ANZCTR search results

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

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32814 results sorted by trial registration date.
  • Effects of a topical botanical cream on subcutaneous fat loss in athletes

    Weight – notably fat - reduction is commonly undertaken by athletes to improve locomotive efficiency and power-to-weight ratio, aesthetic appearance or to reach a target weight class. While energy restriction - or "dieting" - is typically implemented to achieve desired fat loss, this practice is accompanied by compensatory metabolic and hormonal responses that cause attenuation of weight loss, undesirable changes in appetite and mood, performance impairment, and an increase in the likelihood of weight rebound. Thus, novel strategies to achieve fat loss while minimising reliance on ER would be highly advantageous to athletes. This study will be the first to investigate the effects of a topical fat loss agent in a cohort of resistance trained athletes. This study will also be the first to investigate the effects of the popular topical fat loss agent, Subcut. If our hypothesis were to be supported, Subcut would be of extreme value to athletes desiring to lose fat locally without the need of energy restriction. If our hypothesis were to be refuted, consumers would be provided with information that would allow them to allocate their money and time into other, more effective fat loss strategies. Irrespective of the outcome, there is a benefit to the athletic community, as well as to the general population wanting to lose fat.

  • Glucagon-like peptide 1 (GLP-1) for lowering plasma glucose in type 2-diabetic patients: A systematic comparison of intravenous and subcutaneous routes.

    Certain gut hormones, like Glucagon like peptide 1 (GLP-1), have been proven to play a major role in the control of blood glucose. GLP-1 Receptor Agonists (GLP-1RAs) have been developed to treat type 2 diabetes mellitus (T2DM). So far, all GLP-1RAs that are marketed in Australia must be applied subcutaneously (SC). GLP-1RAs can cause gastrointestinal (GI) side-effects. In early studies on GLP-1 action through intravenous (IV) application, GI side-effects were less common or even absent. We want to compare the SC and the IV administration of GLP-1 regarding the potency of lowering BG and GI side-effects. 20 patients with T2DM managed by long-acting insulin will be studied. The study involves 2 study visits. Patients will be asked to withhold their long-acting insulin on the day before each visit. Patients will then, in a double-blind manner, receive continuous GLP-1 infusion. GLP-1 will be applied SC or IV on each study day. Infusion rate will be raised every 2 hours (max. 4 x per study day). Blood glucose and GI symptoms will be monitored closely. This experimental setup will allow to clarify the impact of the application route of GLP-1 on blood glucose and provocation of GI side-effects.

  • A Phase 1, Healthy Volunteer Study to Assess a Patch Delivery System for Alzheimer's type Dementia

    This is a single-site, phase 1, randomized bioavailability study to assess a patch delivery system with and without crystals to be used in Alzheimer's type dementia. The study will enroll 48 healthy volunteers with approximately equal distribution of male and female volunteers. The total study duration is 133 days and includes a 42-day screening window and 2 treatment periods of 36 days each. There will be a washout period between Period 1 and Period 2. In the first treatment period, each participant will receive a single application of once weekly Corplex Donepezil TDS (with or without crystals), applied to either the left or right side of the back according to his or her randomization. After the washout period, the participant will have the other Corplex Donepezil TDS type applied on the opposite side of the back during Treatment Period 2.

  • Improving the ways we put patients to sleep (anaesthesia) for weight loss surgery

    Obesity is a major public health problem in both the developed and the developing world. A therapeutic approach that includes both bariatric surgery and medical management is more effective than medical management alone. However, bariatric patients are more prone to post operative complications that include post operative nausea and vomiting (PONV) and obstructive sleep apnea (OSA) both of which are caused by opiate administration. Despite the potential for both total intravenous anaesthesia (TIVA) and lignocaine infusions to reduce both of these morbidities there are few published reports in the literature on their use in bariatric patients. We propose to perform a pilot study in which patients are randomised to opiate free TIVA (Dexmedetomidine, Ketamine, Lignocaine and Propofol) or standard volatile-opiate based general anaesthesia and post operative care. We postulate that opiate free TIVA will provide improved analgesia, reduce PONV, cause less respiratory adverse events and lead to better post surgical rehabilitation. Ultimately we seek to establish a program of research which assesses the best method of Anaesthesia in Bariatric Patients. Pilot data will be used in grant applications to the Australian and New Zealand College of Anaesthetists (ANZCA) and the National Health and Medical Research Council (NHMRC).

  • Evaluation of the role of an artificial intelligence system (iDA) in embryo selection.

    The project is a randomised controlled trial to evaluate the clinical effects of a deep learning system, (IVY). IVY studies the images of each embryo during culture. Previous work shows that it is a good predictor of which embryo has highest chance of implanting. This project aims to investigate what effects, if any, this has on the success rate from IVF.

  • Association between diet quality, lipid profile and body weight in participants with spinal injury

    Given the wide spectrum of metabolic consequences post SCI in conjunction with age-related co- morbidities with increased life expectancy in recent years, it is imperative to implement timely and targeted risk modification strategies. There is evidence that dietary and lifestyle modifications minimise several CVD risk factors in individuals with SCI and good evidence in the role of physical activity in improving cardio-metabolic outcomes in the population. Therefore, this study aims to examine the association between diet quality on lipid profile and body weight of spinal cord injury patients. Hypothesis: Compliance with a Mediterranean style dietary pattern is associated with lower CVD risk in adults with SCI.

  • Deferred Cord Clamping to Reduce Need for Neonatal Blood Transfusion: the Transfusions In The APTS Newborns Study (TITANS)

    The Australian Placental Transfusion Study (APTS) and other studies provide strong evidence that deferring umbilical cord clamping at birth for up to a minute is a simple, safe procedure that reduces the proportion of preterm infants who need a blood transfusion by 10%. The mechanism is not fully understood – but one potential mechanism is an increased volume of transfusion of blood from the placenta to the baby after birth. Alternatively, deferred cord clamping may reduce severity of illness in the first weeks after birth. This could lead to fewer blood tests, greater tolerance of anaemia, and better opportunities for babies to make their own red cells. The Transfusions In The APTS Newborns Study (TITANS) is designed is to obtain and analyse more data about the babies in APTS to investigate the mechanism behind the reduced need for red cell transfusions, and to explore whether there are other changes in clinical care that could reduce the need for transfusion.

  • Patient Directed Discharge Letter (PADDLE): A novel approach to improve patient knowledge, satisfaction and outcomes

    The overall goal of this study is to see whether we can improve the knowledge patients have about their hospital stay, their satisfaction with their hospitalisation, and their ability to complete the visits and testing that are recommended for when the patient goes home. The reason it is important to conduct our study is that patients may have more complications if they don’t fully understand hospital events and future recommendations at the time of discharge from hospital. An earlier small study showed that a patient’s understanding and satisfaction of their hospital admission improves when they are provided with a personalised one-page Patient Directed Discharge Letter (abbreviated as PADDLE) discussed with them by the doctor at the bedside. The purpose of this study is to see whether a newer and more uniform version of the PADDLE letter will be beneficial for patients compared to those who receive the standard hospital discharge letter. The individualised PADDLE will be explained by the treating doctor at the time of hospital discharge and the letter will include the reason for the hospital admission, the tests and treatments received as well as the recommendations for future management.

  • Comparison of dilatation via endoscopy or by the patient themselves for the treatment of recurrent strictures (narrowings) of the pharyngo-oesophageal junction

    Patients can develop strictures (narrowings) of the oesophagus (gullet) following therapy for head and neck cancers. These strictures can impair swallowing. They are treated by dilatation (stretching open) during endoscopy, but in some patients can recur frequently and lead to need for frequent and repeated procedures. We are examining the effect of patients self-dilating their strictures at home on the recurrence rate of such strictures. Our study hypothesis is that patients treated with self-dilatation have reduced clinically significant re-stricturing necessitating endoscopic dilatation, compared to those treated with endoscopic dilatation on-demand.

  • A Randomized, Single-Dose and Multiple Dose Dose-Ranging Safety and Pharmacokinetics Study of Tacrolimus Powder for Inhalation in Healthy Adult Subjects

    TFF Pharmaceuticals Australia Pty Limited is developing the study drug TFF tacrolimus as a potential new treatment to lower the risk of rejection for lung transplantations. Tacrolimus is an immunosuppressive drug used mainly after an organ transplant to lower the risk of organ rejection. Immunosuppression has been a key factor for the success of organ transplants. Tacrolimus as inhalation therapy (TFF tacrolimus) is being investigated specifically to lower the risk of rejection for lung transplantations. Tacrolimus is available as oral capsules and as intravenous injections (into the vein). The purpose of this study is to determine safe and tolerable inhaled doses that will be investigated further in future human studies.

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