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NCT ID: NCT06462768 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis

NETOSE
Start date: November 27, 2023
Phase:
Study type: Observational

Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS). Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE. The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.

NCT ID: NCT06461481 Recruiting - Multiple Sclerosis Clinical Trials

Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis

SAFEGUIDE-MS
Start date: June 15, 2024
Phase:
Study type: Observational

The study will attempt to closely analyze Multiple Sclerosis (MS) patients after de-escalating or discontinuation of immunotherapy using clinical monitoring as well as digital and serological biomarkers in order to detect clinical progression or disease activity. As this is an observational study, it aims to closely follow-up on patients where the clinical decision to de-escalate or end treatment has been independently made. Specifically, we want to find out to what extent patients will show increased disease activity after de-escalation/discontinuation from high-efficacy treatment (HET) and which measurement method (clinical, digital, serological) retrospectively reflects the disease activity most closely or detects it most sensitively.

NCT ID: NCT06453668 Recruiting - ALS Clinical Trials

A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients

AURORA
Start date: April 16, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.

NCT ID: NCT06451159 Recruiting - Clinical trials for Progressive Multiple Sclerosis

A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis

Start date: June 2024
Phase: Phase 1
Study type: Interventional

The goal of this study is to test a drug called KYV-101 in people who have progressive multiple sclerosis (MS) and who have not responded to standard therapies to slow disease progression. The main questions it aims to answer are: - What is the highest therapy dose that can be given without causing harm? - Can this therapy enter the central nervous system? Participants will be asked to: - Attend 14 visits plus an 8-day inpatient hospital stay over the course of 58 weeks. - Complete apheresis and chemotherapy treatments in preparation for KVY-101 therapy. - Undergo medical and research testing such as physical and neurological exams, MRI, lumbar puncture, blood draws, questionnaires, and vision assessments.

NCT ID: NCT06441448 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

potentiALS - Quality of Life Among Patients With Amyotrophic Lateral Sclerosis

potentiALS
Start date: January 1, 2024
Phase:
Study type: Observational

Amyotrophic lateral sclerosis (ALS) is a rapidly progressing and disabling disease with the majority of patients dying 3-5 years after symptom onset. Given the high symptom burden, many patients and its caregivers are highly distressed. However, few programs to improve mental health for this patient group exist, and the sparse research implies that programs effective in other medical conditions may not be feasible in ALS patients. Therefore, it is highly needed to involve ALS patients, caregivers and medical staff as contributors into the development of such programs to meet the needs they really have. The envisaged project has two aims: First, the investigators want to examine whether and how it is possible to involve ALS patients in the whole research process despite rapid disease progress and severe functional impairments. Second, the investigators are interested in how contributors (i.e., patients, caregivers and medical staff) would compile a concrete psychotherapeutic program, i.e., how they set priorities in terms of format, content and treatment techniques of such a program. The investigators will closely collaborate with contributors across the whole project in designing the research process, planning assessment as well as interpreting and disseminating the findings. At the end of the study, the investigators will gather contributor feedback on their experience with the participatory approach. Results will provide important information on how ALS patients can be effectively involved in psychosocial intervention research. Identified priorites regarding psychotherapeutic programs will serve as concrete starting points to develop and test a disease-specific program within a subsequent study.

NCT ID: NCT06430671 Recruiting - Clinical trials for Relapsing-remitting Multiple Sclerosis (RRMS)

Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis

RED4MS
Start date: June 18, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

RED4MS is a clinical trial to assess the safety, tolerability and efficacy of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.

NCT ID: NCT06426030 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Validation of Czech Language Versions of Questionnaires for ALS Patients' Functional Status and Biomarker Long-term Follow-up

Start date: May 17, 2024
Phase:
Study type: Observational

Questionnaires and scales used to assess the clinical status and quality of life of patients with amyotrophic lateral sclerosis (ALS) are an important tool to monitor the disease progression and current needs of patients. The use of these tools (and in particular their combination) allows to cover the whole spectrum of potential patient difficulties and thus significantly facilitates the process of individualisation and optimisation of care. The aim of the study was to create and validate the Czech language versions of the following questionnaires or scales: (1) ALSFRS-R (ALS Functional Rating Scale - Revised Version) and (2) ALSFRS-EX (EXtended, i.e. extended, version of the same scale), both in the self-assessment version (incl. (3) the ALSAQ-40 (ALS Assessment Questionnaire including 40 questions), (4) the DYALS (Dysphagia in ALS), and (5) the Borg Dyspnoea Rating Scale. All questionnaires were translated using the forward-backward translation method. The scales and questionnaires were administered to ALS patients repeatedly at one-week intervals, first in writing during routine patient follow-up at the Neuromuscular Centre of the University Hospital Brno, and during repeated administrations by telephone.

NCT ID: NCT06418646 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany

Start date: August 1, 2022
Phase:
Study type: Observational

The progressive loss of physical functioning resulting from ALS leads also to high psychosocial burden for those affected, and organizational challenges related to medical care and aids. A multidimensional and -professional care is advised in order to meet the complex requirements of this disease. In Germany, medical care structures may not fulfil these high requirements, since non-medical services such as psychological support or social counselling are not regularly included in care procedures for ALS patients. Specialised palliative care is not a standard and still commonly restricted to the last weeks of life. Additionally, it is well known that caregivers of ALS patients are highly burdened, but there is a lack of support services for them. By means of a cross-sectional, multicentre survey, we aim to investigate patients' and caregivers' perception of medical care for ALS, provided in Germany - with particular regard to psychosocial and palliative aspects. The extent to which physical, psychological, social, spiritual, practical and informational needs are subjectively met will be assessed and correlations with mental wellbeing, subjective quality of life, attitudes towards life-sustaining measures and physician-assisted suicide, as well as caregiver burden will be examined. Currently, study planning (questionnaires and ethical approval) is already completed and recruitment was started. The study aims to recruit 500 participants from nationwide ALS-centres. Cooperating ALS-centres will be recruited via the German Network for Motoneuron Diseases (MND-Net), of which our centre is a member. It is intended to provide data-based starting points on how care of ALS patients and their caregivers can be improved in Germany, in line with their needs.

NCT ID: NCT06403631 Recruiting - Multiple Sclerosis Clinical Trials

Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis

MindFlowMS
Start date: November 6, 2023
Phase:
Study type: Observational

The overall goal of this observational study is to learn about the psychological resources of mindfulness and flow experience available to persons newly diagnosed with multiple sclerosis (MS). The primary study aim will be to analyze the relation of flow and mindfulness with mental health among individuals who received an MS diagnosis within the last year. Secondary aims will be to analyze the daily activities preferentially associated with flow, and to evaluate possible changes in daily flow retrieval. Participants will answer questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression at project start and 6 months later.

NCT ID: NCT06396039 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis

Start date: May 15, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.