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NCT ID: NCT05784441 Recruiting - Clinical trials for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Start date: November 6, 2023
Phase: Phase 1
Study type: Interventional

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: - can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients. - will JNJ-90009530 help patients achieve a response and for how long?

NCT ID: NCT05784272 Recruiting - Clinical trials for Cardiovascular Diseases

Determinants of Progression From Phase III to IV Cardiac Rehabilitation

Start date: March 1, 2024
Phase:
Study type: Observational

This study will determine the limiting factors in progression from phase III to IV cardiac rehabilitation in underepresented populations (as defined by the National Audit of Cardiac Rehab, NACR). This will be done by recruiting participants from phase III cardiac rehab programmes and issuing questionnaires (either a non-initiator questionnire, or an initiator questionnaire based on if the participant is intiating into phase IV cardiac rehab. The questionnaires will assess reasons for/against progression as well as collecting some demographic and data indicative of socioeconomic status. Semi-structured interviews will then be conducted to assess reasons/barriers for progression to phase IV in a convenience sample of both initiators and non-initiators.

NCT ID: NCT05784246 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

SHINE-2
Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT05782907 Recruiting - Ulcerative Colitis Clinical Trials

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05782361 Recruiting - Clinical trials for Non Small Cell Lung Cancer

POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC

POTENT
Start date: May 3, 2023
Phase: Phase 1
Study type: Interventional

This clinical study is looking at the combination of two experimental drugs called tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is licenced and available by prescription to treat a variety of cancers. Tepotinib is currently licensed in the UK for use in non-small cell lung cancer (NCSLC) and is being investigated for this purpose. Cancer immunotherapy drugs hold great promise but still do not work for many patients. Laboratory studies on cancers that do not respond well to immunotherapy reveal that most of these tumours do not have any immune cells. This suggests that the cancer has successfully hidden itself and avoided being recognised by the immune system. This study aims to use a novel approach using a targeted drug, tepotinib, to target the gene involved with NSCLC. Tepotinib is a type of drug called a kinase inhibitor. Kinase inhibitors are a newer type of drug being used to try to treat cancers. They act by blocking some of the chemical messengers that are part of the signalling process within cancer cells that control their growth. Tepotinib is used in adults to treat NSCLC that can have certain abnormal changes in the mesenchymal-epithelial transition factor gene (MET) and which has spread and/or cannot be removed by surgery. The changes in the MET gene can make an abnormal protein which can lead to uncontrolled cell growth and cancer. By blocking this abnormal protein, tepotinib may slow or stop the cancer from growing as well as potentially shrinking the cancer. This study will include patients with and without the MET exon 14 mutations. In this clinical study, the investigators aim to test our ideas in a small number of people for the first time, specifically in those patients with cancers which do not respond to cancer immunotherapy.

NCT ID: NCT05781750 Recruiting - Lupus Nephritis Clinical Trials

A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

Start date: November 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

NCT ID: NCT05781113 Recruiting - Multiple Sclerosis Clinical Trials

A Novel Wearable Digital Biomarker for Detecting Changes in Multiple Sclerosis (MS) Condition

Start date: July 1, 2023
Phase:
Study type: Observational

To measure the effectiveness of a Remote Patient Monitoring solution based on the use of a smart insole wearable device (and associated smart phone app), for monitoring MS patients' condition on a day-to-day basis. The main focus is the objective measurement of gait, given that 75% of people with MS display clinically significant gait impairments. Initial gait lab "gold standard" data indicate that the Artificial Intelligence (AI)-based digital biomarker will prove to be highly effective at detecting changes in the MS patient's condition.

NCT ID: NCT05781087 Recruiting - Clinical trials for Coronary Artery Disease

Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack

OCT-RISK
Start date: April 25, 2023
Phase:
Study type: Observational

Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time. Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack. Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA). If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.

NCT ID: NCT05780853 Recruiting - Clinical trials for Autism Spectrum Disorder

A Game-based Neurodevelopmental Assessment for Young Children

BRIGHTEN
Start date: January 30, 2023
Phase:
Study type: Observational

The aim of this study is to evaluate a novel tablet game-based neurodevelopmental assessment tool for young children aged 3 to 8 years old. The study's main aims are: (1) to determine whether the novel tablet-game based assessment tool can accurately differentiate children's neurodevelopmental status based on their performance on the game and (2) assess the validity of the game-based neurodevelopment assessment tool. The study aims to recruit 590 children who are 'typically' developing and/or have a diagnosed neurodevelopmental disorder including Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder. All participants will complete the tablet game-based assessment which aims to assess a range of neuropsychological functions including attention, memory, language, motor, executive functions and social-emotional skills. Parents/carers of participants will also complete a demographic questionnaire and the Adaptive Behaviour System - Third Edition (ABAS-3), which is a questionnaire that assesses a child's development. Some participants will be re-tested on the tablet game-based assessment approximately 2 weeks after the first tablet game-based assessment to ensure the game's validity.

NCT ID: NCT05780164 Recruiting - Lung Cancer Clinical Trials

Improving Access to Lung Cancer Clinical Trials

Lung I-ACT
Start date: July 1, 2023
Phase:
Study type: Observational

There are ~85,000 lung cancer patients (LCPs) in the UK; yet only around 8% were recruited into clinical trials in 2021/22. LCPs need opportunities to take part in clinical trials to access new treatments, increasing their quality of life, treatment choices and life expectancy. Discussions with nurses can help patients make better treatment decisions, improving experiences of care. However, research has shown that lung cancer nurses (LCNs) often feel unable to discuss participation in trials with patients due to lack of knowledge, confidence, time and training. This study aims to develop and test a research recruitment tool for LCNs, to support LCPs to enter clinical trials. Objectives include to: - Explore reasons for low uptake of LCPs into clinical trials - Develop a tool for LCNs to talk to patients about clinical trials - Test whether the tool improves the number and quality of discussions nurses have with LCPs about clinical trials The study has four phases: Phase 1: A literature review will identify problems that make clinical trial uptake difficult for LCPs, carers and clinicians Phase 2: Six group discussions with LCNs, patients and carers will explore issues that create potential barriers for patients taking part in clinical trials. The groups will take place online, last approximately one hour and be recorded. Phase 3: Part 1&2 findings will help us develop a LCN research recruitment tool. The tool will contain information on how nurses obtain information about LC clinical trials, research teams, communication issues, practical issues and how to reach LCPs. Phase 4: The research recruitment tool will be tested in four UK NHS hospitals. A survey will identify any changes in nurses' clinical trials awareness and confidence before and after using the tool. Interviews with LCNs, patients and carers will explore their views on the tool, clinical trials participation and experiences of care.