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NCT ID: NCT06412263 Completed - Clinical trials for Assessment of Pain After Root Canal Treatment

Pain Following Root Canal Treatment

PfRCT
Start date: November 5, 2021
Phase:
Study type: Observational [Patient Registry]

This study is a prospective clinical study, which evaluates pain following the completion of non-surgical root canal treatment and re-treatment cases. The study is planned to take place from October 2021 until April 2022. Patient cohort would be patients referred to the Edinburgh Dental Institute for root canal treatment. Root canal treatment and re-treatment cases will be performed by Postgraduate Trainees (Years 1,2 and 3) in Endodontology and Prosthodontics, core trainees, specialist registrars in the Restorative Departments and staff members of the Restorative Department, Edinburgh Dental Institute. (Please refer to Appendix 1) Patients who are deemed suitable for this study, screened by clinicians on duty during Restorative New Patient Clinics, will be invited to participate in this study. They will be given the Patient Information Sheet (PIS) at the beginning of the session and will be given time to decide on whether to participate in the study or not. If a suitable patient happens to not have the PIS and consent form during the 1st treatment visit, the patient will be provided with the PIS and consent form during the 1st treatment visit and will be given up to 24H to decide on participating in the study or not. The pre-operative assessment, which will include pain assessment will be conducted as per normal routine prior to the commencement of RCT. At 24H (+/- 2H) the Principal Investigator will call the patient to follow-up. If the patient has agreed to participate in the study, the 24H post-operative pain and quality of life assessment will be conducted at the same time. Once patients have agreed to participate, they will be required to provide written consent which will be attached together with the PIS. On the first treatment day, patients will be required to answer a pre-operative Pain Assessment Questionnaire, which will be answered in the presence of the clinician treating the patient, before the commencement of RCT. The Pain Questionnaire is the combination of Numeric Rating Scale (NRS) and Modified Verbal Rating Scale (MVRS) adapted from previous published studies, with the addition of question on the presence of pre-operative pain duration. The pre-operative questionnaire will incorporate questions on pain intensity, the need, name and dosage of painkillers used by the patient on that day, and the last dose taken (in hours) as well as the duration of pain felt, as the longer the duration of pre-operative pain felt has been associated with higher incidence of post-operative pain (Polycarpou et al., 2005). Also, pre-operative pain felt within the last 24 hours prior to root canal treatment has been associated with higher probability of post-operative pain (Arias et al., 2013). Following the completion of treatment, patients will be provided with post-operative Pain Assessment Questionnaire, for the evaluation of post-operative pain. A copy of the pain questionnaire will be given to the patients which will be used as a guide when the pain history is obtained. This will be carried out verbally via phone by the main investigator of the study (NAF). Patients will not be required to return the forms to the institute. In addition to pain evaluation, this Pain Questionnaire also incorporates the intake of painkillers taken. In the event that painkillers are taken by patients for pain control, patients are required to record the pain intensity before the consumption of painkillers, apart from recording the dosage and frequency of painkillers taken. Patients will be advised on the standard painkiller regimen as a post-operative instruction after the completion of RCT. Painkiller consumption is also an indirect measure of post-operative pain intensity, hence, that is why this has been added to the Pain Assessment Questionnaire. Apart from the pain assessment, post-operative quality of life post-treatment will also be assessed, based on the questionnaire adapted from Pasqualini et al., 2016 and Mijiritsky et al., 2020. Patients will be given the liberty to pull out from the study at any time, throughout the duration of the study. Similarly, the investigator will also be able to remove patients from the study, throughout the duration of the study, in the event that the teeth being root-treated were faced with complications that may alter the accuracy of the study. Withdrawal or removal will be recorded in the 'Withdrawal/ Removal Form'.

NCT ID: NCT06411964 Recruiting - Muscle Loss Clinical Trials

Galactooligosaccharide and Aging

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

Sarcopenia is a progressive muscle disease, most commonly affecting older individuals, that is categorised by 1) low muscle strength, 2) low muscle quantity or quality, and 3) low physical performance. This disease has several negative implications for human health, including an increased risk of falls, fractures, mobility limitations, and mortality. Sarcopenia also imposes significant burden on healthcare systems. For example, it was estimated that a 10% reduction in the prevalence of sarcopenia would save the US healthcare system $1.1 billion per year. Strategies to reduce the incidence and severity of sarcopenia are therefore of great interest. One potential cause for sarcopenia is long-term, low-level inflammation, which can occur for a number of reasons. One cause may relate to the intestinal wall becoming more susceptible to leaking of toxic particles. Evidence suggests that prebiotic supplementation can reduce this 'leakage'. Galactooligosaccharide (a prebiotic) has previously been shown to reduce inflammation in elderly individuals. The investigators hypothesise that galactooligosaccharide will improve physical function in the elderly indirectly via a reduction in inflammation. This will be a randomised, placebo-controlled, double-blind, parallel study. 32 elderly individuals (65-85 years; mix of males and females) will be randomised to one of two groups, GOS or PLACEBO. The GOS group will supplement their diet with 2.9 g galactooligosaccharide per day for 16 weeks in the form of one sachet (3.65 g) of Bimuno® Daily. The PLACEBO group will supplement with 3.65 g maltodextrin per day for 16 weeks. The study will involve one screening visit and two main trials (baseline and 16 weeks). For the main trials, participants will complete the short physical performance battery (SPPB) and handgrip strength test. In addition, participants will provide blood, urine and faecal samples, as well as a dual-energy x-ray absorptiometry (DEXA), and a peripheral quantitative computed tomography (pQCT) scan.

NCT ID: NCT06411912 Recruiting - Clinical trials for Spinal and Bulbar Muscular Atrophy

A Study of NIDO-361 in Patients With SBMA

PIONEER KD
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of NIDO-361 in adult patients with Spinal and Bulbar Muscular Atrophy (SBMA).

NCT ID: NCT06411405 Recruiting - Neonatal Sepsis Clinical Trials

Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe

NeoRisk
Start date: April 11, 2024
Phase:
Study type: Observational

The goal of this observational study is to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe. The main questions it aims to answer are: - What are the risk factors for early-onset neonatal sepsis in low-resource settings? - How can these be combined into a risk prediction model? Mother-baby pairs will be recruited in Uganda. They will have extensive data taken on their medical and obstetric histories and lifestyles, and their newborns will have a blood sample taken just after birth for culture. Machine learning techniques will be used to create the risk prediction model, which will then be validated in a second population in Zimbabwe.

NCT ID: NCT06411119 Completed - Healthy Clinical Trials

Virtual Reality Exergaming on Heart Rate, Perceived Exertion, and Technology Acceptance in Healthy Individuals

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

This pilot cohort study aimed to investigate the immediate impact of Virtual Reality (VR) exergaming on heart rate (HR), rate of perceived exertion (RPE), and technology acceptance using the Unified Theory of Acceptance and Use of Technology (UTAUT) in healthy adults. Participants engaged in a 20-minute session of VR exergaming using the Meta Oculus Quest 2™ headset. HR and RPE were measured at baseline, during, and after the intervention, while technology acceptance was assessed pre- and post-intervention using the UTAUT questionnaire. The results showed that VR exergaming increased HR while maintaining perceived exertion at low to moderate levels. Technology acceptance also improved significantly across all domains measured by UTAUT, with particularly notable increases in Performance Expectancy and Effort Expectancy. The findings suggest that VR exergaming is an effective method to enhance physical activity, motivation, and engagement, providing promising support for its use as a rehabilitation tool for individuals struggling with adherence and motivation.

NCT ID: NCT06410976 Recruiting - Hypochondroplasia Clinical Trials

Prospective Clinical Assessment Study in Children With Hypochondroplasia

HCH
Start date: June 5, 2024
Phase:
Study type: Observational

This is a long-term, multicenter, non-interventional study of children ages 2.5 to <17 years with hypochondroplasia (HCH).

NCT ID: NCT06409806 Suspended - Brain Injury Clinical Trials

Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

EMBRI
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments. Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.

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

NOVEL Program for Stroke Telerehabilitation

Start date: July 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, the investigators still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team.

NCT ID: NCT06409585 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition

CHIEFTain
Start date: May 1, 2023
Phase:
Study type: Observational

Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities. These abnormalities of the heart muscle can lead to major issues such as symptoms of heart failure, dangerous heart rhythm disturbances and even death. However, a lot of these conditions are still not fully understood and treatment options are limited. We here aim to use a new radioactive dye called 68Ga-FAPI to identify patterns and the activity of heart muscle scarring. This radioactive dye is being used in humans particularly in identifying and monitoring cancers and has shown promise in identifying scarring in the heart as well. This will help us not only understand the underlying disease process and risk stratify these patients but also potentially help us develop new targeted therapies that can affect heart muscle scarring. Participants will undergo a baseline MRI scan using this new dye and a plain MRI scan will repeated 12-18 months after to see if there are any changes in the process.

NCT ID: NCT06409221 Enrolling by invitation - Clinical trials for Triple Negative Breast Cancer

VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study

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

Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis. There is an urgent need to identify reliable biomarkers of response for chemotherapy and immunotherapy. Study Aims: To update Concr's existing predictive algorithms specifically for use in women newly diagnosed with TNBC. The plan is develop technology which will predict which drug the cancer will respond best to, treatment A vs. treatment B AND how the individual's prognosis could change if treatment A is chosen overtreatment B. Study Design: The VISION study is a clinical study looking back in time (retrospective study), specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery. The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concr's existing treatment prediction algorithms. Hence there are no extra research biopsies needed in order to participate in the Study. Study Sites: UK and Australia Study Funding: This study is funded by the a Techbio company called Concr with support from Innovate UK (UK Government funding).