ANZCTR search results

A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed herbal extract, Gynostemma pentaphyllum extract (ActivAMP) capsules on body composition in overweight men and women aged over 18 years.

Vitamin D has been increasingly recognised to play a part in immunomodulation and could have a possible role in IBD pathogenesis. However, only one randomised controlled trial has been conducted to date that used vitamin D supplementation as the main intervention in IBD paediatrics patients. This study investigated the efficacy and safety of vitamin D supplementations in vitamin D deficient pediatric IBD patient for 6 weeks. In this study patients were randomized into one of the three arms – 2000IU vitamin D2 daily, 2000IU vitmain D3 daily and 50,000IU vitamin D2 weekly. The outcomes were determined by 25OHD levels and secondary change in parathyroid hormone and adverse events. Another similar study was undertaken in adult Crohn’s disease patients and investigated the effects of vitamin D on improved disease course. This current proposal is unique in that it will compare vitamin D supplementation method (daily dosing vs a single high dose) in IBD, which has not previously been addressed in the literature. Further, the proposal will add to the literature in that there is a one year follow-up which will provide longer term observation of the effects of vitamin D supplementations in pediatric IBD. In addition this study will specifically address the question of whether additional vitamin D supplementation can improve disease activity in patients in a specifically defined Vitamin D sufficient group. In conclusion, vitamin D is generally well-tolerated and adverse effects in these clinical trials were mild and non-specific. None of the studies required withdrawal of subjects due to adverse events from vitamin D intake regardless of their 25OHD levels at the point of recruitment.

Movement quality has been described as an individual’s ability to perform a specific movement pattern in an optimal manner. Poor movement quality is typified by the inability to perform basic, or ‘fundamental’, movement tasks in a balanced and well-coordinated manner, which is underpinned by a disruption to the way muscles normally move and support joints during these movement tasks. Poor movement quality has been shown to significantly alter the loading of individual joints, reduce an individual’s ability to express strength and power, and limit the ability to complete movement tasks effectively. Conversely, good movement quality has been said to allow the safe and effective loading of joints, subsequently improving performance capabilities. The assessment of movement quality is therefore said to provide an indication of muscular dysfunction. We suggest that this information can then be used to design an appropriate exercise intervention targeting improvements in that dysfunction, and therefore improvements in movement quality. The proposed research will look to see whether a specific training intervention can yield improvements in movement quality and physical performance, and whether those improvements occur to a greater degree in comparison to a more traditional resistance training program. To achieve these aims, healthy adults (18-55 y) will undergo 1 of 2 interventions, either 1) an individualized exercise intervention guided by a movement quality assessment, or 2) a standard resistance training program in accordance to the ACSM guidelines. Each training protocol will involve 2 60 minute training sessions per week, for a duration of 8 weeks. Primary (movement quality score) and secondary (physical performance measures) outcome measures will be recorded at baseline, and at the completion of the 8 week intervention.

Chronic post surgical pain (CPSP) is a recognised and adverse outcome of many surgical procedures. It was first reported by Macrae and Davis and is defined as “pain persisting for at least two months duration following a surgical procedure”. Other causes for the pain and the possibility that the pain is from a pre-existing condition should be excluded before classifying the pain as CPSP. The prevalence of CPSP varies depending on the operation with higher rates observed after major thoracic surgery. In fact, patients undergoing thoracotomy have one of the greatest incidences of CPSP among all surgical procedures. The etiology of chronic post-thoracotomy pain is not understood fully. It is thought to result from potential intercostal nerve damage. As there is also a component of neuropathic pain, rather than inflammatory or nociceptive pain, central sensitisation is likely involved. Central sensitisation relies on N-methyl-D-aspartate (NMDA) receptor activation by excitatory neurotransmitters, such as glutamate and aspartate. Studies have shown that NMDA receptor antagonists, such as ketamine, can decrease CPSP. In theory, magnesium, which is a physiologic antagonist of NMDA receptors, should prevent central sensitisation and therefore reduce the incidence of CPSP. The aim of this study is to investigate the effects of intraoperative systemic magnesium on chronic postsurgical pain in patients undergoing thoracotomy. We propose to perform a single centre, prospective, double-blind, placebo-controlled study over the period of one year. Our hypothesis is that intra-operative systemic administration of magnesium will reduce the incidence of CPSP in patients undergoing thoracotomy. On the morning of surgery, block randomisation and sealed envelope method will be used to assign patients to one of the two groups: magnesium group or control group. The anaesthetist, surgeon, patient and those assessing outcomes will be blinded to the group assignment. A bolus dose of 50mg/kg of magnesium (magnesium sulfate) will be administered for 15 minutes immediately after induction and prior to skin incision, followed by infusion at 10mg/kg/hr. Patients in the control group will be administered the same volume of isotonic saline. Patients will be assessed on postoperative day 1 and 2 by a pain team (includes anaesthetist and pain nurse). A 0-10 point numeric rating scale (NRS) will be used to measure the degree of pain intensity. Higher scores indicate a higher degree of pain. Postoperative opioid consumption (24 hours and 48 hours) will also be recorded by converting to the equivalent dose of intravenous morphine. Patients will be assessed at 2 and 6 months post surgery. This will be done via a telephone call from a pain nurse. Patients reporting pain will be asked to present to a chronic pain clinic for assessment by an anaesthetist. All patients will be asked to complete a Medical Outcome Study 36-Item Short Form to assess health related quality of life.

The purpose of this clinical study is to evaluate a new, medical device called the TriCinch Coil System. This is an early phase study. This device is designed to treat patients suffering from tricuspid valve disease, It has not been approved by the Therapeutic Goods Administration (TGA) as a treatment for tricuspid valve regurgitation in Australia., The study is a multi-centre study, which means that up to 20 hospitals may be participating in this study. Implantation of the TriCinch Coil System will be attempted in up to 90 patients in this study. The goal of this clinical study is to evaluate the safety and performance of the TriCinch Coil System as a new method to treat leaking tricuspid valves which cause regurgitation (backflow of blood). Through the trial, information will be collected about the safety of the device, the success of placing the device, and its ability to reduce tricuspid regurgitation in a less invasive way for patients who have a high risk for undergoing open-heart surgery.

We will systematically assess the dose-response relationship between dietary fat and postprandial glycaemia in adults with type 1 diabetes. Optimal insulin bolusing algorithms for dietary fat will be derived through predictive modelling of the data and validated in adults with type 1 diabetes.

Background: The perioperative management of inpatients with diabetes is complex given carbohydrate intake and diabetes medication administration is altered. Suboptimal glycaemia in the perioperative period is well documented in the literature and is associated with increased morbidity and mortality. Aim: This study has been undertaken to determine the effect of a structured perioperative diabetes management plan (PDMP) on the appropriate recommendation, prescription, and administration of diabetes medications in the perioperative setting. A multidisciplinary team developed a novel structured PDMP endorsed by the Departments of Diabetes & Endocrinology and Pain & Anaesthesia. This observational study consisted of pre- and post-intervention periods, where pre-intervention care for perioperative diabetes management (non-structured) was audited for 4 months in 2016 and then re-audited for 4 months post-intervention in 2017 (structured plan). The primary outcome measure was documentation of appropriate recommendation, prescription and administration of diabetes medications in the perioperative setting according to the PDMP. Secondary outcome measures included glucose monitoring practice and glycaemic measures.

Premature babies admitted to neonatal intensive care units routinely undergo insertion of Peripherally Inserted Central venous Catheter (PICC) lines. It is a routine practice to perform x-ray to visualise the line tip to ensure it is in the ideal location. There is a varied practice in different NICUs in Australia, with some NICUs including Nepean Hospital NICU routinely injecting iodine containing dye to enhance visibility of PICC tip on x-ray. Exposure to high doses of iodine potentially increases the risk of hypothyroidism. Although the hypothyroidism due to iodine is likely transient, the effects during the critical period of neurological development in premature babies are potentially detrimental. There is paucity of evidence from randomised controlled study regarding the potential benefits and risks of using iodine-containing intravenous contrast in PICC insertions in premature babies. Thus, a study examining these outcomes in neonates with a placebo-controlled group is urgently required. Design: double-blind RCT. Infants eligible for 28 G PICC line will be enrolled following parental consent. Participants will be excluded from the PITFALLS study should they be: Infants with diagnosed thyroid disorders, Born to mothers with thyroid disease with potential to influence fetal thyroid function, Infants being given iodine iodine-containing contrast for some other reason, PICC inserted for the second /subsequent times in an infant who was already enrolled once, Anuria, Severe decompensated cardiac failure, Major lethal congenital/chromosomal anomalies. Babies will be randomised to receive the study agent(iodine dye or normal saline). Treatment allocation will be made by the method of stratified block randomisation using computer generated codes. Randomisation will be done by the clinical trials pharmacist, soon after successful insertion of the PICC. All others will be blinded. Treatment arm will receive 0.2 mL water-soluble, non-ionic, iodine-containing agent iohexol [Omnipaque (Trademark) 180, GE Healthcare, Little Chalfont, UK] through PICC line during X-ray. Control arm will receive 0.2 mL normal saline through PICC line during X-ray. Both these agents will be prepared in identical looking syringes in the Pharmacy and labelled as Study agent. Only the clinical trials pharmacist will be aware of the agent and will not be involved in the study. Researchers will be blinded as to what study agent is being administered to infants. Primary outcome: fT4 and TSH in controls and exposed. Primary end points: fT4 and TSH before PICC line insertion and subsequently on a weekly basis for next 4 weeks Secondary outcome: Clearly identifiable tip position of PICC on X-ray Secondary end point: Following successful insertion of PICC line Sample size: 60

Affecting 15% of youth, anxiety disorders are among the most prevalent psychiatric conditions in adolescents in Australia. These disorders are associated with significant morbidity and risk of suicide attempts and predict a range of psychiatric conditions later in life. Current treatments for anxiety disorders in this age group include cognitive-behaviour therapy and/or medication. However, only 50% of young patients with anxiety disorders show satisfactory improvements with these treatments. CBD is one of several components of the plant Cannabis sativa, Unlike other substances found in this plant, CBD is devoid of psychotropic effects (i.e. alterations in thinking and perception). There is evidence from experimental studies that CBD is safe in humans and effective in reducing anxiety in healthy volunteers (e.g. in simulated public speaking tasks). A systematic review of potential side effects in humans found that CBD was well tolerated across a wide dose range, up to 1500 mg/day. However, CBD has not been tested in young people with anxiety disorders. The aim of the present study is to produce preliminary evidence for the safety and anxiolytic effects of CBD in youth with anxiety disorders. This is a single-centre, 12-week open label trial of CBD in patients aged 12-25 (inclusive) who do not respond to current treatments for anxiety disorders. All patients included into the study will receive CBD on a fixed-flexible schedule, beginning with 200mg of CBD per day, which can be adjusted up to 800mg/day for participants who tolerate CBD. The study will be conducted at a headspace centre funded through the Commonwealth Government of Australia. The headspace centre is located in the suburb of Glenroy, Orygen manages the clinical governance of this headspace site. Headspace centres focus both on youth mental health and early intervention, young people may present for care with varying illness severity (e.g. sub-threshold through to severe disorder, and mild to severely impaired functioning) across a range of mental health problems

This study will investigate the safety and protective effect of a new, experimental malaria vaccine called the GAP Vaccine. This vaccine consists of human red blood cells collected from healthy donors by the Australian Red Cross Blood Service (ARCBS) that are infected with live, genetically attenuated or modified (GM) malaria parasites of the species Plasmodium falciparum. A gene that has been shown to be critical for the ability of P. falciparum blood stage parasites to cause illness has been removed by genetic manipulation to produce this so-called Genetically Attenuated Parasite (GAP). The use of this experimental vaccine has been reviewed by the Australian Government Office of the Gene Technology Regulator (OGTR) and approved for use in this study. It is expected that information obtained from this study will assist researchers to develop vaccines to control malaria in areas of the world where this disease continues to cause much illness and many deaths.