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NCT ID: NCT06022380 Completed - Clinical trials for Mucopolysaccharidosis Type II

Core Outcome Set for Head, Neck and Respiratory Disease in Mucopolysaccharidosis II

COHERE
Start date: September 28, 2020
Phase:
Study type: Observational

The Mucopolysaccharidoses (MPS) are a family of genetic metabolic disorders, caused by specific enzyme deficiencies which result in accumulation of partially degraded glycosaminoglycans (GAGs) within various tissues. As GAGs are common in the body a number of different organ systems can be affected. Involvement of the upper and lower respiratory tract in MPS Type II results in significant airway compromise, with progressive airway obstruction being responsible for a significant proportion of the morbidity and mortality associated with this condition. Hearing loss is a universal finding in MPS, with a third of patients suffering with severe profound hearing loss. There is an unmet need for strong clinical evidence to guide treatment of head, neck and respiratory disease in MPS disorders. A Core Outcome Set (COS) describes the minimum outcome data that should be measured in a clinical study for a particular condition. The lack of an agreed COS for MPS II in general, and specifically head, neck and respiratory disease, makes comparison between studies difficult. There is also a lack of information detailing patient and parent perspectives on the MPS disorders. The ideal COS for head, neck and respiratory disease associated with MPS II would combine both patient/parent and clinician opinion and could be used in the design of all subsequent clinical studies. Following literature review the investigators have created a list of outcomes previously reported for qualitative and quantitative studies investigating head, neck and respiratory disease in MPS II. For the proposed research the investigators will seek opinions of patients, parents, clinicians and scientists to rate these outcomes via the Delphi method. Outcomes scored highest by patients, parents, clinicians and scientists will form a COS for head, neck and respiratory disease in MPS II. The development of a COS can help limit variability outcomes in studies investigating different interventions in MPS II.

NCT ID: NCT06022367 Completed - Clinical trials for Activation Technique in cVEMP Testing

Activation Technique in cVEMPs

ACTIVE
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

This study will investigate two different techniques used for eliciting sternocleidomastoid (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are used clinically to assess the function of structures within the vestibular system. The British Society of Audiology (BSA) guidelines recommend the head turn and head raise techniques as effective methods for eliciting SCM contraction. However, they do not recommend which technique to employ, leaving that to the discretion of the clinician. The purpose of this study is to determine which activation technique to recommend in the local standard operating procedure on cVEMP testing developed by the Audiology and Vestibular Function Testing service based at the Royal Liverpool University Hospital. Healthy volunteers will be recruited to the study. The study will be conducted at the Royal Liverpool University Hospital, Liverpool, UK. The participants will each be invited to attend one appointment in which they will undergo cVEMP testing, performed using each activation technique in turn. After testing the participants will be asked to complete a questionnaire in which they will comment on their experience of performing each technique and assign each a tolerability rating.

NCT ID: NCT06019338 Completed - Clinical trials for Trigeminal Neuralgia

A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia

Start date: November 20, 2021
Phase:
Study type: Observational

The aim of the study is to establish the validity of a patient reported diary in TN . The following objectives have been identified: 1. To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs). 2. To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.

NCT ID: NCT06014307 Completed - Health Behavior Clinical Trials

SWAP-MEAT With Athletes for MC-URC: Three Diets on Athletic Performance

Start date: October 4, 2023
Phase: N/A
Study type: Interventional

This study aims to investigate the impact of two plant-based diets-whole food plant-based (WFPB) and plant-based meat alternatives (PBMA)-vs. an omnivorous diet (Animal) on endurance and muscular strength in recreational athletes.

NCT ID: NCT06014216 Completed - Clinical trials for Postoperative Thirst

Treating Post-Operative Thirst With Flavoured Ice Lollies or Water - a Comparative Study to Improve Post-operative Discomfort

THIRST
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

Patients are asked not to eat and drink before their operation, and we know that this can make people feel thirstier when they wake up from their anaesthetic. We want to know if giving patients ice lollies improves their thirst more than if they were given water. Gloucestershire Royal Hospital is funding and running a research study to find ways to try and improve this.

NCT ID: NCT06011447 Completed - Vascular Diseases Clinical Trials

Laser Speckle Imaging in Ischaemic Tissue Loss

Start date: April 1, 2020
Phase:
Study type: Observational

Peripheral arterial disease is a condition in which the arteries become narrowed due to a build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and this can compromise the parts of the body supplied by these arteries. In its most severe form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading to ulcers or gangrene. Patients with peripheral arterial disease undergo procedures to improve blood flow. However, there are often multiple arteries to treat and each intervention carries risk. It therefore can be difficult to judge how much treatment is sufficient to promote healing. Laser Speckle Imaging is a technique used to demonstrate blood flow in the skin. It is hoped that changes in skin blood flow, as measured by LSI, immediately after a procedure to improve blood flow, may help in the decision making as to whether further intervention is necessary. An LSI scan will be performed before a procedure for tissue loss and immediately after it is performed. The patient's clinical records will then be checked to see whether the wound has improved and whether the difference in LSI scans correlated with this.

NCT ID: NCT06011070 Completed - Problem Gambling Clinical Trials

Brief Online Personalised Feedback Intervention for Gambling Harm

Start date: August 21, 2023
Phase: N/A
Study type: Interventional

Purpose and significance A brief self-directed online personalised feedback intervention was developed for the UK context designed to prevent, reduce, and address gambling harm. The intervention, which also comes in a paper format, comprises of normative feedback and personalised information on the risk of gambling above lower-risk gambling guidelines. The content is based on recent work adapting the Canadian lower-risk gambling guidelines to the UK context. The purpose of this exploratory research is to conduct the first randomised controlled trial of this intervention. Further, given the increased prevalence of online gambling, the project will target this at-risk population. Rationale This project will generate participant feedback on the intervention important to improve its utility. The project will also produce publishable findings on the intervention's efficacy. This evaluation provides a necessary first step towards the wide-spread implementation of this free-of-charge intervention in the UK. Methodology First, using methods developed in our previous research, we will rapidly recruit 926 online gambling participants with moderate or problem gambling from an existing online panel of UK residents. These participants will be randomised to receive the self-directed online intervention or assigned to a no intervention control group. Participants will be followed-up up at one- and three-months to provide detailed feedback on their impressions of the intervention (and what further modifications are needed) and to assess the short-term impact of the intervention on gambling frequency and harm. Potential implications of the proposed research The intervention can be accessed at any time of the day and allow the delivery of help without requiring face-to-face contact. Online interventions also have the potential to promote reductions in social inequalities through reducing barriers to accessible care. At present, there appears to be no UK online at-risk gambling intervention that is publicly available.

NCT ID: NCT06009185 Completed - Clinical trials for Pulmonary Arterial Hypertension

Safety and Efficacy of BIA 5-1058 in PAH

Start date: June 26, 2019
Phase: Phase 2
Study type: Interventional

This study aims to assess the safety and tolerability of the individual highest tolerated zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in Pulmonary Arterial Hypertension (PAH) disease.

NCT ID: NCT06006468 Completed - Type 1 Diabetes Clinical Trials

Evaluating ImmuNe Changes in the Evolution of Pre Type 1 Diabetes With Adult ONset

INCEPTiON
Start date: February 1, 2023
Phase:
Study type: Observational

Little is known about how type 1 diabetes or coeliac disease develop in adults. Studies following children at risk of type 1 diabetes from birth have shown that the marker of type 1 diabetes autoimmunity (antibodies against the insulin producing cells in the pancreas (Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulin Autoantibodies (IAA), Zinc Transporter 8 Autoantibodies (ZnT8), Anti-tyrosine phosphatase-like insulinoma antigen 2 (IA-2))) can develop many years before glucose levels are raised and diabetes is diagnosed. In adults, it is unclear when antibodies develop in relation to high blood glucose levels and the diagnosis of type 1 diabetes. Similarly in coeliac disease it is unclear to what degree Tissue transglutaminase autoantibodies (TTG) in adults proceed the development of clinically diagnosed disease. The investigators will use samples collected and stored in The Exeter 10,000 volunteer research bank (https://exetercrfnihr.org/about/exeter-10000/) and so no new sample collection is required. This includes ~8000 participants with no history of coeliac disease or diabetes at recruitment. The investigators wish to determine prevalence of autoantibodies in the background adult population split by the highest genetic risk for type 1 diabetes and separately coeliac disease compared to a control population with lower genetic risk for these conditions. The investigators will also evaluate the proportion of these identified cases progressing to clinically diagnosed disease. The aim of this study is to investigate evidence of autoimmunity prior to disease development and generate pilot data for the validity of screening based on genetic predisposition for type 1 diabetes and coeliac disease.

NCT ID: NCT06004921 Completed - Cancer Clinical Trials

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers

ARC-26
Start date: October 16, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.