Clinical Trials Logo

Filter by:
NCT ID: NCT06089447 Not yet recruiting - Clinical trials for Wellness, Psychological

A Pilot Randomised Controlled Trial of Intervention for Children and Young People Experiencing Family Substance Use

Start date: October 2024
Phase: N/A
Study type: Interventional

The study is investigating the feasibility and acceptability of the story-based intervention, The Shadows of Tallystick Valley, aimed at improving the psychological wellbeing and resilience of children and young people who are affected by familial substance use. A secondary aim of the study is to identify whether there is a 'signal of efficacy'. The early intervention is a story and activity book designed and developed by Book of Beasties, in collaboration with the charity Change Grow Live (CGL), who work directly with children and young people experiencing familial substance use. The intervention is used by s at CGL with children and young people engaged with the service. In the present study, we aim to evaluate the story-based intervention within a pilot randomised controlled trial. Participants will be randomised to either receive the intervention or to join a waitlist for the same intervention. The effects of the story-based intervention will be assessed using pre and post psychological well-being and resilience measures, including KidCOPE, the Stirling Children's Wellbeing Scale and the Child and Youth Resilience Measure. The primary outcome measures are concerned with overall psychological wellbeing.

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: NCT06087471 Not yet recruiting - Depression Clinical Trials

Snack Foods and Their Impact on Mental Health and the Gut-brain Axis

NutriMood
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.

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: NCT06085885 Enrolling by invitation - Tinnitus Clinical Trials

Tinnitus and Cochlear Implants

TICIT
Start date: December 30, 2023
Phase:
Study type: Observational

Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation, and (4) Explore associations between tinnitus and changes in hearing, psychological health, cochlear implantation-related factors, and quality of life in cochlear implant recipients with and without tinnitus. Participants will be adults eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Participants will undergo routine pre- and post-operative assessments as part of usual care, and complete online questionnaires before and after implantation to measure tinnitus and other health related factors. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors after implantation.

NCT ID: NCT06085001 Not yet recruiting - Hypertension Clinical Trials

Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia

Lumella
Start date: November 10, 2023
Phase:
Study type: Observational

women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE.

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).