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NCT ID: NCT05840211 Recruiting - Clinical trials for Stage IV Breast Cancer

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ASCENT-07
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

NCT ID: NCT05839626 Recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma

A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Start date: May 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA). The study will comprise 3 parts: A dose escalation phase (Part 1) in RRMM participants (Part 1a) that will evaluate several doses administered to determine 2 doses that will be tested in the dose optimization part. A dose escalation will also be done in RRLCA participants (Part 1b) but started sequentially after the end of the dose escalation in RRMM participants. This dose escalation will evaluate the 2 doses planned to be used in dose optimization in RRMM, to ensure those doses are safe also for RRLCA participants. A dose optimization phase (Part 2) that will be evaluating 2 doses determined from Part 1 to determine the preliminary recommended Phase 2 dose (pRP2D) and schedule for SAR445514 in RRMM. A dose expansion phase (Part 3) that will evaluate the preliminary efficacy of pRP2D and schedule for SAR445514 in RRMM (Part 3a) and RRLCA (Part 3b). Approximately 101 participants will be enrolled and treated by study intervention and separated as such: Part 1a: Approximately 18 to 30 participants Part 1b: Approximately 6 to 12 participants Part 2: Approximately 30 participants Part 3a: Approximately 15 participants Part 3b: Approximately 14 participants

NCT ID: NCT05839418 Recruiting - Status Epilepticus Clinical Trials

Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

SENSEII/AROUSE
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

NCT ID: NCT05839405 Recruiting - Anxiety Clinical Trials

Food Allergy in the Brain

FAB
Start date: September 29, 2023
Phase:
Study type: Observational

Preventing food allergic reactions predominantly relies on allergen avoidance and managing this daily causes high anxiety in some patients, while having an allergic reaction can cause a post-traumatic stress disorder-like syndrome in children. The underlying mechanisms of these psychological changes are poorly understood, but one potential mechanism may be post-natal hippocampal neurogenesis (HN). HN is the production of new neurons from stem cells in the hippocampus which is one of the brain centres for memory and mood regulation. HN has been associated with cognitive function and some psychiatric disorders. Importantly, it can be influenced by both internal (bloodstream) and external (exercise, diet, etc.) factors. This study will explore the link between food allergy and children's mental health and cognition, and to determine whether this is linked to changes in HN.

NCT ID: NCT05838859 Recruiting - Contraception Clinical Trials

Contraception and Mental Health: Are we Doing Enough?

Start date: February 9, 2021
Phase:
Study type: Observational

The study seeks to determine current practices and perspectives of contraceptive advice of both service users and professionals. It aims to examine 1) the experiences of female service users of reproductive potential with mental health conditions of contraceptive advice from mental health professionals and 2) the current practice of providing contraceptive advice by mental health professionals.

NCT ID: NCT05838755 Recruiting - Pain Clinical Trials

A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

NEPTUNE-17
Start date: September 20, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

NCT ID: NCT05838742 Recruiting - Pain Clinical Trials

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis Pain

MARS-17
Start date: September 13, 2023
Phase: Phase 2
Study type: Interventional

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.

NCT ID: NCT05838677 Recruiting - Chronic Pain Clinical Trials

Pain at Work Toolkit in Employees With Chronic Pain

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

This project will test the feasibility and acceptability of the Pain at Work (PAW) Toolkit which aims to help employees self-manage chronic or persistent pain at work. Ultimately, the investigators want to discover if it improves employees' health, wellbeing, confidence to self-manage their condition, and reduces impacts on their ability to work and be productive at work. Prior to testing the effectiveness and cost-effectiveness of the PAW Toolkit in a large-scale randomised trial, the investigators are conducting a multicentre pragmatic cluster randomised controlled feasibility trial. This will establish whether the PAW Toolkit, and our research processes, are feasible and acceptable in workplace settings, and will inform the design of a future trial. In this feasibility study, organisations will be randomised at site level to receive the intervention (PAW Toolkit plus occupational therapist (OT) support calls) or control (treatment as usual) for any individual employees who consent to take part. The investigators aim to recruit around 120 participants ("individual employees") from around 8 sites ("clusters"). Data will be collected from employees and organisations at baseline, 3 months and 6 months, using online surveys. At 6 months, up tp 40 people from across different sites and job roles will be interviewed, including employees who have accessed the PAW Toolkit, and other stakeholders (people who have been involved in supporting them at work, such as their line manager). The data will be used assess whether the intervention and the research processes are acceptable and feasible, and the information collected will be used to plan a large-scale randomised controlled trial.

NCT ID: NCT05838196 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Service Development of POCUS in the IBD Clinic

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

Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.

NCT ID: NCT05837390 Recruiting - Preterm Birth Clinical Trials

Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?

PRECISION
Start date: July 6, 2023
Phase:
Study type: Observational

Preterm birth (PTB), defined as delivery before 37 weeks gestation, is a common complication of pregnancy and affects up to 1 in 10 women in the UK. PTB is the leading cause of neonatal mortality and morbidity with babies born earliest being at the greatest risk. Identifying women at high risk of having a PTB and offering treatments and intervention to try and prevent this outcome is a huge priority in clinical practice and in government policy. The PRECISION study will explore the use of a new antenatal test of cervical stiffness to try and improve the recognition of women who may deliver early. Current clinical practice involves measurement of cervical length (CL) and fetal fibronectin in women known to be high risk for PTB. However recent research suggests these methods could be improved upon and we may be able to recognise women at risk more reliably and at an earlier stage in the pregnancy if we use cervical stiffness assessments. A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index scores during pregnancy. This study will directly compare cervical length measurements and fetal fibronectin results with cervical stiffness, using the Pregnolia system, during the second trimester in women known to be high risk for preterm birth. The investigators will aim to explore the best possible predictive tool kit bundle for PTB using any combination of these assessments.