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NCT ID: NCT06193239 Recruiting - Lung Cancer Clinical Trials

Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution Phase 2)

Start date: October 5, 2023
Phase: Phase 2
Study type: Interventional

The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups. The contrast groups will be representative of the clinical populations in which the test is intended to be used. Thus, Evolution Phase 2a will be designed as a cross-sectional, case-control trial that will be conducted at various sites, both in the UK and EU.

NCT ID: NCT06180278 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

N-MOmentum LT
Start date: April 2, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety measures, and to further monitor repletion of immunoglobins and B-cell counts in participants with NMOSD who discontinue treatment. The objectives include: 1. To establish the nadir in circulating immunoglobulins (Ig) during chronic treatment with inebilizumab and ascertain the time needed to ensure restoration of pre-treatment baseline serum levels of IgG and IgM after discontinuation of treatment 2. To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels) 3. To assess long-term safety of inebilizumab 4. To assess other long-term effects of inebilizumab

NCT ID: NCT06173570 Recruiting - Dyslipidemia Clinical Trials

A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

PURSUIT
Start date: January 19, 2024
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

NCT ID: NCT06173089 Recruiting - Heart Failure Clinical Trials

REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

REMOTE-HEART
Start date: January 30, 2023
Phase:
Study type: Observational

However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events. The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class. By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated. Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.

NCT ID: NCT06168409 Recruiting - Clinical trials for Resistant Hypertension

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Bax24
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

NCT ID: NCT06167135 Recruiting - Obesity Clinical Trials

Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort

POMODORI
Start date: September 10, 2021
Phase:
Study type: Observational [Patient Registry]

Enrolling of 150 female patients of fertile age diagnosed with PCOS, insulin resistance, infertility, or mitochondrial disease, and the same number of age- and sex-matched controls are planned. During the research biomarkers already with mitochondrial dysfunction in the scientific literature and common mtDNA abnormalities (deletions, point mutations, copy number changes, etc.) are examined.

NCT ID: NCT06159231 Recruiting - Clinical trials for Coronary Artery Disease

FAME II-10-year Follow-Up

FAME2-10yFU
Start date: April 25, 2023
Phase:
Study type: Observational

The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.

NCT ID: NCT06147687 Recruiting - Endometriosis Clinical Trials

Machine Learning for Early Diagnosis of Endometriosis(MLEndo)

MLEndo
Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The project aims to create a large prospective data bank using the Lucy medical mobile application and collect and analyze patient profiles and structured clinical data with artificial intelligence. In addition, authors will investigate the association of removed or restricted dietary components with quality of life, pain, and central sensitization.

NCT ID: NCT06146673 Recruiting - Sleep Clinical Trials

A Multidimensional Study of Premenstrual Syndrome and Body Image

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

The goal of this cross-sectional study is to investigate the influencing factors of body image in women of reproductive age. The main question[s] it aims to answer are: - Is there a connection between physical activity, body mass index and body image? - Is there a connection between body image, premenstrual syndrome and sleep quality? Participants will fill out a complex online questionnaire.

NCT ID: NCT06143878 Recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Start date: January 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.