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NCT ID: NCT06283966 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

THARROS
Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

NCT ID: NCT06283212 Recruiting - Dravet Syndrome Clinical Trials

A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome

UK Only
Start date: April 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to < 48 months. The study follows and open-label, dose-escalation design.

NCT ID: NCT06282705 Completed - Clinical trials for Healthy Participants

Dose Response Effect of Drop Jumps on Bone Characteristics

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

The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants. The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals?

NCT ID: NCT06282432 Enrolling by invitation - Clinical trials for Leukocyte Adhesion Deficiency

Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I)

Start date: March 9, 2022
Phase:
Study type: Observational

This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene

NCT ID: NCT06281600 Recruiting - Clinical trials for Irritable Bowel Syndrome

An Intervention Study Using HMOs to Improve IBS Symptoms

GUT-HEAL-IBS
Start date: February 20, 2024
Phase: N/A
Study type: Interventional

There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms. IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life. IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" [8]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS. Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens [9]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation. Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high. Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS. This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over. With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies.

NCT ID: NCT06280391 Recruiting - Bronchiectasis Clinical Trials

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

Start date: February 20, 2024
Phase: Phase 2
Study type: Interventional

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: - The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. - The treatment duration will be up to 24-52 weeks. - The follow-up duration will be 20 weeks. - Site/phone visits are at a monthly interval.

NCT ID: NCT06280209 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy

Start date: January 3, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping.

NCT ID: NCT06280157 Enrolling by invitation - Clinical trials for Group B Streptococcus Infection

A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers

Start date: January 18, 2024
Phase:
Study type: Observational

The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations. Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.

NCT ID: NCT06277037 Not yet recruiting - Long Term Follow-up Clinical Trials

Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Start date: July 15, 2024
Phase:
Study type: Observational

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study [EOS] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

NCT ID: NCT06276335 Not yet recruiting - Dental Implant Clinical Trials

Influence of Timing of Implant Placement on Early Healing Molecular Events

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP). The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP).