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NCT ID: NCT06460090 Not yet recruiting - Clinical trials for Developmental Language Disorder and Language Impairment

Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.

HappyTalk
Start date: June 2024
Phase: N/A
Study type: Interventional

The overall aim of this clinical trial is to evaluate an at scale version of 'Happy Talk' in a large scale effectiveness study (examining inputs, outputs and outcomes) based on a sample of children from socially disadvantaged areas. Researchers will compare Happy Talk to usual care and children's allocation to the programme will be decided on randomly. The investigators also aim to - complete a pre-trial process evaluation to inform intervention implementation - examining factors which promote parental engagement and partnership between SLTs and educators and incorporating these into SLT training and future rollouts of the programme. - complete a concurrent process evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context and therefore what would need to be considered for successful implementation across varied settings. Our SWAT is embedded in this process evaluation and addresses the Trials Methodology Research Network methodological priority questions 1 and 5 https://priorityresearch.ie/priority-one-questions/ - Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard pre/school care. The study aims to answer the following research questions: When implemented at scale 1. Does 'Happy Talk', a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children? 2. Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts? 3. What programme features support successful real-world application of 'Happy Talk' including factors which promote parental engagement; partnership between SLTs and educators; and fidelity of implementation? 4. How do contextual factors influence Happy Talk implementation /outcomes? 5. How can trials become part of routine care? 6. Is Happy Talk cost effective compared to usual care? Intervention: The programme is informed by general systems theory and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour. There are both parent and preschool staff components to the programme.

NCT ID: NCT06453330 Recruiting - Clinical trials for Osseointegration Failure of Dental Implant

A Randomised Control Clinical Trial Investigating the Effect of H-PRF on Implant Stability and Marginal Bone Levels

Start date: May 17, 2024
Phase: N/A
Study type: Interventional

This research will be a randomised controlled trial (RCT) investigating whether the use of Horizontal Platelet Rich Fibrin (H-PRF) increases implant stability compared to those implants placed without H-PRF, and therefore, contributes to the implant's overall success. H-PRF is a second generation platelet concentrate that consists of a fibrin mesh containing cytokines and leukocytes. It has been shown to stimulate mesenchymal stem cells and osteoblasts that encourage bone formation as a result of the growth factors released from platelets, which should aid in osseointegration of implants. There is limited research that investigates the effects of H-PRF on implant stability. There is, however, some evidence that platelet-rich fibrin (PRF), which is produced in a fixed-angle centrifuge, increases implant stability and H-PRF is considered the evolution of PRF products. This research would follow a H-PRF preparation protocol which involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood. After the tube of blood is collected, it would immediately be placed in a horizontal centrifuge machine with 3 tubes of water to balance the centrifuge, and placed opposite each other. A set rpm and time will be chosen, and the centrifuge will run until the time is complete. The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells. Following randomisation, implants will be placed in the upper or lower jaws of patients attending the Dublin Dental University Hospital using the standard implant protocol. Half of the implants will be coated with H-PRF, the other half (control group) would be placed without HPRF. Implant stability and marginal bone levels will be measured at three different stages: 1) Initial implant placement, 2) Second stage surgery when the implant is uncovered after healing and integrated with the bone, 3) When the definitive crown or bridge is attached to the implant. Insertion torque at baseline will also be measured. The above results will be collected and assessed to determine the effects of H-PRF, if any, on implant stability and the preservation of bone levels around implants.

NCT ID: NCT06433557 Not yet recruiting - Achondroplasia Clinical Trials

A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia

COACH
Start date: June 2024
Phase: Phase 2
Study type: Interventional

This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.

NCT ID: NCT06432920 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study

ResWave
Start date: July 6, 2023
Phase: N/A
Study type: Interventional

The goal of this exploratory clinical trial is to evaluate the initial clinical safety and performance of a prototype wearable chest wall vibration (CWV) device intended to relieve exertional dyspnea in adults with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are: - Can CWV be delivered safely to participants via a wearable device? - Is there evidence of an effect on participant-reported dyspnea, endurance time and other measures of cardiorespiratory function? Participants will undergo two cycle-ergometer exercise testing sessions while wearing the prototype wearable device. The device will be active in one session (intervention) and inactive in the other (control). The order in which intervention or control occurs will be randomised. Researchers gather data relating to adverse events, device deficiencies, participant-reported symptom severity, endurance time and measures of cardiorespiratory function recorded via standard CPET apparatus.

NCT ID: NCT06424236 Terminated - Dementia Clinical Trials

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation

DIAN-TU
Start date: June 30, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

NCT ID: NCT06422884 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

Start date: September 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in these patient populations.

NCT ID: NCT06416254 Recruiting - Clinical trials for Overweight and Obesity

The Fibre Full Study

Start date: March 28, 2024
Phase: N/A
Study type: Interventional

This study will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (Body Mass Index (BMI) 25-35kg/m2). Hypothesis: The investigators hypothesise that a diet enriched in fibre will be beneficial to post-prandial glycaemic response, well tolerated and satiating, as compared to the standard Western-style diet.

NCT ID: NCT06413810 Not yet recruiting - Stress Clinical Trials

A Randomised, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of a Food Ingredient on Self-reported Stress in Healthy Adults

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this study is to investigate if a food ingredient can improve stress in healthy adults who experience moderate symptoms of self-reported stress. The main question it aims to answer is if 4 weeks of daily intake of the ingredient reduces stress compared to 4 weeks of daily intake of a placebo product. Participants will: - consume both the test and placebo products for 4-weeks each in a randomised order, with 4 weeks in between - visit the test site 6 times over the 13 weeks - complete a series of assessments on stress and sleep quality and provide blood, stool and saliva samples

NCT ID: NCT06411847 Recruiting - Compliance, Patient Clinical Trials

The Effectiveness of Virtual Appointments on Compliance With Twin Block Wear

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

The investigators aim to determine the effect of virtual appointments on compliance with Twin Block wear. Patients satisfying the inclusion criteria requiring a Twin Block appliance will be requested to participate in the study. Those selected will be allocated to either the intervention or control group. The control group will receive routine verbal instruction and a standard information leaflet at the start of their treatment. The intervention group will additionally receive virtual appointments over the initial period of treatment involving focussed discussion on twin block wear experience and use of visual aids. Wear time will be objectively recorded in both groups using a temperature-sensitive microsensor embedded in the Twin Block appliance, and occlusal changes will be measured at each standard recall visit. A comparison of the data obtained from each group will be undertaken to determine whether there is a significant difference in compliance with twin block wear between participants who receive adjunctive virtual appointments to those who do not.

NCT ID: NCT06410053 Recruiting - Infectious Disease Clinical Trials

The All Ireland Infectious Diseases Cohort Project

AIID
Start date: March 2011
Phase:
Study type: Observational

The All-Ireland Infectious Diseases (AIID) Cohort is a multicentre, prospective, longitudinal observational cohort that enrols consecutive adult subjects attending participating institutions for infectious disease services. This is an ongoing prospective observational cohort of unlimited duration.