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NCT ID: NCT05611671 Recruiting - Clinical trials for Inflammatory Bowel Diseases

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

EMERALD-2
Start date: October 31, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

NCT ID: NCT05609968 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Start date: February 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

NCT ID: NCT05600088 Recruiting - Clinical trials for Coronary Artery Disease

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina

POLARSTAR
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

The POLARSTAR study is an early safety and feasibility study to evaluate the performance and safety of the CryoTherapy System (CTS) for the treatment of coronary plaque lesions that are not obstructing blood flow but are at high-risk of rupture which would cause a major heart attack. The CTS is used to apply local freezing of the lesion using a balloon catheter, controlled by a console that regulates in- and outflow of a cooling agent into the catheter. The treatment is expected to stabilize the lesion, diminishing the risk of rupture. The study will enrol subjects with acute coronary disease who have suitable coronary lesions. Subjects will be followed for 1 year after the CTS treatment. Baseline identification of lesions will be done using Coronary CT-angiography (CCTA), which will be repeated at 3 and 9 months after procedure.

NCT ID: NCT05599295 Recruiting - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.

NCT ID: NCT05552326 Recruiting - Clinical trials for Severe Hypertriglyceridemia

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Start date: August 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT05535946 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT - Maintenance

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

NCT ID: NCT05534009 Recruiting - COVID-19 Clinical Trials

Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)

Start date: April 1, 2022
Phase:
Study type: Observational

The WP3 healthcare workers cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed SARS-CoV-2 infection. Samples from HCW are sent to central laboratories for WP2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. Eight countries will participate (Portugal, Italy, Germany, Lithuania, Georgia, Russia, Vietnam and Mexico).

NCT ID: NCT05531773 Recruiting - COVID-19 Clinical Trials

Post COVID-19 Condition

Start date: July 1, 2022
Phase:
Study type: Observational

The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19 patients recovered from the acute phase of disease to investigate the prevalence and possible predictors of post COVID-19 condition. The study will retrospectively analyze data already collected at the post COVID-19 outpatients services of the participating centers; furthermore, a prospective cohort study will be performed.

NCT ID: NCT05531149 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

TRICOVID
Start date: December 22, 2022
Phase: Phase 3
Study type: Interventional

The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

NCT ID: NCT05526170 Recruiting - Atrial Fibrillation Clinical Trials

Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

TriggersAF
Start date: August 1, 2021
Phase:
Study type: Observational

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.