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NCT ID: NCT05780151 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

RADIAL
Start date: July 10, 2023
Phase: Phase 4
Study type: Interventional

Pan-European proof-of-concept study comparing Decentralised Clinical Trial (DCT) and hybrid approaches to conventional clinical trial approaches in patients with Type 2 diabetes mellitus treated with Toujeo®.

NCT ID: NCT05779696 Recruiting - Physical Inactivity Clinical Trials

Artificial Intelligence and Physical Activity Among People From Ethnic Minority Groups

AI-ACTIV-E
Start date: April 1, 2023
Phase:
Study type: Observational

Despite the high interest in physical activity, many individuals lack the necessary experience in being active and therefore have low levels of knowledge and confidence to become and stay active. For effective lifestyle changes to occur, information must be tailored to the individual's health, goals, motivations, and overall ability. Lifestyle interventions, for example those designed to increase physical activity, are only effective when adapted to the physical, social, and psychological needs of the patient and progressed at rate appropriate for their development by specialist health professional. In the context of ethnic minority health, information must also be culturally adapted, sensitive to religious needs, and accessible to those where English is not proficient. Behavioural digital health interventions have been moderately successful in increasing physical activity, although opportunities for further improvement remain to be discussed. New technologies involving the use of artificial intelligence (AI) are growing, and allow the dissemination of individualised and tailored advice and information. Whilst a few AI-driven physical activity-based applications exist, they are not widely used, particularly amongst people from ethnic minority groups where both physical activity and digital health literacy is poor. Research has identified that whilst many people would be receptive to using health chatbots, hesitancy regarding this technology is likely to compromise engagement. In particular, user perspectives, motivation and capabilities need to be taken into account when developing and assessing the effectiveness of health chatbots. Guidance suggests that developing health chatbots should focus on issues of digital literacy, linguistic and cultural issues, privacy concerns, and personalization. As such, any development needs to involve user-driven co-creation techniques and involving community partners to increase the probability that it will ultimately be effective. Aims Aim 1 Gain a new understanding of barriers and facilitators to digital physical activity interventions and AI-delivered healthcare in people from ethnic minority groups through an online survey Aim 2 To conduct a series of focus groups to explore participants understanding and identifying barriers and facilitators to digital physical activity interventions. In particular to: i)Better understand general barriers and facilitators (focus on access and provision of education, and physical, environmental, cultural and psycho-social barriers) to physical activity; ii)Explore current and future usage of digital-based resources to facilitate physical activity behaviour; iii)Investigate views of use of AI in digital-based healthcare applications (e.g., trust in such applications)

NCT ID: NCT05779527 Recruiting - Parenting Clinical Trials

Mindful Parenting - A Single Case Experimental Design Study

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

Some parents of children living with a visible difference can experience heightened stress due to the associated challenges of this. Parent's views of the child's visible difference and their responses to the child are important. Mindful parenting approaches have been found to reduce stress or distress for parents of children with disabilities, physical health problems and skin conditions. This study will be completed with a small number of participants (around six to 12). Participants will be parents or carers of a child living with a visible difference aged four to 16 years, who are experiencing stress. Parents or carers will complete an online mindful parenting intervention (called Two Hearts) including video content, audio files and a workbook, over six weeks. Over the twelve-week study period participants will also provide the following information which will be compared over time: - Complete four group support sessions during the intervention via videoconferencing - Complete questionnaires at four timepoints - Provide information about their use of the intervention materials and home practice weekly - Answer two questions daily via text message about parenting stress levels We hope to learn about the initial effects of the mindful parenting programme for parents or carers of children living with a visible difference. We also hope to learn whether parents or carers find completing an online programme possible and practical. Finally, we hope to learn what parents' or carers' views are of the online programme and whether this type of intervention in online format would be helpful for other parents or carers.

NCT ID: NCT05779475 Enrolling by invitation - Parkinson Disease Clinical Trials

An Observational Study of Patients With Moderate Parkinson's Disease

TRANSCEND 1
Start date: April 5, 2023
Phase:
Study type: Observational

The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.

NCT ID: NCT05779358 Completed - Clinical trials for Non-celiac Gluten Sensitivity

Gluten and (Extra-)Intestinal Symptoms in NCGS

WoW
Start date: October 19, 2018
Phase: N/A
Study type: Interventional

The goal of this randomized, double-blind, placebo-controlled study is to investigate the effect of expectancy related to gluten consumption versus actual gluten intake on overall GI symptoms in individuals with non-coeliac gluten sensitivity (NCGS) The main questions it aims to answer are: - what is the effect of consumer expectancy, related to either gluten-containing or gluten-free oat bread, on short-term (within 8 hours) overall GI symptoms in individuals with NCGS? - what is the effect of actual gluten intake on short-term (within 8 hours) overall GI symptoms in individuals with NCGS Participants will be randomised into four groups: 1. Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day. (E+ G+) 2. Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day. (E+ G-) 3. Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day. (E- G+) 4. Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day. (E- G-)

NCT ID: NCT05779072 Completed - Myopia Clinical Trials

Dual Focus Soft Contact Lens Wear Cessation Study

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of ceasing treatment with dual focus soft contact lenses.

NCT ID: NCT05778617 Not yet recruiting - Parkinson Disease Clinical Trials

Ambroxol to Slow Progression in Parkinson Disease

ASPro-PD
Start date: September 2023
Phase: Phase 3
Study type: Interventional

This is a UK only clinical trial in patients with Parkinson's disease (PD) of a drug called ambroxol hydrochloride, which is an already licensed drug for the treatment of respiratory conditions (such as a common cold) in many European countries. The aim of this trial is to find out whether ambroxol hydrochloride can slow down the progression of Parkinson's disease and to evaluate it's safety and tolerability.

NCT ID: NCT05778071 Active, not recruiting - Clinical trials for Endocrine System Diseases

Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism

CALYPSO
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 28 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.

NCT ID: NCT05777551 Recruiting - Atrial Fibrillation Clinical Trials

AF Ablation With High Power Short Duration RF

AIR HPSD
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF). Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters). Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD. At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.

NCT ID: NCT05777499 Not yet recruiting - Stroke Clinical Trials

MUSic Therapy In Complex Specialist Neurorehabilitation

MUSICS
Start date: March 2023
Phase: N/A
Study type: Interventional

Aim: Investigate whether patients undergoing specialist rehabilitation after complex neurological injury show different functional outcomes if music therapy is included in their rehabilitation program compared to usual care. Background: Patients with complex needs following a brain, spinal cord, and/or peripheral nerve injury often require a period of specialist neurorehabilitation. This involves multiple therapy disciplines, led by a Consultant in Rehabilitation Medicine, Neurology, or Neuropsychiatry. Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury, it is not routinely commissioned in clinical care due to a lack of supportive evidence. Hypothesis: Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care. Number of participants: 75, aged 16-80 years. Methods: Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy. Both arms receive 1-3 additional therapy sessions per week, matched for duration and number, total 15 hours. After approximately 10-weeks intervention, assessments are repeated. All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit (NRU), with additional qualitative data collection using semi-structured interviews, field notes, staff reports, staff stress surveys, and broader ecological observations. Duration for Participants: From consent to discharge from NRU. Primary Outcome: Change in Functional Independence Measure+Functional Assessment Measure (FIM+FAM), Northwick Park Dependency Scale (NWPDS), and Barthel Activities of Daily Living pre and post 15 hours intervention. Secondary Outcome: Change in quality of life (Flourishing Scale), psychological distress (Hospital Anxiety and Depression Scale, Depression Intensity Scale Circles), social interaction (Sickness Impact Profile Social Interaction Subscale), well-being (WHO Well-Being Index), and communication (Communication Outcomes After Stroke Scale), pre and post 15 hours intervention. Mean difference in well-being (WHO Well-Being Index) throughout the intervention period between music therapy and control therapy groups. Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups.