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NCT ID: NCT06457126 Not yet recruiting - Stroke Clinical Trials

Piloting the Attention Training Technique for Post-Stroke Emotionalism

Start date: June 24, 2024
Phase: N/A
Study type: Interventional

The aim of this mutli-phasic systematic case series is to explore if the Attention Training Technique (ATT) can improve symptoms of Post Stroke Emotionalism. It will teach the ATT to at least three people who have had a stroke at least six months ago, have PSE and are currently receiving support from a Community Neurorehabilitation service in the North West of England. Stroke survivors will also require the support of a carer/loved to record their symptoms on a daily basis. Stroke survivors will attend weekly appointments either at the community service site or via video-call for up to 15 weeks. There is also the option to complete an interview to discuss their experiences of learning the ATT. This study hopes to be the first step in establishing evidence in support of a novel psychological intervention to help improve PSE symptoms. Phase 1 of the study aims to explore the effects associated with the ATT on PSE symptoms. The primary research questions are: 1a. Is the ATT associated with an improvement of PSE symptoms? 1b. Does this replicate across individual cases? If these are not initially supported, the ATT delivery will be extended, addressing: 1. c. Is the ATT associated with an improvement of PSE symptoms when some parameters (e.g., frequency and dose) are modified? Only if a clear association between ATT and symptom change is demonstrated, will Phase 2 begin. Phase 2 aims to understand the relative mechanisms underlying any treatment effect. The primary research question for Phase 2 is: 2. a. Is the ATT associated with a greater change in PSE symptoms than a comparator passive listening intervention (controlling for non-specific factors, (e.g., provision of a credible intervention, task practice and therapist involvement))? The comparator intervention will be a passive version of the ATT whereby participants are instructed to not follow the instructions on the audio-recording. Secondary research questions throughout Phase 1 and 2 will address: 1. Is the active ATT (and passive ATT) associated with an improvement in executive functioning, attention, mood and quality of life and is there any difference between the two interventions?

NCT ID: NCT06455462 Recruiting - Severe Asthma Clinical Trials

Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres

TPAP
Start date: April 22, 2024
Phase:
Study type: Observational

This is a retrospective, observational chart review that will include patients with severe asthma (SA) who have participated in the tezepelumab patient access programme (TPAP). Electronic case report forms (eCRFs) will be used for data abstraction of clinical information from the health records of patients enrolled in the TPAP from eight NHS acute trusts. Approximately 200 patients with SA who took part in the TPAP with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023, and who meet the study eligibility criteria will be recruited to the study. Participation in the study does not affect the patients' treatment decisions since all data will be collected retrospectively from medical records. Key study definitions include: - Index date - the date of tezepelumab initiation (i.e., the date of first dose). - Pre-index period - defined as any time prior to tezepelumab initiation - Baseline period - defined as the 52 weeks prior to the index date - Outcomes period - defined as the 52 weeks post-index date. Patients will be followed up from their index date until the first of the following events (whichever is first): reach 52 weeks post-index, they switch to a different biologic treatment, die, or are otherwise lost to follow-up.

NCT ID: NCT06455449 Not yet recruiting - Clinical trials for Polymyositis, Dermatomyositis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06453993 Active, not recruiting - Esophageal Cancer Clinical Trials

Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.

NCT ID: NCT06453954 Completed - Pregnancy Related Clinical Trials

Evaluating the Saving Babies Lives Care Bundle Version 2

eVOLVE
Start date: October 17, 2023
Phase:
Study type: Observational

The purpose of this study is to learn about the implementation of NHS England's Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality. It will explore whether the care bundle is effective at reducing stillbirth rates, neonatal death rates and preterm births in England. It will also explore the lived experiences of women's maternity care and their babies neonatal care, and the views and experiences of healthcare professionals who are involved in delivering the care bundle. The main questions it aims to answer are: - Does the care bundle reduce perinatal mortality rates? - What are women's views and experiences of their maternity and neonatal care? - What are the barriers around delivering the care bundle and how can this be improved? - How do health inequalities affect the care women receive? - How does the workforce culture affect how healthcare professionals use the care bundle? Perinatal mortality rates and other pregnancy outcomes will be obtained from national data sources. Women and healthcare professionals will be asked to complete a survey and we will interview select groups of participants to further explore their experiences. Mortality rates will be compared before and after the implementationof the care bundle where data allows. Data from the surveys will be descriptive. Data from the interviews will be analysed using thematic analysis to determine patterns and recurring ideas in the data.

NCT ID: NCT06453785 Not yet recruiting - Prostate Cancer Clinical Trials

Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection

IP10-COMPACT
Start date: March 2025
Phase: N/A
Study type: Interventional

Currently, patients suspected of having prostate cancer undergo an MRI followed by targeted biopsies of any suspicious lesions under trans-rectal ultrasound (TRUS) guidance. This pathway is labour, time, and cost-intensive. Additionally, TRUS-MRI-Fusion devices are needed, which overlay the MRI scan onto the TRUS used for biopsies. This can lead to targeting errors due to mismatched images. Although biopsies can be performed in the MRI scanner to reduce these errors, it requires a significant amount of time within an expensive MRI scanner in the radiology department, along with special MRI-compatible equipment. Portable MRI technology has the potential to reduce these errors and streamline the diagnostic pathway to one visit. The Promaxo portable MRI is an FDA-cleared MRI device for MR-guided procedures. It uses a novel "truly" open MRI with an unobstructed field of view and a central aperture for robotic-guided intervention and has a limited footprint, allowing it to be placed in a standard operating theatre or large clinic room. The strength of the magnet is also low enough that special precautions and equipment are not needed to take biopsies. The intention is to conduct a study that answers the following research question: How does the accuracy of targeted biopsies of the prostate performed under the guidance of a portable MRI scanner compare to TRUS-MRI-fusion biopsies? Design: A single-arm, single-center IDEAL stage 2a study (n=85 patients) of patients undergoing prostate biopsy for suspected prostate cancer, where each patient would undergo both a portable MRI-registered biopsy and a TRUS-image-fusion biopsy. To reduce the risk of bias between the two modalities, the order of the modality will be randomized 1:1. There will be no blinding of the surgeon. The primary outcome will be the technical feasibility of performing portable MRI and portable MRI-targeted biopsies and estimates on cancer detection.

NCT ID: NCT06453733 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Crainio Non-invasive ICP Monitor for TBI

Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring. This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury. The primary objective is to establish the diagnostic accuracy of the Crainio device, aiming for at least 90% sensitivity and specificity in detecting raised ICP (above 20 mmHg). Secondary objectives include evaluating patient-related factors such as skin tone, skull thickness, and skull density, as well as the tolerability and acceptance of the device by both patients and healthcare professionals.

NCT ID: NCT06453226 Recruiting - Parkinson Disease Clinical Trials

Non-invasive Detection of Volatile Metabolites in Parkinson's Disease

PANORAMA
Start date: January 25, 2023
Phase:
Study type: Observational

Parkinson's disease (PD) is the second most common neurodegenerative disorder. Currently, a diagnostic test for early PD does not exist. The aim to address this problem by developing a non-invasive breath test to differentiate early PD from controls. Small molecules contained in breath, which offers precious information about disease presence, will be analysed. Data from the breath molecules and gut bacterial changes occurring in PD will be combined. These bacterial changes have been shown to arise years before the development of PD symptoms. Thanks to earlier diagnosis, therapies could start in advance and improve clinical outcomes and quality of life.

NCT ID: NCT06452277 Not yet recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

SOHO-02
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: - BAY 2927088 twice every day as a tablet by mouth, or - Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: - take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer - check the overall health of the participants by performing tests such as blood and urine tests, and checking - heart health using an electrocardiogram (ECG) - perform pregnancy tests for women - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06451965 Active, not recruiting - Clinical trials for Post-stroke Depression

SCED - Wisdom Enhancement for Post-Stroke Depression

WE-PSD
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

One-third of stroke survivors experience post-stroke depression, but there are currently no official guidelines for supporting them. Researchers aim to investigate whether the wisdom enhancement timeline technique can reduce depression in stroke survivors. The investigators also want to understand how this technique positively impacts mood, identity, self-esteem, and wisdom. The study will involve nine stroke survivors from the National Health Service (NHS) to gain insights into effective ways to support those with post-stroke depression.