ANZCTR search results

This phase 1 study will determine the feasibility of a technique that adapts imaging to patients breathing for use in radiotherapy treatments of lung cancer patients. 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 primary or secondary lung cancer. Study details Participants will undergo normal radiotherapy treatment with the addition of 5 imaging scans at the time of radiotherapy treatment on 2 days of treatment.

What is this study? The purpose of this trial is to determine whether an infusion of intravenous iron results in improved exercise capacity or iron levels in the blood in patients undergoing surgery for colorectal cancer. Who is it for? You may be eligible for this study if you are an adult scheduled to undergo elective surgery for colorectal cancer who has iron deficiency. Study details All participants in this study will undergo an exercise stress test and undergo a blood test. Participants will then be randomly allocated to either receive an iron infusion or to receive placebo. A few weeks after their infusion, participants will undergo exercise testing again and complete a number of questionnaires. They will then have their surgery, and be interviewed 30 and 90 days after surgery to assess their recovery. It is hoped that this research will help determine whether iron infusions are beneficial for those with iron deficiency undergoing colorectal cancer, and will help improve physical and mental health during their cancer treatment.

This project will examine feasibility, mechanisms and efficacy of reactive step training as a fall-prevention strategy for people with MS. Forty-four people with MS will be recruited and assessed for balance recovery responses after slips and trips. Equipped with a full-body safety harness and foot protectors, People with MS will be exposed to a slip (70cm length) and a trip (14cm height) using our perturbation system. Twenty-two participants randomized to the intervention group will undertake 2 weekly individual 50-minute sessions (100 minutes in total) with each session focusing on balance recovery from a mix of trips and slips (week 2). Intensity of the training (e.g. gait speed, slip distance/speed and trip height) will be individualized and progressed according to participant ability. The control group will undertake 2 weekly 50-min session of sham training. Following training/sham, balance recovery response to slips and trips will be assessed. Kinematic, kinetic and physiological data will be collected to explore mechanisms for how people with MS improve their balance recovery responses.

This study aims to determine if delivering a standard dose of 1,200,000 units of benzathine penicillin G (BPG) into the fat layer rather than the recommended injection deep into the muscle will result in slower absorption of penicillin into the blood stream, and if the slower absorption results in the penicillin lasting longer above the level needed to prevent infection with the bacteria Streptococcus pyogenes that is responsible for the development of sore throats, skin sores, blood stream infections and the delayed autoimmune conditions of glomerulonephritis and rheumatic fever. The healthy male volunteers recruited for the study will received 2 injections of BPG 10-weeks apart; one into the fat layer of the buttock and the other into the muscles of the buttock. The injections will be guided by ultrasound scan. The volunteers will be randomised at first injection, i.e. they will not know or be able to tell if the injection was into muscle or the fat layer. Measuring the blood penicillin levels will be carried out using drops of blood from a finger prick which will be stored on filter paper -dry blood spots (DBS) and analysed together at the end of the study. Pain which is a recognised side effect of the injection into the muscles will assessed along with other unwanted side effects to determine the safety of injecting BPG into the fat layer. A follow up ultrasound of the injection site to look for any changes that are not visible externally will also be conducted to document what happens around the injection site. The objectives of this study will be assessed through DBS collection, pain scores associated with receiving study drug subcutaneously and intramuscularly, adverse events assessments, safety blood collection and physical examination.

An early start to upper limb rehabilitation after stroke is critical to optimize functional outcomes. Our project aims to test this theory by delivery high dose upper limb rehabilitation, consistent with 2-hours of therapy in the first 6-months post-stroke. We will randomise participants to one of two groups based on our current understanding of the timing and biology of recovery: Early will start <10 days post-stroke and continue up to 3-months post-stroke, and Late will start 3-months post-stroke and continue to 6-months post-stroke. This study will identify if high dose upper limb rehabilitation in the first 6-months shows promise, is feasible and safe. Our study adopts an innovative approach to how we undertake rehabilitation trials in stroke.

Neck of femur fractures are common, and generally treated with surgery. One of the most commonly used devices is an intra-medullary nail. There are numerous devices on the market, all with individual data, but there is very little comparative evidence. The majority of IM nail designs have a proximal ‘lag screw’ which can be used in either static or dynamic modes. There is no published evidence regarding which of these modes is better. We aim to recruit a total of 900 trauma patients aged over 60, who will be randomly assigned to receive one of 2 different nail designs, as well as 2 different locking modes. We will then follow the patients for a minimum of 6 months (or until the fracture has healed) and compare the clinical and functional outcomes of the groups. Of the 900 patients randomised into the study, the first 100 from each of the three randomised arms of the study will be selected for the observational element of the study involving gait analysis and activity monitoring. We hypothesize that there is a difference in clinical and functional outcomes between patients managed with the Gamma or INTERTAN nailing systems, in either locking mode.

Bruxism is a diurnal or nocturnal involuntary repetitive oral activity consisting of a non-functional rhythmic (or spasmodic) grinding, clenching or gnashing movement of the teeth. The diagnosis of bruxism is made by reports of tooth grinding/clenching during sleep, and one of either: abnormal tooth wear, sounds associated with bruxism, and/or jaw muscle discomfort. In adults, the prevalence of sleep bruxism is reported to be around 6% for the grinding type and 20% for the clenching type. Sleep bruxism has been linked to a variety of headache syndromes including temporomandibular disorders and chronic migraine. The ultimate goal of this research is to develop a more effective therapeutic intervention for bruxism sufferers with the use of BTA injection. Patients will mainly be recruited via the Botulinum Toxin Clinic at Royal Melbourne Hospital, as well as via referrals from dental orofacial pain specialists and neurologists. The study is a randomized, double blind, placebo-controlled trial with a crossover design; the study duration is 40weeks from the time of randomisation. All participants meeting eligibility criteria will be required to consent to approved study protocols.

This initial Phase 1 study will be conducted in normal healthy volunteers to gain an unconfounded understanding of the safety, tolerability, pharmacokinetics and pharmacodynamics of NJA-730. NJA-730 is being developed as an immunosuppressive drug for prevention and treatment of acute graft versus host disease associated with allogeneic hematopoietic stem cell transplant. This first-in-human, randomized, double-blind study will evaluate single ascending doses (SAD) and subsequently multiple ascending doses (MAD) of NJA-730/placebo. In the SAD part of the study, there will be 7 cohorts of 8 subjects each, with subjects in each cohort randomized in a 3:1 ratio to receive a single blinded dose of study drug i.e. NJA 730 or placebo, respectively (i.e. 6 subjects to receive NJA-730 and 2 subjects to receive placebo). In the MAD part of the study, there will be 3 cohorts of 8 subjects each with subjects in each cohort randomized in a 3:1 ratio to receive multiple blinded doses of NJA-730 or placebo, respectively, 3 times a week for a 1-week period (total 3 doses). A third part, an Extension Study (Part 3), will include approximately 24 healthy subjects divided into 4 cohorts of 6 subjects each. Subjects in each cohort will be randomized in a 2:1 ratio to receive a single blinded dose of study drug i.e. NJA-730 or placebo, respectively (i.e. 4 subjects to receive NJA-730 and 2 subjects to receive placebo).

Engaging patients in their own recovery after surgery is gaining momentum. A pilot study revealed that participants that received real-time recovery feedback (as a method of patient engagement) had better overall recovery at six weeks after surgery. Health-care providers must also kept informed of each individual patient’s recovery journey, as this alerts them to the patient with suboptimal recovery at the time that it is occurring, which may ultimately improve patient recovery in addition to what occurs when patients alone are informed. We will conduct a pilot trial investigating whether keeping both patients and their treating teams updated as to each patient’s recovery improve ultimate patient outcome. Recovery will be measured by the Postoperative Quality of Recovery Score (PostopQRS). Patients will be randomised to either receive no real-time feedback on their recovery assessment, or for there to be feedback to both patient and their treating health care team. This trial will determine the feasibility of providing both patients and their health teams with recovery data at the time of assessment, and will form the basis of a larger trial assessing the impact of each on the quality of a patient’s recovery journey.

To assess how long memantine HCl (50 mg) modified release prototype capsules stay in the stomach, as determined by imaging assessments (MRI or abdominal ultrasound) To evaluate the safety of memantine HCl modified release capsule formulations