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The primary aims of this first-in-human study are to investigate the safety and tolerability of CBP-201. The secondary aim is to investigate the pharmacokinetics and pharmacodynamics of CBP-201 related to contact pathway activation. Up to 40 participants will be recruited to five Cohorts of 8 participants each in this double-blind study. Participants in Cohort 1 will be randomized to receive an subcutaneous injection of 75 mg of CBP-201 (6 participants) or placebo (2 participants). Two sentinel participants (one allocated to placebo and one allocated to CBP-201) will be dosed initially. If dosing of these sentinel participant proceeds without clinically-significant adverse events (AEs) over a defined period (as adjudicated by a Safety Monitoring Committee), the remaining participants will be dosed. Cohorts 2-4 will be analogous to Cohort 1 in terms of study procedures. The dose level will be established following assessment of safety and PK data of the preceding cohorts but is planned to increase to 150mg (cohort 2), 300mg (cohort 3) or 600mg (cohort 4). An additional cohort (5) will receive 300mg of CBP-201 or placebo via IV injection instead of subcutaneous injection but all other study procedures will be the same of previous cohorts.

Inclusion body myositis (IBM) is the most commonly acquired skeletal muscle disease associated with aging. The cause is not known, and it affects men more often than women. The condition is progressive, resulting in muscle weakness and wasting including the muscles used for breathing and swallowing. There is no known cure and the impact on health-related quality of life is considerable. Exercise helps to prevent loss of muscle mass and maintain strength; and in healthy men the combination of testosterone and exercise has been shown to further increase muscle strength, performance and physical activity overall. In this study we propose to examine whether testosterone treatment, used in combination with exercise improves muscle strength and rates of physical activity in men affected by IBM. The study will be done in the context of a double-blind, randomised, clinical trial. The study investigators have expertise in neurology, endocrinology, immunology and physical sciences. In March 2019, a 12 month Open Label Extension study was approved.

The study aims to find out if giving local anaesthetic (a medication that numbs an area of the body) into the bloodstream and via small plastic tube placed during surgery into the abdomen will improve part of the immune system in patients undergoing surgery for colorectal cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and are scheduled to undergo a keyhole operation (laparoscopic surgery) for colorectal cancer to remove a section of the bowel (also known as colon). Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will receive a local anaesthetic drug called Lignocaine infused directly into the bloodstream and also into the abdomen using a small plastic tube placed during surgery. Lignocaine is very commonly used to numb areas of skin or muscle before or during an operation. Importantly it has also been shown to help the natural killer cells (NKC) to destroy cancer cells. NKCs are a special type of white blood cell which recognises and destroys cancer cells. Participants in the other group will instead be given a placebo (salty water). Participants will not know which group they are in. All participants will be monitored for up to 30 days post-surgery in order to evaluate safety and also to see if the natural killer cells in the blood work better after lignocaine is used.

Study Aims This study aims to assess the impact of a telehealth-delivered cognitive and exercise training (CET) program versus lifestyle guidance on cognition in breast cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 21 years or older, have been diagnosed with Stage I-III breast cancer and have received chemotherapy treatment. Study details Participants will be randomly assigned (by chance) to receive either the cognitive & exercise training (CET) program or lifestyle guidance program. Those in the CET group will be asked to undertake cognitive and exercise training four times per week (4 hours in total). The lifestyle guidance group will be provided with evidence-based recommendations regarding cognitive and exercise training. All participants will undergo a series of diagnostic and clinical tests, including blood tests, fitness and cognitive tests, sleep tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of breast cancer patients presenting with detrimental cognitive changes as a result of chemotherapy, and this research may lead to better quality of life for patients.

This controlled trial aims to determine the feasibility of virtual reality as a non-pharmacological approach to improve mood states within Residential Aged Care. Specifically, we aim to determine the effects of virtual reality on: • Mood as measured through the use of observer and participant ratings of emotional response, apathy, and group engagement • Agitation, anxiety, and depression levels • Psychotropic prescribing and the administration of pro re nata (PRN) medications We hypothesize that group based VR sessions will increase resident engagement and social interactions, reduce agitation, anxiety and apathy, and improve mental wellbeing. Based on the finding of the pilot study we have conducted we anticipate results that have the potential to change the landscape of leisure and lifestyle activities conducted in RAC homes, and to supplement our current knowledge of non-pharmacological approaches for RAC resident mental wellbeing.

In this randomised, double-blind, placebo-controlled study, 160 adults who are currently taking an antidepressant medication but continue to suffer from depressive symptoms (mild-to-moderate severity) will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 8 weeks. Participants recruited for this study will be on a stable medication dose for at least 8-weeks and will have no plan to change the dosage or medication type during the study. We will assess change in depressive symptoms via a validated clinician-rated instrument and a self-report measure (to be completed every 4 weeks). We will also assess whether saffron is able to reduce some of the side effects associated with antidepressant drug use (in 2 studies it has previously shown to reduce sexually-related side effects).

Currently, we use a stethoscope to listen to the bowel sounds during examination of the newborn baby. We have now a simple sensor the size of a 20 cent coin, which when placed on the surface of your baby’s abdomen, can pick up bowel sounds without disturbing the baby. Purpose of this study We want to check the usefulness of the new method in picking up bowel sounds in newborn term babies and term sick babies.. What does this study involve? We would like your help with making a 10 minutes recording of bowel sounds in well babies – for 5 minutes before and 5 minutes after a feed in healthy well term and near term babies who are in the NICU. Having recordings of normal bowel sounds may allow us to use the bowel sounds sensor to help babies who are unwell. The bowel sounds sensor may allow us to detect early bowel problems in sick babies and also help us to decide the right time to start feeding in sick babies who are recovering.

Cold snare polypectomy (CSP) is a relatively recent development but has rapidly gained international acceptance as an effective and safe polypectomy technique. It is now the standard of care internationally for resection of small polyps (i.e. sized <10mm), and has become the standard of care for resection of intermediate-sized polyps (sized 10-19mm) at leading academic endoscopy centres. It has not yet been adopted at most other non-academic endoscopy centres for polyps in this intermediate size range. It is now known that “cold snares” (that don’t use electrocautery) are effective for polyp resection. Cold snares use a thin, stiff, monofilament wire to cut out the polyp, without the need for electrocautery. This is a big advance, as it is the electrocautery that is the main cause of post-polypectomy complications such as bowel perforation, serositis, post-polypectomy syndrome, post-procedure pain and post-polypectomy bleeding. Therefore, polypectomy using cold snare has the potential to significantly reduce the risk of complications following colonoscopy. While the evidence for the efficacy of cold snare polypectomy for resection of small polyps is established, rigorous data for intermediate-sized polyps is still limited. In our own practices, and in the setting of small, published retrospective studies, we have observed cold snare polypectomy to be very effective for intermediate-sized polyps as well. However, to establish robust evidence, a well-designed, prospective, multicentre, observational study is required. The primary aim of this prospective observational multicentre study is to measure the incomplete resection rate of intermediate-sized sessile polyps as determined by the histological examination of polypectomy site biopsies. The major secondary aims include to measure residual polyp rate during first surveillance colonoscopy, measurement of immediate and delayed complications. All patients undergoing elective colonoscopy at all participating academic centres will be screened to assess their eligibility into the study based on exclusion and inclusion criteria. During the colonoscopy procedure if a medium sized polyp (10-19 mm) is detected and excised using cold snare polypectomy technique will become the part of the study. Study data Study data from multiple sites will be entered into an encrypted, password protected web-based database. The study is a prospective audit of all new cases of CSP for one year with an additional follow up to review endoscopic findings during the first routine surveillance colonoscopy. At least fifteen leading endoscopy centres around Australia are expected to contribute to the study. 350 polypectomy cases are expected to be recruited during the study during the first year, another two to three years of follow up is required to obtain results of the surveillance colonoscopies.

In a previous small single centre study of twenty four children with new diagnosis CD, we confirmed symptoms based score alone (PCDAI) was unreliable, blood test (CRP) had moderate utility and stool biomarkers (FC) had the best individual utility in predicting endoscopic mucosal healing. We also demonstrated that combination of PCDAI less than10, CRP less than 5mg/dl and FC less than 500 µgram/gm has greater accuracy identifying mucosal healing (SES-CD equal to 0-2) following standard EEN or Steroid induction therapy with specificity of 85% and positive like hood ratio 5.3. The reliability of this composite score (PCDAI less than 10, CRP less than 5mg/dl and FC less than 500 µgram/gm) in this small pilot study needs further validation in a larger prospective multicentre cohort study. To overcome limitations of this pilot study, we also want to extend this study to include; children with established CD experiencing clinical relapse, those in clinical remission with raised surrogate biomarkers (CRP more than 5mg/L and/or FC more than 250 µgram /gm of stool) and confirming mucosal healing in those with normal surrogate markers (CRP less than 5mg/L and FC less than 250 µgram /gm of stool and no symptoms. Our hypothesis is that establishing reliability of this composite index in predicting endoscopic healing in this mixed sample population will be useful both as a discriminative tool (for distinguishing active (SES-CD equal to 3) vs. inactive inflammation (SES-CD equal to 0-2) and evaluative tool (for defining treatment success).

Australian men are recognised as hard-to-reach for the promotion of healthy lifestyles and disease prevention. Evidence suggests, however, that when gender-specific concerns and approaches frame program design and delivery, men tend to engage with weight management, physical activity (PA) and health promotion initiatives. Active Breed is a 12-week, gender-tailored men's health program targeting weight loss, physical activity, nutrition, mental health, and violence prevention. The program will be delivered through the Canterbury-Bankstown Bulldogs Rugby League club and will include weekly education and physical activity sessions held at the club's home stadium.