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NCT ID: NCT06203457 Active, not recruiting - Clinical trials for Primary Sjögren's Syndrome

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Rho plus
Start date: August 15, 2023
Phase: Phase 2
Study type: Interventional

Efgartigimod contributes to successfully treat pSS and has the potential to improve disease manifestations by the reduction of IgG autoantibodies in pSS. This open-label extension study will evaluate the long-term safety of efgartigimod in participants with pSS who have completed the treatment period of the qualifying efgartigimod studies (including ARGX-113-2106).

NCT ID: NCT06203210 Not yet recruiting - Clinical trials for Small Cell Lung Cancer

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

IDeate-Lung02
Start date: June 10, 2024
Phase: Phase 3
Study type: Interventional

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

NCT ID: NCT06195930 Recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction

Start date: April 18, 2024
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is too weak to pump enough blood to the rest of the body. This results in a reduced supply of the oxygen that the body requires to function properly. The common symptoms of HFrEF include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays or even death. Vericiguat is an approved drug for use in people with chronic HFrEF. It works by activating a protein called soluble guanylate cyclase, which helps dilating the blood vessels and in turn improves heart function. Currently, treatment with vericiguat starts at a daily dose of 2.5 milligrams (mg), which increases to 5 mg after 2 weeks. The dose is then increased to the target dose of 10 mg after another 2 weeks. In this study, researchers are trying to learn how well participants can tolerate and how safe it is to start vericiguat at a dose of 5 mg. Starting directly at the 5 mg dose is expected to help reach the target dose of 10 mg faster. Participants will take vericiguat 5 mg as a tablet by mouth once daily along with their regular heart medications. At the start of the study, study doctors will check participants' medical history and perform full health check-ups to confirm if they can take part in the study. Throughout the study, study doctors will monitor participants' previous and current medications, their heart health, and their overall well-being. This will help researchers assess how safe the study drug is and if they experience adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Everyone, including study doctors and participants, will know what drug the participants receive during the study. Participants may be in the study for about 4 weeks. Participants may not benefit from the treatment as the study is designed to assess safety and tolerability: the duration of the study is very short and participants will be taking a low dose of vericiguat without moving to the target dose of 10 mg during the study. However, the findings of this study may enable people with chronic HFrEF to safely skip one initial dosing step and reach the target dose of vericiguat faster. Participants may experience medical problems such as low blood pressure, upset stomach, nausea, dizziness, and headache. Researchers will monitor and manage all these, and other, medical problems participants may have during the study.

NCT ID: NCT06194552 Completed - Alzheimer Disease Clinical Trials

A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07

Start date: September 6, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted.

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.