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NCT ID: NCT06413225 Not yet recruiting - Clinical trials for Cervical Degenerative Disc Disease

Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc®

Start date: September 1, 2024
Phase:
Study type: Observational

This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.

NCT ID: NCT06412939 Not yet recruiting - Fractures, Bone Clinical Trials

Retrospective Study on Clinical Performance and Safety Profile of Agile Nail

Agile
Start date: June 2024
Phase:
Study type: Observational

This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals.

NCT ID: NCT06412913 Not yet recruiting - Fractures, Bone Clinical Trials

Retrospective Study on Clinical Performance and Safety Profile of MJ-Flex Elastic Nail

MJ-Flex
Start date: June 2024
Phase:
Study type: Observational

This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the MJ-FLEX elastic nail used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals.

NCT ID: NCT06412341 Not yet recruiting - Clinical trials for Breast Cancer Female

Feasibility Study of ABC for Women Treated for Breast Cancer

Start date: May 5, 2024
Phase: N/A
Study type: Interventional

The investigators aim to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) to test whether receiving ABC (an online-delivered, Cognitive Behavioural Therapy [CBT], group-based, body image programme) alongside a psychoeducational body image booklet provides greater benefits to women treated for breast cancer compared to a receiving a psychoeducational body image booklet alone. Results from this feasibility study will inform the design, management, and future delivery of a definitive randomised controlled trial to assess effectiveness and cost-effectiveness of ABC. Specific objectives are to: - Establish appropriate, inclusive, and acceptable methods of participant recruitment, retention, and management procedures. - Establish the feasibility and acceptability of quantitative data collection, including determining appropriate primary and secondary outcome measures. - Adapt and test a measure of health and social care service use, to inform a future economic evaluation. - Establish intervention adherence and acceptability (of online setting) among participants and ABC facilitators. Participants will be randomised to either the intervention or control arm. The control arm will receive the Macmillan Cancer Support psychoeducational body image booklet. The intervention arm will receive the Macmillan booklet and the ABC programme, a 7-session, CBT group-based programme delivered online. All participants will complete self-report validated outcome measures at weeks 1 (T1; baseline/pre-intervention), 9 (T2; immediate post-intervention), 20 (T3; three-month post intervention), and 32 (T4; six-month post intervention). Following drop-out or completion of all study procedures, a subset of participants will be invited to take part in interviews.

NCT ID: NCT06412276 Not yet recruiting - Eating Behavior Clinical Trials

Out-of-home Consumer Food Purchase Behaviour in the Presence and Absence of Value Pricing and Price Promotions

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

It is important to understand the role that price-based incentives in the out-of-home food sector play in food purchasing, and whether they lead to positive savings for the consumer (as they would likely anticipate when making purchases), or whether these incentives lead to increased spending and increased purchasing of unhealthy products. Additionally, it is important to consider whether the impacts of price-based incentives differ according to a range of demographic characteristics. For example, some evidence suggests that effects of removing a price-based incentive are greater in individuals with a higher BMI(22). Evidence also suggests there may also be differences in impact according to socioeconomic position (SEP) as individuals in lower SEP groups reportedly use price-based incentives more frequently(23). If lower SEP individuals are more affected by price-based incentives (i.e. they prompt ordering in excess and greater spend), then the banning of such strategies could help to reduce health inequalities, by nudging lower SEP consumers toward healthier dietary choices in the OOH food sector. To date, it is unclear what effect policies which remove specific types of price-based incentives would be likely to have on consumer behaviour. In particular, individual product price reductions (e.g. £ off this product), bulk buy price reductions (e.g., Save £ when bought together) and volume value pricing (e.g., the price increase from a small to large portion size not being directly proportional to volume increase). Therefore our primary objectives are: • To observe the effect of removing price-based incentives (individual product price reductions, bulk buy price reductions, volume value pricing) in the OOH food sector on: - Energy purchased per household - Money spent per household Secondary Objectives: • To explore whether any effects of removing price-based incentives differ based on participant characteristics (BMI, SEP, food choice motives)

NCT ID: NCT06409598 Not yet recruiting - Chronic Stroke Clinical Trials

NOVEL Program for Stroke Telerehabilitation

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

Strokes are estimated to be the third most common cause of death in the world and the second most common cause of disability. Recently, the incidence of stroke has increased due to population aging. It is common for stroke survivors to experience a functional decline in their capacity to carry out daily activities as a consequence of their increasing dependence, which ultimately affects motivation levels, self-efficacy, and quality of life. Following a stroke, people often experience problems with upper limb function. Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward. A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance, but such interventions are difficult to access. As a cutting-edge method of neurorehabilitation, extended reality technology like virtual reality provides a more intensive simulation of functional activities than traditional physical therapy methods (aerobic, resistance, flexibility exercises, balance and coordination training, and functional exercises. The non-immersive type of VR can provide the patient with a safe experience so they can practice their exercises using gamification features integrated into the VR system, while remaining aware of their surroundings. According to the most recently published studies, there is promising evidence regarding the use of home-based exercises in stroke management especially after the Covid-19 pandemic. However, there is still a gap in identifying the evidence for using non-immersive home-based virtual reality exercises as telerehabilitation on the upper limb function and balance motor outcomes, adherence, and compliance with rehabilitation programs. In addition, no study have evaluated the validity and fidelity of the gamified features that can be added to the non-immersive VR exercises in terms of improving patient adherence and experience to their rehabilitation program. Moreover, we still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team.

NCT ID: NCT06405230 Not yet recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Patient-derived Organoids and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

Start date: August 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate the utility of two biomarker tools: Patient-derived organoid (PDOs) and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

NCT ID: NCT06404229 Not yet recruiting - Clinical trials for Surgery-Complications

Use of CPETarm for Risk Stratification of Patients With CLTI

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.

NCT ID: NCT06403475 Not yet recruiting - Aphasia Clinical Trials

Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke

TRANSLATES
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

Aphasia is an acquired language disorder. Stroke is the most common cause of aphasia, which affects 30% of stroke survivors. Speech and Language Therapy (SLT) can help people with aphasia but it may not be provided at the required intensity. Access to therapy is often limited after the first few months following stroke. People with aphasia can improve with therapy many years after stroke but these benefits have not been found to translate to day to day conversation. Transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive technique which involves stimulating a branch of the vagus nerve through the skin of the ear, using a small earpiece. This technique is safe and has been approved for use in headache. There is promising evidence that tVNS can improve motor rehabilitation in chronic stroke. This technique may be helpful in aiding language recovery in individuals with chronic aphasia. The current pilot study will primarily assess the feasibility, safety and tolerability of self-directed tVNS paired with computer-based SLT, in individuals with chronic stroke-related aphasia. Secondly, the study aims to explore the effect of the intervention on word-finding ability and to explore potential mechanisms of action. Participants will be randomly allocated to an active or sham tVNS group. Participants will be asked to use the stimulation device at home for 6 weeks, whilst completing computer-based SLT. To date, there are no published studies exploring the use of tVNS in aphasia. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.

NCT ID: NCT06402578 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

A 12-week Digital Physical Activity Programme, With or Without Physical Education Support for Type 2 Diabetes Patients.

Start date: June 2024
Phase: N/A
Study type: Interventional

Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.