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NCT ID: NCT05740787 Recruiting - Breast Cancer Clinical Trials

Chemotherapy Induced Cognitive Impairment

CONCERT
Start date: December 15, 2022
Phase:
Study type: Observational

Chemotherapy is toxic and challenges everyone differently. Most chemotherapy side-effects are known and well documented. However, the phenomenon of "chemo fog" also known as "chemobrain" has not been fully investigated and is often based on comments of breast cancer patients attending outpatient clinics during and after their chemotherapy. Changes in thinking ability like lack of concentration, loss of memory and the inability to hold a thought or even a conversation has a significant impact on the lives of breast cancer patients. Without understanding what "chemobrain" is, and what causes it, there is little that doctors can do to help at the moment. The team proposing this study believe that chemotherapy causes chemicals associated with inflammation to attack parts of the brain that are important for concentration and making new memories. Unfortunately, it is not possible to measure these chemicals directly in the brain, but we believe that a brain scan sensitive to excess iron, a marker of brain inflammation, can help. This project will measure thinking ability, such as memory and concentration, take a blood sample and do a brain scan before, during and after a patient has chemotherapy. We will then look for changes in iron in the brain areas that are important for concentration and memory and compare those to changes in thinking ability and to levels of inflammation chemicals in the blood. This information will be essential to help plan our next step which is to test ways to reduce the effects of "chemobrain".

NCT ID: NCT05740709 Recruiting - Acute Kidney Injury Clinical Trials

Identification of Patients at Risk of CKD After AKI

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

The investigators will investigate whether new kidney biomarkers can identify patients who are at risk of chronic kidney disease after an episode of moderate / severe acute kidney injury in ICU.

NCT ID: NCT05740566 Recruiting - Clinical trials for Small Cell Lung Cancer (SCLC)

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

DeLLphi-304
Start date: May 31, 2023
Phase: Phase 3
Study type: Interventional

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

NCT ID: NCT05740384 Recruiting - Clinical trials for Eustachian Tube Dysfunction

The Accuracy of Sonotubometry to Assess the Eustachian Tube

Start date: April 21, 2023
Phase: N/A
Study type: Interventional

The Eustachian tube (ET) connects the middle ear with the throat and is important for maintaining a healthy middle ear. Sonotubometry is a new method to measure how well the ET works by using sound. A speaker is placed at the nostril and a microphone records sound in the external ear canal. The ET is closed at rest and opens with swallowing. This is measured as an increase in sound measured in the external ear by sonotubometry. Previous research has not proven that sonotubometry is reliable enough to be used in clinics to assess ET dysfunction (a disease where the ET does not open properly). In a recent study with healthy volunteers, it was possible to identify many of the existing issues of sonotubometry and improve the reliability of this method. This was primarily achieved by testing different sound types and sound volumes. This study aims to assess the reliability and usability of the new testing protocol in study participants with ET dysfunction. The results of this study will then be compared with the results from the previous study with healthy volunteers to work out how well sonotubometry works. Ultimately, this research aims to improve the ability to diagnose ET dysfunction.

NCT ID: NCT05739383 Recruiting - Clinical trials for Primary Prevention of Atherosclerotic Cardiovascular Disease

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Start date: March 9, 2023
Phase: Phase 3
Study type: Interventional

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

NCT ID: NCT05738486 Recruiting - Dementia Clinical Trials

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Start date: February 28, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

NCT ID: NCT05737940 Recruiting - Heart Failure Clinical Trials

A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2

Re-PHIRE
Start date: April 24, 2023
Phase: Phase 2
Study type: Interventional

This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance (PVR) after 24 weeks of treatment in participants with heart failure (HF) and pulmonary hypertension (PH) Group 2

NCT ID: NCT05737875 Recruiting - Pancreatic Fistula Clinical Trials

Distal Pancreatectomy Pancreatic Fistula Risk Prediction Model Validation Study

DPFValid
Start date: April 7, 2023
Phase:
Study type: Observational

Distal pancreas resection is a relatively rare procedure with a known risk of postoperative pancreatic fistula. Until quite recently, no valid risk prediction models for this have been available. In 2022 two different risk scores DISPAIR and D-FRS were published. The aim of this study is to compare, validate and possibly improve those scores in a international retrospective multicenter cohort.

NCT ID: NCT05737823 Recruiting - Feasibility Clinical Trials

Supporting Family Carers' Mental Health

Start date: May 12, 2023
Phase: N/A
Study type: Interventional

Brief Summary: Background: Feasibility and acceptability of the Carers-ID intervention to improve mental health outcomes in family carers of people with intellectual disabilities. Objective: 1. To conduct a Phase II feasibility randomised controlled trial and process evaluation of the Carers-ID programme. 2. To determine the acceptability of outcome measures of stress, anxiety, depression, resilience and well-being in assessing the impact of the programme on family carers. 3. To determine the recruitment and retention rates of participants in the trial. 4. To identify potential effect sizes and estimate appropriate sample size for use in an effectiveness trial. 5. To determine if progression to a phase III effectiveness trial is warranted. Methodology: Family carers (n = 120) will be randomised to receive the programme (n=60) or assigned to a wait-list control (n=60) group. The intervention (Carers-ID) consists of ten modules which cover topics including: promoting resilience, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in the process evaluation. Outcome: 1. Retention of Subjects in Study Assessments (>80% of family carers) 2. Recruitment of Subjects into Study (>90 carers) 3. Acceptability and feasibility of the outcome measures (>80% of family carers) 4. Depression, Anxiety and Stress Scale - 21; The Warwick-Edinburgh Mental Well-being Scale; The Resilience Scale; and The Social Connectedness Scale Revised. Number of participants to be enrolled: 120 family carers Main inclusion criteria: Participants will be UK adults >18 years of age and will be caring for a family member with an intellectual disability. Statistical Analysis: Descriptive statistics will be used to summarise baseline data including demographic variables and questionnaire responses. Inferential statistics (t-tests or ANOVA) will be used as indicators of difference between the intervention and control arms and will be used to determine effect sizes for sample size calculation in a future phase III trial. Study duration: 24 months

NCT ID: NCT05737628 Recruiting - Lymphoma Clinical Trials

First-in-human Dose Escalation and Expansion Study With the SIRPĪ±-directed Monoclonal Antibody BYON4228

Start date: March 4, 2024
Phase: Phase 1
Study type: Interventional

This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPĪ±.