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NCT ID: NCT05551741 Recruiting - Alzheimer's Disease Clinical Trials

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

Start date: February 23, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled first-in-human, Phase 1, safety, tolerability, pharmacokinetic (PK) and preliminary exploratory activity study of escalating multiple intravenous (IV) doses of IBC-Ab002 in persons with early Alzheimer's disease. The study will have both Single- and Multiple-Ascending Dose components.

NCT ID: NCT05550532 Recruiting - Clinical trials for Depressive Disorder, Major

A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants With MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

VENTURA-2
Start date: December 6, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

NCT ID: NCT05549297 Recruiting - Advanced Melanoma Clinical Trials

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

Start date: December 19, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the efficacy and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma

NCT ID: NCT05549258 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Start date: August 25, 2022
Phase: Phase 2
Study type: Interventional

A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to < 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin [Ig]G).

NCT ID: NCT05549102 Recruiting - Anxiety Clinical Trials

CBT and the Neural Circuits of Anxiety

Start date: February 2, 2020
Phase:
Study type: Observational

This study will aim to test whether specific neural circuitry changes, proposed on the basis of a neurocognitive model of anxiety, are a mechanism of action for Cognitive Behavioural Therapy (CBT) interventions. This study aims to provide a theoretical model of the neurobiological mechanisms of CBT's therapeutic effect, where there currently is none, and potentially allow for more targeted/specific approaches to anxiety disorders following the identification of key CBT mechanisms. The ultimate aim is to improve the efficacy of CBT, and more generally, psychological interventions for anxiety disorders.

NCT ID: NCT05548036 Recruiting - COPD Clinical Trials

A Feasibility RCT of Aerobika Verses ACBT in People With COPD

TIPTOP
Start date: September 10, 2021
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is a common preventable and treatable respiratory condition. Its main symptoms include, breathlessness, cough and frequent chest infections. Many people with COPD struggle with excessive production of sputum, resulting in more hospital admissions and worse symptoms affecting quality of life. Guidelines suggest techniques to help clear sputum but there is not strong evidence behind these. In particular we don't know how effective cough clearance techniques are and indeed if any are better than others. This study will recruit people admitted to hospital with an exacerbation of COPD who have excessive sputum and randomise them to receive a hand-held airways clearance device or chest physiotherapy exercises. We will compare symptoms, quality of life, treatment burden and hospital admissions over the following year.

NCT ID: NCT05547594 Recruiting - Cancer Clinical Trials

Prehabilitation in Patients With Cancer and Type 2 Diabetes

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation. Although these aspects are well known, having a cancer diagnosis and the likelihood of an incoming operation during the weeks after diagnosis, place patients in a situation where they may be more receptive to adopting lifestyle changes aimed at promoting health. Such changes could be incorporated, not just in the short-term in preparation for surgery, but also in the medium- and long-term, improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence and other diseases. Although the benefits of prehabilitation before surgery are understood, the effects it may have in non-insulin-dependent Type 2 diabetes patients are unknown. This project aims to: (i) Analyse the effects of a multimodal prehabilitation programme vs. the current National Health Service (NHS) standard approach, on physical performance in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii) Explore the impact of the programme on body composition and metabolic markers. (iii) Analyse the programme adherence, markers of well-being and quality of life during a post-surgery period of up to 12 months as well as its effects on clinical outcomes.

NCT ID: NCT05545878 Recruiting - Clinical trials for Computer Vision Syndrome

Impact of 'SESL01' Lens on Computer Vision Syndrome

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The increased use of digital devices such as computers, smart-phones, tablets, and laptops has transformed how people learn and work and has increased the use of screens. This has created visual challenges for some users, such as maintaining a clear vision for a long period even when looking at different devices. Consequently, digital device users can experience eye problems such as blurred vision, eye strain, headaches, and dry eyes. Such problems are more common in people aged 21-45, and it seems that the COVID-19 pandemic has worsened them. Studies suggest that using specially designed lenses could reduce these problems. Therefore, the investigators aim to study whether specially designed lenses are more effective than standard ones in minimising these problems. The study will be conducted at the University of Central Lancashire at the Preston campus (UK). The study will recruit 300 participants, divided into two equal groups. Participants in group A will receive spectacles with special lenses while group B will receive spectacles with standard lenses. All Participants will be assessed three times, at 4-week intervals, and the final analysis will be performed at 14 weeks. The reduction of the eye problems will be assessed using a validated questionnaire which will produce a score that will be compared between the two groups at the end of the study. The study's potential benefits are twofold: 1. Patients using the new lenses will hopefully see a reduction in eye problems 2. Opticians will provide be able to provide better patient care.

NCT ID: NCT05545540 Recruiting - Epilepsy Clinical Trials

Music as an Adjunctive Epileptic Seizure Treatment Option

MAESTRO
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Mozart's Sonata for two pianos in D major (K448) has been found to reduce the presence of abnormalities in the electroencephalograms of patients with epilepsy. We will examine the long term effects of listening to the K448 sonata on seizure frequency and cognitive functioning in children with drug resistant epilepsy allocated to either a study group or a control group. Patients' parents will complete a seizure diary for the whole study period, during which antiepileptic drug therapy of the child will remain unchanged. Baseline neuropsychological testing will be performed and a seizure diary will be kept for 3 months. The study group will listen to K448 for 8 continuous minutes every day for 2 months, while those in the control group will listen to control music for the same amount of time. Neuropsychological testing will be repeated at the end of the study period and any change from baseline examined. Seizure frequency during periods of exposure to music will be compared to baseline in both groups. Feedback questionnaires and parent focus groups will be used to gather information around the practicalities of exposure to music, potential problems and suggestions for how future studies might be improved.

NCT ID: NCT05544526 Recruiting - Clinical trials for Diffuse Midline Glioma, H3 K27M-Mutant

CAR T Cells to Target GD2 for DMG

CARMIGO
Start date: August 15, 2023
Phase: Phase 1
Study type: Interventional

The CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma (DMG). The study will evaluate the feasibility of generating the ATIMP, the safety and tolerability of the GD2CAR T-cell therapy and how effectively GD2CAR T-cells engraft, expand and persist following administration in patients with DMG.