ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31097 results sorted by trial registration date.
  • Mallet and Extension Relative Motion Splinting Trial

    The primary purpose of this study is to improve the healing of an injury to the extensor tendon of the finger known as ‘mallet finger’ by improved splinting. The disorder is caused by disruption of the extensor tendon to the most distal bone of the finger, resulting in an inability to fully straighten the finger. The current standard care for mallet finger injuries uses a splint that statically immobilises the most distal finger joint (DIPJ) in extension. However, in many patients the tendon heals slightly long, ending up with them losing the ability to fully extend their finger, known as a lag. Therefore, we propose using an additional splint that attaches to the adjacent (uninjured) fingers just beyond the knuckles and lifts the injured finger up slightly, known as an extension relative motion splint (ERMS). This results in the injured finger adopting a slightly flexed posture that relaxes the extensor tendon. We hypothesise that this will result in improved healing of the extensor tendon and therefore a reduced risk of lag. Importantly, the uninjured joints can still be fully straightened whilst wearing the ERMS, to prevent them becoming contracted in one position. This project will randomise around 60 patients to have either one (standard) or two (standard and ERMS) moulded plastic splints. The patients will also be stratified according to whether or not they have a small associated fracture. Splinting will be for eight weeks, with an additional two weeks if there is a lag noted after 8 weeks. The primary outcome will be extensor lag measured at two weeks after ceasing full time splinting. Secondary outcomes will be patient satisfaction, active range of motion (AROM) at the DIPJ, change in AROM at the proximal finger joint, total AROM of the finger, and complications.

  • Probiotic use and post-operative recovery following appendicectomy in children.

    The study aims to determine the health benefits of oral probiotics in improving the post-operative recovery following appendicectomy for acute appendicitis. Children with appendicitis will randomly allocated to receive probiotics or placebo for 1 month following appendicectomy. We will collect information regarding post-operative recovery (e.g. return to normal physical activities, number of bowel actions, etc.) to confirm if probiotics might be beneficial following surgery and provide a quicker recovery.

  • A Double-Blind, Randomized, Parallel, Controlled, Study to Compare Pharmacokinetics and Pharmacodynamics of BP13 (filgrastim) with EU-approved Neupogen® in Healthy Male Adult Subjects

    The purpose of this study is to compare the pharmacokinetics (what the body does to a drug), Pharmacodynamics (effect of drugs on the body), immunogenicity (ability to provoke an immune response) and safety of BP13 with Neupogen in healthy males. Who is it for? Healthy male aged 18 to 55 years. Study details All participants in this study will undergo treatment utilizing a double-blind, randomized, parallel, controlled study design. The total study duration for each subject is expected to be approximately 15 days (excluding the 28-day screening period). This drug is recommended for use in cancer patients undergoing chemotherapy, to reduce the incidence of infection. All participants will undergo regular blood tests and safety assessments throughout the study, in order to evaluate how the body responds to the drug. We hope that BP13 (filgrastim) will be comparable to Neupogen, warranting further investigational trials to evaluate its efficacy in cancer patients.

  • Parental and Healthcare Professional Concern in the Diagnosis of Paediatric Sepsis

    The primary purpose of this study is to determine if the level of concern of parents and healthcare workers, within the emergency setting, can help improve diagnostic accuracy for paediatric sepsis.

  • REscuing bone marrow function in patients with aplaStic anaEmia and bone marrow faiLure post allogEneiC Transplantation (RESELECT) Phase I/II single arm with historical control study assessing the efficacy and safety of Atorvastatin and N-Acetyl Cysteine in the treatment of Poor Graft Function post allogeneic transplantation and relapsed/refractory aplastic anaemia

    Allogeneic Stem Cell transplant (alloSCT) is a curative procedure for many blood disorders and involves the transplantation of donor blood cells into a compatible recipient. Engraftment is a key milestone of success of alloSCT and is measured by standard blood tests to ensure normal levels of blood cells as well as a specialised blood test to confirm this blood is being produced by donor tissue. Poor graft function (PGF) is a significant complication of alloSCT and results in poor blood cell production by engrafted donor tissue. Aplastic anaemia(AA) is an autoimmune disease that results in the body's own immune cells attacking the bone marrow (the organ that produces blood cells) resulting in decreased production of blood cells. The mechanisms leading to PGF and AA are similar. There is evidence that the bone marrow microenvironment, the ecosystem in which blood cells reside, is abnormal in both PGF and AA. Atorvastatin is an old drug that has been used to treat high cholestrol and N-acetyl-cysteine (NAC) has been used as an antioxidant to treat paracetamol overdose. There is evidence that atorvastatin and NAC may be able to reverse this microenvironment dysfunction in PGF and AA. This study is aimed at testing the efficacy and safety of atorvastatin and NAC in the treatment of PGF and relapsed/refractory Aplastic anaemia.

  • A cluster randomised controlled trial of the impact of a multi-strategy behavioural intervention on the nutritional quality of secondary school student food purchases from online canteens.

    The aim of this study is to assess the effectiveness of integrating consumer behaviour strategies (including menu labelling, item positioning, tailored feedback & prompts) into an online canteen ordering system, to improve the nutritional quality of foods purchased by secondary school students via online canteens. This study will employ a clustered randomised controlled design. Ten NSW secondary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed via between group differences in the proportion of online orders classified as ‘Everyday’, ‘Occasional’ or ‘Should Not Be Sold’ according to the NSW Healthy School Canteen Strategy, using purchase data automatically recorded by the online ordering system at baseline (the 2-month period prior to intervention commencement) and follow up (the 2-month period immediately post-intervention commencement).

  • A randomised controlled single blinded multicentre trial of polyethylene glycol sealant to the staple line vs staple line alone in distal pancreatectomy.

    Distal pancreatectomy is a surgical procedure commonly used to remove tumours in the body and tail of the pancreas. Postoperative pancreatic fistula formation, where fluid leaks from the remaining pancreas into the abdomen, is the most common and significant surgical complication after this surgery. This can lead to further complications such as intra-abdominal abscess, bleeding, sepsis, and delayed emptying of the stomach. Different techniques have been tried to reduce the rate of POPF. The most successful to date is the use of staples to close the cut edge of the pancreas but the rate of fistula formation continues to be clinically significant. Polyethylene glycol sealants have been successfully used in lung resection surgery to stop air leaks. This type of sealant has not been tested in pancreatic surgery. This study will examine if a polyethylene glycol sealant reduces the rate of postoperative pancreatic fistula formation when used in conjunction with stapling to seal the pancreas.

  • A Telehealth Cancer-Related Fatigue Clinic Model for Cancer Survivors: A Pilot Randomised Controlled Trial (The T-CRF Trial)

  • Outback Quit Pack: A cancer risk reduction trial for Rural, Regional, and Remote Smokers in New South Wales

    The purpose of this study is to determine if the Outback Quit Pack, an information and pharmacological support pack, for those who are trying to quit smoking, is feasible, effective and acceptable to participants. Who is it for? You may be eligible for this study if you are an adult residing in rural, regional and remote areas of New South Wales who is trying to quit smoking. Study details Participants will be randomly allocated to either: Arm A: the Outback Quit Pack intervention, and receive nicotine patches, nicotine gum, nicotine lozenge counselling and self-help materials; or, Arm B: a minimal support group which receives an information sheet about support for quitting smoking. Participants will complete a survey after the 12-week program to assess their tobacco smoking. If feasible, the Outback Quit Pack may become a model for cancer risk reduction intervention for other health risk behaviours.

  • Effect of topical coconut oil on infection rates in extremely premature infants

    Late-onset sepsis (bloodstream infection) remains one of the most common complications of extremely early birth (more than 3 months before the due date). Skin condition in preterm infants deteriorates quickly after birth and the majority of bloodstream infections are caused by bacteria that reside on the skin. At present there is no available skin care product with proven benefit on skin condition and rates of infection. In this new trial, Neonatal Intensive Care Units of the Australia and New Zealand Neonatal Network will be randomly allocated to either using topical coconut oil or their current standard of skin care for all infants born extremely early to determine if coconut oil may reduce the rate of bloodstream infections. The findings of this trial could be readily translated into clinical practice.

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