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NCT ID: NCT04284072 Completed - Epilepsy Clinical Trials

Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

SeizeIT2
Start date: June 22, 2020
Phase: N/A
Study type: Interventional

Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.

NCT ID: NCT04283786 Completed - Osteoporosis Clinical Trials

Exploring Efficacy, Cost Effectiveness and Experiences Related to Adherence of Different Bisphosphonate Regimens for the Prevention of Osteoporotic Fragility Fractures.

BLASTOFF
Start date: March 6, 2020
Phase:
Study type: Observational

Osteoporosis is a condition where bones become weak and fragile and can easily break. Suffering from one fragility fracture doubles your chance of having another. These fractures can affect a person's life significantly and contribute to significant costs to the UK (United Kingdom) health service. Bisphosphonates are used to treat osteoporosis and help prevent fractures. The most commonly used bisphosphonate treatment is Alendronate, but taking it correctly is complicated and side-effects are common. Therefore only 1 in 4 people continue with Alendronate beyond 2 years. There are different forms of bisphosphonates that can be given in different ways and frequencies and may be more acceptable and tolerated by patients. The study will look at how effective different bisphosphonate regimens are compared to Alendronate at preventing fractures, whether the reduction in fracture risk can be achieved at reasonable financial cost and establish acceptability of different approaches to patients. The study will be completed in 2 stages, Stage 1A and Stage 1B in parallel, followed by Stage 2. Stage 1A will update a systematic review to inform which regimens are most effective at reducing fractures and provide the best value for money. Stage 1B will consist of qualitative, semi-structured interviews from a sample of stakeholders in receipt of or involved in the delivery of different bisphosphonate regimens, in order to identify which bisphosphonate regimens are most acceptable to patients and the barriers to effective compliance and adherence. Stage 2 will use focus groups and workshops with stakeholders and commissioners to discuss uncertainties from Stage 1 and identify the most important outstanding questions for future research.

NCT ID: NCT04283071 Completed - Multiple Sclerosis Clinical Trials

Kinematic Assessment In Multiple Sclerosis

KAIMS
Start date: November 7, 2019
Phase:
Study type: Observational

Multiple sclerosis (MS) affects more than a 120,000 people in the United Kingdom and is the commonest neurological condition in young adults. MS causes a number of symptoms including weakness, altered sensation, pain and memory difficulties. There are different forms of MS, including relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Currently there are several effective treatments for RRMS, but no NICE approved treatment for SPMS. Patients with PPMS and SPMS experience a gradual progression in disability that affects individual patients differently. A number of clinical scores are used to quantify the disability in individual patients and some of these scores focus on the patients' lower limb function. In the progressive forms of MS, preservation of upper limb function becomes a more important concern for patients to maintain their quality of life. With the advent of new treatment trials for PPMS and SPMS, it is important that clinicians and researchers are able to use accurate and quantifiable measures of upper limb function to evaluate any changes with time or response to treatment. The use of motion tracking software provides a unique opportunity to accurately track movements in real time and space and give a tailored assessment of an individual's function. The overall aim of this study is to use established kinematic assessment tools to explore the extent and progression of upper limb dysfunction in patients with progressive MS. This aim will be achieved via the following objectives: - Recruit a sample of participants with PPMS and SPMS from the local MS population - Quantify the physical impairment in these participants using existing clinical scores as well the kinematic assessment tools that have been developed - Follow-up the participants for a period of 12 months to identify and quantify any progression in their upper limb dysfunction - Identify any factors that may influence upper limb dysfunction in this group - Develop and evaluate the role of further kinematic techniques in this group of participants

NCT ID: NCT04281953 Completed - Cancer Clinical Trials

Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors

Start date: September 5, 2019
Phase:
Study type: Observational

This project aims to explore, in depth, the burden of hearing loss and tinnitus on cancer survivors. Using semi-structured interviews, audiograms and a variety of validated questionnaires, the specific impact ototoxicity has on quality of life will be investigated. From this, we can identify the specific needs of patients experiencing hearing loss and tinnitus following chemotherapy and develop a tailored and personalised support system.

NCT ID: NCT04281550 Completed - Dementia Clinical Trials

Hydration Care in Dementia Care Homes

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The study aimed to provide evidence of the feasibility of implementing a multi-component intervention for optimising hydration in people with dementia living in care homes. To undertake a multi method feasibility study to investigate the suitability of methods and outcome measures for future research. Objectives: 1. Explore personal barriers experienced by people with dementia regarding drinking in care home contexts 2. Explore professional and organisational perspectives of approaches to optimal hydration of residents with dementia and the barriers in everyday practice 3. Develop a multi-component intervention to enhance hydration for residents in collaboration with care home staff, mental health and geriatric specialists, and residents' family 4. Assess the feasibility of implementing the intervention in care homes, and impact on recommended daily intake of fluids 5. Explore the impact of the intervention on daily fluid intake, and designing suitable secondary outcome measures - admission to hospital due to dehydration, falls, laxative use, urinary tract infection, upper respiratory tract infection and skin breakdown.

NCT ID: NCT04281472 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

ADHERE
Start date: April 15, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

NCT ID: NCT04280887 Completed - Enuresis Clinical Trials

MyPad - Intelligent Bladder Pre-void Alerting System

MyPad
Start date: August 3, 2018
Phase: N/A
Study type: Interventional

Development a 'dry alarm' that can help children and adolescents become dry at night.

NCT ID: NCT04280705 Completed - COVID-19 Clinical Trials

Adaptive COVID-19 Treatment Trial (ACTT)

Start date: February 21, 2020
Phase: Phase 3
Study type: Interventional

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

NCT ID: NCT04280575 Completed - Clinical trials for Coronary Artery Disease

Symptomatic Trial of Angina Assessment Prior to Revascularization

ORBITA-STAR
Start date: January 16, 2020
Phase:
Study type: Observational

The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.

NCT ID: NCT04280445 Completed - Depression Clinical Trials

Acceptance and Commitment Therapy for Older Adults

Start date: April 29, 2020
Phase: N/A
Study type: Interventional

Title: Acceptance and Commitment Therapy for older adults experiencing psychological distress: A hermeneutic single case efficacy design (HSCED) series. Anxiety and depression in older age is associated with increased level of disability and lower quality of life (OAs). Unfortunately, pharmacological treatments are disproportionality relied upon to manage the mental health of OAs. Despite cognitive behaviour therapy (CBT) being the recommended psychotherapy, there is evidence that CBT is less effective for OAs than younger populations. An alternative treatment, Acceptance and Commitment Therapy (ACT), has been shown to be effective in reducing distress for OAs experiencing physical health difficulties. Several case studies have also indicated that ACT can be effective for OAs with psychological difficulties. ACT aims to change how a person interacts with their thoughts/feelings; to reduce avoidance; and to promote value-focused living. The study aims to use an adjudicated HSCED to answer the following questions: i) Is ACT an effective intervention for older adult clients experiencing psychological distress. ii) Do meaningful changes occur for client-participants over the course of ACT intervention? iii) What specific factors (ACT-specific, non-specific, extra-therapeutic) contribute to observed changes? iv) Are observed changes broadly attributable to the ACT intervention? v) What adaptations may facilitate change when using ACT with older adult clients. For the study, up to four participants will be recruited from an OA community mental health team, each receiving up to 12 individual sessions of ACT. Participants will be required to complete a number of questionnaires throughout the study, including before/after sessions. Post-treatment, there will be a semi-structured 1:1 interview to explore any changes participants experienced, before a six-week follow-up is employed to check stability of change.