ANZCTR search results

Lenalidomide and Azacitidine each have clear evidence of efficacy in MDS, and have shown activity in AML. However, not all patients respond so better regimens, including combinations, are required. MDS and AML are heterogeneous diseases, and lenalidomide and azacitidine may target different cellular populations and induce differing clinical responses. Combinations of immunomodulatory drugs and azacitidine have been explored and shown to be feasible. This is an open label, multi-centre, randomised Phase II study exploring the toxicity and efficacy of the combination of lenalidomide and 5azacitidine compared to 5azacitidine alone. After an initial 2 cycles with 5azacitidine (75mg/m2/day x7days over 9days of a 28 day cycle; 5-2-2 regimen), patients will be randomised 1:1 to either combination 5azacitidine and lenalidomide (5azacitidine 75mg/m2/day x5days of a 28 day cycle + lenalidomide commencing cycle 3 10mg/dayx21days of a 28 day cycle) or 5azacitidine alone (75mg/m2/day x7days over 9days of a 28 day cycle; 5-2-2 regimen) for 12 months to primary endpoint, then all patients may continue 5azacitidine alone until progression or toxicity. Response will be determined by peripheral blood counts, transfusions, bone marrow morphology and cytogenetics, according to IWG criteria. The study also incorporates a correlative laboratory component designed to determine the mechanism of action of 5azacitidine +/- lenalidomide and to determine a baseline profile which may predict those most responsive. These studies will incorporate gene methylation and expression, and enumeration of lymphocyte subsets, natural killer cell function and cytokine profiles.

Heart operations is frequently accompanied by a degree of inflammation and irregular heart beat.This study aims to determine if the use of a solution containing bicarbonate during heart operations will reduce the amount of inflammation and improve heart rhythm. During heart bypass surgery, patients' circulation is supported by a heart lung machine. During this process, the patient's blood is mixed with around 2 L of fluid. In Brisbane, we have developed a fluid for use during heart surgery. Initial results suggest that it maintains the acid levels in the blood better than the conventionally used fluid. This project is seeking to determine whether the new fluid also improves the overall well being of the patient. If shown to improve the overall well being of the patient, it has the potential to reduce hospital stay and hospital costs.

Each subject will be required to attend the Discipline of Medicine, Royal Adelaide Hospital, on four occasions. They will receive in randomised, double-blind order, infusions of either lipid (Intralipid (Resgistered Trademark) or 0.9% saline. On two occasions, they will receive infusions of saline (control) and on the other two occasions they will receive lipid (once each during the luteal and folicular phases). The primary outcome evaluated will be energy intake assessed using measuring food intake at a buffet meal after the intraduodenal infusion.

A randomised controlled intervention study investigating the effect of sustained osteopathic treatment on the pain levels and medication usage in primary dysmennorrhoea

The results of the study will examine the association between performance impairment on a simulated driving task and eye measures of drowsiness, induced by acute sleep loss, alcohol and hypnotic drug administration. These findings will help to determine the validity of eye measures as a countermeasure to fatigue-states, with the aim of reducing sleep-related motor vehicle accidents.

We hypothesised that in the context of weight maintenance and identical macronutrient (e.g. carbohydrate) and fibre intake, the replacement of high GI carbohydrates with low GI carbohydrates would improve acne severity by lowering blood insulin concentrations. We studied adolescent males attending boarding school so that food intakes could be more easily controlled.

Children aged 0-3 month presenting to a participating emergency department and have been found to require medically indicated interventions ( placement of an intravenous access device, phlebotomy, heel prick) are enrolled after parental consent. After consent , patients will receive 1 ml of a study drug ( either 1 ml of 24% sucrose or 1ml of 66% sucrose). This is offered by a nurse to the infant who is encouraged to suckle on a pacifier or glove and is swaddled by a parent or caregiver at the same time. 2 minutes after the sucrose commenced, the procedure commences. During the procedure the attending nurse scores the maximum pain response as measured by Alder Hey pain score

Sevoflurane is one of the widely used anaesthetic vapours for general anaesthesia. This vapour is delivered to the patients lungs through a breathing tube. It is known to alter the electrical activity of the heart. This manifests as a prolonged QTc interval of the electrocardiogram (ECG). One of the potential dangers associated with this phenomenon is the occurrence of a dangerous irregular heart beat. However, it is a very rare condition. People with diabetes mellitus are more prone to have a prolonged QTc interval due to various reasons. It is not known whether the diabetic patients are at an increased risk of QTc prolongation compared with non diabetics on exposure to sevoflurane anaesthesia. This study tries to look at the impact of sevoflurane on the QTc interval in patients with diabetes mellitus. The primary outcome parameters of interest are the Tp-e interval and Tp-e / QTc ratio of the ECG, as these measures are sensitive in predicting dangerous arrhythmias. The secondary outcome measures of interest are Qtc and QTcd values of the ECG.

Postnatal depression (PND) interferes with the interaction between mother and infant, which in turn has long-term implications for the child's development. Further, treatment for PND directed at elevating mood has not been found to improve mother-infant interactions. For this reason we developed Community HUGS - a specialised 10-session playgroup for improving mother-infant relationships following PND. The aim of this project is to evaluate Community HUGS in a randomised controlled trial. It is hypothesised that women receiving the Community HUGS intervention will show less parent-child dysfunctional interactions and parental distress and higher maternal self-efficacy than women in the waitlist control condition post-treatment.