ANZCTR search results

This is a Phase I, open-label study of the safety and biodistribution of two escalating doses of PEG-AVP0458, labeled with 3-5 mCi of 124I for PET imaging. This is the first study of PEG-AVP0458 in humans. PEG-AVP0458 is an experimental molecule, meaning that it is not approved for use in Australia or other parts of the world outside of this trial. The ultimate purpose of this research is to find better ways to detect and treat prostate and ovarian cancers. The product under investigation, PEG-AVP0458, has been designed to attach to a specific protein called TAG-72, which is found on the surface of some types of cancer cells however it is not a treatment for cancer. The aims of this study are to determine the safety of PEG-AVP0458 at the doses studied, and to demonstrate that PEG-AVP0458 can attach to the TAG-72 protein on prostate and ovarian cancer cells in humans. To enter the study patients with prostate or ovarian cancer need to screen as positive for TAG-72 and have disease deemed likely to be assessable by PET scan. An ECOG performance status of 0-1 and an expected survival of at least 3 months are also requirements for study entry. At screening participants must be of at least 18 years of age, provide informed consent to participate and show appropriate blood parameters. Patients with ovarian or prostate cancer are ineligible to participate if any of the exclusion criteria noted in the exclusion criteria section above. Trial Details PEG-AVP0458 will be combined with a low dose radioactive iodine particle by a process called radiolabelling, and injected. The radiolabel acts as a tracer, which means that it can be detected in tissue by a special scanning system called a PET scan. This study is designed to assess the safety and targeting ability of PEG-AVP0458, and no direct therapeutic benefit from the infusion of PEG-AVP0458 is anticipated. The first group of 3 participants enrolled will be allocated to the 1mg/m2 dose group. If any Dose Limiting Toxicities (DLTs) are seen for these 3 participants, the second group of 3 participants will also receive 1mg/m2. If no DLTs are seen in the first group of 3, the second group of 3 participants will receive the 10mg/m2 dose. If any DLTs are seen for these 3 participants, the third group of 3 participants will also receive 10mg/m2. If no DLTs are seen in the second group of 3, the third group of 3 participants (alongside a further 3 participants, total of 6) will receive either the 1mg/m2 or 10mg/m2 dose level, as determined by the outcome of the interim analysis.

The primary aim of this six-month randomised controlled trial (RCT) is to determine whether access to a cardiometabolic health nurse (CHN) results in improved primary care for the prevention and treatment of cardiometabolic disorders such as cardiovascular disease and diabetes, compared to usual care in a regional Queensland mental health service. The secondary aim is to determine whether the CHN group demonstrate improvements in objectively-assessed and self-reported physical and mental health. We hypothesise that: 1. Greater numbers of primary health care services for cardiometabolic health disorders will be provided to the CHN care group than the usual care group during the six-month intervention. 2. Greater improvements in measures of physical and mental health will be observed in the CHN care group over the six-month intervention compared to the usual care group, and the CHN care group will also demonstrate improvements in health behaviours.

This study aims to assess the safety and efficacy of combined infusion of immune cells and vaccination to boost immunity to infection after bone marrow transplantation. Who is it for? You may be eligible to join this study if you are undergoing bone marrow transplantation for any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non Hodgkins and Hodgkins lymphoma or myeloma. Trial details Participants in this trial will be allocated to one of three groups. The first group will receive multi-infection specific T-cells intravenously (via the vein) 28 days after bone marrow transplantation. The second group will also receive this treatment in addition to the Fluvax vaccination. The third group will undergo the immune cell infusion, Fluvax vaccination and Varivax vaccination. All participants will be assessed regularly over a period of 12 months in order to determine the safety of this treatment, and to determine whether it can prevent viral and fungal infection following allogeneic blood or marrow stem cell transplantation.

At least 20% of older people that are seen in a hospital emergency department and discharged will reattend the ED within 28 days. There are many negative consequences associated with ED reattendance and rehospitalisation soon after discharge. We will conduct a randomised trial to determine whether referral to and intervention by a Complex Needs Coordination Team after discharge can reduce the risk of ED reattendance.

The peak plasma propofol levels of endoscopy patients (Derived mathematically from the 3 measurements) along with the context sensitive half time of propofol (determined by the length of infusion) will allow the researchers to determine the time taken for plasma propofol levels to drop below levels known to cause driving impairment and thus estimate how long it takes for patients to drive safely after receiving a propofol only anaesthetic.

It has been argued that alcohol mixed with energy drink (AmED) consumption results in a misperception of intoxication, whereby participants recorded lower subjective ratings on specific indices of intoxication following AmED consumption relative to alcohol only consumption, despite simliar alcohol-induced deficits on objective performance outcomes. However, previous studies have yielded equivocal findings in regards to the subjective and objective physiological, cognitive performance, and motor performance outcomes of AmED consumption relative to alcohol only consumption, and there has been relatively no exploration of the dose-dependent effects of these substances on such indices. Furthermore, while this misperception of intoxication has been argued to result in increased risk-taking, there has been no objective measurement of risk-taking post-AmED consumption. Consequently, the aim of the current study will be to establish the dose-dependent impact of ED and alcohol ingested independently and in combination on (i) objective measures of cognitive and motor performance, physiology (e.g., heart rate), and behavioural risk-taking, and (ii) subjective measures of intoxication.

Control of moderate to severe pain in children following limb injury is a significant challenge in the emergency department. Intranasal administration of fentanyl is commonly used to reduce pain in this group. Ketamine, is a commonly used drug for procedural sedation in the ED. It has recently been shown to also provide good analgesia in doses that do not produce sedation and can also be administered intranasally (IN). An observational dose-confirmation, first time in ED, study was recently undertaken in the paediatric emergency department of Monash Medical Centre revealing that IN ketamine provided pain relief comparable to that reported in observational studies where IN fentanyl was used in children with limb injuries. The observationa study suggests that IN ketamine may be an alterantive pain reliver in children with moderate to severe pain. However, neither ketamine or fentanyl have been assessed in a blinded fashion in treating pain in children. We aim to compare the effectiveness, side effects and satisfaction of IN ketamine to IN fentanyl in a randomised controlled double-blind fashion in children presenting to the ED with moderate to severe pain and limb injuries. The results of this study will help confirm the effectiveness of both pain relievers and ascertain whether IN ketamine can be used in place of fentanyl in this patient group.

Continuous positive airways pressure (CPAP) is the treatment of choice for patients who have obstructive sleep apnoea (OSA). The patient wears an interface attached to a pump which delivers pressurized air to the upper airway, thereby splinting the airway open. The interface is usually one of three types, nasal pillows which sit directly in the nostrils, a nasal mask which covers the nose or a full-face mask which covers the nose and mouth. The nasal pillows and nasal mask require the patient to keep their mouth closed during treatment as opening the mouth releases pressure and this mouth leak results in less air pressure in the upper airway where it is required to splint the airway. The full-face mask ensures the nose and mouth are both in the pressurised area and thus prevents mouth leak from being a problem. Although the difference in dead space between the interfaces has been examined, the effect of the mechanical pressure from the headgear on the position of the lower jaw which is required to seal the full-face mask has not been clearly assessed. The force applied to the headgear to seal the full-face mask may result in the lower jaw being pushed back and thus the diameter of the upper airway being reduced. If this occurs, a higher CPAP pressure would be required to splint the airway. An alternative treatment for OSA is the mandibular advancement splint which relies on a dental device to pull the jaw forward to enlarge the airway opening. It is not unreasonable to presume that pressure in the reverse direction would have the opposite effect. This study aims to assess the pressure requirements of nasal versus full-face mask in patients with OSA by using auto-titrating continuous positive airways pressure (APAP).The APAP devices sense flow limitation and snore and respond to these by increasing or decreasing the positive airways pressure as required. The downloaded data can be examined to assess the pressure requirements of the patient. Patients will be assessed in a random order, crossover study comprising a two week period each of a suitably fitted nasal interface and a suitably fitted full-face interface. As the data will be collected over a two week period, night to night variation should be minimised. The APAP will assess the pressure requirements for each period to examine if there is any difference in pressure requirements between the two interfaces. The Mallampati score and pharyngeal dimensions will also be evaluated to examine if this is a possible pre-disposing factor.

This study aims to determine the efficacy of Adalimumab for active hand osteoarthritis. Primary hypothesis is Adalimumab will be superior to placebo for pain at 3 months in osteoarthritis of the hand. The design is a randomised, double blind, placebo controlled, crossover trial. Subjects will be randomised to Adalimumab/placebo followed by a 60 day washout and then the converse Adalimumab/placebo.

Identifying alcohol misuse early and delivering simple advice can be effective in moderating people’s drinking patterns and related harms such as injury. The evidence indicates that for every eight people who receive advice, one will reduce their drinking to low risk levels. The internet is becoming an increasingly recognised tool for delivering self-help materials. The project seeks to evaluate change in alcohol use and injury (self-reported) after participation in an internet delivered program compared with an information only control condition.