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NCT ID: NCT05556096 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

NCT ID: NCT05555914 Completed - Tetraplegia Clinical Trials

Neural Stimulation for Hand Grasp in People With Tetraplegia

AGILIS
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery. Our main hypothesis is that multipolar neural electrical stimulation of the median and the ulnar nerve (flexion) and the radial nerve (extension) allows: - on the one hand, a selective, individualized motor activation (muscle by muscle) - on the other hand, a synergistic motor activation (association of several muscles) for the purpose of production of functional movements.

NCT ID: NCT05555784 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy (LHON)

Evaluation of Impact of Disease and Visual Disability on Quality of Life and Loss of Independence of Patients Living in France With Leber's Hereditary Optic Neuropathy (LHON) Through Qualitative and Quantitative Data Collection

Start date: August 4, 2022
Phase:
Study type: Observational

Leber's hereditary optic neuropathy (LHON) is a rare mitochondrial genetic disorder characterized by optic nerve atrophy due to the degeneration of retinal ganglion cells, which leads to acute visual loss. Males are more likely to develop optic neuropathy than women. They experience blurring or clouding of vision in one eye. The fellow eye develops similar symptoms sequentially with a delay of weeks. This sudden vision loss has devastating consequences on the life course of young men, with the impact of LHON on their quality of life and loss of independence. Yet, data describing the impacts of LHON on the life-course of patients is lacking, with very little data available in the literature. This study aims to understand the life of patients living with LHON disease through the analysis of the impact of LHON on the quality of life and loss of independence of patients living in France and to accurately describe the consequences of the disease on their social, familial and professional life.

NCT ID: NCT05555732 Recruiting - Clinical trials for Metastatic Non Small Cell Lung Cancer

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

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

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

NCT ID: NCT05555615 Recruiting - Clinical trials for Irritability Associated With Autism Spectrum Disorder

Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

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

52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years). ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).

NCT ID: NCT05555433 Recruiting - Spondylarthritis Clinical Trials

Calprotectine in Spondyloarthritis

Calprotectine
Start date: August 15, 2022
Phase:
Study type: Observational

To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology

NCT ID: NCT05554432 Recruiting - Cancer Clinical Trials

Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2

EORTC ICI
Start date: October 12, 2022
Phase:
Study type: Observational

Over the past 20 years, the views and experiences of patients in the field of oncology (through patient-reported outcomes, PROMs) have become increasingly important. When used in clinical trials, PROMs contribute to better detection and are used in clinical trials to improve the detection and management of treatment side effects. The Health-related quality of life assessments are widely used in oncology research, and the development of reliable and valid measurement instruments has become a major challenge. In this context, health-related quality of life in cancer patients covers various aspects (functional status, physical or psychological symptoms) and several cancer-specific measurement instruments have been developed, including the EORTC QLQ-C30 quality of life questionnaire. Among the different therapies used to treat cancers, immunotherapy with immune checkpoint inhibitors has been gaining momentum in recent years. Commonly used to treat a wide variety of cancers, it also has a wide range of known side effects. However, little is known about the health-related quality of life of patients patients who receive this therapy: specific self-questionnaires are almost non-existent or inadequate, not covering all the effects related to immune checkpoint inhibitor toxicity. As for the data currently collected, they suffer from methodological problems. In view of the increasing use of immune checkpoint inhibitors in cancer treatment, their known side effects and the lack of valid questionnaires specific to these treatments, it appears important to provide a valid questionnaire to take into account these impacts on the quality of life of patients.

NCT ID: NCT05554055 Not yet recruiting - Thrombosis Clinical Trials

Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)

AXAES
Start date: November 2022
Phase:
Study type: Observational

Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated. Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre. In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.

NCT ID: NCT05553808 Completed - Neoplasms Clinical Trials

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.

NCT ID: NCT05553418 Completed - Healthy Volunteers Clinical Trials

Investigational On-body Injector Clinical Study

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.