ANZCTR search results

This study aims to determine whether 3 months of treatment with oral dichloroacetate can supress multiple myeloma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Plasma Cell Myeloma which is in a 'Plateau-Phase', i.e. a period of neither progression nor response at least 28 days following the last change in myeloma treatment. Study details: All participants in this study will be treated with a drug called dichloroacetate. This will be taken orally (by mouth) daily for 3 months A number of blood samples will be taken throughout treatment in order to determine how the body responds to treatment. This information will help us determine how well dichloroacetate is tolerated, and whether it has the ability to suppress multiple myeloma.

To achieve the benefits of a medicine, the patient must be willing to take it in the correct amount at the appropriate time. Most medicines are not formulated for use in children. For those that are, few are considered sufficiently palatable. Lack of palatability can be attributed to poor taste and, for children below 6 years, the inability to swallow solid medicines, such as tablets. Midazolam is a highly effective oral sedative and pre-procedural medicine for children and adolescents. The lack of an oral commercial product in Australia has led the local hospitals to administer midazolam injection solution which has a foul taste and is often rejected by the children. Inadequate sedation presents difficulties in children who are very anxious or uncooperative in the preoperative setting (e.g. children with autism). Uncooperative children have then to be held down and restrained for the induction of anaesthesia, which is traumatizing for the child and the family. In adolescents, this can also pose significant safety risks for the attending staff. We believe that chocolate-based mini tablets can effectively provide palatable formulations for bitter drugs such as midazolam to assist clinicians achieve the desired therapeutic outcomes in paediatric patients. The aims of this project are: 1. To evaluate the rate of acceptance of the chocolate-based midazolam tablets in children (age 3-16) required pre-procedural midazolam 2. To evaluate the pharmacokinetic prarameters of the chocolate-based midazolam tablets in children We have developed prototype chocolate tablets measuring 0.5 x 1 x 0.5 cm that can mask the taste of the highly bitter drug. The aims of this project are to perform further clinical evaluations on these formulations to fully realise the potential of midazolam for preprocedural sedation and anxiolysis of sick children in WA. This study will pave the way for the scaled up manufacture of chocolate-based midazolam tablets for use in WA paediatric hospital wards, and the adaptation of the chocolate base for the formulation of other bitter drugs (e.g. antibiotics). Pharmaceutically, the chocolate tablets, which are prepared without water, will provide more stable products for labile drugs than liquid mixtures. They are also more convenient and cheaper to store and transport than bulky liquid formulations.

A preliminary trial to assess the effectiveness of lifestyle and dietary intervention for the management of T2DM using electronic reminders, a fitness tracker wristband collecting exercise data and a web-based questionnaire to encourage participation. The question to be answered is whether the provision of quality dietary and exercise information known to be of benefit in T2DM control is better adopted by diabetics using simple electronic reminders and easy access to that information. There will be no control group, and this is an "n-of-one" trial in which each participant acts as their own control the beginning of the study. The degree of the participation will be matched to the outcome measures (HbA1c) to determine effectiveness of the entire approach. There is potential for follow-up of willing participants at 12 months. The hypothesis investigated for this clinical trial proposes to demonstrate that blood HbA1c levels can be successfully and significantly reduced through a healthy eating / exercise programme that is implemented at baseline to 25 weeks participation. Blood levels of HbA1c is an objective and accurate marker of metabolic syndrome status and T2DM progression. A 13.5 % (from at least e.g., 55.5 mmol/mol to 48 mmol/mol) reduction in blood HbA1C level will be associated with significant improved health outcomes from baseline. This benefit may translate into a significant reduction in health care costs associated with T2DM. The electronic intervention serves as a motivating tool and guide that supports patient programme compliance, resulting in fewer doctor and other allied health affiliated practitioner visits and most importantly decreased T2DM disease progression.

The aim of this study is to investigate the safety and feasibility of an advanced technique of external beam radiotherapy, termed stereotactic body radiotherapy (SBRT), in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has a confirmed diagnosis of intermediate or high risk prostate cancer. Study details Studies have shown that escalated doses of radiotherapy increase cure rates for prostate cancer. Higher doses are achievable with high dose rate (HDR) brachytherapy, and data suggests outcomes are superior. However, HDR brachytherapy is invasive, expensive and requires access to operating theatres and specialised equipment. In this study we aim to investigate whether an advanced technique of external beam radiotherapy, termed stereotactic body radiotherapy (SBRT), is able to emulate the doses and outcomes of HDR brachytherapy while being a noninvasive technique that employs commonly available radiotherapy equipment. All participants in this study will receive SBRT and be monitored for up to five years. in order to evaluate treatment toxicity, feasibility and efficacy.

This study will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. This study is for cancer patients who are diagnosed with cancer who are aged under 45 years old. Who is it for? You may be eligible to join this study if you are aged 13 years or above and have been diagnosed with cancer or aged 0-12 years diagnosed with cancer who have been referred for fertility preservation only. Study Details This study will collect data regarding uptake and utilisation of fertility preservation, future use and complications of assisted reproductive technologies as well as the potential for infertility following treatment for cancer survivors will be collected. Patients will be asked to consent to the research team collecting the results of fertility tests following cancer treatment. In males (semen analysis and fertility hormone blood tests in years 1,3,5). In females fertility hormone blood tests and ultrasound scans looking at the number of follicles in the ovaries. The research study will be undertaken under five broad and interlinked themes. These themes include: Themes 1: Awareness and referral for fertility preservation Theme 2: Strategies, uptake, complications and quality of fertility preservation in cancer patients Theme 3: Reproductive health following cancer treatment Theme 4: Family planning and use of assisted reproductive technologies with pregnancy and birth outcomes The data from the registry and patient Medicare records will be used to perform a cost modeling health economics study for theme. Patients who consent to being part of the AOFR study wil be asked to supply data at diagnosis, end of treatment and then annually for 20 years. Eligible patients or their parents/guardians/carers on behalf of the patient no longer being treated for their cancer at their cancer centre will be contacted retrospectively (2 years retrospectively from diagnosis) by the International FUTuRE Fertility Research Manager to explain the study and to determine whether eligible patients or parent/guardian/carer on behalf of their child would be interested in having their/their child's details stored on the registry. If a patient or parent/carer/guardian on behalf of the patient, is interested in having their/their child's Medical records reviewed in order to ascertain personal, cancer and fertility history then an information pack will be sent out to the patient/patient's family. The information pack will include study information details and patient consent forms.

Patients having an ERCP may have the procedure lying on their left side or on their stomach. Currently, the position chosen is decided by the doctor performing the procedure. We do not know if one position is better than another. This project aims to assess whether the position a patient is in affects the ease and time taken to perform the procedure as well as any affect this may have on the rate of potential complications.

The purpose of this study is to test the safety and tolerability of new interferon beta-1b product called PF530. Who is it for? You may be eligible to join this study if you are aged between 18 to 50 years and are in good general health. Females must not be pregnant or breastfeeding. Study details The study will consist of two parts (Part I and Part II). Twelve participants will be enrolled in Part I, and the results of this part will determine how many participants will be enrolled in Part II. The study is divided into a screening phase lasting about 4 weeks and an on-study phase. The on-study phase will be broken into 2 periods with at least a 14 day gap (called a wash-out) between each period to ensure that the study drug is completely gone from your body before the next period starts. Doses will be administered subcutaneously (under the skin), with participants receiving PF530 in one period and BETAFERON in the other period. The order in which you receive those doses (i.e. in period 1 or period 2) will be random. The chance of receiving PF530 first compared to BETAFERON is 1:1. Which treatment you receive first (PF530 or BETAFERON) will not be known by the study staff or yourself. The study dose will be given to you by a clinical unit staff member. Study doses will be administered in the abdomen. Initially in Part I, the first 2 participants will receive a randomised dose – one with PF530 and one with BETAFERON - on the morning of Day 1 and will complete 48 hours of monitoring by site staff before the remaining participants receive their dose. This is referred to as a sentinel dosing. Dosing of the remaining participants will depend on safety information obtained from the 2 sentinel participants. Each of the two study periods will include a confinement period of 5 days and 4 nights, commencing the day before your dosing each period. After leaving the clinical unit on Day 4, you will be required to attend the unit at the same time each morning on Days 5, 6 & 7 for a brief appointment. Your total involvement in the study will be approximately 8 weeks. It is anticipated that each visit will last from 1-2 hours depending on the procedures required. These will include: blood and urine sampling; physical examination; vital signs; medical history, concomitant medications and adverse events (AE) assessment; completion of questionnaires.

This study evaluates an online parenting program that aims to help shy/sensitive young children become more confident and prevent them developing anxiety problems. Parents will receive access to the website program immediately or after a 24-week delay, and will complete questionnaires at baseline, 12 weeks, and 24 weeks later.

Many people with type-1 and type-2 diabetes develop critical illness, which inevitably leads to deterioration in glycaemic control. However, most critically ill patients with hyperglycaemia are not diabetic, but develop disordered glucose metabolism that normalises once the acute illness resolves – so-called critical-illness induced hyperglycaemia (CIIH). While a number of studies have evaluated the effects of modulating glycaemia, using insulin, on outcomes in the critically ill, a major limitation of these studies, given recent information, is that critically ill patients with hyperglycaemia have been considered a homogenous cohort, rather than classifying hyperglycaemia in the critically ill according to pre-morbid glycaemia or presence of diabetes. Recent data indicate that a paradigm shift is required, and that patients with CIIH should be considered separately to those critically ill patients known to have diabetes, particularly those patients with ‘chronic’ hyperglycaemia, or ‘poorly controlled’ diabetes. Given these data (and that it intuitively makes sense) the medical staff at Austin Hospital Intensive Care Unit believe we should be personalising blood glucose targets and that, in diabetic patients, the target glucose level in ICU should simulate the sort of glycemic levels these patients are likely to commonly experience in their daily lives, especially during situations of physiological stress (between 10-14 mmol/L). Such target glucose level would also be expected to prevent any episodes of even mild hypoglycaemia, which have been associated with increased risk of death. However, allowing slightly increased blood glucose concentrations in critically ill patients known to have diabetes is a slight change from current practice, and evidence to support this change, although logical and strong, is from observational studies only. Accordingly, we wish to collect data after the implementation of the new protocol to audit the effects of glycaemia on outcomes and ensure that this protocol proves safe and does indeed prevent hypoglycemic episodes as expected. This audit represents a formal assessment of a quality improvement initiative dedicated at increasing the quality of glycaemic care in critically ill diabetic patients.

This study will determine the effect of mindfulness based cognitive therapy on the fear of recurrence in ovarian cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with ovarian cancer, have completed all hospital based adjuvant treatment and are now disease free. Study details All participants will receive the same intervention and will involve intensive training and practice in mindfulness based cognitive therapy. Treatment is designed as an 8 week course of 2-2.5 hour small group sessions once weekly with approximately 8-15 individuals in each group. Sessions are run at locations in Shenton Park, Duncraig and East Fremantle by the Cancer Council WA, or by SolarisCare Foundation, at Sir Charles Gardner Hospital in Nedlands. Courses take place during the day and are free of charge. The groups will be run by experienced clinicians in psychotherapy, counselling and meditation and will have a clinician manual and a participant workbook outlining the themes and exercises for each week. Group members will be expected to practice skills between sessions. Participants will be asked to answer questionnaires before, during and after the group sessions to collect information on how participants are feeling.