ANZCTR search results

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

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33675 results sorted by trial registration date.
  • Accelerated versus conservative rehabilitation following rotator cuff surgery to repair full-thickness tears: Clinical outcomes and recovery of muscle function.

    Rotator cuff tears may affect one or more of the tendons of the four rotator cuff muscles in your shoulder, principally the supraspinatus. These tears cause significant pain and restricted movement of the arm, affecting the ability to perform daily activities, participate in sport and exercise, and the ability to work. Arthroscopic rotator cuff repair is the most popular surgical treatment for rotator cuff pathology. While surgery is considered an effective treatment, high failure rates and recurrent tears are common, especially degenerative tears, which are frequently observed in the older population. Post-operative rehabilitation is a critical part of the treatment following rotator cuff repair. Specific exercises to improve mobility and strength of the rotator cuff are commonly prescribed after repair. However, the role of post-surgical immobilisation, the amount of load that can be safely borne by the repair site throughout the early post-operative stages, and when and how to safely graduate this progressive load through rehabilitation, is currently unclear. Traditionally, repairs have been managed with passive range of motion followed by delayed active motion and, finally, strengthening exercises. However, as the incidence of repair failures grew, it has been suggested that overly aggressive rehabilitation and excessive loading at the healing repair site may play a role. Subsequently, delayed rehabilitation involving an early period of immobilization (arm in a sling) has become common practice. The rationale behind a delayed rehabilitation program stems from concerns that early repair site loading may negatively affect tendon healing, and that the repair site requires suitable time to heal without aggravation via loading. However, improvements in surgical techniques and current evidence and expert opinion suggesting that this period of immobilisation is too conservative and may potentially increase the risk of post-operative shoulder stiffness and a delayed return of shoulder muscle function, have allowed the possibility of an early, controlled post-operative treatment protocol. We hypothesise that a structured, accelerated post-operative rehabilitation program designed to safely return patients to work and sport faster, will improve patient based outcome scores and accelerate recovery of muscle function compared to a conservative regime, without risk to the repaired shoulder. This is a prospective randomised controlled trial (RCT), which seeks to investigate the benefit of an accelerated post-operative rehabilitation program after your rotator cuff repair surgery. This will be evaluated via validated questionnaires about your pain and function, clinical scores looking at your strength, mobility and function, as well as the time taken to return to work/sport, overall satisfaction and re-injury rate. This information will be of benefit to you in your return to full function, as well as other patients who require such treatment in the future.

  • Infants of Vitamin D deficient mothers-trial comparing Pentavite and Vitamin D3 supplement-effect on Vitamin D level at 6 weeks

    the aim is to define the appropriate type and length of treatment with vitamin d for infants of vitamin d deficient mothers

  • The Role of Oseltamivir During Influenza Outbreaks in Aged-care Facilities in the Context of Optimal Influenza Vaccination and Infection Control

    This protocol proposes a cluster-randomised study of 70-100 aged-care facilities with partnership between various stakeholders: aged care facilities, clinical researchers, general practitioners, government public health bodies, and relevant industry partners. It has two main purposes: (i) to examine the impact of oseltamivir, as treatment only, versus treatment and prophylaxis, for residents and staff of ACFs during influenza outbreaks with respect to morbidity, mortality and outbreak size, and (ii) to develop and test an enhanced surveillance system, utilising bedside rapid point-of-care tests with laboratory confirmation, for respiratory infection outbreaks in ACFs; both in the context of promoting influenza vaccine uptake and infection control measures.

  • Canakinumab Add-on Treatment in Schizophrenia (CATS)

    This research study will use medication to try to improve language, memory, and symptoms in schizophrenia. This medication (called canakinumab) is used to reduce harmful by-products of infection. We hope to learn how this medication in addition to antipsychotic medication can improve thinking and reduce symptoms in people with schizophrenia and to determine if this medication can be used as a new treatment for thinking problems and symptoms in people with schizophrenia.

  • A phase II study of induction therapy using idarubicin and infusional high-dose cytarabine for adult patients with de novo untreated acute lymphoblastic leukaemia

    The primary hypothesis is that an intensive chemotherapy protocol, incorporating high-dose cytarabine and Idarubicin, as originally designed for treatment of Acute Myeloid Leukaemia, when used in the treatment of adults with Acute Lymphoblastic Leukaemia, has acceptable tolerability and safety. The subsidiary hypothesis is that this regimen will result in a greater degree of reduction of the number of leukaemia cells, than conventional treatment.

  • Low level laser treatment for women showing signs and symptoms of capsular contracture following implant-based breast reconstruction for breast cancer (LaTCon study)

    The study is investigating if treatment with a low level laser can help improve the signs and symptoms of capsular contracture: chest pain, chest tightness, limited arm movement and unsatisfactory appearance of the affected breast(s). Who is it for? Potential participants who have undergone mastectomy and breast reconstruction (with tissue expander/implant) will be identified from the databases of the RT and QoLID studies as well as from participating surgeons’ patient files. Study Details All participants will complete a pre-treatment questionnaire to determine if they have significant capsular contracture, those who do and have consented to participating in the trial will then be randomly assigned to a group (A or B). They will then undergo an initial clinical examination by a Clinician followed by 6x16min low level laser therapy sessions at weekly intervals. One of the groups will receive the laser therapy while the other group will be treated with a deactivated laser. Neither the clinician administering the treatment or the participant will know which group is receiving the active therapy. At the conclusion of the treatment participants will undergo clinical and aesthetic assessments as well as complete the initial questionnaire at the 1 and 6 month post treatment mark.

  • A randomized trial of midazolam versus placebo on cognitive recovery in adult patients following elective outpatient colonoscopy using postoperative quality of recovery scale.

    Patients undergoing day surgery procedures are usually discharged the same day. They are not assessed further unless they come back for follow up or they have some medical or surgical complications. The recovery from general anaesthesia can vary considerably between individuals. Due to paucity of randomized trials, it is unclear if the brief anaesthesia the patients receive for their surgery, can affect longer-term recovery (especially cognitive recovery). Midazolam, a short-acting benzodiazepine, enhances the action of gamma aminobutyric acid (GABA), thereby acting as a neural inhibitor. It increases binding of GABA to GABA-a receptors that are highly concentrated in hippocampus. It is widely used as anxiety relieving, sedative and as a premedicant. There are concerns about the residual effect of midazolam on the cognitive status of patients following its administration as a part of anaesthetic induction. In day surgery procedures, quality of recovery has profound implications for the individual patient and for the community, in terms of return to work and safe driving. An ideal anaesthetic for day surgery procedures should not affect the mental capabilities for a long period of time. Our objective is to identify if administering midazolam in addition to propofol affects the recovery of cognitive function in patients undergoing elective colonoscopy.

  • The construction and experience of fertility in the context of cancer: Patient, partner and health professional perspectives.

    Fertility is a key aspect of quality of life detrimentally affected by cancer, resulting in significant reductions in well-being for people with cancer and their partners. However, health professionals rarely address this important health problem. This study will examine the experience and construction of fertility post-cancer, from the perspective of people with cancer, their partners, and health professionals, and elucidate pathways to difficulty or re-negotiation. Based on these findings, interventions will be developed, and evaluated in a randomised controlled trial.

  • A multi-centre prospective observational study of simultaneous pulse oximeter and arterial oxygen saturation recordings in Intensive Care Unit patients.

    Pulse oximetry is commonly used in the clinical setting to guide oxygen therapy . The purpose of this study is to investigate the level of agreement between pulse oximeter measured oxygen saturations and arterial blood gas measured oxygen saturations (the gold standard for oxygen saturation measurement) in Australian and New Zealand Intensive Care Units.

  • Atrial fibrillation (AF) screening using a smartphone electrocardiogram (ECG): pilot study to test implementation in the primary care setting.

    Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 1 in 4 adults worldwide, and at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population. Almost one in every three strokes is AF-related, and AF-related strokes are likely to be more severe, with a whole of life cost of each stroke estimated at $103,566. However, strokes in AF can be effectively prevented using oral anticoagulants. Many people in the general population are unaware that they have AF, with first diagnosis being made when they are admitted to hospital with a stroke or transient ischaemic attack. The diagnosis of unknown AF can be easily made using a 30 second ECG rhythm strip obtained with a TGA approved smartphone ECG (iECG). Using this device, unknown AF can be identified and treated, thus reducing the number of strokes due to AF. We have previously shown that community screening for AF to prevent stroke is likely to be cost-effective, but the magnitude of the benefit in terms of numbers of strokes prevented, is determined by the proportion of the population screened. The current study therefore explores screening for AF in primary care, by performing iECG screening during annual influenza vaccination currently administered to over 70% of patients aged 65 years and over in general practice. This opportunistic method of screening, through its reach, would approximate systematic population screening for AF. Screening will be performed in a small number of practices in this pilot study to optimize the process and inform any refinement of a larger scale study of implementation. The pilot will also ensure the tools are ready for the larger implementation study.

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