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NCT ID: NCT05864846 Recruiting - Clinical trials for Tuberous Sclerosis Complex Associated Neuropsychiatric Disease

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

EpiCom
Start date: June 29, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

NCT ID: NCT05862649 Recruiting - Parkinson Disease Clinical Trials

Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease

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

This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinson's disease, who will be evaluated in several clinical centers with a clinical assessment and an oculometric examination during a time period with specific intervals. This study aims to evaluate the correlation between oculometric measures and clinical assessment over time, as well as the potential to detect early change in clinical status using an oculometric assessment.

NCT ID: NCT05862636 Recruiting - Healthy Clinical Trials

Who Fares Best With Mindfulness Meditation

Start date: February 21, 2023
Phase:
Study type: Observational

The overall aim of this observational study is to investigate how individual differences influence the effects of mindfulness meditation to uncover for whom mindfulness is beneficial and for whom it may be harmful. The first objective is to identify the mechanisms underlying the effects of mindfulness meditation on mental health. The second objective is to examine how three candidate factors, namely trauma symptoms, tendency to dissociate, and repetitive negative thinking, influence the effect of mindfulness meditation on mental health. Adults who enrolled for a Mindfulness-Based Intervention (MBI) at the participating sites (n=120 for each site) will be invited to participate. Before the start of the MBI, after half of the sessions, at the end of the MBI and at 3-months follow-up, participants will complete self-report questionnaires. The main outcomes are symptoms of anxiety and depression, quality of life, wellbeing, and adverse effects resulting from the MBI. A subset of participants will be invited for a semi-structured interview after the end of the intervention.

NCT ID: NCT05862532 Active, not recruiting - Obesity Clinical Trials

Gut Microbiome and Blood Markers After Habitual Herbal Tea Consumption

SRTT
Start date: November 17, 2022
Phase: Early Phase 1
Study type: Interventional

TeTrimTeas intends is to establish a long-term cooperative with local growers and producers who will become partners in the business, with profit share to local growers and producers. The overall aim of the company is to produce quality, science-based botanical/herbal teas to improve health and wellbeing, growing as many of the ingredients locally and organically, to reduce food-to-fork miles within the decarbonisation and sustainability agendas in Wales. TeTrimTeas have created herbal green tea blends, improving on existing Chinese formulation, and would like to test it as 'health tea'. The recruited cohort will be randomised into one of three intervention teas (green tea control, senna herbal mix and rhubarb root herbal mix). They would like to explore if consumption of the teas for 21 days has an impact on digestion and potentially help control weight gain. Aberystwyth University will use high resolution metabolomics to investigate the chemical composition of capillary blood samples, in particular the short chain fatty acids. They will also assess lipid composition in capillary bloods and the microbiome of stools. Diet data, stool consistency and anthropometric measurements will be collected pre and post intervention. Results will advance product development and data would be used in grant applications into the health benefits of the herbal teas.

NCT ID: NCT05862285 Recruiting - Cancer Clinical Trials

A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

UmbrellaMAX
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

NCT ID: NCT05860764 Recruiting - Amputation Clinical Trials

Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

VAmPP-Q
Start date: February 1, 2023
Phase:
Study type: Observational

Background: Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years. After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems. Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance. PerBOMs are used with for: - Setting goals with patients - Assessing how patients respond to treatment/rehabilitation - Predicting if patients are likely to use a prosthetic limb in the future Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments. Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb. Methods: Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks. Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs. In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM. All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences. This study has been developed with patients and public involvement.

NCT ID: NCT05860478 Recruiting - Clinical trials for Musculoskeletal Chronic Pain Conditions

Wearable Device to Increase Physical Activity Amongst Adults With Pain

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

This protocol is for a pragmatic mixed methods randomized parallel-group exploratory feasibility trial to examine all facets of a proposed future phase III trial on the use of wearable device to increase physical activity and possibly reduce pain amongst middle-aged people with musculoskeletal (MSK) chronic pain. The feasibility study is intended to answer the following research questions: Question 1 Evaluate the acceptability of all aspect of the study design of wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain. Question 2: Is it feasible and acceptable to use wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain? Question 3: How can using wearable device promote physical activity effectively in middle-aged adults with musculoskeletal chronic pain? Participants will be recruited from a National Health Service (NHS) pain clinic and randomised on a ratio1:3 into control group (standard care) and intervention group (standard care combined with wearable device). The feasibility study will last for 18 months, participants involvement will be for 24 weeks. Patients in both groups can participate in any physical activity, including planned, structured, and repetitive bodily movement exercise or occupational and recreational PA. Qualitative semi-structured interview will be conducted at baseline and week-12, while outcome measures will be conducted at baseline, 4-week, 8-week,12-week, and 24-week for all participants to examine their pain, physical activity, and their responses to the trial. Qualitative interview will be conducted for stakeholders which include clinicians and service managers after all patient data has been collected. This study has the potential to make an original contribution to provide key data on the feasibility, acceptability, and effectiveness of using wearable technology to support physical activity intervention for middle-aged adults with musculoskeletal chromic pain.

NCT ID: NCT05860101 Recruiting - Clinical trials for Bipolar Affective Disorder

Compassion-Focused Therapy for Distressing Mood Swings: A Case Series

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

The goal of this case series is to investigate whether a brief compassion-focused intervention is a safe, acceptable and feasible therapy for clients with bipolar affective disorder. The secondary questions are whether a brief compassion focused intervention for BPD clients is associated with changes in bipolar mood symptoms and/ or with changes in psychological processes linked to mood symptoms in bipolar, including: Self-compassion, perfectionism, social comparison and social safeness. Four visual analogue scales will also be completed daily by each participant throughout the project. These scales will measure domains relevant to BPAD symptomology and self-compassion. Participants will complete a 4 session Compassion-Focused Therapy Intervention. The first session will involve completion of the psychoeducation and formulation work which was started during the initial assessment session. Each intervention session will also involve the introduction and practice of CFT techniques or exercises. The trial therapist will introduce the exercise and practice it together with the participant during the session. Participants will then be asked to continue practicing the exercises for homework. Their experience of the practice and any difficulties can then be discussed at the start of the next session.

NCT ID: NCT05859828 Recruiting - Clinical trials for Head and Neck Cancer

The GOAL27-6 Study

Start date: April 21, 2022
Phase:
Study type: Observational

The main purpose and goal of this study is to find out if a particular course of radiotherapy for non-curable cancers, together with palliative care support, can help improve patients' quality of life.

NCT ID: NCT05859438 Recruiting - Dysarthria Clinical Trials

INcorporating VoIce acTivated Communication Aids Into Everyday Communication

INVITE
Start date: May 2023
Phase: N/A
Study type: Interventional

Dysarthria is a speech disorder resulting in speech that is slow, slurred and difficult to understand, limiting a person's opportunities to study, work, and develop relationships. People with dysarthria often use communication aids to help them to communicate creating spoken messages using a keyboard, touchscreen or joystick. Communication aids can increase independence but are often too slow to keep pace with normal conversation. Developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output. The investigator's previous research provides some evidence that these voice input communication apps may be faster than traditional communication aids. This study aims to find out who can benefit from this technology, and what support they will need to use it successfully. This information can be used by professionals involved in providing communication aids, and will help the investigators to plan further research into their effectiveness. This research has two phases: 1. 20-30 individuals with dysarthria will be asked to use a voice input communication app for 6 months. The investigator's will collect information on whether VocaTempo improves their communication, and helps participants to reach their goals. 2. Focus groups will be held with professionals involved in providing and supporting people with communication aids, to understand factors affecting their ability to provide the support identified as needed in part 1 of the research. The investigators have a panel of communication aid users, who are advising and contributing throughout the study, for example, helping the investigators to identify informal support networks to recruit participants from. The investigators will let people know about the findings through support groups used by people with dysarthria, publications read by people involved in providing communication aids, and academic papers and conferences.