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NCT ID: NCT05939076 Not yet recruiting - Clinical trials for Atrial Fibrillation, Persistent

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation

Start date: August 21, 2023
Phase: Phase 3
Study type: Interventional

The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are: - Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting > 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF? - Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular; - Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor, - Regular echocardiographic exams for reverse atrial remodelling assessment, - HRQoL questionnaires - Assessment of cognitive function - Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression - Assessment of Health care use and costs - Safety

NCT ID: NCT05938283 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)

HICD
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

Pilot randomised trial to assess recruitment for a larger trial to compare the efficacy and adverse effects of the subcutaneous and transvenous ICD in patients with hypertrophic cardiomyopathy (HCM) and indication for ICD therapy, with no requirement for pacing

NCT ID: NCT05938270 Recruiting - Prostate Cancer Clinical Trials

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

ASCERTAIN
Start date: September 21, 2023
Phase: Phase 1
Study type: Interventional

A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN)

NCT ID: NCT05938114 Not yet recruiting - Clinical trials for Alveolar Ridge Augmentation

Comparison of the Use of Natural and Synthetic Bone Substitutes in Dental Implants

BSNS
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effectiveness of a natural and synthetic bone substitute in preserving the alveolar ridge (bone) of a single- rooted tooth after an extraction. The main question it aims to answer: Is there a difference between natural (Bio-Oss®) and synthetic (Bonalive®) bone substitutes in preserving the alveolar ridge dimensions based on changes in the width of the alveolar ridge (expressed in millimetres) from augmentation (baseline) to 24-week follow-up (post augmentation)? Participants will have a tooth extraction and a bone substitute will be inserted into their socket immediately after. Participants will be divided into two equal groups and those in group A will receive Bio-Oss® while those in group B will receive Bonalive®. In both groups measurements of the alveolar bone will be taken when the bone substitute is inserted and 24 weeks after the insertion of the bone substitute. These measurements will be used to compare the effectiveness of Bio-Oss® and Bonalive in preserving the alveolar bone of a tooth after an extraction.

NCT ID: NCT05938023 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

A Study of ATL1102 or Placebo in Participants With Non-ambulatory Duchenne Muscular Dystrophy

Start date: May 18, 2023
Phase: Phase 2
Study type: Interventional

This Phase IIb study is a two part, multicenter study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of ATL1102 in non-ambulant boys with Duchenne Muscular Dystrophy aged 10 to <18 years old. The study includes a randomised, double-blind, placebo-controlled treatment period (Part A), followed by an open labelled treatment period (Part B).

NCT ID: NCT05937542 Recruiting - Osteoarthritis Clinical Trials

A Qualitative Investigation of CLEAT Participants

Start date: September 5, 2023
Phase:
Study type: Observational

As the United Kingdom's National Health Service (NHS) waiting list soars above seven million people, with treatment wait times over two years, older people with chronic conditions face worsening symptoms, increased use of medications, more complicated surgeries with slower recovery, reduced quality of life, and loss of independence. As part of its plans to tackle this crisis, the NHS promotes exercise as a "miracle cure" for arresting the progress of disease and helping disease management and recovery. However, current plans promoting individual, home-based exercise, as well as on-site hospital-based programs of delivery, have met with only limited success, and face problems of decreased space, capacity, clinician time, as well as lack of knowledge and expertise with regard to effective behavior change. We have developed a community-based group exercise programme for older people with hip osteoarthritis. This community-based group exercise programme has successfully helped those with hip osteoarthritis (3.5 million over 45s in the UK) reduce pain and need for medication, as well as avoiding surgery, and has formed part of an NIHR trial examining the use of exercise and education versus standard physiotherapy care for the treatment of hip osteoarthritis. In order to better understand the mechanisms of action of this programme, the present study will examine, via focus groups interviews, the experiences of participants who have undertaken the exercise and education programme. The data generated from the focus groups will help to elucidate what "works" within the programme and will help inform future development of resources to support health professionals in providing exercise rehabilitation for older people with chronic conditions.

NCT ID: NCT05936853 Active, not recruiting - Pediatric ALL Clinical Trials

The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)

EPIVA
Start date: August 3, 2023
Phase: N/A
Study type: Interventional

More than half a million children have an anaesthetic each year in the UK. Though anaesthesia is usually thought to be safe and necessary to improve health, concerns remain the effects that the drugs used may have on brain development in children and the potential long-term consequences for health. The two techniques used to keep someone asleep during anaesthesia are either giving the appropriate drugs through a small plastic tube into a vein or introducing different drugs into the lungs in gas form. Gene expression is the process by which instructions in DNA are used to make products such as proteins. Anaesthetic drugs may change how a child's genes are expressedÍž a process called epigenetics. Studies have shown that different anaesthetic drugs can cause epigenetic changes in animals and affect the processing ability of their brains. This study will focus on children aged under 3 undergoing general anaesthesia for planned hypospadias surgery (a developmental condition where the look and function of the penis may not be completely normally). Participants will either receive their general anaesthetic in gas form or through directly into their veins - both techniques are commonly used. A small blood sample (between 1 and 2 teaspoons) will be collected at the start and end of the operation whilst under anaesthetic. Samples will be analysed to look for any changes in signals on DNA (epigenetic changes) and other markers. Further analysis may then look at other measures of gene expression and additional processes/markers that could be affected. There is relatively less medical research carried out in children and this work will show whether this type of study is possible in this age-group and provide information for future trials. It will help towards improving our understanding of the effects of anaesthesia ultimately help doctors and families make better informed decisions.

NCT ID: NCT05936632 Completed - Cancer Clinical Trials

Preferences for Certainty Versus Access When Evaluating New Cancer Drugs. A Discrete Choice Experiment.

Start date: July 7, 2023
Phase:
Study type: Observational

To provide timely access to new treatments, some eligible drugs can be approved despite uncertainty surrounding the level of clinical benefit they offer patients. It is not currently known if (and under which circumstances) people would prefer to wait to access some new drugs in exchange for greater certainty surrounding their clinical benefit. This study aims to elicit the preferences of people in the US with experience of cancer for wait times and clinical uncertainty of new drugs. To elicit this information, in a survey format, respondents will be presented with a hypothetical scenario and asked to state their preferences for new treatments, each with different attributes.

NCT ID: NCT05936502 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma

Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer

EPIC-iENE DATA
Start date: July 11, 2022
Phase:
Study type: Observational

Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery. As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered. The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors. By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning.

NCT ID: NCT05936359 Recruiting - Clinical trials for Myeloproliferative Neoplasms

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Start date: September 25, 2023
Phase: Phase 1
Study type: Interventional

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.