Cucuta, Colombia

Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery.

Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ HNSCC. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was >1 year after the last dose of cetuximab are eligible.

M-CHOP in Richter´s Syndrome

The primary study objective and associated endpoint is to evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) in patients with RS who have never received therapy. Primary endpoint will be complete remission (CR) evaluated by an independent review committee according to modified Lugano classification using PET/CT scan after the EoI visit. CR is defined as a score of 1, 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. All PET evaluable in patients with at least one dose of mosunetuzumab will be included in the efficacy population. The secondary study objectives and associated endpoints are: - To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) and maintenance (EoM) in patients with therapy naive RS. - Overall response rate (ORR), defined as the proportion of participants with a complete response (CR) or partial response (PR) at the end of induction (EoI) and maintenance (EoM), as determined by local and independent review committee according to modified Lugano classification using PET/CT scan and IWCLL criteria (Hallek 2018). - Complete remission (CR) at the EoM will be defined as a score of 1, 2 or 3 (no uptake above background) for lymph nodes and extralymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. In addition, patients need to have a normal blood count with normal/immunohistochemistry (IHC)-negative bone marrow morphology as per iwCLL criteria (Hallek 2018). All PET evaluable patients with at least one dose of mosunetuzumab will be included in the efficacy population. - Best overall response: the best response is defined as the achievement of a PET score of 1-3 associated with a normal blood count with normal/immunohistochemistry (IHC)-negative bone marrow morphology as per iwCLL criteria, or a PET score of 1-3 associated with incomplete recovery in blood and normal/immunohistochemistry (IHC)-negative bone marrow morphology evaluated at any time during the treatment induction or maintenance, whichever occurs first. - Minimal residual disease (MRD) response rate determined by the proportion of patients with MRD-negativity (defined as < 1 CLL cell in 10,000 leukocytes), assessed by flow cytometry in responders (CR/PR) in peripheral blood (PB) and/or bone marrow (BM) after the EoI and EoM. - Progression free survival (PFS), defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be assessed by the investigator, using the Lugano criteria. - Overall survival (OS), defined as the time from first dose to death from any cause. - Duration of response (DoR), defined as the time from best overall response (the first occurrence of a documented objective response) to disease progression by Lugano criteria or death from any cause, whichever occurs first. To determine the incidence and severity of adverse events - Incidence of adverse events (AEs): number and percentage of patients with 1 or more AE. - Severity of AEs according to NCI CTCAE v5.0. For events of CSR, severity will be determined by ASTCT CSR consensus grading criteria. For events of TLS, the presence of laboratory and/or clinical TLS will be determined according to Howard criteria. To evaluate the study treatment exposure: - Treatment duration - Total dose received - Number of cycles and dose modifications - Treatment interruptions and discontinuations

A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma

Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.

Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face

Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma

The study will enroll participants with moderate to severe uncontrolled asthma who are on low-dose inhaled corticosteroid (ICS) - a long-acting beta-agonist (LABA) or medium-to-high-dose ICS with or without LABA background treatment. The study will be initiated by Lead-in pharmacokinetics (PK) cohort in asthma participants. Participant will be randomised globally, including participants in Lead-in PK cohort (2 arms) and in Part 1 of the study (2 arms). In the Lead-in PK cohort, participants will be randomised to Atuliflapon or placebo (recruitment completed). In Part 1 of the study, participants will be stratified by geographical region, and grouped based on high or low levels of biomarker at screening (Visit 1).