms as well as adherence will be completed online by the participant and if pain levels rise or adherence reduces the care manager will be automatically alerted to make contact with the participant.

  • Normalisation of Advance Care Planning (ACP) for People With Chronic Diseases in acute and community settings

    This study aims to evaluate the uptake of Advance Care Planning (ACP) for people with chronic diseases in acute and community settings. Who is it for? You may be eligible to join this study if you are aged 18 years or above, are admitted to a ward/community centre in a participating hospital or community setting, and have a chronic health condition (diabetes, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, hypertension, chronic kidney disease, cancer, frailty and/or dementia). Study details Participants admitted to an intervention site will receive Advance Care Planning assistance from a specially trained registered nurse. This involves a series of facilitated conversations regarding you or your family member’s healthcare wishes for the future. Participants admitted to a control site will receive standard care only. This study will measure uptake of Advance Care Planning. Participants will also be followed up after 6 months in order to evaluate the level of satisfaction with their healthcare experience. It is hoped that this study will promote Advance Care Planning conversations as part of routine (normal) clinical practice.

  • COntinuous or Bolus Administration of Local Anaesthesia for Thoracic Surgery : a single blinded randomized trial (COBALT Trial)

    Our study will examine if the use of intermittent boluses improves pain and decreases opioid use when compared to continuous infusions when delivered through an exrtrapleural catheter in patients undergoing thoracoscopic surgery (VATS), a form of lung surgery. We will also investigate whether lung function is improved in the post-operative period. Design: Randomised single centre blinded clinical trial. Both groups will receive the same overall dose of ropivacaine.

  • Tolerability of different doses of blood pressure lowering Polypill

    Very low dose multiple combination antihypertensive pharmacotherapy can improve risk/benefit compared to (conventional) moderate dose simple combination therapy because the multiple actions lower blood pressure (BP) more efficiently and the lower doses cause fewer adverse effects. We aim in stable hypertensive patients to carefully quantify and compare blood pressure, tolerability and all adverse effects on 2 different dose very low dose multiple combination antihypertensive regimens, compared to moderate dose simple combination regimen. All patients will receive the 3 treatments, in randomised sequence. All patient file data will be entered into a database by a Research Assistant. All data recorded will be de-identified. All patient data recorded will remain confidential, kept secure in a computer database on a computer locked in the research office. The Principal Investigator will not discuss data collected with the patients during the study. Statistical variance in Polypill treatments like these is not established. This is a pilot trial. The statistical analysis will be undertaken on Excel under the oversight of Professor Hans Stampfer. Should either efficacy or safety appear encouraging, we will seek grant support to extend the study to 3 sites, to recruit sufficient numbers to best establish risk/benefit of the Polypill regimen. A consultation after the study will resolve recommendations for ongoing treatment.

  • The effects of melatonin, administered prior to sleep at an irregular time, on Rapid Eye Movement (REM) sleep and fear inhibition in healthy young adults

    Circadian misalignment disrupts REM sleep, a stage of sleep which is important for fear memory processing. The aim of this study is to explore whether the sleep aid melatonin, when administered prior to circadian misalignment, will rescue REM sleep and recover fear inhibition processes. This study will provide important insight into the relationship between REM sleep and processes critical for treatment and recovery from Posttraumatic Stress Disorder (PTSD).

  • Sodium Chloride Or Plasmalyte Evaluation for patients with Diabetic KetoAcidosis (SCOPE-DKA)

    This is a cluster crossover trial to determine whether fluid therapy with a buffered salt solution (Plasmalyte-148) reduces the time to resolution of acidosis compared to 0.9% sodium chloride (saline) in critically ill patients presenting to the emergency department with diabetic ketoacidosis (DKA). • We hypothesise that the use of PL as fluid therapy in these patients will lead to earlier resolution of acidosis and avoidance of hyperchloraemia, thereby reducing morbidity and length of stay

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