Shinanomachi, Shinjuku-ku, Japan

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions

Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. It is a particularly important site, since it supplies up to 75% of myocardial blood supply, and damage at this level thus implies a large amount of left ventricular myocardium at risk, with a mortality rate close to 40% at 3 years, if revascularisation is not performed. Anatomically, it has a number of particularities compared to the rest of the coronary arteries, such as its larger diameter (5±0.5 mm) and variable length (10.5±5.3 mm), a composition, particularly at the aorto-ostial level, more similar to the aorta than to the coronary arteries, and in up to 20-30% of the population there is also a division between the anterior descending artery (LAD) and the circumflex artery (LCx) of a third branch called the ramus intermedius or bisector branch. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (ICUS or IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Several ICUV studies have attempted to find a minimum luminal area (MLA) as the cut-off point, ranging from 4.5-7.5 mm2, to decide whether to perform revascularisation or not. However, the most commonly used cut-off value is 6 mm2 for various reasons. First, it is correlated with functionally significant values using pressure guidewire. Second, the linear law is applied (assuming the fractal nature of the vasculature and a cut-off value of 3 mm2 for the LMCA branches). Finally, it has been validated by the prospective LITRE study with clinical results at 2 years of follow-up. Other studies in Asian population have proposed lower cut-off values (4.5 mm2). However, this population has different body size and therefore smaller LMCA size, the study has lower sensitivity (1/4 of patients with area >4.5 mm2 had positive pressure guidewire), and clinical validation is not presented unlike the LITRE study. In addition to its value in diagnosis, use of ICUSE allows for optimisation of percutaneous coronary intervention (PCI) if necessary, with decreased events as compared to angiography. Therefore, current clinical practice guidelines consider the use of IVUS to stratify the severity of all LMCA lesions as an indication IIa B. In turn, it has been proposed to integrate the use of ICUS and pressure guidewire in the assessment of doubtful LMCA lesions. Thus, in ambiguous lesions of the LMCA, a MLA >6 mm2 would indicate no revascularisation, a MLA <4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from ICUS. It is an expanding technique. However, its usefulness in LMCA is somewhat more limited, mainly due to the difficult technique of complete filling with contrast and the native area of the ostial segments. Another disadvantage of its use in LMCA is its limited penetration depth (2-3 mm) compared to ICUS (4-8 mm), and since the LMCA usually has diameters of 3.5-4.5 mm, inadequate assessment may occur. In addition, no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. On the other hand, because of the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. There are, however, some correlation studies between ICUS and OCT, both in vivo and in vitro, but not specifically in LMCA. In all these studies, it has been shown that ICUS consistently overestimates OCT measurement by ≈10%, the latter being the closest to the real value. The underuse of this technique in the LCMA is justified by the potential technical problems already mentioned and the lack of a validated MLA cut-off point at this level. The potential prognostic implication of finding, even in patients with functionally nonsignificant lesions, vulnerable plaques or thin-cap fibroatheromas (TCFAs) in OCT has recently been highlighted. The objective is to compare the minimal luminal area by ICUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)

Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI), and revascularization compared to medical therapy. However, the risk of future clinical events remains high, and about 10% of patients experienced further cardiovascular events after PCI. Facing intermediate coronary lesions the use of pressure wires is the standar of care, however, limitations in the management of angiographically intermediate coronary lesions continue to be a challenge for the interventional cardiologist. The measurement of fractional flow reserve (FFR) to determine the hemodynamic relevance of coronary stenosis has been shown to be a technique that improves the prognosis and cost-efficiency of the procedures when compared to visual angiographic interpretation alone. Due to this evidence, the use of FFR to guide interventional procedures is a class I recommendation in current clinical practice guidelines. Patients with multivessel coronary artery disease are another field in the use of pressure guiding. In these patients, the use of FFR has demonstrated the reclassification of the severity of coronary lesions in up to 40% of cases, modifying the number of functionally significant lesions and making it possible to reorient therapeutic decisions, avoiding interventional treatment of non-significant lesions and with a better prognosis. However, the use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.) and time consuming. In addition, the presence of atrioventricular block, asthma or severe chronic obstructive pulmonary disease are relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed , demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions. In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI. The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up.

Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared with Placebo in Adult Participants with Moderate to Severe Hidradenitis Suppurativa

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) with a biliary lumen-apposing metal stent (LAMS) has been widely accepted as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). Recent studies (DRAMBO and ELEMENT trial) compared EUS-CDS vs ERCP as a first line treatment in MDBO in palliative patients, showing similar clinical and techinal success and adverse events rate between both techniques, demonstrating that both procedures could be options for primary biliary drainage in unresectable MDBO. Furthermore a recent clinical trial (BAMPI trial) has proven that the addition of a coaxial double pigtail (DPS) offers benefits in terms of safey and clinical success. In the last years there has been an increasing interest for the EUS-guided gallblader drainage (EUS-GBD) in unresectable MDBO as an alternative for EUS-CDS, and recent studies and reviews have been reported with acceptable techinal and clinical success, but no clinical trial has been performed up to date. Our hypothesis is that EUS-GBD may offer benefits in terms of safety over EUS-CDS, maintaining similar clinical and techinal success rates.

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Efficacy of Zelpultide Alfa in Preterm Neonates At High Risk of Developing Bronchopulmonary Dysplasia (BPD)

Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.