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NCT ID: NCT04880213 Completed - Healthy Clinical Trials

Study of M5049 in Healthy Japanese and Caucasian Participants

Start date: May 6, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate and determine the safety, tolerability and pharmacokinetics of single-doses of M5049 up to 3 dose levels administered as film-coated tablet under fasted conditions in healthy Japanese and Caucasian participants.

NCT ID: NCT04879524 Completed - Defecation Disorder Clinical Trials

Infracoccygeal Botox for Dyssynergia

Start date: August 6, 2021
Phase:
Study type: Observational

Background: Constipation is a common problem, affecting up to 20% of the population during their lifetime. Some patients respond poorly to standard treatments such as laxatives. A subgroup of these have dyssynergic defaecation where the muscles that control bowel movements fail to relax during pushing, preventing evacuation of stools. Currently, the mainstay of treatment requires muscle retraining by a therapist using a technique called biofeedback. Patients in whom biofeedback has failed are left with few options, one of which includes Botox injection into the pelvic floor muscles involved in the defaecation process. However, current method of injection is inaccurate and often requires anaesthesia. The investigators propose a novel technique for Botox delivery which reduces the risks and associated costs. Objectives: 1. The primary objective is to demonstrate technical feasibility of percutaneous infracoccygeal Botox injection as an alternative to transanal puborectalis muscle injection for the treatment of dyssynergic defaecation. 2. The secondary objectives are to assess the safety and acceptability of this technique, and to derive pilot clinical effectiveness data to inform future studies. Methods: The investigators will carry out Botox injection into the puborectalis muscle under ultrasound guidance in the outpatient department. This will be done by percutaneous injection below the coccyx where the puborectalis has been demonstrated to be easily accessible. An electromyography of the puborectalis is obtained before the injection to demonstrate proof of mechanism. The investigators will collect data using a combination of questionnaires, patient baseline data, and anorectal physiology test results before and after the treatment. Outcomes: - Feasibility: procedure duration, rate of identification of puborectalis by ultrasound scan and pre-injection EMG, procedure limitations, and successful injection rate - Safety: rate of adverse events - Acceptability: patient pain and comfort, willingness to undergo repeat procedure - Preliminary data on effectiveness: Cleveland Clinic constipation score, anorectal physiology test results

NCT ID: NCT04878744 Completed - Clinical trials for Mental Health Wellness 1

Feasibility Study of an App-based Intervention to Improve Wellbeing

IWUN
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to understand how different aspects of city living affect wellbeing. The investigators hope that the results from the study will inform town planners and policy makers about how city spaces can be designed for better health and wellbeing of residents. What? This study will test the use of a new intervention amongst adults with common mental health difficulties such as depression and anxiety. The intervention will be a smartphone app which will prompt users twice a day to notice and record the good things about green spaces or built spaces around Sheffield. Previous research has shown that engaging with the natural environment can benefit health and mental wellbeing. Who? Adults over 18 years old, who have a mild to moderate common mental health problem (such as depression or anxiety), and who own a smartphone will be able to participate. Where? Participants will use the app as part of their day to day routine as they travel around Sheffield and the surrounding area. The app will prompt them to notice green or built spaces around them. How? The app will be delivered as a 'green prescription' which means that health professionals will tell their patients about the intervention. If patients choose to take part, they will be allocated at random to either noticing the good things about green spaces or the good things about built spaces. This is to control for whether noticing green space or noticing other aspects of city life affects health and wellbeing. Patients will complete questionnaires about health, mental wellbeing and their feelings about nature, before, after and 3 months after using the app for one month.

NCT ID: NCT04877990 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Start date: May 7, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.

NCT ID: NCT04877769 Completed - Clinical trials for Healthy Volunteer Study

Bronchopulmonary PK of AT-527 (R07496998)

Start date: April 25, 2021
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)

NCT ID: NCT04876495 Completed - Clinical trials for Appetite and General Nutritional Disorders

The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men

PROTEIN
Start date: July 20, 2018
Phase: N/A
Study type: Interventional

INTRODUCTION: Global protein consumption has been increasing for decades due to changes in socio-economic demographics and consumer trends towards higher protein intake, which may be related to their health benefits in performance nutrition and appetite regulation. The additional intake of protein often occurs in the form of supplements. One of the main ingredients used in sports and weight loss supplements are animal-derived proteins such as whey, which are of high quality, containing all the essential amino acids required in human nutrition with a high absorption rate. However, whey protein has a high environmental footprint, and it may contribute to insulin resistance in susceptible groups (e.g. obese, T2DM, insulin resistant, or those with sarcopenic obesity). Rice and potato protein isolates are high-quality plant proteins containing all essential amino acids comparably to whey protein. These plant-derived proteins may provide a more sustainable and accessible alternative to animal-derived proteins for appetite regulation and weight management.

NCT ID: NCT04875377 Completed - Iodine Deficiency Clinical Trials

Seaweed Iodine Delivered Via Food or Supplementation

INNOVATE
Start date: February 12, 2018
Phase: N/A
Study type: Interventional

In this project, the investigators propose an intervention design testing the efficacy of a food reformulated with seaweed as an ingredient in meal, capsules against placebo and no intervention controls. The randomised control trial (supplementation) will last 24 weeks. The aim is to study the effect of the food matrix on variables associated with iodine nutrition: iodine status and thyroid function.

NCT ID: NCT04875117 Completed - Fatigue Clinical Trials

Fatigue and Hearing Loss.

Start date: April 4, 2018
Phase:
Study type: Observational

An intervention group and a control group will complete a battery of questionnaires at four time points to investigate the impact of first-ever hearing aid fitting on fatigue and associated variables. The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care.

NCT ID: NCT04873466 Completed - Quality of Life Clinical Trials

The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.

NCT ID: NCT04871971 Completed - Healthy Clinical Trials

Glycaemic Response and Insulinaemic Response for Nutralys S85 Plus and Whey Protein

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

A comparison of the glycaemic response and insulinaemic response to glucose, Nutralys S85 Plus pea protein and whey protein using a single-blind, randomised, repeat measure, crossover design trial.