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NCT ID: NCT05354219 Recruiting - Clinical trials for Mucopolysaccharidoses

Validation and Reliability of Iris Cameras in Mucopolysaccharidoses

Start date: March 8, 2023
Phase:
Study type: Observational

To assess the reliablity and validity of 2 new iris cameras in the assement of corneal opacification in mucopolysaccharidoses

NCT ID: NCT05352672 Recruiting - Melanoma Clinical Trials

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life

NCT ID: NCT05351177 Recruiting - Clinical trials for Overweight and Obesity

8-Weeks of High-Intensity Interval Training or Concurrent Training in Overweight and Obese Adult Males

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

Overweight and obesity is becoming increasingly prevalent, constituting 64% of all adults in England, causing an incessant rise in cost to the National Health Service. Exercise and physical activity have the potential to reduce incidence of overweight and obesity, as well as improve obesity-related ill health. However, overweight and obese individuals are inherently sedentary and do not meet exercise guidelines. Same-session concurrent exercise training may be the most efficient exercise strategy to incorporate both cardiovascular- and strength-based exercise, both of which are vital for health-related benefits. This research project will aim to determine the feasibility of completing an 8-week concurrent exercise training programme in overweight and obese sedentary males. This study will aim to recruit adult males with a BMI above 25 kg.m2, who are otherwise healthy, but not regularly achieving exercise guidelines (less than 150 minutes of physical activity and 2 strength training sessions per week). Participants will undergo baseline and post-training testing of cardiorespiratory fitness, strength, heart and metabolic health, as well as a series of questionnaires and a semi-structured interview. They will then be randomised into one of two groups (high-intensity interval training or concurrent training) to complete twice-weekly exercise sessions for 8 weeks. The aims of this study are to evaluate the feasibility of performing 8-weeks of either concurrent, resistance or high-intensity interval training in overweight and obese males. This will be determined through assessment of cardiorespiratory fitness, strength, heart health, metabolic health, enjoyment, adherence and attendance.

NCT ID: NCT05350436 Recruiting - Healthy Aging Clinical Trials

More Singing, Less Swinging - Is Singing Related to Improved Postural Control?

Start date: February 25, 2022
Phase: N/A
Study type: Interventional

This study will investigate the extent to which singing affects balance and breathing. Singing therapy has potential as an adjunct or component of falls prevention programmes and in the treatment of breathing hypervigilance. Reducing fall risk, and levels of hypervigilance and anxiety could have widespread benefits on participants participation and quality of life. Investigators will aim to recruit both singers and non singers from older and younger adult age groups. Investigators will then be able to determine the balance response in untrained healthy young adults to understand the affects of singing training and aging on balance. The participants' balance will be measured via a force plate as they perform a series of speaking and singing tasks. Other outcomes will include breathing specific anxiety and attention to breathing, and balance specific anxiety and attention to balance.

NCT ID: NCT05350020 Recruiting - Addison's Disease Clinical Trials

The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles

Start date: March 14, 2022
Phase: Phase 4
Study type: Interventional

The study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (Solu-Cortef® & Hydrocortisone 100mg/ml). The investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the thigh muscle.

NCT ID: NCT05349214 Recruiting - Sjogren Syndrome Clinical Trials

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-2
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

NCT ID: NCT05348785 Recruiting - Parkinson Disease Clinical Trials

A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80

LUMA
Start date: April 19, 2022
Phase: Phase 2
Study type: Interventional

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study: - Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it. - Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. - Certain medications for PD will be allowed at enrollment for a subset of participants. - Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.

NCT ID: NCT05348577 Recruiting - Prostate Cancer Clinical Trials

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

CAPItello280
Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.

NCT ID: NCT05348499 Recruiting - Type 1 Diabetes Clinical Trials

Impact of Hybrid Closed Loop Systems in People With Type I Diabetes

ProHCL
Start date: November 14, 2021
Phase:
Study type: Observational

Type 1 diabetes requires people with type 1 diabetes to constantly monitor their blood glucose and adjust their insulin doses to try and keep glucose levels in range. Hybrid closed loop systems (also called artificial pancreas) consist of a sensor that continuously measures glucose levels, an algorithm that then decides every few minutes how much insulin to deliver and an insulin pump that then delivers the insulin. These systems have been shown in observational and randomized studies to improve glucose levels and have high levels of user satisfaction. The National Health Service (NHS) in the UK has launched a pilot for up to 1,000 people with type 1 diabetes to trial these devices for up to 1 year and the results of that pilot will be audited by clinical teams. This study will recruit people from that pilot and use well validated as well as bespoke questionnaires to assess the impact of this technology on various key patient reported outcomes such as depression, diabetes related distress and fear of hypoglycemia (low blood glucose). We will invite a small number of participants to take part in semi-structured interviews to gain a more detailed understanding of the benefits and challenges of using these devices, and the impact they have on people living with type 1 diabetes. We know that living with a partner with type 1 diabetes can also have a negative impact on quality of life, and so we will invite partners of people using the hybrid closed loops systems to complete some validated and bespoke questionnaires. A small sample will also be invited to participate in interviews. The data from this real-world study of the impact of hybrid closed loop systems on patient reported outcomes will be of value to clinicians, people with type 1 diabetes and policy makers in understanding the value of these systems to people with type 1 diabetes and their families.

NCT ID: NCT05347745 Recruiting - Colo-rectal Cancer Clinical Trials

Therascreen® KRAS RGQ PCR Kit

Start date: January 7, 2022
Phase: N/A
Study type: Interventional

An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from patients with Colorectal Cancer (CRC) who have previously tested positive for the KRAS G12C mutation for potential inclusion into the Amgen Phase III clinical trial (Protocol No 20190172) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit