Department of Neurology, Kyjevska 44, Czech Republic

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

This single-arm, open-label study aims to determine the efficacy and safety of low-dose (1.0 mg/kg), limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients after 3 (three) VRd cycles as induction therapy. Patients with MMND who meet the established inclusion criteria will be invited to participate. A single-arm phase 2 study will be conducted in the Hematology Department of the University Hospital, where an induction schedule of 3 cycles of bortezomib, lenalidomide, and dexamethasone (VRd) will be administered followed by consolidation with 4 therapeutic doses of teclistamab at 1.0 mg/kg subcutaneously. Four weeks after the last dose of teclistamab, the clinical response will be assessed according to standard International Myeloma Working Group (IMWG) criteria. Those with a complete response (CR) or better will be assessed for measurable residual disease (MRD) with multiparametric flow cytometry with a sensitivity of 10^6. Patients with CR and negative MRD will be kept under active surveillance for 18 months, while those with positive MRD or high cytogenetic risk will be offered biweekly bortezomib as maintenance. On the other hand, patients with very good partial response (VGPR) or worse will be offered 1-2 additional therapeutic doses of teclistamab and reevaluated 4 weeks after the last dose. Finally, patients who do not achieve CR will exit the study and will continue their management according to the standard of care recommended by their treating physician.

PPIs and In-Hospital Morbidity in Acute Variceal Bleeding with Chronic Liver Disease

An Ophthalmic Safety Study in Patients With Breast Cancer

This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.

Clinical Trial on the Efficacy of Intralesional Triamcinolone Versus Candida Albicans Antigen in Treating Alopecia Areata

NeuroCytotron in the Treatment of Autism Spectrum Disorder

Experimental, pilot, one-arm, open-label, single-center, 13-month, single-center study to evaluate the effect of NCX neuronal regeneration treatment in subjects with Autism Spectrum Disorder (ASD) to explore the therapeutic effects of NeuroCytonix neuronal regeneration technology on ASD symptoms. Specific objectives include collecting preliminary safety and efficacy data, assessing appropriate dosing, and measuring the impact on participants' quality of life after treatment.

Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft

The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

A Study of Zigakibart in Adults With IgA Nephropathy

Approximately 272 participants with eGFR ≥ 30 mL/min/1.73m^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy. Participants will have assessments of safety and efficacy for 2.5 years (up to 134 weeks). To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.