There are about 25435 clinical studies being (or have been) conducted in United Kingdom. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. It is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. The outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.
Inflammatory bowel disease (IBD) which is associated with low bone mineral density is divided into 2 major disease entities: Crohn's disease and ulcerative colitis. Medical therapy is directed at controlling symptoms and reducing the underlying inflammatory process. Studies have reported that 60% of patients with Crohn's disease and 15%-30% of patients with ulcerative colitis require surgical intervention for the management of their disease. In the United Kingdom almost 13,000 ileostomy procedures are undertaken annually. A 29.4% prevalence of low bone mineral density (BMD) was reported in a cohort of US patients with IBD and ileostomy who were >5 years postoperative. Possible risk factors for bone loss in patients with IBD and ileostomy are considered to include malabsorption secondary to bowel resection, malnutrition and more aggressive disease and inflammation which led to bowel resection in the first place . These factors also contribute to reduced intestinal absorption of nutrients and vitamins including B & D subsequently leading to potential health complications including low BMI and low lean body mass. It has been reported that IBD patients who have surgical intervention to create ileal pouches also have low levels of vitamin D. Surgical procedures such as an ileostomy alter the normal anatomy and physiology of the small intestine. Bile acid (BA) malabsorption which is common to IBD is caused by impaired conjugated BA reabsorption and a consequence, numerous pathological sequelae may occur, including the malfunction of lipid digestion . Further, bacterial overgrowth can lead to deconjugation of bile salts, leading to formation of free bile acids, again inducing dietary fat malabsorption, which in turn can lead to vitamin D deficiency. As vitamin D is a fat-soluble vitamin, malfunction of lipid digestion or absorption is problematic. Given the paucity of data in the area of ileostomy patients BMD, vitamin D status and calcium intake, we will establish baseline observations within the Northern Ireland (NI) population with an observational study to assess bone mineral density (Dexa), collecting ileal fluid and plasma samples assessing vitamin D status, calcium, dietary intake and other measures including questionnaires on quality of life and exercise.
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.
The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
This observational long-term follow-up study is designed to collect safety and efficacy data from ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA LV encoding for human adenosine deaminase (ADA) gene (EFS-ADA LV), as part of the OTL-101 clinical development program. No investigational medicinal product will be administered to these patients as part of the OTL-101-6 study.
The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
WeReha is an innovative device for the home rehabilitation of stroke patients developed within the scope of the EU funded project MAGIC-PCP [5]. WeReha is a system that allows patients to perform exercises in a home environment with remote supervision integrated within regular rehabilitation. The principle on which the product is based is that of biofeedback guided rehabilitation, designed to stimulate muscle recovery and contribute to a more effective and more motivating rehabilitation of neuro-motor patterns. WeReha is completely adaptable, allowing only authorized to assign exercises, by planning specific sequences of movements. WeReha product is composed by the following elements: - a tablet with a proprietary application on it (the "WeReha app") - an inertial sensor with accelerometers, gyroscopes and magnetometers (the "sensor") - elastic straps allowing the user to wear it on different parts of the body (the "straps") - a series of 3D printed objects where the sensor can be placed that become animated (the "smart objects") - a web portal for clinical staff through which they can manage and monitor users (the "web-application") The WeReha app presents the patient with a series of rehabilitation exercises in the form of a number of interactive games, driven by body movement, which is captured by the sensor or the hand specific movements using the smart objects. A session with WeReha always starts with a questionnaire on the system, through which the software gains an understanding of the patient's health conditions and the presence or not of a caregiver for the session. Based on this questionnaire, the software adapts the daily session to minimise risks while maintaining a high level of rehabilitation to help the patient reach their goals. The device works with and without an internet connection, but when the device is connected to the internet, supervisors are able to provide supervision and remote support through a web application. The web application is hosted on a dedicated server located inside the hospital. Only trained staff will be provided with access to the web application with a unique username and password required for sign on. The exercises assigned for the client to perform at home, are at the discretion of the clinician who is caring for the patient and might require the presence of a caregiver. The goal of this study is to investigate the applicability and utility of an innovative technology product such as WeReha to the home rehabilitation of stroke patients as an integrative solution to a conventional exercise program and to assess its acceptance by the patient, caregivers and clinic professionals. Patients will use WeReha for their home rehabilitation in addition to traditional treatments for up to 12 weeks. The Inclusion criteria for the study have been kept broad in order to assess these factors on a large enough scale, so as not to limit the usage of the device to a specific sub-group of patients. If patients enrolled are in a subacute phase (i.e. within the first 6 months after the stroke onset), they will be enrolled before leaving the hospital or the rehabilitation department and reaching their home. If patients are considered to be in their chronic phase (i.e. over 6 months after stroke onset), they will be enrolled during an outpatient treatment or on a volunteer basis. Before starting the trial with WeReha, every patient enrolled will receive proper training from a person dedicated to the project (who will be referred to as the "dedicated figure") appointed by the hospital and financially supported by the sponsor of the study.
Multi-centre, non-randomised, non-controlled quasi-experimental study with nested qualitative study and economic appraisal. Improving the identification of patients at high risk of cardiovascular disease in primary care, caused by conditions such as familial hypercholesterolaemia (FH), is a well-recognised national priority to prevent morbidity and mortality by early effective intervention. This study will prospectively evaluate the clinical utility of the new primary care FH identification tool (FAMCAT) for identifying undiagnosed FH in routine primary care practice; and to assess its appropriateness, acceptability and cost-effectiveness. This study will answer the following research questions (RQ): 1. What is the detection rate for new genetically-confirmed FH cases using the FAMCAT algorithm? 2. Is the FAMCAT tool appropriate and acceptable to practitioners and patients? 3. How can the FAMCAT tool be optimised to improve identification of FH? 4. What is the potential cost-effectiveness of the FAMCAT tool compared with current practice to identify patients with FH? 5. Can the FAMCAT intervention be improved? 6. What definitive study design and outcome measures are needed to provide robust evidence on whether to introduce FAMCAT into primary care practice? RQ(1) & (3) will be answered by a quasi-experimental diagnostic accuracy study; RQ(2) & (5) answered by qualitative study; RQ (4) answered by economic appraisal and RQ(6) informed by all previous studies.
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with high moderate-severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).