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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: 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: NCT05776069 Recruiting - Clinical trials for Von Willebrand Diseases

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease

Start date: March 16, 2023
Phase: Phase 1
Study type: Interventional

This is a multi-center, Phase 1a study to assess the safety, tolerability, PK, and PD of VGA039 following single IV or SC dose administration in healthy subjects and Von Willebrand disease patients.

NCT ID: NCT05775848 Recruiting - Clinical trials for Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)

Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Fortify
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2I/R9. The study will include patients ages 12 to 60, consistent with the existing preclinical toxicology profile. This will encompass the significant majority of existing diagnosed patients based upon the established epidemiology of the disease.

NCT ID: NCT05775159 Recruiting - Clinical trials for Hepatocellular Carcinoma

Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Start date: April 24, 2023
Phase: Phase 2
Study type: Interventional

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

NCT ID: NCT05774951 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

CAMBRIA-1
Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

NCT ID: NCT05774587 Recruiting - Cardiac Event Clinical Trials

Mobile Health for Cardiac Rehabilitation (Motivate-CR+)

Start date: July 6, 2023
Phase: N/A
Study type: Interventional

The investigators aim to conduct a feasibility study to evaluate a model where mobile health (mHealth) technology supports a remote home-based PA and counselling intervention immediately post hospital discharge to increase uptake to cardiac rehabilitation. Our overall objective is to test the feasibility of an evidence-based complex intervention prior to evaluation in a future randomized control trial (RCT)

NCT ID: NCT05774574 Recruiting - Appetitive Behavior Clinical Trials

Physiological and Appetitive Effects of CBD Supplementation

Start date: January 20, 2023
Phase: N/A
Study type: Interventional

CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite regulation and metabolic health. Healthy, adult volunteers will be assigned to placebo or CBD supplementation, in a randomized controlled trial, comparing changes in outcomes across the supplementation period between groups.

NCT ID: NCT05774444 Recruiting - Hypertrophy Clinical Trials

Investigating the Effects of Krill Oil and Krill Protein on Post-exercise Muscle Protein Metabolism

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

The aim of the current study is to find out if krill oil can increase muscle building processes in response to resistance (weightlifting) type exercise. Others aim are to determine the effects of krill protein, and the interaction of krill oil and protein, on muscle building processes in response to resistance (weightlifting) type exercise.