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NCT ID: NCT05737485 Recruiting - Clinical trials for Primary Ciliary Dyskinesia

Study Evaluating the Safety and Tolerability of RCT1100 in Healthy and PCD Subjects

Start date: February 18, 2023
Phase: Phase 1
Study type: Interventional

This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.

NCT ID: NCT05735639 Recruiting - Clinical trials for Venous Thromboembolism

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

THRIVE
Start date: January 22, 2024
Phase: Phase 4
Study type: Interventional

Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg (known as deep veins). Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening. Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures. This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.

NCT ID: NCT05734963 Recruiting - Cancer Clinical Trials

ORganoid GeneratioN Study for Cancer

ORIGINS
Start date: April 4, 2022
Phase:
Study type: Observational

ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers

NCT ID: NCT05734196 Recruiting - Clinical trials for Pseudoxanthoma Elasticum

The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency

ENERGY
Start date: June 25, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of Study INZ701-104 (the ENERGY study) is to assess the safety and tolerability of INZ-701 in infants with ENPP1 Deficiency or with ABCC6 Deficiency.

NCT ID: NCT05734105 Recruiting - GIST Clinical Trials

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

INSIGHT
Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

NCT ID: NCT05733299 Recruiting - Asthma Clinical Trials

Aflo™ Device Trial

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

This randomised, prospective, controlled parallel study aims to evaluate the role and potential of the aflo™ digital platform for improving asthma control, inhalation technique and adherence in patients who use metred dose inhalers (MDI). The study will recruit 104 patients with uncontrolled asthma in the North-West of Northern Ireland. Fifty two patients will remain on standard care over 24-weeks and 52 will combine standard care with the aflo™ platform. The data collected over a 24-week period will be used to determine 1. whether the aflo™platform improves inhalation technique and user adherence to prescribed medication and 2. Lead to better asthma control and reduced symptoms as measured by the Asthma Control Test (ACT). During the study clinicians will be able to remotely monitor and review user analytics via a clinical dashboard. ACT measurements will be recorded at start and end of study. The study aims to test the functionality and impact of automated inhaler technique with real-time feedback, adherence prompts and air quality data sharing for patients who use metered dose inhalers (MDI) using the newly developed aflo™ digital respiratory management platform.

NCT ID: NCT05733143 Recruiting - Asthma Clinical Trials

Using Exercise-testing to Explore Patient Differences in Severe Asthma

Start date: July 18, 2023
Phase:
Study type: Observational

The goal of this observational pilot study is to use exercise-testing to assess patients with severe asthma who have high levels of breathlessness and compare them to other groups of patients with low levels of breathlessness. We will compare the background and overall fitness levels in all groups. This may provide new knowledge to why these patients remain breathless despite being on treatment with low levels of inflammation. The main question we aim to answer is: "How are these patients different compared to patients who respond to treatment?" We will look at reasons why patients with low levels of inflammation in their lungs are still breathless despite being on treatment. Participants will be required to take part in a 6-month study were they will firstly attend a "study visit" and a 6 month follow up. At the study visit participants will be consented and required to: - Complete questionnaires on their symptoms - Provide information on their background - Undergo a physical examination - Provide blood and urine samples for specific testing for asthma and future investigations - Perform breathing tests - Undergo an exercise-test on a treadmill During this study, researchers will compare this group will to participants who are similar but whose symptoms respond to treatment. We will also look at other groups of asthma patients who have who have different levels of inflammation in their lungs to see if there are any differences. We predict, these patients will have a different background and features to those whose symptoms respond to treatment.

NCT ID: NCT05732870 Recruiting - Osteoarthritis Clinical Trials

OSTEOMICS: Identifying Regulators of Bone Homeostasis

OSTEOMICS
Start date: January 12, 2023
Phase:
Study type: Observational

Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS. A number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets. We will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality. Over the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.

NCT ID: NCT05732480 Recruiting - Pancreatitis Clinical Trials

Influence of Gut Microbiome in Gallstone Disease

Start date: May 30, 2023
Phase:
Study type: Observational

The goal of this prospective observational study is to explore the role of the gut microbiome in patients with gallstone disease. The main question[s] it aims to answer are: - if there is a relationship between the gut microbiome and the development of complications associated with gallstone disease (such as pancreatitis and acute cholecystitis) - if there are changes in the gut microbiome following cholecystectomy and the relationship with patient outcomes. Participants will be asked to provide stool samples at fixed time points (recruitment, pre- and post-cholecystectomy if applicable and at 6 months and 3 years. They will also be asked to provide stool samples if they represent to hospital with complications associated with their gallstone disease.

NCT ID: NCT05732402 Recruiting - Lupus Nephritis Clinical Trials

An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

RUBY-3
Start date: March 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period.