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NCT ID: NCT06042478 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

NCT ID: NCT06042348 Recruiting - Pregnancy Related Clinical Trials

Placenta Perfusion and Sufficiency Study

P2SS
Start date: September 15, 2023
Phase:
Study type: Observational [Patient Registry]

Ultrasonography will be used to determine the total blood flow to and from the uterus. This is done by measuring the blood vessels coming from and going to the uterus. This wil hopefully prove viable and open the possibility to further research in the clinical relevance of these measurements.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT06041867 Recruiting - Immune Response Clinical Trials

Agaricus Bisporus and Influenza Vaccination Response

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

There are numerous in vitro and animal studies that suggested that mushrooms beneficially influence the immune system. We have recently shown that a wild isolate of the edible Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of the immune system, both in vitro and in vivo in animals. The question now is whether this efficacy can also be translated to humans. In humans, measuring the antibody response is the golden standard to evaluate immune function. If Agaricus bisporus powder indeed has beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming Agaricus bisporus powder prior to receiving the influenza vaccination.

NCT ID: NCT06040086 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

MIRANDA
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

NCT ID: NCT06039527 Recruiting - Aging Clinical Trials

TINO: T Cells in the Nose of Older Adults

TINO
Start date: January 24, 2021
Phase:
Study type: Observational

Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring lower respiratory tract infections. Besides calendar age, the degree of frailty also associates with increased susceptibility to pneumonia requiring hospitalization. How alterations in the mucosal immune system with advanced age predispose to infections remains unclear as access to relevant tissue samples is limited. With minimally-invasive nasal sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype, underlying mechanisms, key molecules and consequences of this have not yet been investigated. Objective: Elucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the differences of T cells in young and older adults and associate this loss with susceptibility to infections. Study design: Prospective cohort study Study population: Participants will be recruited from 3 groups: - healthy young adults (18-30 years, n=50) - vital older adults (>65 years, n=60) - frail elderly (>65 years, n=60). This group includes individuals without a history of recurrent respiratory infections or with >2 self-reported episodes of respiratory infection in the past year. Main study parameters/endpoints: Frequency of nasal CD8+ T cells in young adults and frail older adults. Secondary study parameters/endpoints: - Phenotype (subsets, activation status), functionality, transcriptomic state, clonality and frequency of nasal and blood T cell populations - Stability of T cells and other immune parameters, as described for main study parameter, during a second sample after 3 months. - Analysis of other immune populations as for main study parameter - Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations - Respiratory tract microbiota profiles and presence of asymptomatic viral infections and their association with T cells and other immune parameters - Chronological and biological age, sex, and other immunologically relevant parameters with T cell populations and other immune parameters - Alteration of T cell phenotype, during and following respiratory tract infections. Levels of antigen-specific T cells and other immune parameters in nose and blood post infection.

NCT ID: NCT06039137 Completed - Solid Tumor Clinical Trials

The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment

H1-Switch
Start date: June 1, 2022
Phase:
Study type: Observational

In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.

NCT ID: NCT06038864 Not yet recruiting - Clinical trials for Lower Limb Lymphedema

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4

EvaLymph-Leg4
Start date: April 1, 2024
Phase:
Study type: Observational

Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?

NCT ID: NCT06038188 Completed - Clinical trials for Coronary Artery Disease

Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease

BOOSTSITLESS
Start date: August 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the effect of a booster program aiming to lower daily sitting time (SIT LESS Booster program) compared to usual care in patient with coronary heart problems. The main question it aims to answer is: What is the effect of the SIT LESS Booster on sedentary time and physical activity levels in patient with coronary artery disease who participated in cardiac rehabilitation. Participants will be randomized into 2 groups: 1. Control group who receives usual care; 2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster program. Objectively measured changes in daily sitting time from pre- to post SIT LESS Booster will be compared between groups to see if participants in the SIT LESS Booster group are able to reduce daily sedentary time more compared to participants in the control group.

NCT ID: NCT06036836 Recruiting - Solid Tumor Clinical Trials

Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)

Start date: September 29, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate pathological complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) [Cohort A] and to evaluate lenvatinib in combination with coformulated favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in participants proficient in mismatch repair (pMMR) endometrial cancer (EC) [Cohort B].