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NCT ID: NCT06124820 Recruiting - Clinical trials for Genitourinary Syndrome of Menopause

RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections

UTIEXTERMINATE
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Recurrent urinary tract infection (rUTI) is a common and difficult to treat problem with limited treatment option; postmenopausal women are disproportionately affected. The genitourinary syndrome of menopause (GSM) describes the broad spectrum of signs and symptoms caused by the loss of endogenous sex steroids. The combined effects of urogenital epithelial tissue thinning and changes to the vaginal and bladder microbiome can predispose to ascending UTIs. Recurrent UTIs is a component of GSM. Intravaginal laser therapy has been shown to be safe and effective for the treatment of GSM, however, the role of laser for treatment of recurrent UTIs is unknown. We hypothesis that the incidence of UTI will be reduced as CO2 laser restores vaginal epithelium to a state similar to that of a pre-menopausal woman, preventing microtrauma, and increases Lactobacillus and normal flora (Athanasiou et al., 2016). Lactobacillus is considered the bacteria that helps keep the vagina healthy and infection free through its production of lactic acid which lowers vaginal pH, this more acidic environment may be protective from uropathogens. We therefore aim to conduct a single-blinded, multi-centre, randomised controlled trial comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and to determine the impact on the microbiome.

NCT ID: NCT06124612 Recruiting - Atrial Fibrillation Clinical Trials

An Investigator-initiated Linked Study to OCEANIC-AF

Start date: November 3, 2023
Phase:
Study type: Observational

Impaired endogenous fibrinolysis is a recently recognised risk factor for thrombotic events in patients with cardiovascular disease. Enhancing endogenous fibrinolysis in such individuals represents a way of reducing thrombosis risk. However, the optimal pharmacotherapy to enhance fibrinolysis is unclear. The aim of this study is to assess the effect of asundexian on endogenous fibrinolysis and compare this to apixaban. If asundexian can enhance endogenous fibrinolysis, this could be used as targeted treatment for patients who despite optimal antithrombotic therapy, demonstrate impaired endogenous fibrinolysis.

NCT ID: NCT06124287 Recruiting - Crohn's Disease Clinical Trials

MRE Predictors of Disease Relapse After Stopping Biologics

METEOR
Start date: February 27, 2024
Phase:
Study type: Observational [Patient Registry]

This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse quickly (disease comes back) after stopping biologic medication. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients.

NCT ID: NCT06123676 Recruiting - Cancer Clinical Trials

Introduction of Y90-PET-CT Post Radioembolisation Therapy Scans

Y90-PET-CT
Start date: October 9, 2023
Phase: N/A
Study type: Interventional

Yttrium-90, attached to microspheres, usually referred to as 90Y-microspheres or Y-90 radioembolisation, can be used in some cases to treat patients with liver tumours or liver metastasis. The treatment aim is to infuse the 90Ymicrospheres into the patient's liver. The microspheres get trapped in the lesions of micro-blood vessels while the yttrium-90, a radioactive compound, delivers radiation doses locally at these sites and damages the diseased cells. Therapy is performed in such a way the 90Y-microspheres are localised in the tumour areas minimising damage to the healthy liver tissue. This treatment requires many steps involving professionals from different medical disciplines. Patients are scanned in the nuclear Medicine Department on a gamma camera the day after the treatment. This scan is referred as Y-90 bremsstrahlung-SPECT. This posttherapy scan provides a 3-dimensional (3D) image of the distribution of the therapeutic agent in the patient's abdomen so an assessment of how much of the therapeutic agent has gone to the sites of disease can be performed. In this research project, the investigators would like to evaluate an alternative post-therapy scan to the one routinely performed on the gamma camera. The alternative scan is done on a PET-CT scanner and is referred to as Y90-PET-CT. This type of scan has been reported to provide improved quality images, providing more accurate information on the distribution of the patients therapeutic dose. For this research project, the investigators will invite a small number of patients undergoing this therapy to be scanned twice after treatment: with the current post-therapy scan on a gamma camera; and with the newly proposed scan method, Y90-PET-CT. Depending on the outcomes of this project, assessed by an expert panel of radiologists and medical physicists, the investigators will determine whether we will introduce this new scanning method into clinical practice in the future.

NCT ID: NCT06120491 Recruiting - Clinical trials for Metastatic Castration-Sensitive Prostate Cancer

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

EvoPAR-PR01
Start date: November 21, 2023
Phase: Phase 3
Study type: Interventional

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

NCT ID: NCT06119581 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C

SUNRAY-01
Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

NCT ID: NCT06119295 Recruiting - Obesity Clinical Trials

Investigating the Effects of Altering Portion Size Reduction Awareness on Compensatory Eating Behaviour

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake.

NCT ID: NCT06119204 Recruiting - Diet Habit Clinical Trials

SAFE-LCD Trial, for Insulin-treated Adults Living With Type 2 Diabetes

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

SAFE-LCD study is a randomised controlled trial aiming to develop and evaluate a safe, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation. The study plans to enrol 72 participants who will be randomly allocated to either receive the intervention or will be provided with weight loss advice suitable for insulin-treated patients through accessing the NHS 12-week weight loss plan. The intervention arm will follow Oviva Diabetes Remission Insulin (ODR-I) programme which includes expert dietitian coaching, support of a Diabetes Nurse, the Oviva app (with a 12-month weight prediction chart), a Capilar Blood Glucose (CBG) meters (for enhanced safety in view of concerns re hypo- and hyper-glycaemia), and BodyTrace weight scales. If successful, this project will provide game-changing evidence for the support of insulin-treated T2D patients and for NHS commissioning of the digital Low-Calorie programme driving patient benefits and cost-savings.

NCT ID: NCT06118632 Recruiting - COPD Exacerbation Clinical Trials

Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease

SENSOR
Start date: September 22, 2023
Phase:
Study type: Observational

The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. This device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. This could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether. The study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition.

NCT ID: NCT06118255 Recruiting - Dravet Syndrome Clinical Trials

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

ORCHID
Start date: May 21, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.