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NCT ID: NCT06156904 Recruiting - Clinical trials for Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

OSsIRIS
Start date: January 31, 2024
Phase:
Study type: Observational

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation. All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties. It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.

NCT ID: NCT06156046 Recruiting - Bee Sting Clinical Trials

Tolerance in Beekeepers

Start date: January 22, 2024
Phase:
Study type: Observational

Beekeepers experience multiple bee stings each year. Many of these beekeepers (25-60%) become sensitized to bee venom through the production of specific antibodies that target the bee venom. Although these antibodies are important in the triggering of an allergic reaction only a small number of sensitised beekeepers go on to have an allergic reaction with symptoms away from the site of the sting. These reactions can be severe and are known as anaphylactic reactions. The study investigates why some beekeepers develop severe allergic symptoms after bee stings while others do not. This study will explore factors in the blood that protect sensitised individuals from having anaphylactic reactions - meaning that despite being sensitised they are tolerant and do not react to subsequent stings.

NCT ID: NCT06154785 Recruiting - Colorectal Surgery Clinical Trials

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

CROSS
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

NCT ID: NCT06153719 Recruiting - Physical Inactivity Clinical Trials

The Effects of a 12-week Combined Exercise Intervention on the Gut Microbiome of Older Adults

Start date: December 2023
Phase: N/A
Study type: Interventional

There are trillions of microorganisms living alongside us in our guts. Recent research has shown that this community, known as the gut microbiome, has a big influence on our health and wellbeing. Imbalances in the composition of the gut microbial community has been linked to several diseases including COVID, mental ill health, and diabetes. When the composition of the gut microbiome changes towards a less healthy one (called dysbiosis) this will, in turn, affect our health in a negative way. The composition of our gut microbiome remains fairly stable during adulthood, however, as we move into older age, there is a shift and its composition will change to a less healthy one; this is one of the reasons why older people can be more susceptible to diseases. Fortunately, there are several tools that we can use to improve our gut microbiome and one of them is exercise. Besides its well-known effects on our health, exercise has been shown to be able to improve the gut microbiome composition of younger people and those with certain metabolic diseases such as obesity. However, less is known about the effects of exercise on the gut microbiome of older adults. The aim of this study, therefore, is to assess the effects of a 12-week exercise intervention on the gut microbiome of physically inactive older adults. Hopefully, after this study, the investigators will have more information on whether exercise can be used as a tool to improve the gut microbiome of older adults therefore improving their overall health and quality of life.

NCT ID: NCT06153693 Recruiting - Hypertension Clinical Trials

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

NCT ID: NCT06152679 Recruiting - Bladder Cancer Clinical Trials

Day-case Endourology; Patient Experience

Start date: December 1, 2023
Phase:
Study type: Observational

A qualitative research study interviewing patients treated in hospitals across England. We will interview patients who have recently undergone one of the following operations as a day-case; transurethral bladder tumour resection (TURBT), transurethral resection of prostate (TURP) or transurethral enucleation of the prostate (TUEP). We are interested to find out about the experience for patients who go home on the day of surgery after they have had one of these operations. We hope that the findings will tell us about how to improve the experience for patients in future. Patients undergoing day-case surgery at a range of different hospitals from across England with varying day-case rates will be interviewed. Hospitals in large city and more rural areas will be included. Interviews are anticipated to take place over a six month period. The study will end when "saturation" is achieved, whereby no new themes are identified through interviews. Saturation will be sought for each individual operation of interest.

NCT ID: NCT06152666 Recruiting - Bladder Cancer Clinical Trials

Day-case Endourology; Enablers, Barriers, Unexpected Outcomes

Start date: December 1, 2023
Phase:
Study type: Observational

A qualitative research study conducted in hospitals across England, in which staff members will be interviewed. We will interview staff who are directly or indirectly involved in delivering care for patients undergoing the operations of interest; namely bladder tumour resection, prostate resection or enucleation, and ureteroscopy for upper urinary tract stones. We hope to find out the reasons why some hospitals can perform day-case surgery with very high rates, and why others do not. We also hope to find out about any unexpected outcomes observed when performing day-case surgery for the operations of interest. Staff working in a range of different hospitals from across England with varying day-case rates will be interviewed. Hospitals in large city and more rural areas will be assessed. Interviews are anticipated to take place over a six month period. The study will end when "saturation" is achieved, whereby no new themes are identified through interviews. Saturation will be sought for each individual operation of interest.

NCT ID: NCT06152406 Recruiting - Atrial Fibrillation Clinical Trials

Ablate and Pace HIS Study

Start date: November 24, 2023
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and estimates suggest its prevalence is increasing. Despite the advances in AF ablation strategies, the outcome of ablation procedures in persistent AF is still unsatisfactory. In addition, many patients are not candidates for ablation due to advanced age, comorbidities and previous failed ablation procedures. It is well known that there is no mortality benefit from rhythm versus rate control strategy in AF, therefore the increased number of AV node ablation and pacemaker insertion for patients with symptomatic AF with uncontrolled heart rate. Following AV node ablation, it is understandable that these patients will be paced 100% of the time where the value of physiological pacing will be at its most. The current standard practice is to pace the right ventricle for this cohort of patients unless they have severe LV systolic dysfunction when a biventricular pacing might be recommended. Previous data showed that RV pacing only can lead to deterioration of LV function, worsening of heart failure symptoms and increased mortality. HIS bundle pacing is a novel technique of pacing through placing the pacemaker lead on the junction box between the top and bottom chamber of the heart. This will allow the utilisation of the normal/intrinsic HIS Purkinjie (eclectic cables) to stimulate the ventricles. This can offer a physiological pacing modality and reduce pacing induced cardiomyopathy specially in pacing dependent pacing. The Ablate and Pace HIS Study proposes that the new method of HIS pacing is safe, effective and superior to the existing method of RV pacing in patients with atrial fibrillation who demonstrate signs of heart failure.

NCT ID: NCT06152237 Recruiting - Rett Syndrome Clinical Trials

Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study)

Start date: December 12, 2023
Phase: Phase 1
Study type: Interventional

The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is up to 6 years.

NCT ID: NCT06151002 Recruiting - Parkinson Disease Clinical Trials

PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's

PD Frontline
Start date: February 15, 2020
Phase:
Study type: Observational [Patient Registry]

PD Frontline (part of RAPSODI GD) is an online study observational study with the goal of bringing People with Parkinson's to the frontline of research by getting them trial ready. To do this, participants are offered genetic sequencing for the GBA and LRRK2 gene with an at-home saliva collection kit.