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NCT ID: NCT06331884 Recruiting - Clinical trials for Safety and Tolerability

Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab)

Start date: March 7, 2024
Phase: Phase 1
Study type: Interventional

Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock. Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects.

NCT ID: NCT06330350 Recruiting - Quality of Life Clinical Trials

Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling

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

The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals.

NCT ID: NCT06330324 Enrolling by invitation - Clinical trials for Epidermolysis Bullosa

Reproductive Options in Inherited Skin Diseases

REPRO-ISD
Start date: January 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children. To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe.

NCT ID: NCT06330298 Recruiting - Stroke Clinical Trials

Improving Social Cognition and Social Behaviour in Various Brain Disorders

T-ScEmo4ALL
Start date: May 31, 2021
Phase: N/A
Study type: Interventional

Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients. Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019). Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders. It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.

NCT ID: NCT06327724 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Belimumab in SLE Synovial Inflammation and Lymph Nodes

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

Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which the cellular and molecular alterations of the immune system driving the diseases still remains largely unknown. Accordingly, it remains difficult to predict the individual patient's response to treatment. Moreover, the patient's response to treatment remains heterogeneous and difficult to predict, despite the development of a variety of novel and powerful drugs (including the so-called biologicals). Therefore, there is a clear need for the identification and validation of cellular and molecular biomarkers which can provide useful clinical information for diagnosis, classification, prognosis and treatment, as well as the development of new therapeutic strategies. Biomarkers can be found and analyzed in different body compartments, of which the peripheral blood and the intra-articular synovial fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs showed that adaptive immune responses in other tissues such as lymph nodes also play an important role. Investigating other immune compartments of the body such as the lymph nodes could result in new insights. To study the early pathogenesis of inflammatory conditions, in 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated and, other than a small hematoma which does not require therapy in most of the cases, no complications were reported. In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by studying the immune alterations taking place in lymph nodes in comparison to peripheral blood and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle) by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been performed frequently in our department over the last 15 years. In this way immune alterations in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end organ for the disease) will be assessed and compared.

NCT ID: NCT06327217 Not yet recruiting - Clinical trials for Femoro Acetabular Impingement

Long Term Results After Hip Arthroscopy

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown.

NCT ID: NCT06324188 Not yet recruiting - Atrial Fibrillation Clinical Trials

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Start date: June 2024
Phase: N/A
Study type: Interventional

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial). The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

NCT ID: NCT06322836 Enrolling by invitation - Clinical trials for Emergency Medical Services

A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home

Electra-1
Start date: February 7, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients. The main question[s] it aims to answer are: Primary objective: In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation). Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention. Secondary objectives: Safety endpoint: Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation). A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.

NCT ID: NCT06322485 Completed - Fibromyalgia Clinical Trials

Online Self-management in Fibromyalgia

Start date: January 25, 2017
Phase: N/A
Study type: Interventional

This study has been previously registered with the National Trial Registry (NTR6267) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov. The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia. A randomized controlled trial (RCT) will be performed, in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition (patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group, i.e., after 6 months). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured.

NCT ID: NCT06322121 Recruiting - Dementia Clinical Trials

Vascular Aspects in Dementia: Part 2

Start date: September 4, 2023
Phase:
Study type: Observational

Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology.