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NCT ID: NCT05828901 Recruiting - Multiple Sclerosis Clinical Trials

Predicting Disease Activity and Rebound Risk in MS Patients Treated With Sphingosine-1-phosphate Receptor Modulators (S1PRM)

PATTERN
Start date: March 27, 2023
Phase:
Study type: Observational

Sphingosine 1-Phosphate (S1P) receptor modulators (S1PRMs) are part of the evolving treatment landscape of Multiple Sclerosis (MS) immunotherapies. They target the G-protein coupled S1P receptor, among other localizations expressed at the surface of lymphocytes. Binding as a functional antagonist leads to internalization of the receptor and therefore lymphocyte sequestration in the secondary lymphoid organs. The first S1PRM approved was fingolimod. More recently newer generation S1PRMs like ozanimod have been approved, which possess differences in receptor affinities, pharmacokinetics and indications (including Secondary Progressive MS or Ulcerative Colitis). Several retrospective analyses have shown that, upon cessation of fingolimod, pronounced relapse of the MS-disease called "rebound disease activity" may occur. Indeed, these relapses, sometimes with considerable severity, take place in up to 10% of patients. The risk of rebound disease of the newer generation S1PRM are not well defined. Although of utmost importance, predictive biomarkers of treatment efficacy in general and in special circumstances, e.g. an impending rebound when S1PRM cessation is planned, are scarce. In this prospective, exploratory observational study, we aim to investigate the predictive potential of the lymphocytic S1PR1 and 5 expression prior to treatment initiation with the newer generation S1PRM ozanimod on the future disease activity ("on treatment" part). Additionally, in a post-treatment part ("off treatment"), the incidence of rebound disease and the predictive potential of the lymphocytic S1PR1 and 5 expression will be examined in patients, where ozanimod has to be stopped due to clinical reasons. T and B cells from patient blood samples obtained prior to treatment start/cessation and 3 - 6 months after start/cessation will be isolated and S1PR1 and 5 staining intensity will be assessed by flow cytometry (FACS). Clinical assessments (relapse assessment, EDSS, medical history etc.) will be performed at every visit and MRI evaluation, following our standard clinical and MRI MS protocol. MRI disease activity will serve as the primary endpoint for both study groups. The relationship between the flow cytometric staining intensity and the defined endpoints will be assessed statistically by using comparative statistical approaches and multivariable regression analysis where needed for both time points. The data collected will correlate the expression pattern of S1P receptors by T and B lymphocytes to the proxy of paraclinical activity as predictive biomarkers for disease activity on treatment and after treatment discontinuation.

NCT ID: NCT05828446 Recruiting - Clinical trials for Hepatocellular Carcinoma

Improving Hepatocellular Carcinoma Screening

AMRIK
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This is a monocentric, single blind, interventional, single arm study. It is designed to compare the rates of detection of hepatocellular carcinoma (HCC) by ultrasound (US) used in clinical routine vs. abbreviated magnetic resonance imaging (AMRI). The hypothesis is that dynamic AMRI with extracellular contrast agent injection has a higher patient-level detection rate of HCC than screening US and non-contrast AMRI. Interested and eligible patients will be enrolled and undergo HCC screening rounds including US +/- contrast-enhanced US (clinical routine) and screening MRI within the same week bi-annually.

NCT ID: NCT05827016 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

NCT ID: NCT05826808 Recruiting - Healthy Clinical Trials

Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).

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

The purpose of this study is to investigate the effect of moderate altitude (>1000 m.a.s.l.) on sleep examinations (polysomnography).

NCT ID: NCT05825898 Enrolling by invitation - Clinical trials for Tricuspid Regurgitation

Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment

TRIGISTRY
Start date: September 1, 2022
Phase:
Study type: Observational

Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.

NCT ID: NCT05824182 Recruiting - Clinical trials for Adverse Childhood Experiences

The FACE Self-help App for Fostering Resilience

Start date: May 31, 2023
Phase: N/A
Study type: Interventional

The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).

NCT ID: NCT05822947 Completed - Back Pain Clinical Trials

Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students

Start date: November 7, 2022
Phase: N/A
Study type: Interventional

There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.

NCT ID: NCT05820074 Recruiting - Parkinson Disease Clinical Trials

Investigating Neural Biomarkers for Gait in Parkinson's Patients

Start date: April 13, 2023
Phase:
Study type: Observational

This observational study's main goal is to learn more about the neural mechanisms during movement in Parkinson's disease. Furthermore, it aims to inspire personalised treatment options. Participants will undergo a protocol that involves walking and gait-related motor tasks, such as seated stepping. During the protocol, brain activity will be recorded.

NCT ID: NCT05819476 Recruiting - Acute Pain Clinical Trials

Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults

BOLPAP
Start date: March 23, 2023
Phase: N/A
Study type: Interventional

This study is to investigate the effect of open-label placebo (OLP) application on acute pain in an experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment). In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated. In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated

NCT ID: NCT05819463 Recruiting - Atopic Dermatitis Clinical Trials

Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - TREATswitzerland

Start date: May 9, 2022
Phase:
Study type: Observational

As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.