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NCT ID: NCT06112977 Enrolling by invitation - Breast Cancer Clinical Trials

Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast cancer or for risk reduction of an inherited breast cancer risk. The main questions it aims to answer are: - To determine the feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction. - To determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction. Participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. Participants will be blinded to their allocation until day 90 post operatively. Participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.

NCT ID: NCT06111014 Enrolling by invitation - Clinical trials for Neurodegenerative Diseases

Continuation Study for Latozinemab

Start date: December 8, 2023
Phase: Phase 3
Study type: Interventional

Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

NCT ID: NCT06107244 Enrolling by invitation - Clinical trials for Paramedic Independent Prescribing

Paramedic Independent Prescribing in Emergency and Urgent Care

Start date: October 17, 2023
Phase:
Study type: Observational

The goal of this mixed methods observational study is to investigate paramedic independent prescribing (PIP) in emergency and urgent healthcare settings. The main questions it aims to answer are: 1. What are benefits and limitations of paramedic independent prescribing in emergency and urgent care settings and how does it contribute to patient care and healthcare service delivery? 2. What facilitators and barriers exist which influence the implementation and delivery of PIP as a new and complex intervention within emergency and urgent care? Participants in the study will include paramedics qualified in PIP and staff working at the case study sites. With participant consent, data will be collected using non-participant observation of the prescribing practice of 4-6 paramedics at each site, capturing this data through field notes. The views and insights of a range of other site staff such as managers, doctors and other clinicians will be interviewed at each case site, during semi structured interviews. At each case site anonymised prescribing frequency data will also be collected to understand the range and frequencies of prescribed medication by paramedics. Relevant meetings (such as clinical governance and medicines management meetings) will also be observed, and documentary analysis of relevant site documents will also be undertaken.

NCT ID: NCT06101979 Enrolling by invitation - Incisional Hernia Clinical Trials

A Prospective Study of Fortiva in Hernia Repair

Start date: November 15, 2023
Phase:
Study type: Observational

The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

NCT ID: NCT06097572 Enrolling by invitation - Food Allergy Clinical Trials

Improved Diagnostics in Food Allergy Study

ID-in-FA
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.

NCT ID: NCT06085885 Enrolling by invitation - Tinnitus Clinical Trials

Tinnitus and Cochlear Implants

TICIT
Start date: December 30, 2023
Phase:
Study type: Observational

Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation, and (4) Explore associations between tinnitus and changes in hearing, psychological health, cochlear implantation-related factors, and quality of life in cochlear implant recipients with and without tinnitus. Participants will be adults eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Participants will undergo routine pre- and post-operative assessments as part of usual care, and complete online questionnaires before and after implantation to measure tinnitus and other health related factors. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors before and after implantation.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT06014567 Enrolling by invitation - Aging Clinical Trials

Twins MR Imaging Study

Start date: December 19, 2023
Phase:
Study type: Observational

This study aims to create a comprehensive Magnetic Resonance Imaging data resource in twins aged 18 years and older. The data will be used alone or in conjunction with existing data to explore organ-specific ageing and twin-pair differences related to ageing and disease.

NCT ID: NCT06011395 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

Smart Watch Insights to Prevent Exacerbations and Recurrence - Health Study: SWIPER-HEALTH

SWIPER-HEALTH
Start date: August 30, 2023
Phase:
Study type: Observational

Aims of the study: - To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT) - To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care. The clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices. Researchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets.

NCT ID: NCT06011356 Enrolling by invitation - Diabetes Clinical Trials

Smart Watch Insights for Prevention of Exacerbations and Enhance Rehabilitation - Movement Study

SWIPER-MOVES
Start date: August 30, 2023
Phase:
Study type: Observational

Aims of the study: 1. To deliver a scalable wellbeing programme to the local population of Imperial College Healthcare NHS Trust, focusing on movement. 2. To describe the natural history of long-term conditions using digital data from a smartwatch. 3. To identify digital information that is routinely collected by a smart watch that can be used to predict outcomes in patients with long term conditions. 4. To identify factors that determine whether participants engage with and improve in a movement programme. Adult patients who are registered to the Imperial NHS Care Information Exchange (CIE), an NHS patient-facing electronic health record, are eligible to participate in the study. Participants will receive a smart watch for self-monitoring of their movement and wellbeing and be asked to wear the device as much as possible. They will be asked to download a smartphone application called Connected Life, which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). Participants will receive secure login details for the Connected Life application from the research team, to ensure data privacy. The research team will look at participants' health records, and attempt to identify associations between the digital data and clinical information. This will allow the research team to identify digital data that predicts the onset and natural history of long term conditions, which may potentially allow for earlier diagnosis for future patients. The primary outcome of the study is the identification of trends in movement based on step-count data recorded by the smartwatch.