ANZCTR search results

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.

Chronic obstructive pulmonary disease (COPD) affects approximately 7.5% of the Australian population over 40 years of age. Many people with COPD suffer periodic exacerbations that can make them feel much worse. We have effective treatments for managing the symptoms of COPD, but they do not cure the disease. The “microbiome” is the term given to all the microorganisms, such as bacteria, that live on and in our body. There are at least 10 times as many bacterial cells than human cells in the gut alone. All these microbes live in harmony with our body and we benefit from them being there; for example, they can produce vitamins that we need and can ward off pathogenic microbes that might do us harm. There are many ways in which the “health” of our microbiome can be affected. We have found that the number and species of bacteria in the microbiome of mice with COPD is different to that in mice without COPD. The purpose of this study is to determine if the same is true in people. The bacteria that are different might serve either protective or negative roles in terms of health.

In this study of 80 obese (BMI greater than or equal to 30Kg/m2) ICU patients we will estimate requirements and deliver nutrition as per current standard practice in 40 patients; the remaining 40 patients will have their energy requirements measured using indirect calorimetry and the provision of nutrition therapy will be targeted to meet this value. We will measure important outcomes to enable us to determine whether this goal directed approach allows nutrition therapy to better meet the patients requirements, and also whether this difference impacts on the patient’s recovery. We hypothesize that patients who receive Goal Directed Nutrition Therapy will receive a higher proportion of their energy needs (energy delivered divided by measured energy expenditure) and that this may lead to improved clinical and functional outcomes.

An area of research that receives a lot of attention currently relates to the physiological mechanisms that are involved in maintaining the feeling of fullness after people have eaten (referred to as satiety). Previous studies have shown that the most satisfying foods were found to be high in carbohydrate or protein, and most were also high in water and fibre. Considering the high carbohydrate (> 60 grams per 100 grams) and high protein (>10 grams per 100 grams) content of Campbell Arnotts Vita-Weat range, these products may produce greater satiety and hence help produce weight loss for those needing to lose weight. The current randomised controlled trial is designed to investigate the beneficial effect of this food product in an overweight and obese population group.

A randomised controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to participate. Following completion of the pre-intervention assessments, people taking part in the study will be randomly allocated to one of the three groups above. Participants allocated to the immediate start intervention groups (Mindfulness or Physical Activity eHealth) will complete online questionnaires at pre-intervention (Week 0), during-intervention, post-intervention (Week 4), 4 weeks post intervention (Week 8) and at a three month follow-up (Week 16). The delayed start wait group will be provided access to their choice of either the Physical Activity eHealth or Mindfulness eHealth program following the Week 8 assessment phase. Therefore participants allocated to the delayed start wait group will complete pre-intervention (Week 0), during-wait intervention, post-wait intervention (Week 4), 4 weeks post-wait intervention (Week 8) and a post intervention assessment once they have completed a ehealth program (Week 12). All participants will also be asked to meet with the researchers on two occasions (Week 0 and Week 8) to undertake three brief computerised cognitive tests (15 minutes), have their resting heart rate variability measured (10 minutes) and to provide a salivary cortisol and blood sample.

Perhexiline is the study drug that is being developed by Heart Metabolics, Ltd to potentially treat hypertrophic cardiomyopathy (HCM). HCM is a primary disease of the myocardium (the muscle of the heart) in which a portion of the myocardium is hypertrophied (thickened) without any obvious cause. The purpose of this study is to evaluate the effects of Perhexiline on heart conduction (the electrical activity of the heart) as compared to placebo (a tablet that will be made to look identical to the real drug but has no active ingredient) in healthy adult male and female volunteers. Moxifloxacin, also known as Avelox Registered Trademark', is a compound designed as an antibiotic that is indicated for the treatment of adults with infections. Moxifloxacin is known to have minor effects on heart conduction.

Diagnostic and therapeutic procedures performed in interventional radiology can provoke anxiety and may be painful. Mild sedation with analgesia is administered by the interventional radiologist to calm patient anxiety, reduce unwanted movements and alleviate patient discomfort. Central line placements are common, (including Hickman line placement, tunnelled dialysis catheter placement, injectable port implantation) and intravenous sedation would typically be used for these procedures. The most commonly used drug for sedation in radiology is midazolam, a benzodiazepine. Midazolam has a short half-life of 2-6 hrs, but very powerful anxiolytic (anti-anxiety), amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative actions. It is administered at 1 milligram per dose to the desired response, has a 2 minute onset time and duration of 45 to 60 minutes. The most common analgesic used is fentanyl, a short acting opioid that is administered at an incremental dose of 25 micrograms and repeated every 5 minutes to a maximum dose of 100 micrograms. Its onset time is 2-3 minutes and it has a duration time of 30-60 minutes. Midazolam and fentanyl are usually administered concurrently, with 1 milligram midazolam and 25 micrograms fentanyl being the standard single dose. Multiple doses are titrated carefully to achieve and maintain adequate sedation and alleviation of anxiety, while preserving cardio-respiratory function, protective reflexes and the ability to respond appropriately to verbal and/or tactile stimulation. Doses are given incrementally, often starting with a double dose with at least 5 minutes interval before the next dose to allow evaluation of drug effect. Oxygen saturation, blood pressure, heart rate, and respiratory rate are monitored continuously and documented every 10 minutes. Neurological response is also monitored continuously by observing the patients response to command or conversation. Reversal "antidote" agents for these medications are flumazenil and naloxone respectively. The current practice is that the radiologist takes a history from the patient, looking for patient factors that may affect the safety and practice of sedation. These would include patient size, age, prior cardiac and respiratory disease, diabetes, renal failure, obesity, allergies, drug interactions, previous anaesthetic history, and airway issues. There will be assessment of the patient’s level of anxiety and expectation of procedural discomfort. The radiologist will then decide on the appropriateness of midazolam/fentanyl sedation, and choose an initial dose. As the procedure starts, the level of sedation is assessed, and if needed, further aliquots of midazolam/fentanyl are administered at the radiologists’ discretion. Our hypothesis is that this practice has problems in that there is a fear of the effects of oversedation (eg low blood pressure or slower respiratory rate), and this results in many patients being undersedated. The patient may be apprehensive to ask for more sedation and thus their overall experience of the procedure is suboptimal. Based on prior evidence in the literature in other medical settings, we believe that by giving the control of sedation to the patient (within a safe dose and lockout period), that the patient is more likely to seek sedation when required and hence will be at less risk of undersedation. We expect that this will lead to an overall greater experience for the patient. The medical procedure being performed (ie insertion of a tunnelled central line) will not be affected by this study.