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NCT ID: NCT06129968 Recruiting - Ovarian Cancer Clinical Trials

Transforming Ovarian Cancer Diagnostic Pathways

SONATA
Start date: January 23, 2024
Phase:
Study type: Observational

The goal of this observational cohort study is to compare the diagnostic accuracy and cost effectiveness of Risk of Malignancy Algorithm (ROMA) compared with CA125 in the diagnosis of ovarian cancer in patients attending their general practitioner (GP) with symptoms that sometimes might indicate ovarian cancer. The main questions it aims to answer are: • what is the accuracy of the ROMA algorithm which uses the blood tests CA125 and Human epididymis protein 4 (HE4) compared to CA125 in diagnosing ovarian cancer, particularly early-stage ovarian cancer, in women tested for suspected ovarian cancer from primary care? • What is the cost-effectiveness of ROMA versus CA125 testing in primary care to diagnose ovarian cancer? When a participant's GP orders a CA125 blood test, the blood will also be tested for HE4 and the ROMA algorithm calculated. The diagnostic accuracy of ROMA and CA125 will be compared to see if ROMA would be a better diagnostic test for ovarian cancer when used in the primary care setting.

NCT ID: NCT06129864 Recruiting - Clinical trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

eVOLVE-HNSCC
Start date: December 14, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

NCT ID: NCT06129500 Recruiting - Bipolar Disorder Clinical Trials

CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB

Start date: August 17, 2023
Phase: N/A
Study type: Interventional

The goal of this case series is to explore whether a talking therapy, specifically Cognitive Behavioural Therapy (CBT) is acceptable and feasible in the management of mood-driven impulsive behaviours in people with bipolar disorder (BD). The main questions it aims to answer are: - Whether CBT Is a feasible intervention for participants with BD who report mood-driven, problematic impulsive behaviours. - Whether CBT for mood-driven, problematic impulsive behaviours (CBT-PIB) is acceptable to service users with BD and therapists. - Whether clinical outcomes are consistent with the potential for this novel intervention to offer clinical benefit to participants with BD. The study also hopes to: - conduct a preliminary examination of the safety of CBT-PIB and the research procedures. - gather information on the potential mechanisms of action of CBT-PIB and, - gather information on the types of mood-driven impulsive behaviours individuals with BD may seek support for. Participants will: - be offered up to 12 individual sessions of CBT focusing on mood-driven impulsive behaviours. - be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment. - be asked to track mood and impulsive behaviours by completing a brief set of measures (3) weekly during the two-week baseline phase, the intervention phase and the 2-week post-intervention phase. - be asked to complete a survey on the acceptability of the intervention and - be invited to an optional semi-structured interview on their research experience.

NCT ID: NCT06129331 Recruiting - Aortic Stenosis Clinical Trials

Aortic Stenosis and Cardiac Amyloidosis

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

The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is <50 patients. It is the aim of the present international, multi-center registry to collect ~300 patients with AS-CA creating a big enough cohort to allow 1. thorough characterization of this condition 2. assessment of log-term clinical outcomes of AS-CA 3. assessment of effectiveness of amyloid-specific treatment on top of valve replacement

NCT ID: NCT06128993 Recruiting - Clinical trials for Myocardial Infarction

Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction

STEMI-Cool
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

A heart attack (myocardial infarction) occurs when an artery supplying blood to the heart is suddenly blocked resulting in damage to the heart muscle. Patients presenting to hospital with a heart attack undergo an immediate angiogram (x-ray of the arteries in the heart) and are usually treated immediately with a balloon and stent to open their blocked artery. This procedure is called "primary percutaneous coronary intervention" (or primary PCI for short). An angiogram is a routine procedure that involves insertion of fine plastic tube (catheter) into either the groin or wrist under local anaesthetic. The tube is passed into the artery in the heart and X-ray pictures are taken to find out if the arteries are blocked. Blocked arteries can usually be opened by passing a small balloon into the artery, via the fine plastic tube followed by placement of a stent (a fine metal coil) into the artery to prevent it from blocking again. Although this treatment is very successful, it can result in damage to the heart muscle when the artery is opened. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others; however, it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. The investigators are conducting a series of research studies to find out if cooling the heart muscle directly through the catheter being used for the normal primary angioplasty treatment using room temperature may be effective in preserving heart muscle, without the shortcomings of entire body cooling. The investigators have already published an initial series of ten cases in which this treatment appeared to be feasible without causing significant clinical problems. The present study is a pilot study designed to assess the rate of patient recruitment and feasibility of this new treatment while exploring some detailed outcomes measuring the restoration of blood flow within the coronary artery at the end of the procedure. Ultimately if the present pilot study is successful, the investigators plan to go on to undertake a much larger randomised outcome study to determine definitively whether this treatment can help reduce heart attack size.

NCT ID: NCT06128629 Recruiting - Clinical trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.

NCT ID: NCT06126731 Recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Combination Study of Antibiotics With Enzalutamide (PROMIZE)

Start date: November 2, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

PROMIZE is an open-label, multi-centre, single-arm, Phase I/II clinical trial, evaluating the safety, tolerability and anti-tumuor efficacy of an antibiotic combination and enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).

NCT ID: NCT06126367 Recruiting - Atherosclerosis Clinical Trials

Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease

ALFA
Start date: October 20, 2023
Phase:
Study type: Observational

Prior studies have shown that impaired endogenous fibrinolysis is a novel, independent cardiovascular risk factor in patients with myocardial infarction and there is currently no known chronic treatment to enhance endogenous fibrinolysis. To date, no therapies have been able to sufficiently reduce Lp(a) and therefore it was considered to be a non-modifiable cardiovascular risk factor. New data, however, has shown that PCSK9 inhibitors and inclisiran (medication that you have been deemed eligible for in order to help further reduce your cholesterol levels) to reduce Lp(a) levels by approximately 20-25%. The aim of this study to is to assess: 1. if there is an association between raised Lp(a) level in blood and the effectiveness of endogenous fibrinolysis (lysis time). 2. whether lowering Lp(a) with PCSK9i or inclisiran can enhance endogenous fibrinolysis

NCT ID: NCT06126224 Recruiting - Clinical trials for Psychosis Associated With Alzheimer's Disease

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

ADEPT-2
Start date: December 26, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

NCT ID: NCT06124911 Recruiting - Quality of Life Clinical Trials

Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life in Older Adults

Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The aims of this study were to: 1. Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training on untrained healthy older adults' quality-of-life, functional capacity, and strength. 2. Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance Training in older adults. Older adults are defined as being 60 or more years of age.