ANZCTR search results

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

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31212 results sorted by trial registration date.
  • Brief Psychodynamic Therapy for Functional Neurological Symptoms

    Adults diagnosed by a Neurologist with Functional Neurological Symptom Disorder with residual symptoms despite diagnosis and treatment as usual will be seen for four two hour sessions of psychodynamic therapy with a Psychiatrist incorporating a comprehensive psychiatric history and formulation followed by management recommendations. Family and carers will be invited to join the planning component of sessions. At the final session a personalised "farewell" letter will be given to participants and a medical letter will be sent to referring and other treating doctors incorporating managment recommendations. All participants will complete a questionnaire in person before each interview and again three months after the last session by phone. A clinician administered measure of dissociation will be completed in the first appointment and again at the final session and during the follow up phone call. A modified adult attachment interview (AAI) will be incorporated into the first session for subsequent analysis. The assessments will be voice recorded for later assessment of interaction and adjherence to protocol by a supervisor and will be transcribed externally for thematic analysis and production of a case series. The clinician will also complete a HoNOS measure about the patient after each session and after the follow up phone call three months after the last session.. Statistical analysis will compare measures from before the first and last sessions as well as the measures at follow-up. The therapeutic interactions and patient narratives will be explored for themes. Rates and nature of additional psychiatric diagnoses in this population will be described. Modified Adult Attachment Interviews and Shutdown Dissociation interviews will be scored to indicate rates of each attachment style and rates of dissociation. Collaborative formulations which are agreed upon with the participants will be used to produce a case series.

  • PRE-BIOTIC: Progressive Resistance Exercise- BIOTa and Inflammation in Crohn’s & colitis

    PRE-BIOTIC will be the world’s first randomised controlled trial (RCT) of anabolic exercise (high intensity PRT) for patients with active inflammatory bowel disease (IBD) who remain symptomatic despite robust medical treatment. Although current treatment is effective in controlling a number of their symptoms, there is a need for better options to prevent disease, increase response and sustain remission. Exercise is one potential complementary strategy to combat IBD and other diseases, and there is rapidly growing evidence that it may also positively and substantially affect the gut biome, and thus could play a role in both prevention and treatment of IBD. Among exercise modalities, the rationale for resistance training (PRT) in IBD is extremely strong, as it has many of the same benefits of aerobic exercise with regards to cardio-metabolic profile and inflammation, but in addition, due to its anabolic nature, provides unique benefits not seen with aerobic exercise, including increases in muscle strength and mass, bone density and appetite. An anabolic/anti-inflammatory intervention such as PRT is theoretically able to change the underlying pathophysiology of this condition, in addition to addressing important physical and psychological symptoms. The global impact and relief of suffering for these individuals and their loved ones would be unprecedented.

  • Coronary and Peripheral Haemodynamic Studies of Angina with No Obstructive Coronary Artery Disease - association between invasive and non-invasive investigation modalities.

    About 20-30% of patients with angina have no obstructive coronary artery disease on coronary angiogram (NoCAD). Despite no significant obstructive coronary artery disease, most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Comprehensive invasive coronary haemodynamic studies at the time of diagnostic coronary angiogram will provide important diagnostic and prognostic implications for the management of coronary vasomotor disorder, but routine assessment is difficult. The hyperaemic microvascular resistance (HMR) is a reliable but invasive measure to assess coronary microvascular function. The planned project will evaluate whether left ventricular contractile reserve (CR), measured with strain imaging on low dose dobutamine stress echocardiography (DSE), is a reliable non-invasive measure of coronary microvascular function.

  • Comparing the Kaufman Speech to Language Protocol to standard care

    Preliminary evidence now exists for the efficacy of the K-SLP approach. Recently, a case report was published which used a multimodal approach combining K-SLP with sign language and oral-motor therapy (Tierney, Pitterle, Kirtz, Nakhla, & Todorow, 2016). This was followed by two separate single case multiple-baseline within-subject experimental designs (SCED) on a total of 6 children (Gomez, McCabe, Purcell, & Jakielski, 2017; Gomez, McCabe, Purcell, & Jakielski, in press). The results of the two SCED studies has provided some positive results indicating feasibility and positive treatment outcomes. This research will continue to expand the evidence base for CAS treatment by completing a pilot randomized controlled trial (RCT) comparing the K-SLP approach to standard treatment. This research may also provide insight into what comprises standard treatment for CAS. This research is important as it provides speech-language pathologists with additional external evidence to ensure that they are providing an efficacious treatment approach for CAS, in accordance with their ethical obligation as allied health professionals.

  • Haem-Fit: Exercise and Wellness Program for Haematology Cancer patients

    The purpose of this research is to test an exercise and wellness program for haematology in-patients receiving cancer treatment. Who is it for? You may be eligible for this study if you are undergoing treatment for a haematological malignancy at the Calvary Mater Newcastle Hospital which requires you to be in hospital for at least 7 days. Study details Each participant will be assessed by a physiotherapist (face to face) and provided with a personalised exercise program (30-60 minutes duration of strength and balance + walking) tailored to be performed daily while in hospital. Each participant will also be given written information on diet, nutrition, and exercise. This study will help to determine adherence and satisfaction of patients and staff to a personalised exercise program while in hospital.

  • Impact of Pre and Post-operative Physiotherapy using a Digital Application on Clinical and Hospital Outcomes after Total Knee Arthroplasty

    The aim of the study is to determine the impact of pre and post-operative rehabilitation provided through a digital application on Clinical and Hospital Outcomes. Clinical outcome will assessed with patient reported outcome measures and knee range of motion. Hospital outcomes measured will include length of stay and inpatient and rehabilitation costs attributed to care after TKA. Patients who are selected for Total Knee Arthroplasty (TKA) and agree to participate in the study will be randomly assigned to a control or experimental group. The control group will be provided current standard care prior to and after their surgery. The experimental group will be provided a pre and post-operative rehabilitation program consisting of Physiotherapy exercises through a mobile electronic application. The program will be monitored and modified by one Physiotherapist. The experimental group will be able to contact the Physiotherapist via telephone or email at any point during the program to discuss their progress. Patients can choose to opt in and opt out of the digital rehabilitation program and will be included in the analysis on an intention to treat basis. Prior to surgery, patient reported outcome measures will be collected to determine the patient’s pre-operative state. After surgery, various patient reported outcomes measures will be collected at two weeks, six weeks and three months to assess patient satisfaction, self-perceived confidence, pain levels and return to function. Patient reported outcome measuress will be captured via a tablet, email and / or letter, based on patient preference. Patient range of motion will be collected pre-operatively and at six weeks post-operatively by the treating surgeon. Hospital data collected will include length of stay, decision for ongoing rehabilitation and complications, which are collected as part of the hospital record. The digital application collects data on patient compliance and reported pain levels whilst using the program. Analysis will be performed between the two groups to determine the impact of pre and post-operative digital rehabilitation on clinical and hospital outcomes after TKA surgery.

  • Improving speech pathologists' implementation of recommended practices in acute aphasia management: What works?

  • The ImPress study: Impact of a nurse-delivered intervention to identify primary care patients with hypertension and provide care directed at improving blood pressure

    This project will comprise of a randomised control trial (RCT). The hypothesis will be tested by randomly allocating participants into two groups; the ImPress intervention and a control group. Clinical differences between these groups will be assessed at 6 and 12 months follow-up. The primary goal of conducting this trial is to evaluate if the ImPress intervention is more effective than usual care in achieving optimal blood pressure control, medication adherence, behavioural risk factors and body mass index in general practice. Randomisation will occur at a practice level and data will be collected by the GPN at baseline, six and twelve months when patients attend the practice. A total sample of 200 patients across 20 practices will be sought. .Once Practices have been recruited, participating GPNs will conduct a structured electronic search of the practice medical record database to identify a list of eligible patients. Following the assessment visit and study enrollment, patients will attend three face to face GPN appointments and two telephone consultations throughout intervention. All consultations will be underpinned by a person centred approach with the GPN utilising motivational interviewing techniques and the 5 As’ to build rapport, set goals and offer support for self-management. While the aim of first GPN consultation is to record baseline BP, biometric measures and lifestyle risks, this initial encounter is an opportunity to build rapport and shared understanding. Subsequent visits will focus on individualised action planning in partnership with the patient, goal setting and feedback on progress. Templates to structure each nursing assessment will be uploaded to the practices computerised clinical files in Director or Best Practice. GPNs will be encouraged to collaborate with the participating GP(s) to share information around the nursing care being provided.

  • Monitoring vascular endothelial function by microdialysis in septic patients.

    Background: Sepsis and the systemic inflammatory response syndrome (SIRS) characterises up to 80% of critical illness in children. The fundamental pathophysiological features underpinning sepsis/septic shock (and SIRS) are changes to the vascular endothelium, which include:1) increased permeability to fluid and protein ("leaky") and, 2) increased activation ("sticky"). Therefore, monitoring the permeability of the vascular endothelium should inform clinicians about the stage and severity of sepsis and assist in clinical decision making regards fluid resuscitation and fluid balance management. Positive fluid balance i s a poor prognostic sign, but without clear science, opinion on fluid management in septic shock i s divided. We recently published data which confirms a direct role for Eph/ephrin signalling in endothelial leakage both in a mouse gut ischaemia/reperfusion injury model and in vitro in TNF-a induced vascular leakage in human umbilical venous endothelial cells. Hypotheses: That vascular endothelial function can be monitored in the intensive care unit by: (a) quantifying interstitial protein levels by microdialysis; and (b) measuring plasma levels of Eph/ephrins as endothelial activation markers. Aims: The aim of this project is to determine whether it is feasible to monitor the integrity of the vascular endothelium in critically-ill children by: a) using microdialysis to quantify interstitial protein levels; and (b) measuring plasma levels of Eph/ephrin proteins as endothelial activation biomarkers. Objectives: Our experiments are designed to improve monitoring of vascular endothelial activation and integrity, in order to guide rational fluid therapy and thereby, reduce ventilator bed days and lower mortality. Methods: In previous experiments in paediatric cardiac surgical patients, we have tested the feasibility of monitoring interstitial protein, fluid and cytokines. In these experiments, we will prospectively identify infants and children admitted to the paediatric intensive care unit (PICU) of Lady Cilento Children’s Hospital (LCCH) with sepsis/septic shock. Briefly, a microdialysis catheter (CMA60) will be inserted subcutaneously into the forearm of septic children (n = 100), and perfused with electrolyte solution and the dialysate collected for protein and cytokine determination. Serial routine blood tests will be analysed for biomarkers of endothelial activation. Approximately 100 infants and children are admitted annually with sepsis/septic shock to LCCH PICU, and are treated according to the paediatric Surviving Sepsis Guidelines. Control patients will be healthy children (n = 20) undergoing routine elective surgery at LCCH. Significance: We will introduce new diagnostic test to identify endothelial activation and a new tool (i.e. microdialysis) for monitoring vascular endothelial integrity. This may improve supportive care in the ICU and result in reduced ventilator days,

  • Examining the effect of combined induced diuresis with euvolemic fluid resuscitation on contrast-induced nephropathy

    Contrast-induced nephropathy is a relatively common complication for chronic kidney disease patients who are undergoing a procedure involving contrast dye, such as a coronary angiogram, affecting around 15% of patients in this population. This condition is characterised by kidney damage that occurs a short time, usually within three days, after having the contrast procedure. We know when a patient experiences contrast-induced nephropathy by observing the levels of creatinine, an enzyme produced by the kidney, in the blood. Creatinine levels are observable from a blood test. Rates of contrast-induced nephropathy can likely be reduced using hydration and forced diuresis (increased urine output using medication). Currently, we try to reduce the incidence of contrast-induced nephropathy by hydrating patients with intravenous saline before and after the angiogram. However, it may be possible to reduce the rates of contrast-induced nephropathy even further by implementing a new regime of hydration and forced diuresis. This research project aims to identify a new, effective method of reducing rates of contrast-induced nephropathy in patients with advanced stage III, IV and V chronic kidney disease who are having a coronary angiogram at the Lyell McEwin Hospital. Patients who consent to participate in this research project will be randomly sorted in one of two groups: the control group (patients who will receive the current usual standard of care, which involves receiving saline through an intravenous drip) and the experimental group (patients who will receive a dose of furosemide for forced diuresis and euvolemic fluid replacement). Participants will not be randomised into a group until they have provided written informed consent agreeing to participate. The primary outcome for this study is development of contrast-induced nephropathy. The secondary outcomes is length of hospitalisation.

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