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NCT ID: NCT04790019 Completed - Bone Resorption Clinical Trials

The Effects of Low Energy Availability and High Impact Jumping on Markers of Bone (re)Modelling in Females

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Osteoporosis is worldwide health epidemic categorized by poor bone health, primarily diagnosed by low bone mineral density, and costs healthcare systems billions every year. Athletes and exercising people who expend large amounts of energy in physical activity, or restrict diet in order to lose weight, are at risk of low energy availability. This is when an individual fails to match their exercise energy demand with a appropriate dietary intake in order to maintain optimal physiological function; which can lead to low bone mineral density, osteoporosis both early and later in life and an increased risk of injury. Runners are particularly susceptible to stress fracture in response to low energy availability due to repetitive ground impact. Research shows that as little as five days low energy availability significantly reduces bone formation, and significantly increases bone resorption, in physically active women. The ideal solution is to restore energy availability; however, this is often very difficult during periods of intense training and conflicts with the goal of weight loss. Therefore, there is a need to develop an alternative tool to protect bone health. It is critical that any exercise intervention does not further reduce energy availability as previous research shows that this accelerates bone loss rather than prevents it. Low repetition high impact jumping exercise is highly beneficial to bone health and has been shown to improve bone structure when used as a long-term intervention in energy replete states. It takes very little time to complete and uses a very small amount of energy. However, no study to date has examined the effects of such an intervention during low energy availability. The current study will investigate whether low repetition high impact jumping prevents or reduces the reduction in bone formation and the increase in bone resorption experienced during five days of low energy availability and findings will have implications on athletic and recreational training recommendations in order to protect bone health.

NCT ID: NCT04789174 Completed - Clinical trials for Obstructive Sleep Apnea

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

SHARP
Start date: May 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.

NCT ID: NCT04788745 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)

MetFlex
Start date: June 29, 2021
Phase: Phase 2
Study type: Interventional

MetFlex is an investigator led, open-label, single-arm, Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND).

NCT ID: NCT04788511 Completed - Obesity Clinical Trials

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

STEP-HFpEF
Start date: March 16, 2021
Phase: Phase 3
Study type: Interventional

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04788199 Completed - Bariatric Surgery Clinical Trials

Novel Technique in Closure of Mesenteric Defects After Laparoscopic Roux-en-Y Gastric Bypass and Its Effect on Internal Hernia: a Case-control Study

Start date: June 15, 2018
Phase:
Study type: Observational

This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue.

NCT ID: NCT04787393 Completed - Heart Failure Clinical Trials

Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot

LOVE-HF-2
Start date: June 7, 2022
Phase:
Study type: Observational

Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited in the LOVE-HF-2 trial at Blackpool Victoria Hospital. The main objective of the study is to test if the Heartfelt device is sensitive to change across the full range of the individual patient's oedema. The participants will be given the Heartfelt device to use in their home. This device automatically and passively measures patient's foot and lower leg's volume without the patient having to remember to do anything. The patients will be seen face to face with a cardiologist to evaluate peripheral oedema using standard clincial technics as well as overall congestion level. The investigators aim to recruit 30 participants for the observational pilot study. The study follows its sister pilot trial, LOVE-HF (NCT04787380).

NCT ID: NCT04787380 Completed - Heart Failure Clinical Trials

Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure

LOVE-HF
Start date: March 5, 2021
Phase: N/A
Study type: Interventional

Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited for the LOVE-HF trial at Blackpool Victoria Hospital. Eligible participants will be randomized to use the Heartfelt Device alongside standard care (weighing + symptom reporting), or standard care alone. Participants and clinicians will be blinded (double blind) as to which arm participants are in, and after 30 days, participants will be crossed over to the other arm. This can be done without disrupting patients as the Heartfelt device can be switched remotely from a 'technical checks only' mode to a 'full data analysis' mode and vice versa. The investigators aim to recruit 30 participants for the pilot study. The study will also run in parallel with its sister pilot trial, LOVE-HF-2. Through this study, we are testing the capability to get the answers from patients, healthcare systems, and devices, in order to inform future clinical trial design.

NCT ID: NCT04786080 Completed - Mental Health Issue Clinical Trials

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

SPARKLE
Start date: May 19, 2021
Phase: N/A
Study type: Interventional

Throughout the COVID-19 pandemic, reduced access to childcare, money- and health-related worries and extended confinement and social isolation have placed great pressure on many families. There is evidence that many parents in the UK have struggled to manage their children's behaviour. For instance, Co-SPACE, an ongoing UK-wide study led by the University of Oxford, found a significant increase in parents reporting behavioural problems in children and an increase in family-related stress in response to various local and national lockdowns. Co-SPACE has also found up to 70% of parents reported wanting additional support. The SPARKLE (Supporting Parents and Kids through Lockdown Experiences) study aims to address this pressing need. SPARKLE is a rapid-deployment randomised controlled trial evaluating whether a digital public health parenting intervention can help parents to manage their children's behaviour problems, as impacted by the COVID-19 UK pandemic and lockdowns. We aim to evaluate whether the negative effects of the pandemic can by reversed by providing parenting advice digitally, using a specially-designed app, Parent Positive. The Parent Positive app will provide advice to parents through animations, delivering messages carefully selected by parents and experts in the field. The messages will be supplemented with practical parenting resources and an opportunity to network with other parents for peer support. The animations are light-hearted, humorous and non-judgmental and are delivered by eight high-profile celebrities who are also parents. The SPARKLE study will involve 616 Co-SPACE parents, half of whom will receive access to the Parent Positive app and half who won't.

NCT ID: NCT04785612 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults

Start date: November 10, 2020
Phase: Phase 2
Study type: Interventional

In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and challenged with RSV one month later. The purpose of this research study is to assess the safety, immunogenicity and efficacy of RSVpreF using a human viral challenge model.

NCT ID: NCT04784962 Completed - Surgery Clinical Trials

NMES for Rehab After Surgery

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

A randomised pilot study assessing the acceptability and feasibility of utilising neuromuscular stimulation devices to enhance post-operative rehabilitation and recovery after general, vascular and urological surgery procedures.