ANZCTR search results

The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity Cognitive Behaviour Therapy (CBT)-based self-management program, the Managing Your Wellbeing Epilepsy Course, in reducing symptoms of anxiety, depression and disability among adults with epilepsy. The Course contains a 5-lesson 8 week CBT program, which can be administered via the internet. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. We expect participants will rate the Course as acceptable and will report that it was worth their time. We also expect that overall sample will make improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment, which will be maintained at 3-month.

APL-2 is an experimental drug being developed by Apellis Pharmaceuticals Inc for the potential use as a treatment for people with a broad range of blood disorders (including paroxysmal nocturnal hemoglobinuria (PNH)) and certain types of auto-immune diseases). PNH is caused by a small change to the individual’s genes, which results in red blood cells being broken down prematurely. People with PNH typically feel tired and often see some blood in their urine. The condition is unfortunately progressive with sufferers needing increasing medical care, with an average life expectancy of only 10 years after diagnosis. The currently available treatments are insufficient to deal with this complex disease with most patients not fully responding to the treatments. APL-2 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent the breakdown of red blood cells and keep them healthy. It is hoped that APL-2 will help improve the quality of life and reduce the severity of the condition for PNH sufferers. In this study, multiple ascending doses of APL 2 will be assessed in healthy volunteers. The assessments of the safety, tolerability, pharmacokinetics, and pharmacodynamics following administration of single doses of APL-2 will guide decisions to further develop the drug.

This study aims to assess whether further cognitive decline can be delayed or prevented in people with mild to moderate dementia through the consumption of flavonoids in cherry juice over 12 weeks. Secondary outcomes included anti-inflammatory effects, changes in functional and physical ability and depressive symptomatology.

The study aims to explore the impact of parent skills training on outcomes of children and families experiencing eating disorders. It is hypothesised that children whoses parents experience the parent skills training treatment will have improved outcomes over treatment as usual. the study is a pilot trial to determine feasibility for a fullscale trial.

Macrosomia remains a common and important complication of type 1 diabetes in pregnancy, with adverse consequences for both mother and neonate. Accurate determination of glycaemic control remains difficult due to limitations in the accuracy of indices of glycaemic control in pregnancy and ongoing controversy regarding the timing of self-monitoring of blood glucose. Continuous glucose monitoring provides accurate glycaemic data but is limited due to cost and availability. Furthermore its use has not consistently shown improvements in pregnancy outcome. We hypothesise that glycated albumin will be a useful clinical tool for monitoring glycaemic control in pregnancy and with the availability of a new automated assay, has the potential to be widely accessable and cost effective.

The proposed study will be the first randomized controlled trial (RCT) of the use of CCS, and will be targeted to 40-70 year old 1st degree relatives of patients with CAD onset <60 years old, or 2nd degree relatives of patients with onset <50 years old. Control patients will undergo standard risk scoring but have blinded CCS results. In the intervention arm, treatment will be initiated based on CCS, applying the new ACC/AHA prevention guidelines. At three years, the effectiveness of intervention will be assessed on change in plaque volume at CT coronary angiography (CTCA), the extent of which has been strongly linked to outcome. The results will provide high-level evidence to inform the guidelines regarding the place of CTCA in risk assessment, specifically in patients with a family history of premature CAD.

The aim of this study is to use a morning dose of armodafinil (50mg) as a short-term aid (4-weeks) to protect against daytime impairments in those with Insomnia Disorder who are undergoing effective sleep restriction therapy. We hypothesise that overall insomnia severity measured through self-report of the Insomnia Severity Index (Primary Outcome) at 12 weeks (14 weeks into study protocol) from the start of treatment will reduce significantly more in patients receiving adjunctive armodafinil and sleep restriction therapy compared to those receiving sleep restriction therapy only (non-drug historical controls). This may then increase adherence by augmenting wakefulness and in turn promote sleep in those with Insomnia Disorder. This is in line with a previous finding involving modafinli and overall CBT-I for insomnia (Perlis et al., 2004, SLEEP, Vol 27). This will be the first study to fully profile the acute effects of sleep restriction therapy + armodafinil for the treatment of insomnia. This study is a pilot study to determine acceptability, safety, efficacy and tolerability of armodafinil specifically in the context of sleep restriction therapy alone for Insomnia Disorder.

The purpose of this study is to determine the highest dose of a new drug known as CRLX301 that can safely be given to patients with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a confirmed diagnosis of advanced solid tumor malignancy that is refractory (i.e. has not responded to treatment), or not a candidate for standard therapy. Study details All participants in this study will be treated with the study drug, CRLX301, which is administered intravenously (i.e. directly into the vein). CRLX301 is a combination of a chemotherapy drug called "docetaxel" and a polymer (group of the same molecules bound together). The docetaxel is attached to the polymer and forms into tiny beads called nanoparticles. The nanoparticles circulate in the blood stream and may eventually build up in tumours, allowing more of the chemotherapy drug, docetaxel, to get into tumour cells and kill them. The CRLX301 nanoparticle with docetaxel inside is larger than docetaxel alone. Therefore, it is hoped that less of it may enter normal healthy cells, so that normal healthy cells are not harmed. The study has 2 parts. In the first part of the study (Part 1) participant groups will receive increasing doses of CRLX301 once every 3-weeks or once a week schedule if tolerated. If the dose causes significant side effects that are intolerable for patients, then no additional patients will be enrolled at a higher dose. In the second part of the study (Part 2), participants will receive the highest dose of CRLX301 which is not expected to cause significant side effects that would require stopping the dosing of study drug. Participation in the study will require frequent clinic visits (at least weekly), to assess participants’ health and monitor side effects. Some visits may take up to 8 hours. Most other visits will last 2 - 3 hours depending on procedures required. These may be include: blood and urine sampling; physical examination; vital signs; medical history, performance status, concomitant medications and adverse events (AE) assessment; CT and bone scans; ECG; and tumour biopsy (second part of study only). After receiving CRLX301, additional blood samples will be required for some participants at 1 and 3 days; and 1 and possibly 2 weeks. Participants will continue to receive CRLX301 once every 3-weeks or weekly, unless they experience adverse events, in which case their CRLX301 may be delayed/given at a lower dose, or they may stop CRLX301. If participants experience unacceptable toxicity or disease progression, CRLX301 will be stopped and the participant will return for a safety follow up visit. It is hoped that CRLX301 can be used to treat people with more chemotherapy in the tumour and with fewer effects on normal cells than with docetaxel alone.

Identify an endogenous metabolic phenotype for the enzyme CYP3A4 that can be used as a component of a pathway phenotyping panel to optimise anticancer drug dosing

This study aims to determine whether the use of Primovist magnetic resonance imaging (MRI) in assessment of pancreatic cancer liver metastases would result in changes in clinical decision-making for these patients and more appropriate treatment decisions. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years old, and have a confirmed diagnosis of locally operable pancreatic adenocarcinoma with no liver metastases on CT staging. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group undergo primovist MRI in addition to standard multiphase CT of the abdomen and CT of the chest as part of their preoperative assessment for pancreatic resection. This involves an MRI, which is a scan, which does not expose the patient to any ionizing radiation. A contrast agent is injected through a cannula, usually in the arm. Patients are then required to lay flat on their back for the duration of the scan, which is usually about 35 minutes. The contrast injected in this situation would be Primovist. Primovist is a liver specific contrast, which helps characterize liver lesions in MRI more accurately. It has been available since 2005 and is used with increasing confidence in many liver centres. It is TGA approved but not yet available on Medicare, and usually takes about 30 minutes. Participants in the other group will undergo standard preoperative assessment which consists of a multiphase CT of abdomen and contrast CT of chest . A CT scan is the current standard scan used to assess pancreas cancer. A cannula for the intravenous contrast is required. There can be discomfort related to its insertion and possible bruising at the site. Although there is exposure to radiation with the CT scan, which is the standard assessment, performed in pancreatic cancer liver assessments there is no additional ionizing radiation from the MRI. All participants will be re-assessed with three monthly CT scans of chest, abdomen and pelvis and tumour markers. Just using CT scans will allow assessment of recurrence, using current standards. The information from follow up scans will allow us to evaluate recurrence rate at 12 months following surgery and the existence of liver metastases. It is hoped that Primovist MRI will be found to be superior to the standard CT tests in the detection of liver metastases in pancreatic cancer, and that this leads to more relevant and appropriate treatment options for patients with pancreatic adenocarcinoma.