ANZCTR search results

CRN00808 is being developed for the treatment of acromegaly. This four-way crossover single dose study will compare the pharmacokinetic and safety profiles of CRN00808 over four periods under the following dosing conditions; Condition A: Subjects will remain fasting for 4 hours after drug administration. Condition B: Subjects will remain fasting for 2 hours after drug administration. Condition C: Subjects will remain fasting for 1 hour after drug administration. Condition D: Subjects will receive a standard dinner then fast for 2 hours prior to drug administration. After dosing, the subject will fast overnight.

NeedleCalm is a single-use disposable medical device to alleviate pain associated with injections and assist with the reduction of fear of injections. The NeedleCalm™ technology uses the gate control theory of pain awareness and transmission.The device will be intended for use for all blood collections, intravenous cannula insertion, IM and SC injections.

Low blood pressure is a common problem in critically ill patients. It is often associated with compromised organ blood flow, leading to organ dysfunction. Administration of fluids into a vein is a common method to treat low blood pressure, which aims to increase blood volume to improve organ blood flow. The effect of fluid temperature on blood pressure and cardiac output is largely unknown. In healthy volunteers, it was found that room temperature fluids led to a bigger increase in blood pressure than warmed fluids, but caused a decrease in cardiac output. This was thought to be due to reflexive constriction of blood vessels in response to cold. A decrease in cardiac output may in turn cause lowered organ blood flow. This study aims to compare the effect of room temperature and warmed fluid therapy on cardiac output and blood pressure, in critically ill patients. We postulate warmed fluids may lead to better increase in cardiac output, compared to room temperature fluids. If this is true, warmed fluid therapy may become standard to improve organ blood flow in critically ill patients.

Children with respiratory illness including CF and non CF bronchiectasis are the largest cohort of children requiring PICCs at Queensland Children's Hospital (QCH). Traditionally PICCs require a general anaesthesia to establish procedural compliance. Midlines are also used internationally to administer intravenous antibiotics without necessitating general anaesthesia. We hypothesise that the need for GA will be reduced in this patient cohort whilst still providing the necessary treatment. This will benefit this patient population and the healthcare institution through reduced procedural risk and corresponding respiratory compromise, as well as reduced costs associated with theatre personnel. . The primary aims of this research is 1) to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity and 2) need for general anaesthetic.

The research project will aim to establish the utility and acceptability of the GroWell for Health Program, a novel self-directed eight week eHealth multiple health behaviour change intervention tailored for midlife adults. The research design is a pre-test, post-test trial and will be conducted with 60 men and women aged 40 to 59 years without any existing diagnosis of cardiovascular disease, type 2 diabetes or cancer in the past 12 months. Each participants will be allocated to either Intervention Group A (Program independent) or Intervention Group B (Program + virtual nurse coaching), where the intervention will be delivered accordingly. Baseline (0 weeks), post-intervention (8 weeks) and follow-up (16 weeks) data will be collected from all participants via an online survey and a virtual appointment. Participants in Intervention Group A will also partake in a short qualitative semi-structured questionnaire to provide feedback about the program delivery.

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.

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.

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.

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.

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.