ANZCTR search results

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

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31326 results sorted by trial registration date.
  • A study to compare 2 methods of inserting a pulmonary artery catheter in high risk cardiac surgical patients.

    The pulmonary artery catheter (PAC), also known as Swan-Ganz catheter, is a catheter that is inserted into the heart through a large vein in the neck or groin. It is used routinely in all patients undergoing cardiac surgery at Austin Hospital and allows direct, simultaneous measurement of pressures in the right atrium and right ventricle of the heart and pulmonary artery. In addition, it allows the calculation of important cardiac and respiratory physiological information. The PAC is also used to evaluate the effects of drugs on the cardiovascular system, assess and optimise fluid requirements, and manage complications of cardiac surgery such as myocardial infarction and heart failure. Complications from PAC insertion, although infrequent can be harmful. Mal-positioning can lead to arrhythmias, trauma to the pulmonary artery causing bleeding or thrombosis (clotting), infection and pneumothorax (puntured lung). The “standard” anaesthetic technique used to insert the PAC involves slow advancement of the catheter through the heart chambers. The catheter cannot be visualised as it is inserted, however as the catheter traverses the chambers of the heart (right atrium, right ventricle, and pulmonary artery), a characteristic change in cardiac pressure waveforms is seen in each chamber. This change in waveform allows the clinician to advance the catheter through the heart chambers until is its final positioning in the pulmonary artery. Because the catheter is inserted “blindly”, malposition of the catheter commonly occurs. Prolonged and repeated attempts at placing the PAC increase the risks of complications, particularly arrythmias (irregular heart beats), coiling and incorrect position. A technique commonly used by radiologists to guide catheter placement is the use of an X-ray image intensifier, or video flouroscopy. This allows the catheter to be visualised as it is being inserted through the heart chambers into its final position in the pulmonary artery. This technique is also commonly employed by anaesthetists to insert the PAC if it insertion by the standard "blind" method fails. The use of this technique to insert the PAC has never been studied any any scientific way, therefore we propose to study this X-ray technique on patients who are at increased risk from having a complication from PAC insertion. High-risk patients will include those with poor heart function, high pre-existing pulmonary artery pressures, or severe valvular heart disease. The use of the X-ray image intensifier involves X-ray exposure to the patient, but studies have shown that the risk is very minimal. We hypothesize that the use of the X-ray image intensifier to guide positioning of the PAC in high-risk patients undergoing cardiac surgery results in a shorter insertion time, with fewer attempts at insertion, and precise final positioning of the catheter in the pulmonary artery when compared to standard "blind" insertion. Primary end point: time taken in seconds to insert the PAC and final positioning of the PAC. Secondary end points: number of attempts at insertion and complications from insertion Final correct PAC positioning will be checked in theatre by trans-oesophageal echocardiography.

  • BL12: A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen

    The purpose of this study is to evaluate the effects of nab-paclitaxel compared to paclitaxel in patients with advanced urothelial cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or locally advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter, renal, pelvis), which has progressed on or after a platinum containing regimen. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive intravenous infusions of the chemotherapy drug Paclitaxel every 21 days. Participants in the other group will receive intravenous infusions of the chemotherapy drug Nab-Paclitaxel every 21 days. Treatment will continue indefinitely as long as you are responding and able to tolerate the drug well. All participants will be followed-up for up to 42 months in order to evaluate disease response, survival, toxicity, and quality of life. This research is being done because currently there is no effective treatment for advanced urothelial cancer that has progressed after prior chemotherapy.

  • The Donor Iron Replacement Study; a study of post-donation oral iron supplementation in female whole blood donors aged 18-45 years

    Approximately 220-250 mg of iron is lost with each 470 mL whole blood donation. This may result in progressive iron deficiency, ultimately leading to iron deficiency anaemia and deferral at a subsequent attendance. This study will investigate the use of oral iron supplments after whole blood donation in women aged 18-45 years who make two or more whole blood donations in a year. Participants will be followed for a period of 13 months and asked to take iron supplements after each whole blood donation during that time (up to a maximum of three occasions during the study period). Donors will be provided with the following options to assist with access to a suitable iron supplement: - having the iron supplied by a pharmacy (at no cost to the donor) or -if preferred by the donor purchasing a supplement at their own cost from any pharmacy from a list of suitable supplements provided by the Blood Service. Participants are not required to donate at certain timepoints. Participants will have ferritin samples collected at baseline and again 8-13 months (if applicable) after their recruitment visit. Participants will be asked to complete up to two surveys. The study will evaluate donor acceptance, efficacy and operational feasiblity.

  • Treating gut flora imbalances in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A pilot open label trial examining sex differences and psychological symptoms.

    An imbalance in gut microorganisms (referred to as gut dysbiosis) has been shown to be related to illness and some ME/CFS symptoms. More research is needed to understand the relationship between the gut and the brain to help with understanding possible causes and treatment options for individuals with ME/CFS. This project will examine how treatment to reduce high levels of Streptococcus bacteria (determined by Bioscreen stool analysis and indicative of abnormal gut functioning) is related to improvements in sleep, mood and cognitive symptoms in individuals with ME/CFS. There is also preliminary evidence to suggest sex differences in response to gut bacteria, thus, this research will examine if there is a sex-differential response to treatment. This is an open-label pilot study that will follow a baseline, treatment and follow-up protocol across 6 weeks. The baseline and follow-up phases are one week each. Possible improvement in sleep, mood and cognition will be measured by using a wrist device (Actiwatch), pen and pencil sleep and day diary, questionnaires and an individual cognitive testing session conducted at Victoria University. A second Bioscreen stool analysis will provide information about changes to gut flora.

  • Moisturisers in the treatment of foot xerosis in adults: Does cost equate to quality? A randomised, double-blinded clinical trial

    Trial to test difference in efficacy between an expensive moisturiser (Eulactol Heel Balm) & inexpensive moisturiser (Walker's Sorbolene) in the treatment of foot xerosis over a 4 weeks period. A secondary cost / benefit analysis will also be conducted to help determine 'value for money' of the interventions

  • A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal extract, Ageratum conyzoides, for the treatment of benign prostatic (BPH) symptoms in otherwise healthy males.

    The study aims to assess the effectiveness of Ageratum conyzoides on day-time and night time urinary frequency, symptoms of BPH, sleep quality and on SHBG and serum testosterone levels. Due to the ant-inflammatory and analgesic actions of Ageratum conyzoides, it has a long history of use traditionally in Caribbean folk medicine for a number of men’s health issues including prostate and urinary problems. The investigational product is a tablet - form herbal medicine, containing 250mg of Ageratum conyzoides extract. The daily dose will be 1 capsule per day taken with the evening meal, taken over 3 consecutive months.

  • A Multi-centre, Observational Study of Patients with Microangiopathic Thrombocytopenia by the Asian-Pacific Microangiopathic Thrombocytopenia (APMAT) Network

    This is an observational study of patients who have previously been diagnosed and treated for Microangiopathic Thrombocytopenia (MAT). The study will collect clinical and laboratory data to assess the disease characteristics, laboratory features, treatments, and clinical outcome.

  • Evaluating the ease of secretion clearance with flutter device compared to lung FLute in patients with Bronchiectasis

    Bronchiectasis is pathological condition with diverse aetiologies, characterised by and abnormal dilation of conducting airways due to repeated cycles of airway infection and inflammation ultimately resulting in airway and lung parenchyma destruction. This leads to an alteration of the ciliated epithelial lining and compromises mucus clearance. In the affected areas there is excess production of mucus, where the impaired clearance of secretions causes colonisation and infections. Airway clearance techniques are regarded as an integral component in the management of Bronchiectasis, as it clears blockages of conducting airway and improves pulmonary ventilation. Some patients with Bronchiectasis only have scant secretions and it is unclear if airway clearance assists them. A systemic review on patients with chronic obstructive pulmonary disease, has reported airway clearance techniques to be useful only in patients who produce greater than 25 ml (one tablespoon) of sputum per day. Mechanical forms of airway clearance such as Flutter (Scandipharm Inc, Birmingham, Alabama, USA) has shown to assist with secretion clearance. Flutter is a simple hand held pipe like device which produces oscillating positive pressure on exhalation, through repeated displacement of the steel ball within a cone. Oscillation frequency within 3-17 Hz range has been shown to facilitate mucociliary clearance. On patients with cystic fibrosis (CF), the flutter demonstrated a mean oscillation frequency of 11.3 Hz 5. This was close to this optimal frequency range to facilitate mucociliary clearance. This study also demonstrated the Flutter to have a peak expiratory flow rate (PEFR) / peak inspiratory flow rate (PIFR) ratio > 1.1, which is critical level required for annular flow of secretions towards the oropharynx. In addition flutter has shown to alter physical properties of mucus in patients with Bronchiectasis which further assist secretion clearance. Lung Flute (Medical Acoustics, LLC, Buffalo, NY USA) is new device which has shown to assist secretion clearance. It is relatively cheaper than the Flutter. The current literature on the efficacy of the lung Flute is limited. The lung flute is a hand held device shaped like a flute with a mouth piece and a reed inside it. When the user blows into the lung flute, it creates a specific low frequency sound. The manufactures claim that this sound generates 18-22Hz with an output of 110 to 115 dB using 2.5 cmH2O pressure. This sound wave, when generated at the mouth with mild exhalation, is thought to travel retrograde down the tracheobronchial tress and vibrates the tracheobronchial secretions. The manufactures claim that this sound vibrates the airways and thins the lung secretions, which facilitate mucocilary clearance. Lung flute has demonstrated to expectorate similar quantity of sputum as active cycle breathing technique in patients with Bronchiectasis. No study has been done to evaluate the effectiveness lung flute compared to the Flutter. Therefore, the aim of the current study was to evaluate if the lung flue was as effective as the flutter in secretion clearance. Method. Study design: After ethics approval participants were recruited from the Bronchiestasis clinic at CRGH and any person with bronchiectasis referred for physiotherapy from other respiratory specialists. During the study patients were seen as outpatients. Inclusion criteria: patients with productive non – cystic fibrosis (CF) bronchiectasis (diagnosed on high resolution computerised tomography) who would produce greater than 25ml of sputum per day. Exclusion criteria: current pneumothorax, untreated cor pulmonale, haemoptysis, patients with an exacerbation in the 4 weeks prior or during the study and if they were hospitalised during the study. Information sheet about the study would be given to the participant and informed consent would be obtained. Patients would attend two visits over a two week period standardised to the same time of day, with advice to withhold usual airway clearance 24 hours prior to attendance. At each session one of the following airway clearance techniques (flutter, lung flute) will be performed in random order determined by computer generated randomisation with concealed allocation. Patients would receive comprehensive standardised practical instructions in each airway clearance technique. Participants would be supervised throughout by an experienced senior respiratory physiotherapist to ensure each technique was performed in a standardised and optimal manner. Duration of treatment would be recorded. Baseline medications were not altered. Treatment techniques Both treatment techniques would be performed in sitting. Patients would be instructed to clear secretions without to swallow the sputum. Flutter The patient would be instructed to inhale deeply and hold his/her breath for 2-3 seconds. Then the patient would be instructed to place the mouthpiece of the device into the mouth and exhale into expiratory reserve volume (ie, slightly further than one would exhale during normal breath but not to residual volume). During expiration through the flutter, the patient would be instructed to tilt the flutter upwards and downwards by a few degrees to induce maximum oscillations within the chest wall. This would be repeated for 10 breaths, with the patient inhaling through the nose and exhaling through the flutter. Then the patients would be performing one or two mid to low volumes huffs combined with periods of breathing control (normal tidal breathing). If the patients felt that they had cleared the secretions to the oropharynx then they would be instructed to do a high volume huff or cough to clear the secretions. Then the cycle was repeated after clearing secretions or if there was no secretions to clear from the oropharynx, after the low volume huff. The duration of periods of breathing control was varied depending on patients, the time required for patients to regain their normal breathing pattern and fatigue. The patients would be allowed to cough as required. The end point of the technique would be defined as two cycles and dry sounding huff. If the defined end point was not achieved within 30 minutes, the session was judged complete. Lung Flute The patients would be instructed to inhale slowly slightly deeper than normal and then place the mouthpiece of the device into the mouth. Then hold the lung flute pointing down at an angle and blow gently into the lung flute as if trying to blow out a candle. As they blow into the lung flute they would hear the reel inside the horn making a fluttering noise as it moves. Instruct the patient to concentrate on making more noise by blowing harder and faster into the lung flute. After blowing into the lung Flute twice, patients would be instructed to remove the mouth piece and wait for five seconds, taking several normal breaths. Then repeat this whole cycle of 20 sets with two blows each, unless the patient feels lightheaded or fatigued. If the patient was unable to tolerate the number of sets, the technique would be modified to do fewer sets. At the end of the session patients would be instructed to wait for 5 minutes and then do a low to mid volume huff , and when the secretions are in the oropharynx to to do a high volume huff or cough to clear the secretions. The average session would for 5 -10 minutes. This would be the end point of this technique.

  • The safe administration of large volume of intravenous fluids in colonoscopy patients to prevent hypotension- guided by patients' level of fluid tolerance on inferior vena cava ultrasound.

    Colonoscopy patients are often "dry" or dehydrated as a result of the bowel preparation. This often results in a drop in blood pressure during the procedure. A study in 2006 showed that by giving patients 15ml/kg of fluid, it did not result in improvement of blood pressures, and it was postulated that the volume infused could have been insufficient. In our study, we plan to give 30ml/kg of fluid to colonoscopy patients before their procedure, as we hypothesise that 30ml/kg may be enough to prevent or reduce the drop in blood pressures. We aim to do this by using echocardiography (taking a picture of the heart) to titrate fluids so that patients will not be overloaded with fluids.

  • The role of sensory parameters in predicting clinical outcome after lumbar discectomy

    Low back pain is one of the most common health problems and affects 80 – 85% of people over their life time. Health costs due to back problems in Australia were estimated to be $4.79 million in 2012. Low back-related leg pain or sciatica is a common variation of low back pain and may require back surgery. Thirty percent of people report persistent pain after back surgery which is associated with disability, reduced quality of life, reduced work capacity and substantial health care costs. Whilst several risk factors have been identified (e.g. psychological factors such as catastrophising, unhelpful beliefs about pain and disability) for poor outcome after surgery, the role of pre-sensory pain sensitivity is unknown. Research suggests that certain people who demonstrate hypersensitivity to sensory stimuli such as hot/cold, touch and pressure, pin-prick and vibration may be more vulnerable to develop ongoing pain, however this has not yet been explored in people with back and leg pain. This study will investigate if pre-surgical responses to these stimuli may play a role in predicting persistent pain after back surgery. The findings may assist in developing pre-surgical screening methods and in using this outcome to target pre- and/or post-operative patient care, with the potential to improve patients’ functional status, quality of life, work capacity whilst also reducing health care costs associated with persistent disability.

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