New Taipei, Taiwan

Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.

PRIDE III Prison Interventions and HIV Prevention Collaboration

Aim 1 consists of the development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). This aim is an implementation science aim involving the collection of OAT scale-up data from each country's national OAT database, as well as administration of survey to prison narcologists every 6 months. Aim 2 consists of the development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. Investigators will collect OAT scale-up data from each member country's national OAT database, and administer a survey to probation officers every 6 months. Investigators will also observe and interview probation clients and staff using ethnographic methods.

A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer

Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia

Investigators will conduct a prospective, observational cohort study to determine the prevalence of frailty in the geriatric population of Georgia, focusing on men and women aged 65 years and older undergoing elective orthopedic surgery. All participants will provide written, informed consent to participate in the study. Frailty will be assessed using the Edmonton Frail Scale preoperatively, at discharge, three months, and one year postoperatively. Baseline cognitive function will be evaluated using the Mini-Cog test, while the Telephone Interview for Cognitive Status (TICS) will enable cognitive screening and the detection of pre-existing cognitive disorders. Postoperative neurocognitive disorders (NCDs) will also be assessed with TICS at one month, three months, and one year postoperatively through telephone follow-ups. Delirium will be evaluated preoperatively and twice daily during the patient's hospital stay using the Three-Minute Diagnostic Interview for Confusion Assessment. If patients require intensive care postoperatively, the Confusion Assessment Method for the ICU (ICU CAM) will also be administered twice daily. Depression will be measured with the Geriatric Depression Scale (GDS) preoperatively and postoperatively at discharge, and again at one month, three months, and one year. Anxiety will be assessed using a visual analogue scale at baseline, discharge, one month, three months, and one year. The Trail Making Test A and B will be administered preoperatively and at discharge. Pain levels will be measured during each assessment using the Numerical Rating Scale (NRS). Disability and the ability to perform daily living activities (ADLs) will be evaluated at baseline, three months, and one year postoperatively using the WHO Disability Assessment Schedule (WHODAS). Additionally, investigators will collect demographic and clinical information, including education level, comorbidities, alcohol use, lifestyle factors, and body mass index (BMI). Laboratory tests will also be conducted to explore potential mechanisms underlying postoperative neurocognitive disorders (PND), such as albumin, HbA1c, triglycerides, electrolytes, creatinine, Vitamin D, and interleukin-6 (IL-6). All assessments and tests originally in English will be translated into Georgian and validated for the Georgian population before being administered to patients in the hospital.

Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt

This observational study serves as an extension to a prior retrospective cross-sectional trial that initially investigated the clinical outcomes of suprachoroidal silicone tube (SST) shunt implantation in patients diagnosed with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG). In the initial study, participants underwent the SST shunt procedure and were followed for an average period of 19 months post-surgery. This initial study focused on assessing intraocular pressure (IOP) reduction and the initial safety profile of the SST device. However, as the device's long-term impact on ocular health, particularly the corneal endothelium, was not fully understood, this follow-up observational study was designed and implemented approximately 1 year after the last FU data collection was completed. The SST shunt device is a relatively novel intervention positioned between minimally invasive glaucoma surgeries (MIGS) and traditional tube shunt surgeries. By facilitating aqueous humor drainage from the anterior chamber to the suprachoroidal space, the SST shunt provides a unique pathway for IOP reduction. Given the risks associated with corneal endothelial health in glaucoma patients, especially following invasive procedures, understanding the long-term impact of the SST shunt on endothelial cell counts (ECC) is essential. Study Objectives: The primary objective of this observational study is to evaluate the long-term safety and efficacy of the SST shunt in reducing IOP and preserving endothelial cell health. This involves: Tracking changes in ECC attributable solely to the SST shunt, as the study design excluded additional interventions to isolate the device's effect. Assessing the device's ability to maintain effective IOP control over an extended period. Documenting any adverse events, including device migration, extrusion, and other complications, to understand the SST shunt's overall impact on ocular health. Study Population: The study is going to re-evaluate approximately 66 eyes, who had previously undergone SST shunt implantation, either as a standalone procedure or in combination with cataract surgery. These evaluations are going to be conducted within the period between 8 Nov/2024 and 30 Nov/2024.Participants in this observational study met the original inclusion criteria set forth in the retrospective trial. This included a cohort of Caucasian patients aged 41 to 88 years (mean age: 69), with a gender distribution of 40 men and 26 women. All patients were untreated with glaucoma surgeries or laser therapies prior to the SST implantation, providing a clean baseline for evaluating the SST device's isolated effects. Study Design: This study is observational and non-interventional, meaning it involved no additional treatments or manipulations beyond the baseline SST shunt implantation. This approach allowed for a naturalistic assessment of ECC and other clinical parameters over time. By not introducing any new variables, the study design aimed to observe and measure outcomes that could be directly attributed to the SST shunt. This design offers valuable insights into the natural progression of endothelial cell health and IOP management in patients who have undergone SST implantation without the influence of confounding factors. Clinical Assessments and Follow-Up Procedures With an average 31 months (std. dev: 8 monts) follow-up, participants underwent assessments to monitor IOP, visual acuity, ECC, C/D ratio and any shunt-related adverse events. Outcome Measures: Primary Outcomes: Endothelial Cell Loss: Tracked to assess corneal integrity. IOP Control: Success was defined as ≥20% reduction in IOP, with "complete success" for IOP control without medications, "qualified success" with medications, and "failure" for <20% IOP reduction or IOP >21 mmHg. Secondary Outcomes: Hypotony: Defined as IOP <5 mmHg, categorized as transient or permanent. Device Migration/Extrusion: Monitored to assess mechanical stability. Other Adverse Events: Any device-related complications documented for safety analysis.

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms: - Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks - Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks - Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks