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This Phase I clinical trial will compare the bioavailability of dihydroergotamine mesylate (DHE) following a single dose administration of INP104 (DHE administered by I123 Precision Olfactory Delivery (POD TM) Device nasal spray to that of D.H.E. 45 for Injection (intravenous [IV]) and Migranal nasal spray in healthy adult subjects. It is hypothesized that INP104 will address the current variability in nasal administration and give more reproducible dose delivery compared to Migranal nasal spray. Blood concentrations of all three investigational products will be compared for 48 hours following dosing. The safety and tolerability of INP104 will be monitored throughout the study. INP104 has been developed for the treatment of acute migraine headache. The device in which the drug will be delivered has been designed to deliver the medication to the upper nasal cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the dose being swallowed. Approximately 36 participants in general good health (equal ratio of males and females desired) will be enrolled and will be allocated to receive 3 treatments in a randomised sequence. They will receive a single dose of INP104 via the POD device, a single dose of DHE via intravenous injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where no treatment will be administered for at least 7 days in between each treatment. Participants are required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be in the study for up to 43 days.

The primary objective of this study is to demonstrate that twice daily application of a ceramide dominant emollient reduces the risk of eczema and food allergy, when compared to standard skin management. Secondary objectives are to determine if twice daily application of a ceramide dominant emollient reduces the risk of infants developing allergic sensitisation (as measured by skin prick test); to determine if twice daily application of a ceramide dominant emollient improves infant skin barrier function; to determine the level of parental compliance with a program to build infant skin barrier function; to confirm that a ceramide dominant emollient does not cause adverse effects in infants; to determine the level of compliance required to demonstrate an improvement in infant skin barrier function and to determine if twice daily application of a ceramide dominant emollient influences infant skinmicrobial colonisation, or skin lipid profile. This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and food allergy in high risk infants. A total of 760 participants with a first degree family history of allergic disease (asthma, eczema, allergic rhinitis or food allergy) will be recruited (380 each group) from maternity wards of seven hospitals. Treatment will be from birth until six months, with a six week, six month and twelve month follow-up. An initial assessment will be performed at baseline which incorporates three surveys, a skin assessment, diary card (which is to be completed weekly and measures compliance), a breast milk sample, guthrie card and tape stripping. The six week assessment entails a skin assessment, survey, compliance check, breast milk sample, tape stripping and guthrie card, while the six month assessment entails a survey. Primary outcomes are assessed at the 12 month follow up where in addition to the aforementioned items, a saliva sample will also be taken and skin prick testing and food challenges will be performed when children have a positive SPT to one or more foods. The primary and secondary outcomes are assessed again at the 4-year follow-up where in addition to the aforementioned items oscillometry testing will be performed to measured lung function.

Tonsillectomy is one of the most frequently performed surgical procedures in kids, with approximately ½ million/annum in US, mainly performed as day cases. In Australia, in 2012/13, there were 38575 admissions due to tonsillectomies, representing 724 admissions per 100000 people aged 17 years and under. Sleep disordered breathing (SDB), rather than infection has become the primary reason for tonsillectomy. SDB is defined as an abnormal respiratory pattern during sleep. It presents as a spectrum from simple snoring to severe obstructive sleep apnoea (OSA). The incidence of peri-operative respiratory complications is 10 times higher for children with OSA compared to those without OSA. Perioperative respiratory adverse events necessitating a medical intervention occur in about 10% of children undergoing adenotonsillectomy, 60% of these occur in the immediate post-operative period. However, desaturations can continue for an unpredictable further period of time in a substantial number of children following tonsillectomy. Currently the gold standard test for assessing presence and severity of OSA/SDB is polysomnography. It is however, a high cost, labour intensive test and is associated with long waiting lists and therefore rarely used in these children. There has been some research on using preoperative oximetry to stratify a patient’s need for more or less observation (e.g. ambulatory surgery, ward special, ICU). This study will enrol patients scheduled for tonsillectomy and assess their baseline sleep quality via a questionnaire, overnight pulse oximetry and awake-sleep pattern using novel portable activity monitoring devices (ActiCal). These will be performed in the patient’s home prior to surgery. Then any breathing problems within 24 hours of surgery will be recorded. We will then examine if these problems can be predicted from our preoperative measures. If successful this would allow better stratification of risk of patients for tonsillectomy allowing them to get the most appropriate level of post-operative observation required for each individual child. We will then follow the patients with the same monitors for up to 14 nights after surgery to determine the extent/course of improvement provided by surgery to blood oxygen levels and the impact on sleeping pattern. This will also allow better characterisation of the course of a patient’s night time oxygen levels in the days after surgery, and allow examination of the impact of strong pain killers given around surgery on this parameter. This would help clinicians make more informed decisions in relation to length of stay after surgery. Currently there is very little data to inform these decisions or care pathways. Additionally the activity monitors will help us track the child’s return to normal physical activity which has not previously been assessed objectively. This would allow more evidenced based information to be conveyed to parents about typical recovery after tonsillectomy surgery.

This study is a randomised cross-over trial assessing the efficacy of the addition of hyaluronic acid (HA) to levobupivicane in pudendal nerve blockade as a treatment for pudendal neuralgia. Previous studies have demonstrated that application of local anaesthetic along the path of the pudendal nerve results in the onset of numbness and a reduction in symptoms. This result is however, most often limited from a few hours to a few days . Recent studies have suggested that the addition of hyaluronic acid to the local anaesthetic blockade can result in improved and prolonged analgesia. AIM; to determine whether the addition of hyaluronic acid to local anaesthetic results in improved post-blockade pain scores, change in medication use and change in pain interference in daily activities. MATERIALS AND METHODS; This is a triple-blind randomised cross-over study in which each participant will receive two pudendal nerve blocks 3 months apart one of which will contain hyaluronic acid + levobupivicaine and the other placebo + levobupivicaine. Assessment of symptoms and effect on function will be via use of The Brief pain inventory – short form. We will also assess analgesia use pre and post blockade. RESULTS; Differences in pain and function scores pre and post blockade will be assessed using the students t-test with adjustments made for multiple comparisons. We will also use descriptive statistics to review any changes in medication use. CONCLUSION; if our null hypothesis is true we would expect to see no difference between HA acid and placebo. However, if the HA is effective then we would hope to see improved pain scores, decreased pain interference with life and potentially decreased medication use.

The end goal of this study is to provide Army with an evidence-based resilience training strategy that can be sustainably integrated into existing training frameworks. The objective of the evaluation is to determine whether RMC Cadets who undergo Mental Fitness Training report reductions in: (1) anxiety, (2) depression, (3) perceived stress, and (4) perceived stressor frequency in comparison to the BattleSMART group. Moreover, we will determine whether Cadets also report a related increase in: (1) adaptive stressor appraisal, (2) performance outcomes, and (3) subjective wellbeing compared to RMC Cadets receiving a revision of the BattleSMART program. It is hypothesised that: H1: Compared with Cadets receiving the BattleSMART comparison condition, Cadets who received Mental Fitness Training would show improvements between initial follow-up and longer-term follow-up in: (a) anxiety symptoms; (b) depression symptoms; (c) perceived stress and (d) perceived stressor frequency. In line with a resilience framework, we anticipate that these changes would be evident from initial follow-up and longer-term follow-up because this period is when training stressors temporarily subside after reaching a crescendo. H2: We anticipate that self-reflection quality (Mental Fitness Training group only) will determine the degree of change over time. Specifically, greater self-reflection quality would be related to a greater decline in: (a) anxiety symptoms; (b) depression symptoms; (c) perceived stress and (d) perceived stressor frequency between initial follow-up and longer-term follow-up reflecting greater return to normal functioning. H3: It is anticipated that compared to the BattleSMART group, the Mental Fitness Training group will report and demonstrate: (1) increases coping self-efficacy; (2) enhanced performance outcomes; (3) increased use of professional support services; and (4) increased perception of stressors as challenges rather than threats.

This research project is testing the safety, tolerability, immunology (how the study drug affects the immune system), pharmacokinetics (how the body effects the study drug) and pharmacodynamics (how the study drug effects the body) of single and multiple doses of a new drug called ACP-014 when given as a subcutaneous (into the skin) injection. Ascendis Pharma is developing the drug ACP-014 for the potential his study will run in 3 Parts: • Single Ascending Dose (SAD) Phase: will assess the effect of a single ascending dose of ACP-014 or placebo when administered as a subcutaneous (under the skin) injection abdomen. • Cross Over (Cohort X) Phase: will assess the effect of a single subcutaneous dose of ACP-014 in their abdomen and thigh. This phase of the study involves all participants receiving both study treatments in a particular sequence. • Multiple Ascending Dose (MAD) Phase: will assess the effect of multiple ascending daily doses of ACP-014 when administered as subcutaneous injections into the abdomen. Up to 80 participants will be enrolled in up to 8 cohorts (groups) with up to 10 participants in each cohort. In each cohort, 8 participants will receive the active drug (ACP-014) and 2 will receive the placebo. This study is a dose escalation study and total participation consists of 35 days.

Our goal is to produce automated continuous, real time ECG interpretation with artificial intelligence (AI), utilising our wristwatch-sized ECG machine. Our initial AI system will be focused on automated detection of atrial fibrillation. We have already developed a prototype ECG detection device and trained our initial AI system, which has undergone validation testing in a clinical environment. This study is intended to further develop our ECG system to be suitable for more widespread use.

Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor post-operative outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes. This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above. A metric for stress hyperglycaemia has been developed at FMC - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months. Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose. Patients undergoing CABG surgery require mandatory post-op observation in the ICU setting, and commonly require intervention for glucose management. There is some conjecture that the commonly used glucose control range is no appropriate for all patients. We aim to determine the glucose control range that is associated with the best post-op outcomes.

Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor post-operative outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes. This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above. A metric for stress hyperglycaemia has been developed at FMC - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months. Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose. This initial work was in a broad general hospital population. This study aims to determine the clinical applicability of the Stress Hyperglycaemia Ratio to post-op outcomes for patients undergoing CABG surgery. This group requires mandatory post-op observation in the ICU setting, and commonly require intervention for glucose management. We aim to determine if the Stress Hyperglycaemia Ratio is more strongly associated with adverse post-op outcomes in this group than glucose alone.

The research study will investigate the effect a common blood pressure tablet has on patients undergoing elective surgery. Participants will be randomly assigned to continue or cease their angiotensin converting enzyme inhibitors and angiotensin receptor blockers at least one day before their operation. Researchers will collate and analyze routinely collected patient information to detect if continuation or cessation results in better outcomes for the participants.