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NCT ID: NCT05669755 Recruiting - Clinical trials for Cardiovascular Disease

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

REDEFINE 3
Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

NCT ID: NCT05669612 Recruiting - Clinical trials for Gastrointestinal Dysfunction

Promephy - Metabolic Fate of Plant-based Proteins

Promephy
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The PROMEPHY study aims to assess differences between animal versus plant-based proteins on metabolic and physiological parameters in healthy adults. It is envisaged that the results from this study will provide important and novel insights into the potential health-benefits of regular consumption of plant-based proteins. This may enable future application in products available to the consumer. The main objective of this study is to compare the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a plant-based protein mix with the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a milk protein isolate. In addition this study will aim to assess the impact of different protein sources on gut microbiota and proteome composition to determine the potential health impact of consumption of plant-based proteins.

NCT ID: NCT05669053 Completed - Body Image Clinical Trials

The Impact of Playing Super U on Pre-adolescents' Body Image

Start date: January 7, 2023
Phase: N/A
Study type: Interventional

Body image concerns can have serious physical and psychological consequences on young people, including anxiety, depression, risk taking behaviours, eating disorders and suicidal ideation. Micro-interventions (brief, low intensity interventions), offer an alternative to traditional, intense interventions that aim to immediately improve specific symptoms. Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among adolescents within digital and community settings. To date, utilising micro interventions in the world of gaming remains unexplored. Specifically, the Roblox platform which is hugely popular among young people (Roblox, September 2022). As such, the aim of the present study is to conduct a randomised controlled trial (RCT) to evaluate the immediate and short-term impact of a Roblox game, Super U story, on American children and adolescents' body image, mood, internalisation of appearance ideals and social media literacy. The primary outcome is immediate change in state-based body satisfaction. Secondary outcomes include immediate changes in state-based mood and body functionality and short-term changes in trait body esteem, body appreciation, internalisation of appearance ideals and social media literacy. The Super U story was developed through a collaboration between Dove (Unilever), Toya (game developers) and The Centre for Appearance Research. It was specifically designed to target sociocultural risk and protective factors for body image including social media literacy, appearance comparisons, positive body image and teasing/bullying around appearance. The comparison control conditions include an active control; an alternative Roblox game; Rainbow Friends story which has been matched to the intervention on style, length, and age appropriateness (omitting body image messaging) and an attention control whereby participants complete a series of word searches. To undertake the main trial, 1,479 girls and boys will be recruited through an external research agency. Participants will be randomised to one of three conditions: 1) the Super U story intervention, 2) alternative Roblox game or 3) attention control. All participants will be encouraged to play the game/word search for a maximum of 30 minutes, where they will be assessed on state-body image and mood immediately before and after completing the game/word search. All participants will be assessed on trait body esteem, body appreciation, internalisation of appearance ideals and social media literacy at baseline (one week pre-intervention) and again at one-week post intervention. At the end of the study, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body and eating concerns.

NCT ID: NCT05668741 Recruiting - Cystic Fibrosis Clinical Trials

A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)

Start date: February 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.

NCT ID: NCT05668689 Recruiting - Anesthesia Clinical Trials

URAISE: Ultrasound Regional Anaesthesia Interpretation Skill Evaluation

URAISE
Start date: February 13, 2022
Phase: N/A
Study type: Interventional

Prospective study based on psychometric principles.# To generate a validated test of ultrasound guided regional anaesthesia that can used to differentiate reliably between users of different skill levels. Primary outcome: Development of a validated, reliable and defensible tool to test ultrasound guided regional anaesthesia image interpretation skills. Secondary outcomes: Development a validated, reliable and defensible assessment tool assessing anatomical, clinical knowledge and the performance of ultrasound guided regional anaesthesia: Assessment of anatomical knowledge relevant to performing a local anaesthetic injection around peripheral nerves Assessment of clinical knowledge relevant to regional anaesthesia required to perform a local anaesthetic injection around peripheral nerves Assessment of knowledge relating to the performance of an ultrasound-guided local anaesthetic injection around peripheral nerve

NCT ID: NCT05668520 Enrolling by invitation - Huntington Disease Clinical Trials

A Pilot Study of Nutritional Status in Patients With Huntington's Disease

Start date: October 1, 2022
Phase:
Study type: Observational

It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. Our long term goal is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. We want to know which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.

NCT ID: NCT05668429 Completed - Fungal Disease Clinical Trials

ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects

Start date: December 14, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.

NCT ID: NCT05667662 Terminated - ABPA Clinical Trials

Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA

Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are: 1. Is PUR1900 safe and well tolerated in adults with asthma and ABPA? 2. Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA? 3. Is there fungal resistance to A. fumigatus? This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period. Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.

NCT ID: NCT05667493 Recruiting - Clinical trials for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Start date: November 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

NCT ID: NCT05667142 Recruiting - Clinical trials for Primary Generalized Tonic-Clonic Seizures

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

X-ACKT
Start date: February 14, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).