ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Photodynamic therapy for prevention of skin cancers

    A prospective multicentre multinational randomized controlled trial is planned. The control group will be managed by observation, review with surgical management of future skin cancers if and when they occur. The observation group reflects current common practice. That is, current practice is that patients who have had skin cancers are followed through indefinitely to observe for new skin cancers to be then treated once they are diagnosed. The intervention group will have pre-treatment with AHA followed by PDT. Intervention centres: This trial will take place at 6 centres managing patients with skin cancer and actinic keratoses. There will be 6 centres in Australia, Victoria X 2, Western Australia, New South Wales and Queensland X 2 sites. These sites provide a combination of northern, central and southern latitudes as well as eastern and western longitudes. There will also be a northern hemisphere centre based in Missouri USA. Each treatment centre will be provided with the required products and illumination light. Intervention arm: Patients randomized to the intervention arm will be supplied with “Face Repair” (Allmedic ® 10% alpha hydroxy acid solution) to use twice daily for 14 days prior to the initial PDT treatment. They will also be provided with a SPF 30 antioxidant sunscreen (Allmedic ®) for usage twice daily in the lead up to PDT. Two PDT treatments will be effected 10 to 14 days apart. The patient will be incubated with Allmedic ® 20% ALA to each side of the face. Incubation will involve the liquid being massaged into each side of face to provide a thin and uniform cover. Incubation will be effected by the doctor or practice nurse. All such medical staff will be trained in advance regarding this technique. A firm massage of the liquid into the face will be effected. No product will be applied close to eye lashes or pink lip. Otherwise all skin areas from the hairline to the lower border of the mandible and from anterior border of the ear to the opposite anterior border of the ear will be included. There will be 5 hours planned between incubation and illumination. During this period, the patient will be advised to wear a broad brimmed hat and to avoid sunlight or bright lights. The patient will be encouraged to remain indoors whenever possible between incubation and illumination. Prior to illumination, the face will be washed with warm water and dried. During illumination, the eyes of the patient will be shielded from the light source. Each patient will have an attendant(s) at all times during illumination. A fan to reduce heat of treatment will be provided as required. The attendant(s) will wear dark sun glasses during illumination. Illumination will involve the Allmedic ® Tru+PDT light source, applied with the blue light for 20 minutes and then the red light for 10 minutes. No ultraviolet light will be used in the illumination phase. Following treatment, the patient will be advised to continue to wear the broad brimmed hat indoors and outdoors for five days and to continue to avoid bright lights. Advice re analgesia and moisturising cream will be provided. A second PDT treatment 10 to 14 days later will follow the same process. Observation arm: No immediate treatment or intervention will be provided for their background sun damaged skin. They will be followed up as detailed below. All patients, (including observation patients) will be given general advice regarding sun protection including sunscreens when outdoors. It is recognised that even sunscreens can have an effect on reducing actinic keratoses.31, 32 Follow up: All patients will have scheduled appointments each six months for two years following randomization. Patients will be further invited to attend for appointments in addition to scheduled appointments if they consider problems have arisen or occurring requiring such attention. At follow up, any face lesion suspicious of skin malignancy will be punch biopsied or locally excised. The punch biopsy will be a minimum of 4 mm in diameter. Where histology demonstrates actinic damage but no skin cancer (as previously defined), the lesion will be observed. Where the histology indicates skin cancer, treatment will be by surgical excision. This may involve Mohs’ surgery if considered appropriate. New face skin cancers occurring during the follow up two year period will not be treated with imiquimod, 5FU, curettage, ablation, etc,. At each follow up appointment, a further on line progress form will be downloaded to the central study database. The doctor and patient will both compare their face at each appointment to the baseline enrolment photograph. If a lesion is biopsied and / or excised on the face in that two year period, a further form will be completed on line and downloaded detailing such an event. Photography: Each enrolled patient will be photographed prior to any intervention. The digital photograph will be taken with the camera at least 1.5 metres from the patient. A minimum 6 Megapixel digital camera image will be taken and stored. The photograph will involve only the face from the neck up. The subject will be facing directly towards and looking at the camera. Controlled lighting and conditions will apply. At 6 months post randomization and at completion of follow up, photographs of the same methodology will be taken. Photographs will be used to assist patients and clinicians detecting an appearance alteration during the trial period.

  • ACCORD: Assessment of Carnitine for Clinical Outcomes in Renal Disease

    Carnitine is found in all mammals and is required for energy production. A large proportion of carnitine within the body is obtained from the diet and a lesser amount is made by the kidneys and liver. Carnitine deficiency is common in haemodialysis patients due to their low protein diet and abnormal kidney function, and also because carnitine is easily removed by the dialysis procedure. Carnitine is administered to dialysis patients in the United States and other countries for the treatment of dialysis-related carnitine deficiency. This study is being conducted to investigate the effect of carnitine administration on a number of common problems associated with dialysis, including muscle fatigue, anaemia and symptoms such as muscle cramps.

  • Acute effects of resveratrol on circulatory function in obese people with elevated blood pressure.

    It is well established that obesity and elevated blood pressure can lead to impaired vascular function. However, it is less clear how impaired blood vessel function affects cardiovascular and, consequently, blood pressure responses during exercise. Exaggerated blood pressure responses to exercise can be an early risk factor for the development of future hypertension. The aim of this study is to establish a dose/response relationship for the effect of resveratrol on endothelial vasodilator function as measured by flow mediated dilation (FMD) and blood pressure (BP), both at rest and during exercise, in volunteers who are overweight/obese with elevated BP. The results of this study will inform the design of future trials which will explore the effect of combinations of resveratrol and other vasoactive nutrients on cardiovascular and mental health.

  • Comparing two techniques of skin closure, purse string closure and linear closure, in terms of the incidence of surgical site infection in adults undergoing elective reversal of ileostomy

    This study compares two methods of skin closure following the reversal of ileostomy, purse string and linear closure. The study seeks to determine the incidence of surgical site infection following surgery when these two techniques are used. There is a high incidence of surgical site infection following reversal of ileostomy, and so determining if the use of different skin closure technique can reduce this incidence is important.

  • Comparing the use of a "wound protector" with traditional retraction techniques, in terms of the incidence of surgical site infection in adults undergoing elective open colorectal resection surgery.

    This study compares two methods of retracting the sides of the surgical incision to expose the operation field in open elective colorectal resection surgery, using a "wound protector" versus "traditional retraction techniques". The study seeks to determine the incidence of surgical site infection following surgery when each of these techniques is used. There is a high incidence of surgical site infection following colorectal surgery, and so determining if the use of different retraction techniques can reduce this incidence is important.

  • Effect of lifestyle intervention on Chronic Kidney Disease Skeletal Muscle - Landmark III Muscle Sub Study

    Chronic kidney disease (CKD) patients experience skeletal muscle wasting and this leads to decreased functional capacity and quality of life. A lifestyle intervention consisting of exercise and dietary advice is known to slow muscle wasting in older individuals however the effects in CKD patients is unknown. Furthermore, the mechanisms underlying these potential effects are not well understood. The aim of this study is to investigate the effects of an 8 week lifestyle intervention containing supervised exercise and dietary advice will effect markers of skeletal muscle structure and function in patients with chronic kidney disease. Patients will be recruited as part of the Landmark III study that is currently underway at the Princess Alexandra Hospital, Brisbane Australia. Following radomisation in to the larger study patients will be approached to participate in this sub study. 15 patients from each group will be recruited and undergo a muscle biopsy following baseline testing and then 12 weeks later. Muscle samples will be taken from the vastus lateralis muscle using the Bergstrom method and will be performed by a qualified medical practitioner. Muscle tissue samples will be stored in standard conditions, and analysis will be undertaken on completion of the sub study.

  • The effects of an orientation program conducted by a multidisciplinary team on self-efficacy and anxiety of newly registered cancer patients: A randomised controlled trial

    There are 283 new outpatients each month registered to cancer care services at the Royal Brisbane and Women’s Hospital (RBWH). The first visit of oncology patients and families to an outpatient cancer centre often causes intense anxiety and negative emotions. Recent nursing initiatives in cancer care services include a multidisciplinary orientation program for the head and neck cancer patients. This multidisciplinary orientation program will be extended to all newly registered cancer patients in 2009. This pilot study will evaluate the effects of the multi-disciplinary orientation program on the levels of self-efficacy and anxiety of newly registered cancer patients at the RBWH.

  • A qualitative exploration of the needs of patients with severe chronic obstructive pulmonary disease (COPD)

    This study is exploratory in focus, and aims to (1) identify the concerns of patients with severe COPD and their families including physical, emotional and social, (2) obtain insights into bereaved families’ experiences of caring for someone with COPD and their end of life care, (3) explore the staff perceptions of the palliative care needs of patients (and their families) with severe COPD, and (4) identify points when information about illness course, prognosis and goals of care are perceived as critical by patients, families, bereaved families and staff. Semi-structured in-depth interviews will take place with patients who have COPD, with family members and with bereaved family members. Focus groups will be held with health care professionals. Data will be analysed using a phenomenological approach, giving rise to a thematic analysis, and the identification of general themes and theme-clusters. It is anticipated that a synthesis of results from this and related quantitative investigations into the end of life care needs of patients with COPD will inform the development of a model of palliative care that may best serve this population.

  • A randomised cross over pilot study of inhaled tobramycin as a treatment option for hospitalised patients with cystic fibrosis versus standard treatment of intravenous tobramycin

    This study hopes to show that when tobramycin is given via inhalation in those patients with cystic fibrosis who are sick enough to need intravenous (into a vein) antibiotics, the levels in the lung are adequate for effective bacteria killing and that they recover from the acute infection. The study will be undertaken in all eligible patients who are admitted to the hospital for treatment of an exacerbation of their lung infection.

  • A randomised control trial on the effect of a herbal product, 30Plus, on mood swings and anxiety in younger women

    The study will evaluate how effective a herbal formulation is in decreasing psychological symptoms such as anxiety and depression. The study will run for 12 weeks in total, and over that time participants will be asked to complete one questionnaire every 4 weeks to evaluate their symptoms of depression and anxiety. Half the women in the study will take 2 tablets daily of the study product while the other half will take 2 placebo tablets. A placebo is a dummy treatment, which looks and tastes like the real medication, but contains no active ingredient.

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