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NCT ID: NCT06091254 Recruiting - Clinical trials for Follicular Lymphoma (FL)

A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

OLYMPIA-1
Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) - The impact from the study drug on your quality of life and ability to complete routine daily activities.

NCT ID: NCT06091163 Recruiting - Depression Clinical Trials

Ketogenic Diet for Treatment-Resistant Depression: Dietary Interventions for MEntal Health Study (DIME)

DIME
Start date: February 22, 2024
Phase: N/A
Study type: Interventional

Depression is a debilitating chronic illness affecting 1 in 6 adults in the United Kingdom (UK) at any one time. Antidepressants and psychological therapy are the main treatments, but some people do not respond to these. Neurons and signals in the brain are greatly disrupted in people with severe depression. A ketogenic diet, a high-fat and very low-carbohydrate diet, supplies a form of energy that appears to help brain cells communicate and may improve the treatment of depression. Our goal is to find out whether a ketogenic diet could be an additional effective treatment for patients with depression for which antidepressants do not work. Using social media advertising, 100 patients, ages 18-65, who have previously tried at least two different antidepressant medications within the current depressive episode will be recruited. Enrolment, consent, and data collection will be collected online using self-report questionnaires. Participants will be allocated by minimisation 1:1 to the KD group or control group based on depressive severity (moderately severe vs. severe) and body mass index (<30kg/m2 vs. 30+ kg/m2). The intervention group will receive 6-weeks of prepared ketogenic diet meals (3 meals with snacks per day) and weekly ketogenic diet-focused nutrition counselling. The control group will be asked to follow a diet to reduce their saturated fat intake and increase vegetable consumption by one portion a day. The control group will receive vouchers to assist with purchases and will be provided with weekly nutritional counselling. Existing treatment for depression will remain in both groups. The primary outcome is the change in depression symptoms at six weeks. All participants will complete assessments of depression and anxiety every two weeks, starting before treatment to post-intervention (week 6), and again at week 12. Additional outcomes include participants' ability to experience pleasure, quality of life, ability to socialise and work, cognitive processing, morning cortisol, and gut microbiome. At all stages of the study, adults with lived experience of depression will advise the research team to take into account the needs and views of patients. This study will provide evidence of whether following a ketogenic diet leads to a short-term improvement in depression in people whose depression cannot be relieved by antidepressants.

NCT ID: NCT06091111 Recruiting - Clinical trials for Urinary Incontinence

A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product

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

The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. The study is cross-over and subjects will act as their own control, using their regular device during a 10-day period and comparing this to use of investigational device for 10 days with an initial 3-5 day transition period. In total the subjects participate in the study for about 30 days. The sequence of device use is randomized. The target population are subjects who are suffering from urinary incontinence and are current users of AHPs to manage the incontinence. Subjects are care dependent and being cared for in a care home. The study is conducted at multiple care homes in the United Kingdom. The investigational device is a new type of AHP developed to be more sustainable with a disposable insert placed into a reusable pant. The leakage performance will be tracked by collecting used AHPs and assess the occurrence of leakages and urine content. The number of leakages during the intervention period will be compared to that of the reference period. As secondary outcomes safety, changes in skin condition and caregiver and subject product satisfaction is assessed. In total 42 subjects are planned for the study.

NCT ID: NCT06091059 Recruiting - Clinical trials for Ultrasound Diagnostic, MRI Fusion

Ultrasound - MRI Fusion Guided Injections in Muscles

Start date: April 6, 2024
Phase:
Study type: Observational

This study is using a new technology of combining MRI and ultrasound images to help guide the injection into the correct muscles. Combining MRI images with real-time ultrasound images is a new technology which has recently become available. Sometimes ultrasound images can be difficult to interpret, especially when there are problems with stiffness in the muscles. The MRI images create a "road-map" to help understand the ultrasound images at the time of the injection. This may help guide the injection, compared with using ultrasound alone. This technique has not currently been used in muscle injections, therefore we would like to use it as part of a research study. This study is comparing current standard practice of using ultrasound guidance alone versus ultrasound guidance with an MRI road-map to direct muscle Botox injections.

NCT ID: NCT06088290 Recruiting - Leiomyosarcoma Clinical Trials

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma

SaLuDo
Start date: September 21, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this phase IIb/III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

NCT ID: NCT06088108 Recruiting - Exercise Clinical Trials

Metabolic Responses to Exercise and Recovery

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

Exercise benefits health through diverse metabolic processes and is central to healthy ageing. However, intense exercise also challenges the body, causing cellular damage that must be repaired. This means that we need to identify the level of exercise that can optimise health, and this level might potentially differ by age and sex. Our research aims to tackle this question, by studying the metabolic responses of the body both to exercise and during the subsequent recovery in 48 healthy and active participants between the ages of 8-10, 23-27 and 53-57. Participants will complete an inclusion questionnaire and, if eligible, be invited to visit the exercise laboratory 4-5-hours. We will collect questionnaire data and body measurements before participants undertake exercise on a treadmill. Biological samples (blood from adults only and saliva from everyone) will be collected at three time points (before, right after and one hour after exercise).

NCT ID: NCT06087835 Recruiting - Clinical trials for Chronic Kidney Disease With High Proteinuria

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

NCT ID: NCT06086886 Recruiting - Clinical trials for Healthy Participants

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants

Start date: November 16, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.

NCT ID: NCT06086574 Recruiting - Clinical trials for Lung Cancer Stage III

Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

VIGILANCE
Start date: March 24, 2023
Phase:
Study type: Observational

In stage 3 NSCLC, treatment and follow-up are generally performed in a 'one-size-fits-all' manner. In the setting of metastatic lung cancer there has been considerable success identifying biomarkers, which allow treatments to be tailored and lead to more personalised medicine. In patients with stage 3 disease there exists a significant unmet clinical need for equivalent biomarkers to guide treatment decisions such as to identify poor responders, predict benefit from treatment and diagnose relapse before standard of care imaging. Recent advances have made it possible to detect and quantify circulating-tumour DNA in peripheral blood of patients with stage 3 NSCLC, a promising prognostic biomarker and a measure of minimal residual disease. In addition, the information contained in routine medical images and electronic patient reported outcome measure (ePROM) questionnaires can add further predictive power to circulating tumour DNA and other clinical factors to determine patient's outcome. There is scope to integrate biomarkers in treatment decision algorithms aiming to make personalised treatment modifications (e.g. decision to treat with immunotherapy or not). VIGILANCE is a highly exploratory observational study to understand how these biomarkers might inform a future hypothesis driven interventional study.

NCT ID: NCT06084936 Recruiting - Lymphoma Clinical Trials

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

GLOBRYTE
Start date: October 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).