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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: NCT06008847 Recruiting - Bowel Cancer Clinical Trials

Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

CESCAIL
Start date: February 9, 2022
Phase:
Study type: Observational

The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a minimally-invasive imaging device, to improve efficiency and accuracy of the detection of polyps, which are little outgrowths within the lining of the bowel.

NCT ID: NCT06008756 Recruiting - Arteriosclerosis Clinical Trials

MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

NCT ID: NCT06008496 Recruiting - Pain Clinical Trials

Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY)

POPPY
Start date: January 15, 2024
Phase:
Study type: Observational

Around 3 out of 4 operations in the UK are performed as day-case, meaning the patient goes home on the same day of their operation. Hospitals usually do not follow up patients after day-case operations so we do not know very much about their short or long-term recovery. Some patients, even those who have had small operations, can develop persistent pain afterwards that continues for a long time (months to years). These patients may end up taking strong painkillers for a long time and this risks serious side effects and long-term health problems. The POPPY study aims to find out what recovery from day-case operations is like from the patient's point of view. We will look at the first week after patients' operations and then at 3 months to see if they are in pain, and if so what pain relief they are taking. All adults over the 5-day study period having day-case operations in the UK, with an anaesthetist, will be eligible if they have access to a smartphone. Patients will be recruited on the day of their operation from over 100 NHS hospitals. Some relevant information about the patient's current health, operation and anaesthetic will be recorded from their notes. Afterwards participants will get a text message at days 1, 3 and 7 and the at 3 months. These will connect to a data secure online questionnaire about pain, recovery, and what medications they are taking. A small number of participants with ongoing pain at 3 months will be invited to take part in a structured interview to understand their experience in more depth. This study will provide important information that may be used to improve care of patients having day-case operations and plan future research studies aimed to prevent persistent pain and long-term use of strong painkillers.

NCT ID: NCT06008249 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)

Start date: August 9, 2021
Phase: Phase 3
Study type: Interventional

The objective of this phase III, placebo-controlled platform study is to investigate the efficacy of drugs for patients with ALS (Amyotrophic lateral sclerosis).

NCT ID: NCT06008145 Recruiting - COPD Clinical Trials

COPD Case Finding In Nottingham and District: C-FIND COPD A Pilot Study

C-FIND
Start date: September 21, 2023
Phase:
Study type: Observational

The Targeted Lung Health Check (TLHC) is currently being rolled out in many regions of the United Kingdom and has just started in Nottingham. The same cohort of people are also at high risk for Chronic Obstructive Pulmonary Disease (COPD), a lung condition often caused by smoking and leading to breathlessness and cough. This study aims to provide pilot evidence of the role of breathing tests in those who have had a Computerised Tomography (CT) scan, in order to early diagnose COPD. Currently, at diagnosis, many patients have lost 30-40% of lung function already, which is not reversible. This study will use the Nottingham University Hospitals Trust Mobile Research Unit. The unit will follow the CT scanner route 2-3 weeks later, and people who have had a CT scan will be invited for breathing tests. Participants will also collect further information on potential treatment options for people diagnosed with COPD earlier -including smoking cessation, symptom management and general health advice (vaccinations, diet, activity and managing infections). There is also an optional blood test. The study aims are to determine the uptake and acceptability of breathing tests in patients at high risk of COPD, and if a community based approach co-locating with TLHC can increase uptake.

NCT ID: NCT06007989 Not yet recruiting - Myeloma Clinical Trials

Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)

CHIME
Start date: November 1, 2023
Phase:
Study type: Observational

The study is looking at how myeloma is related to low oxygen levels (hypoxia) in the bone marrow. This is to understand the disease better. It might also guide treatment in the future. For the study, we will run tests on a portion of the samples taken during a bone marrow biopsy. A bone marrow biopsy is taken as part of the diagnosis or follow up of myeloma. The tests in our study will look closely at the make-up of immune cells in the bone marrow, highlight areas of low oxygen, and look at genetic changes in cells from low-oxygen areas. We will ask patients to take a capsule the day before their bone marrow biopsy containing pimonidazole hydrochloride, a substance which will show up areas of low oxygen on tests. Overall we want to know: 1. If myeloma cells 'live' in areas of low oxygen in the bone marrow 2. What are the immune and bone marrow cells which are neighbours of myeloma cells? 3. Are there genetic changes in low oxygen myeloma cells For the pilot study, we want to know: 4. Can we use new techniques to study questions 1-3? The techniques we want to use are pimonidazole with multiplex immunohistochemistry and single cell RNA sequencing. The information we get from the tests will help us get a better understanding of how myeloma works. Future studies may also use these results to develop new kinds of drugs for myeloma.

NCT ID: NCT06007898 Recruiting - Celiac Disease Clinical Trials

Supporting Children and Young People to Live Well With Coeliac Disease

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

Managing a strict gluten-free diet is crucial for children and young people with coeliac disease. However, this can have adverse effects on psychological well-being and quality of life. Despite appeals from families, clinicians, and researchers, psychological support is not routinely provided to these families. This project aims to adapt existing self-help psychological resources used for food allergy, gastrointestinal disease, and type one diabetes to cater to families dealing with coeliac disease. The process involves collaboration with families and clinicians to modify these resources. Subsequently, a feasibility randomised controlled trial will be conducted to assess the viability and acceptability of these resources. In the trial, 50 families will complete well-being and quality of life questionnaires, along with assessments of their child's gluten-free dietary management. Families will be divided into groups receiving the psychological resources either immediately or after a two-month delay. Follow-up questionnaires will be administered at one and two months for all families, regardless of intervention access. Feedback on the resources and research participation will be gathered. The expectation is that these self-help psychological resources for parents will enhance gluten-free diet management, quality of life for coeliac children and young people, and well-being for parents.

NCT ID: NCT06007690 Recruiting - Uveal Melanoma Clinical Trials

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

CoMpass
Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).