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NCT ID: NCT05646862 Recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

INAVO121
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.

NCT ID: NCT05646628 Recruiting - Depression Clinical Trials

The Impact of Comorbid Chronic Pain on Older Adults With Depression in Behavioral Activation

Start date: November 28, 2022
Phase:
Study type: Observational

This qualitative nested sub-study will aim to explore how chronic pain (as defined as pain lasting for more than 3 months) impacts older adults' depression and treatment in a brief psychological therapy of behavioral activation (BA)

NCT ID: NCT05646381 Recruiting - Aortic Stenosis Clinical Trials

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Start date: March 7, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

NCT ID: NCT05646082 Recruiting - Clinical trials for Refractory HIV Associated Kaposi Sarcoma

Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma

STARKAP
Start date: May 26, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1b, open label, single arm study evaluating the safety and tolerability of the drug dostarlimab in combination antiretroviral therapy (cART) refractory HIV-associated Kaposi Sarcoma (KS), a rare type of cancer usually seen in people with the HIV infection. Dostarlimab is a type of immunotherapy, and is a monoclonal antibody that has been designed to inhibit the receptor programmed death-1 (PD-1). One of the two ligands for PD-1 has been shown to be upregulated in KS patients, the PDL-1 ligand. By preventing PDL-1 form binding to PD-1, dostarlimab increases the body's immune response to attack more cancer cells. The safety profile of dostarlimab in this specific cancer has not been explored. The primary aim of this study is therefore to provide confirmatory evidence of safety of dostarlimab in KS patients and to preliminary evaluate its effects on HIV reservoirs and assess how it causes its anti-cancer effects through studying tumour tissue before and after treatment. This study will be conducted in two parts and will recruit a total of up to 20 patients. Upon completion of screening investigations inclusive of a fresh tumour biopsy within a 28-days window, patients will receive dostarlimab at the fixed dose of 500 mg dose every 3 weeks for the first 4 doses followed by a fixed 1000 mg dose every 6 weeks. Treatment will be continued until loss of clinical benefit, unacceptable toxicity, patients' withdrawal or completion of a total of 48 weeks of treatment. Part 1 will consist of 6 patients being dosed and observed for toxicity for 21 days following first dose. A trial steering committee will evaluate any treatment related adverse events (AEs) and dose-limiting toxicities (DLTs) reported before deciding on whether to continue onto part 2, where a further 14 patients may be enrolled.

NCT ID: NCT05645783 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Liquid Biopsy for Early DiagNosis of Squamous Cell Carcinoma of the HeAd and NeCk rEgion

ENHANCE
Start date: February 1, 2023
Phase:
Study type: Observational

The 5-year survival for Head and Neck squamous cell carcinoma (HNSCC) across all TNM stage groups is approximately 50%. Patients who are present with stage I & II disease have significantly better survival. When a patient presents to their general practitioner (GP) with symptoms suggestive of HNSCC, they may be referred for urgent specialist input through the suspected cancer referral (SCR) pathway, which include dedicated neck lump clinics. HNSCC is known to shed fragments of DNA, called circulating tumor DNA (ctDNA) into the bloodstream. The investigators have developed novel ultra-sensitive (>90% sensitivity) next generation sequencing (NGS) assay for circulating HPV DNA in patients with non-metastatic locally advanced head and neck cancer. The use of ultra-sensitive NGS assay for detection of ctDNA using a simple blood test (liquid biopsy) holds a great promise for cancer screening and early diagnosis and can lead to better survival results and less disease burden. With a quicker turnaround (1-2 weeks), the liquid biopsy can help expedite the patient journey through the cancer pathways reducing the incidence of cancer target breaches. In order to design studies to test this hypothesis the investigators require preliminary data quantifying sensitivity and specificity of the assay in this setting.

NCT ID: NCT05645692 Recruiting - Urothelial Cancer Clinical Trials

A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer

Start date: April 13, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.

NCT ID: NCT05645081 Recruiting - Stroke, Ischemic Clinical Trials

Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

PREDICT-EV
Start date: October 1, 2021
Phase:
Study type: Observational

Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.

NCT ID: NCT05644457 Recruiting - Clinical trials for Head and Neck Cancer

Exploratory Study of Early Biomarkers Allowing Dynamic Assessment of Response to Treatment in Cancers of the Head and Neck

DART
Start date: March 9, 2022
Phase:
Study type: Observational

DART is an exploratory molecular analysis study to assess potential early biomarkers of treatment response in squamous cell carcinoma of the head and neck (HNSCC)

NCT ID: NCT05643924 Recruiting - Asthma Clinical Trials

COM-B Asthma Questionnaire

COM-B
Start date: February 24, 2022
Phase:
Study type: Observational

Asthma is a common lung condition that cannot be cured, although usually it can be effectively controlled with available treatments. Yet, it is well recognised that 70% of patients are non-adherent to their asthma treatment. Personalising treatment by offering the most relevant interventions based on the patient's psychological/behavioural needs results in great success. However, health care providers have limited available resources to deliver a patient-centred approach to their psychological/behavioural needs, resulting in a current one-size-fits-all strategy due to the non-feasible nature of existing surveys. The solution would be to provide health care professionals with a clinically feasible questionnaire that identifies the patients personal psychological/behavioural factors to adherence.

NCT ID: NCT05643430 Recruiting - Clinical trials for Coronary Artery Disease

ULTRA LONG: BioFreedom Ultra

Start date: February 27, 2024
Phase: N/A
Study type: Interventional

The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.