ANZCTR search results

The caesarean section (CS) rate has risen to the point where a third of all mothers in Australia give birth by this method [1]. CS is a major contributing factor to maternal mortality and morbidity following childbirth in developed countries and reducing the overall CS rate is a major policy goal for NSW Health [2]. The highest risk of adverse outcomes associated with CS occurs when it is performed during labour which is 40% of all CSs[1, 3]. Most of these are due to failure to progress (FTP) which accounts for around 8% of all births[3]. Induction of labour (IOL) reduces the risk of CS, particularly when there is a low risk of fetal distress [4, 5], but it is not feasible to offer this intervention to all women because given time, most women will labour naturally. To date, there is no method of prospectively identifying women who are most likely to benefit from IOL. Predictive models could identify women who might benefit from preventative measures such as induction of labour. We have created a model which will be used to screen for women at high risk of caesarean section in labour. This model incorporates maternal age, body mass index (BMI), height, gestational diabetes, estimated fetal weight, amniotic fluid index, and parity. We will be investigating if induction of labour compared with routine antenatal care at 39 weeks of gestation in women with a cephalic presenting fetus reduces the risk of caesarean section for abnormal progress in labour. References: 1.Hilder, L., et al., Australia's mothers and babies 2012. Perinatal statistics series no. 30. Canberra: AIHW, in Australia's mothers and babies 2012. 2. Health, N., Maternity - Towards normal birth in NSW, N. Ministry of Health, Editor. 2010. 3. Zhang, J., et al., Contemporary cesarean delivery practice in the United States. Am J Obstet Gynecol, 2010. 203(4): p. 326 e1-326 e10. 4. Gülmezoglu, A.M., et al., Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database of Systematic Reviews, 2012(6). 5. Boers, K.E., et al., Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ, 2010. 341: p. c7087.

This study will evaluate the effect of exercise on health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours in people with multiple myeloma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of multiple myeloma, and are free of any conditions that may prevent safe completion of the exercise demands of the study. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will immediately commence a 3 stage exercise program. The first stage will be gym-based and involves 2 x supervised sessions and 1 home-based session per week for 12 weeks. All supervised classes will be delivered by an Accredited Exercise Physiologist. Stage 2 is a 12 week home-based program (3 sessions/week) with weekly telephone support, with the option to attend one group-based class each week delivered by an Accredited Exercsie Physiologist. Stage 3 involves a maintenance home-based program for a further 6 months. The program will be individualised to the participants’ cardiorespiratory fitness and bone lesions, and will involve high-intensity aerobic exercise, resistance training and impact loading. Participants in the other group will receive the same program after a 12 week wait, during which time they will receive usual care. All participants will undergo a number of assessments at baseline, 12 weeks, 24 weeks, 36 weeks (group 2 only) 12 months (group 1 only) and 15 months (group 2 only) in order to evaluate health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours. The potential findings of this proposed research will ultimately influence the inclusion of exercise as part of standard care to improve the health and longevity of people with multiple myeloma.

The primary purpose of this trial is to evaluate the safety and efficacy of a combination treatment consisting of EDV's packaged with a chemotherapeutic targeted to cancer cells and an adjuvant therapy that is designed to boost the bodies own immune system to fight the cancer. In Phase I the study will enrol 5 evaluable patients per cohort. In Phase IIa the study, will enrol up to an additional 35 evaluable patients per cohort. Therefore up to 40 evaluable subjects per cohort will be enrolled in the study. Who is it for? You may be eligible to enrol in this trial if you are aged 18 years old or older and have either advanced pancreatic cancer or any solid tumour that has been treated with at least one prior treatment regime or where other standard therapies are not appropriate. Study details All participants enrolled in this trial will receive combination treatment with the following: 1. The EnGeneIC Dream Vector(TM) (EDV(TM)). The EDVs are very small particles known as nanocells, which are made from Salmonella bacteria. The type of Salmonella is one that does not cause disease. The EDV is the delivery vehicle used to transport the study drug directly to the site of the cancer. 2. The Cancer Treatment. The study drug is a type of chemotherapy. The study drug is packaged inside the EDVs (E-EDV-D682) and is targeted directly to the site of the tumour, rather than the body’s healthy cells and tissues. The EDVs will also be packaged with another substance that is designed to boost the immune system, called EDV-GC. 3. Bispecific antibody. The EDV delivery system works in 2 ways, as well as carrying the study drug, the EDV surface is also coated with a bispecific antibody. A bispecific antibody is two antibodies linked together, such that one can attach to the EDV and the other to cancer cells. Once attached, the EDVs are taken up inside the cancer cells, and the study drug is delivered directly inside the cell itself, causing the cancer cell to die. Treatment will be administered in 5-week cycles. The treatments are prepared in a syringe and administered into a vein (intravenous), over a period of 20 minutes using a special pump. Two doses of the treatment are given twice per week for the first 2 weeks, followed by weekly treatment for a further two weeks, with a treatment free week where a CT or MRI scanning is performed to evaluate the tumours response to treatment (Week 5). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the patients disease continues to grow. It is hoped that the findings from this trial will provide information on whether E-EDV-D682 and EDV-GC treatment may be safe and effective for the treatment of otherwise incurable pancreatic and other advanced solid tumours.

The current study aims to assess the efficacy, safety, and usability (i.e., clarity, efficiency, ease of navigation) of a new online psychological treatment for fears of death. We expect that this new treatment will result in reductions in fears of death and few adverse events, and will be seen seen as helpful and easy to use.

Peripheral Venous Catheters (PVC) are inserted for the administration of medications and fluid;. two billion are sold worldwide annually. While patient need for PVCs is high, up to 69% fail due to complications such as occlusion or phlebitis necessitating additional PVC insertions to complete treatment. PVC replacements increase healthcare costs (staff time/equipment) and some patients require higher risk central venous device, because they have run out of PVC insertion sites. Midline catheters (MCs) are an alternative to PVCs, increasingly used, but rarely in Queensland, Australia. On average 10cms long, they terminate at the axillary vein, not in the central venous circulation. As with any invasive device, leaking, infection and thrombosis can occur. Their rising popularity is due to concerns that patients’ veins are depleted by multiple consecutive PVCs. There have been no randomised controlled trials (RCTs) comparing these devices to guide practice. This pilot randomised control trial will test the feasibility of a large study comparing PVCs and MCs for patients with difficult vascular access and/or prolonged therapy.

Hormones called “incretins” are released from the gut in response to meal ingestion and greatly enhance postprandial insulin secretion (the “incretin effect”), thereby playing a critical role in limiting the rise in blood glucose concentrations. Glucose-dependent insulinotropic polypeptide (GIP) was the first incretin discovered in 1973. While its capacity to stimulate insulin secretion appears to be diminished in people with type 2 diabetes (T2DM), recent studies suggest that this loss of effect is reversible if good blood glucose control is regained. A second incretin, glucagon-like peptide-1 (GLP-1), was discovered in 1987 and has risen to prominence, in part because drugs that mimic its effects have been developed and are used to treat T2DM, with great success. Incretin-based therapies are attractive because they only stimulate insulin secretion when blood glucose concentration elevated, so unlike insulin injections, they entail a low risk of hypoglycaemia. The role of GIP has been neglected, in part because we have lacked an antagonist suitable for human experiments to block the action of GIP. One factor that enabled GLP-1 to be developed into a drug was the availability of a GLP-1 antagonist, exendin9-39, that was suitable for use in humans. In collaboration with Prof Jens Holst from University of Copenhagen, who has recently identified a GIP antagonist, GIP(3-30)NH2, that can be used in human research, we can now for the first time to identify exactly what role GIP plays in insulin secretion and blood glucose control. In the current proposal, we will employ this novel human GIP antagonist and the GLP-1 antagonist, exendin9-39, to determine in healthy humans whether GIP and GLP-1 together account for the entire incretin effect, or whether there is a “third incretin”.

The number of people forcibly displaced worldwide is ~68 million. Refugees report rates of posttraumatic stress disorder (PTSD) that are over five times that seen in the general Australian community. PTSD in refugees is associated with elevated depression, suicidality and functional impairment, however many do not benefit from evidence-based interventions for this disorder. Thus, there is an urgent need to improve existing psychological interventions for PTSD in individuals with a refugee background, by directly targeting the specific mental health needs of this vulnerable population. Narrative Exposure Therapy (NET) is currently the leading evidence-based trauma-focused intervention for PTSD relevant to the refugee context. Previous research suggests that emotion regulation difficulties are highly prominent in refugees, and demonstrate a strong association with PTSD. Skills Training in Affective and Interpersonal Regulation (STAIR) is a treatment that comprises a skills training phase in which patients learn skills related to emotional and interpersonal regulation, prior to engaging in trauma-focused therapy for PTSD. In this study, we investigate the efficacy of a phase-based treatment for PTSD (STAIR-Refugees [STAIR-R] + NET) that has been specifically adapted for refugees. Participants will complete assessment and treatment sessions in either a face to face setting or online using videoconferencing software. Eligible participants will be randomised to one of two parallel treatment arms. In Arm 1, the first phase will comprise 6 sessions of STAIR-R. Participants then complete phase 2, which will comprise 7 NET sessions. In Arm 2, the first phase will comprise 6 supportive problem-solving (SP) treatment sessions, which have been developed specifically for refugees. Participants then complete phase 2, which will comprise 7 NET sessions. We predict that participants in the STAIR-R +NET condition will show greater improvements in PTSD symptoms compared to those in the SP + NET condition. Participants will complete assessments at baseline, after completing Phase 1, post-treatment (one week after completing NET session 7), 3 months follow-up (3 months following treatment completion), and at one year follow-up (12 months after treatment completion). The primary outcome is change in PTSD symptom severity. There is also a range of secondary outcomes that will be examined including symptoms of depression, anxiety, emotion regulation, and quality of life.

A new mobile app, (Niggle) has been developed by QUT staff, to be used independently, or in conjunction with Kids Helpline's counselling services. This project will aim to evaluate the effectiveness, acceptability and usability of the new app among help-seeking young Australians, contacting Kids Helpline (KHL) for support. Help-seeking young people, aged 13-25 years, who contact Kids Helpline will be invited to take part in a Randomised Controlled Trial evaluating the efficacy of their counselling services. Interested participants will be randomised to receive treatment as usual (TAU), or TAU + the access to the ToolKit app. Participants will complete surveys at Baseline, 1, 2 and 3 months post baseline.

Motor Neuron Disease (MND) is a fatal neurodegenerative disease. MND is thought to arise from a combination of genetic susceptibility and environmental exposure, possibly due to a multi-stage process. There is considerable evidence that gut health is important in human disease and particularly in neurodegenerative disease. Given the lack of proven therapies in MND, there is an urgent need for new approaches. A range of approaches have been suggested and could involve diet, probiotics, prebiotics or antibiotics or therapies to antagonize the effects of the toxic molecules. This trial will study the effects of squalamine, an antibacterial first discovered in the dogfish shark that has a novel mode of action, and its efficacy as treatment aimed at improving gut health in MND patients. Squalamine is effective against methanobacter, which are difficult to detect, but are the likely organism responsible for methylation by gut microbes. Squalamine is rare, being one of the few non-toxic antibacterials which is active against this class of gut microbes. Squalamine is an attractive candidate because it is already widely available as a natural product in the dietary supplement Squalamax. This study will assess the safety and efficacy of squalamine (at a daily dose of 1.2 mg) in the dietary supplement Squalamax in patients with MND. The study includes 2 main periods: an unblinded treatment period (3 months) and an open label long term follow up phase (9 months). Patients in the standard care arm (i.e. no drug) will be switched to Squalamax treatment after 3 months. This study will test: - the tolerability of squalamine in patients with MND (indicated by diarrhoea or other symptoms). - the effects of squalamine on levels of gut derived toxins (before and after treatment with squalamine) - the effects of squalamine on levels of gut microbes in MND patients (collection of faecal samples for later analysis) - the effects of squalamine on MND standardised assessments (Amyotrophic Lateral Sclerosis Revised Functional Rating Scale (ALS-FRS R), Respiratory function testing (RFT)) and comparing treated and untreated patients over 3 months.

Intermittent exotropia (IXT), characterised by periodic divergence of visual axes and exacerbated when tired or sick, is the most common subtype of ocular misalignment among children affecting about 25% of the total strabismic population. Minus lens over-correction is one of the most common non-surgical method used in the treatment of IXT. Although improved control has been reported, no clear clinical guideline exists in determining the over-correcting minus lens strength; some adopted ‘one-for-all’ approach prescribing a constant power (-2.0D or -2.5D) while others used a ‘trial and error’ method. In this study, a novel method of customising minus lens over-correction based on angle of deviation, AC/A ratio and amplitude of accommodation will be used. Primary outcome is the IXT control after using customised minus lens where the success defined as the improvement of greater than 1 control score from the pre-treatment (baseline) score. Additional outcomes include measurement of angle of deviation, range of fusional vergence, suppression, distance stereopsis, and progression of myopia. This is a single site, prospective, randomised clinical trial. Subjects will be block-randomised depending on severity of IXT among children aged between four and fifteen years old. The treatment group will receive custom minus lens overcorrection whereas the control group will receive only their refractive correction, if any. The study will be conducted at ophthalmology department of Queensland Children’s Hospital under strict ethical guideline subject to approval from the relevant ethical committee. 2. OBJECTIVE The major objective of the study is to investigate efficacy of uniquely customised minus lens over-correction in the treatment of IXT. Additional objectives are to compare effectiveness in controlling distance deviation and to assess improvements in distance stereopsis, fusional vergence and suppression. 3. HYPOTHESIS Maximum tolerable minus lens overcorrection without compromising visual acuity and comfort is governed by available accommodative amplitude. Similarly, minimum strength of minus lens required to control IXT is governed by angle of deviation and fusional vergence in reserves. Having knowledge of these factors, a clinician can determine an individualised optimum over minus prescription. Therefore, we hypothesise that custom optimised minus lens based on angle of deviation, AC/A ratio and accommodative amplitude produces improved control of the IXT without compromising visual acuity and comfort.