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NCT ID: NCT06046677 Not yet recruiting - Clinical trials for Sepsis in Cancer Patients

Sepsis in Oncology Patients

SEPONC
Start date: September 2023
Phase:
Study type: Observational

The overall objective of this prospective observational study is to address the significant knowledge gap that exists around the impact of immune dysfunction on the development and survival from sepsis in patients with cancer. This proposal primarily focuses on establishing the transcriptomic immune profiles of sepsis patients with a background of cancer. This analysis will be complemented with in vitro functional analyses, and in addition will commence a collection of genome-wide data, including a focus on predicting white cell number and function in health. Uniquely, the investigators propose to establish a robust link between these analyses: transcriptomic, in vitro, and genome-wide, to enable them to comprehensively explore septic oncology patient 'immune phenotypes' and effectively identify novel exploitable therapeutic pathways. To this end, this project will collect, analyse and/or sequence DNA, RNA, leukocytes and soluble materials from a cohort of oncology patients presenting to intensive care with sepsis. This cohort will include all-comers with an oncological background but will also focus on two core groups at high risk of sepsis where baseline samples can also be sought prior to major immunosuppressive events in the cancer pathway. These are: 1. Oesophageal/upper gastrointestinal (GI) cancer patients prior to systemic anticancer therapy initiation or surgery 2. Haematological malignancy patients prior to stem cell transplantation. These sub-cohorts will provide a previously unexplored unique insight into the role of pre-existing patient transcriptomic phenotypes.

NCT ID: NCT06046664 Active, not recruiting - Breast Cancer Clinical Trials

Oncotype DX DCIS: Impact on Radiotherapy Decision Making

ONCOTYPE
Start date: July 7, 2020
Phase: N/A
Study type: Interventional

Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.

NCT ID: NCT06046599 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis

RHAALS
Start date: October 24, 2022
Phase:
Study type: Observational

The goal of this observational study is the develop new ways of remotely monitoring the health and symptoms of people living with amyotrophic lateral sclerosis from within their homes. The main questions it aims to answer are: - Can we integrate a new muscle monitoring device into Imperial College London's home monitoring platform? - Can we investigate and understand the relationship between muscle activity and measure of patient behaviour (e.g., patient movement), physiology (e.g., pulse/blood pressure variation) and sleep quality from the home? - Can we establish a home-based multimodal biomarker that tracks the neurodegenerative process in ALS? Participants will have passive internet-of-things sensors and internet-enabled medical devices installed in their homes for one year. Some sensors will record automatically without any interaction from the participants, but some will require participants to engage with daily (e.g., blood pressure monitor) on their own or with the help of a study partner. Where possible, researchers will compare the collected data to other neurodegenerative diseases and healthy controls to understand differences over time.

NCT ID: NCT06046534 Completed - Clinical trials for Systemic Lupus Erythematosus

Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

ERYTHRO
Start date: October 27, 2023
Phase:
Study type: Observational

The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

NCT ID: NCT06046235 Not yet recruiting - Haemophilia Clinical Trials

Virtual Evaluations of Joint Health Using Wearable Sensors in Persons With Haemophilia (VESPA)

VESPA
Start date: May 1, 2024
Phase:
Study type: Observational

Recent technological innovations have enabled the creation of portable and easy-to-wear sensors with incredible potential to alter the clinical practice of rehabilitation. Using wearable sensors we have gathered preliminary data in the clinical setting measuring walking ability and function. Preliminary data shows that these wearable sensors can detect improvements in walking ability and function after a 12-week physiotherapy exercise programme in boys with haemophilia. In this proposal, we want to test the use of these wearable sensors in the patient's home to remotely monitor joint health and the effects of rehabilitation for people with haemophilia. We expect that wearable sensor technology is an efficient and promising tool to evaluate and monitor joint health and pain in persons with haemophilia. If usable in the home setting, the wearable sensors have the potential to provide immediate real-time feedback on joint health and rehabilitation goals to the patient and their haemophilia care team without the patient having to leave their home. The project will also support educational activities with researchers and patients to ensure that the use of this new type of rehabilitation will be fully integrated with their future treatment and management.

NCT ID: NCT06046118 Recruiting - Clinical trials for Age-Related Macular Degeneration

Photobiomodulation in Dry Age Related Macular Degeneration

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

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are: - Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD? - Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group. Treatment consists in two cycles with two phases each: - 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened; - 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened. Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks). Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.

NCT ID: NCT06045910 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

Start date: January 19, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in patients with relapsed non-Hodgkin lymphoma (NHL) who have failed to optimally respond to prior treatment with anti-CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 will be evaluated in Phase I in order to define a recommended dosing level and schedule for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

NCT ID: NCT06045806 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06044454 Recruiting - Lung Cancer Clinical Trials

Radiograph Accelerated Detection and Identification of Cancer in the Lung

RADICAL
Start date: December 4, 2023
Phase:
Study type: Observational

Lung cancer is the most common cause of cancer death in the UK yet compared to Europe it has low survival rates.The NHS aims to find 75% of cancers at an early stage as this can improve the chances of survival. To support this target, Qure.ai have developed the UK-approved qXR product, which is a software program that automatically analyses chest x-rays using artificial intelligence to identify features associated with lung cancer, indicative of other diagnoses, or that contain no abnormal features ('normal'). qXR is a class IIb medical device that can be used by radiologists to prioritise reporting based upon the presence or absence of these features. This may improve the accuracy and efficiency of reporting these images. The project includes different elements including: i) Clinical effectiveness study across 3 sectors within NHS Greater Glasgow and Clyde (NHSGGC).The primary objective is to assess the clinical effectiveness of qXR to prioritise patients that have suspected lung cancer (identified from AI analysis of a chest x-ray) for follow-on CT. Secondary objectives include: i) To assess the potential utility of qXR within the optimised lung cancer pathway in terms of the impact on both patient treatment and radiological workflow. ii) To assess the safety of qXR at ruling out patients from entry onto the cancer pathway iii) A technical evaluation utilising retrospective and prospective cohorts. The technical retrospective study will determine the performance of qXR using a sample of 1000 CXR images from all chest x-ray referral sources across all sectors (this differs from the prospective study, which only examines outpatient referred chest x-rays). iii) A health economic evaluation. Use of per patient healthcare utilisation costs to model cost benefits of qXR, including implementation of supported reporting of normal CXR. iv) A qualitative evaluation to assess acceptability and barriers to scale-up and implementation

NCT ID: NCT06043986 Recruiting - Nurse's Role Clinical Trials

Would Artificial Intelligence Reduce Delays to Nurse Response Times

WAiRD
Start date: May 23, 2023
Phase:
Study type: Observational

Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations. Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.