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NCT ID: NCT06075147 Recruiting - Visual Impairment Clinical Trials

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

Start date: February 15, 2024
Phase:
Study type: Observational

This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.

NCT ID: NCT06075056 Recruiting - Clinical trials for Spinal Cord Injuries

Neuro-navigated TMS for Chronic SCI Patients

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

Can neuro-navigated Transcranial Magnetic Stimulation be used as an additional outcome measure to EM-SCI assessments in a Spinal cord injury trial? - Compare EM-SCI assessment with nTMS in ten chronic thoracic SCI patients - Compare EM-SCI assessment with nTMS in ten chronic cervical SCI patients

NCT ID: NCT06073821 Recruiting - CLL Clinical Trials

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Start date: November 11, 2023
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

NCT ID: NCT06073314 Recruiting - Sarcoma Clinical Trials

Novel Applications for Sarcoma Assessment

NASA
Start date: August 9, 2023
Phase:
Study type: Observational

This research aims to improve the way of deciding whether a lump in soft tissue such as fat or muscle is a type of cancer called a soft tissue sarcoma, or if it is benign (non-cancerous). To do this the investigators will use routine clinical MRI scans, additional quantitative MRI scans and artificial intelligence. The aims of this research are: To develop AI algorithms that can accurately classify soft tissue masses as benign or malignant using routine and quantitative MR images. To classify malignant soft tissue masses into their pathological grade. Compare different AI models on external, unseen testing sets to determine which offers the best performance. Participants will be asked if they can spend up to a maximum of 10 extra minutes in an MRI scanner so that the extra images can be acquired. A small subset of participants will be invited back so the investigators can check the reproducibility of the images and the AI software.

NCT ID: NCT06073119 Recruiting - Psoriasis Clinical Trials

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

SPECIFI-PSO
Start date: October 26, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details include a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of study visits will be 7.

NCT ID: NCT06072872 Recruiting - Respiratory Disease Clinical Trials

Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study

Start date: July 27, 2023
Phase: N/A
Study type: Interventional

This study will investigate the role of a portable Continues Positive Airway Pressure device (pCPAP) in management of patients with symptomatic Excessive Central Airway Collapse (ECAC). ECAC is characterised by complete or partial collapse of central airways on exhalation. In some cases, this can cause persistent breathlessness and severely limited exercise capacity. Current treatment options for ECAC are very limited. Standard assistive breathing devices such as CPAP machines are sometimes used to relieve symptoms at night or at rest. This does not address breathlessness during activity which drives accumulation of disability over time. The main aims of this project are to assess the effect of a portable CPAP (pCPAP) device on exercise capacity and symptoms and evaluate the feasibility of wearing pCPAP at home during routine activities. Lightweight battery-powered portable CPAP devices have been recently developed to facilitate travel to remote areas by people with Obstructive Sleep Apnoea (OSA). Patients with ECAC can wear them during physical activity to prevent airway collapse but their potential benefits have not been evaluated in clinical trials. For this study, the investigators will recruit 20 patients with ECAC who will attend for two study visits 4-6 weeks apart in a single centre (The Royal Papworth Hospital). The primary outcome measure will be a shuttle walk test performed repeatedly with and without pCPAP in a randomised order. Secondary outcomes will include assessment of activity level, breathlessness, quality of life ,pCPAP usage and its acceptability. The study will evaluate a pragmatic way of CPAP titration and application. Previously acquired diagnostic baseline computed tomography (CT) scans will be analysed with a novel Functional Respiratory Imaging (FRI) tool. This software tool will enable retrospective reflections on the changes occurring within the lungs for patients with ECAC. This may help identify predictive features of potential pCPAP responders and inform future use.

NCT ID: NCT06072781 Recruiting - Clinical trials for Low Grade Serous Ovarian Cancer

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

RAMP 301
Start date: March 18, 2024
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

NCT ID: NCT06072300 Recruiting - Clinical trials for Proportion of Total High Calorie Beverages

Effects of Physical Activity Calorie Equivalent Labelling on Hot Drink Vending Transactions

PACE-VEND
Start date: October 30, 2023
Phase: Phase 3
Study type: Interventional

Food nutritional labels are one way to support people to make more informed, healthier food choices. However, there is limited evidence from trials showing that nutrition information on food or drinks is changing the food purchasing or food/beverage consumption behaviours. Many people do not understand the meaning of kilocalories (kcals, calories) or grams of fat displayed on food labels, and often underestimate the number of calories when labelling is not provided. An alternative or complementary approach to current nutrition labelling, is to provide calorie information with a clear interpretation of what the calorie content of the food item/meal or beverage means in terms of energy expenditure. This approach has been called physical activity calorie equivalent (or expenditure) labelling (PACE), which aims to show the public how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in food/beverages. For example, "the calories in this chocolate bar require 95 minutes of walking to burn off". One context in which the public consume a lot of calories is from vending machines. We hypothesise that providing consumers with PACE information on hot beverage vending machines will reduce the average number of calories per transaction dispensed from the vending machines compared with when no PACE information/labelling is presented on vending machines. The study will adopt what is called a stepped wedge randomised controlled trial design involving 42 hot beverage vending machines in 27 buildings (clusters). Clusters will be randomly allocated to one of eight sequences across 24 weeks, which will dictate the time (weeks) at which clusters display the vending machine PACE labelling intervention. Weeks one to four will constitute a baseline period, during which the data will be collected from all vending machines without PACE labelling in place. This will be followed by 20 weeks during which the PACE labelling intervention will be introduced and maintained at each building according to a stepped wedge design (Figure 2). Specifically, every two weeks, three or four clusters will move to the intervention condition. The number of transactions from the vending machines will be collected over the study period and we will compare the number of transactions in the weeks when the PACE labelling is displayed compared to when it was not.

NCT ID: NCT06072287 Recruiting - Obesity Clinical Trials

The Living With a Long-Term Condition Study

LTC
Start date: June 28, 2023
Phase:
Study type: Observational

Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is. The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.

NCT ID: NCT06071910 Recruiting - Cardiac Arrest Clinical Trials

Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest

ERICA-ARREST
Start date: June 5, 2024
Phase: N/A
Study type: Interventional

This study will assess the feasibility of performing pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to conventional Advanced Life Support (ALS) in patients suffering from non-traumatic out of hospital cardiac arrest (OHCA). As well as providing valuable insights into the technical feasibility of performing this procedure as part of a resuscitation attempt, the study will also document the beneficial physiological effects of REBOA in this group of patients.