This study is a Phase IV multicenter, open-label (BCVA assessor-masked) study designed to assess the response to treatment with SUSVIMO every 24 weeks in patients with Neovascular Age-Related Macular Degeneration (nAMD) who have been previously treated with anti-VEGF agents other than ranibizumab.
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Open label trial of letermovir for secondary prophylaxis for solid organ transplant recipients at risk of relapsing cytomegalovirus infection and disease
This is a prospective, multi-center clinical study to validate the effectiveness of the Boppli Blood Pressure Monitor as compared to an invasive arterial reference. This study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP, DBP, and MAP against the reference methodology in pediatric and neonatal populations.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in patients with traumatic injury and confirmed or suspected acute major bleeding predicted to receive a large volume blood product transfusion. Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site. Subjects will receive a single IV infusion of either BE1116 or placebo, in addition to the study site's standard resuscitation methods and protocol.
Obesity is a chronic, debilitating, multi-factorial disease that has reached worldwide pandemic proportions. The prevalence of obesity has tripled since the 1980s in many countries of the World Health Organization (WHO) European region. The WHO estimates that by 2015, 2.3 billion people will be overweight and over 700 million will be obese.
A prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial. Up to 40 sites in the United States, at least 480 subjects will be enrolled in the trial. An interim analysis will be performed prior to the end of the initial enrollment of 480 patients. The final sample size may be increased up to a maximum of 600 subjects enrolled in the trial.
The objective of this study is to compare the safety and effectiveness of the Route 92 Medical Reperfusion System to predicate AXS Vecta Aspiration System.
Study CTQJ230A12203 is a phase 2 clinical trial which aims to evaluate if treatment with pelacarsen (TQJ230) versus placebo slows the progression of mild or moderate calcific aortic valve stenosis, and to further characterize the safety profile of the drug.
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
In this study, researchers are hoping to improve post-operative pain control and reduce opioid use using a technique called TAP block. A TAP block is a form of pain relief that "blocks" the pain receptors in a person's abdomen and can be performed during minimally invasive hysterectomy. Enrolled participants undergoing minimally invasive hysterectomy will be randomized to three pain control or TAP block options.
Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants. There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC.
The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve function in patients with acute traumatic cervical spinal cord injury (SCI).
The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.
This is a phase 2, randomized, double-blind, placebo-controlled, crossover study to evaluate the safety and efficacy of atrasentan vs placebo while on background therapy with SGLT2i in subjects with IgAN. The primary efficacy assessment is the change from baseline in proteinuria (UPCR) at week 12. Eligible subjects who are enrolled in the study will be randomly assigned in a 1 to 1 ratio to either sequence AB or sequence BA.
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, efficacy and safety study of subjects with Progressive Pulmonary Fibrosis (PPF) treated with inhaled treprostinil over a 52-week period
The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF. This study hypothesizes that inhaled treprostinil will have a positive effect on absolute FVC after 52 weeks of therapy as compared with placebo when administered to subjects with IPF.
This is a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study, with the objective of comparing Progression-Free Survival (PFS) in newly diagnosed GBM patients treated with IGV-001 with patients treated with placebo.
This is a randomized, open-label study of HLX10 plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: Arm A (HLX10): HLX10 + chemotherapy (carboplatin-etoposide) Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
This is a randomized, phase 2, double-blind, placebo-controlled study of KER-012 in combination with background therapy in participants with PAH of World Health Organization (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 2:2:2:3 ratio to receive KER-012 (Dose A), KER-012 (Dose B), KER-012 (Dose C), or placebo by subcutaneous injection (SC) every 4 weeks for a period of 24 weeks in the placebo-controlled treatment period of the study while on background therapy.
This is a randomized, sham controlled, double-blinded multi-center global clinical trial to evaluate exhalation synchronized abdominal functional electrical stimulation (FES) in adult patients receiving, or recently disconnected from, invasive mechanical ventilation to prevent or retard disuse atrophy of the abdominal wall muscles and reduce the number of days of ventilator support. Eligible participants will be randomized 1:1 to the VentFree Respiratory Muscle Stimulator or a sham treatment. FES or sham treatment will be applied as an adjunct to standard of care.