CLINICAL TRIALS

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

There are several areas in which this study will advance human knowledge. This study will enhance our understanding of the populations that may benefit from psilocybin therapy. Previous research has largely examined a relatively narrow sliver of the human experience. This study will enroll individuals from populations in underserved urban and rural living communities that have been underrepresented in previous psychedelic research. Moreover, this study will focus on methamphetamine addiction, which currently has no FDA approved treatments available

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo.

This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.

To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms.

This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor.

The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.

Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.

At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

The purpose of this study is to learn about the safety and immune effects of a new pneumococcal vaccine in infants. The immune response is how the body's cells, tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help us understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease, which include a variety of infections caused by a specific germ, Streptococcus pneumoniae.

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).

This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

This protocol will direct the execution of subject enrollment and the sample collection for the VITROS Immunodiagnostic Products Free PSA III (VITROS Free PSA III) test. The purpose of this clinical study is to collect data to substantiate the use of the VITROS Free PSA III test as an aid in distinction of prostate cancer from benign prostatic conditions.

Subjects presenting with symptomatic BPH seeking minimally invasive therapy will be approached to discuss study participation. Medical history will be reviewed, and initial assessments will be completed to assess suitability for treatment with the Optilume BPH Catheter System. Following treatment subjects will be assessed at 1 month, 3 months, 6 months, 1 year, and annually through 5 years post-treatment.

The purpose of this study is to investigate the effects of oral administration of 1 mg/day V117957 each evening in female subjects with overactive bladder syndrome as compared to placebo. The study will consist of a Screening/Washout Period (up to 4 weeks), Single-blind Placebo Run-in Period (2 weeks), Double-blind Treatment Period (8 weeks), Single-blind Placebo Washout Period (1 week), and Follow-up Period (up to 1 week).

The goal of this prospective, multicenter, single-arm study is to test the safety and effectiveness of eCoin ® tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). 

This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.

The overall objective of this study is to evaluate the efficacy and safety of BIIB059 compared to placebo in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The objectives of the study are different for each portion of the study.

This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation.

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral Ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure.

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called bivalent BNT162b2 Omicron containing vaccine) in healthy children. The trial is divided into 4 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 4 sub-studies study vaccine as a shot depending on what group they are in.

• Substudy A design: includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial which may be followed by a fourth dose of study vaccine.
• Substudy B design: includes 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
• Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescent participants (12 to < 18 years old) with International Society of Nephrology and the Renal Pathology Society (ISN/RPS) Class III or IV active lupus nephritis (proliferative LN) receiving standard of care therapy with mycophenolate mofetil (MMF) an

The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.

Trial Details: 

The primary objective is to compare the safety and efficacy of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone.

To demonstrate safety and assess the clinical use and outcomes of the LUTONIXÒ DCB for treatment of dysfunctional AV fistulae located in the arm in a heterogeneous patient population in real world clinical practice.

The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with Idiopathic pulmonary fibrosis (IPF).

The primary objectives of the study are: • To evaluate the safety of IV peramivir (study drug) in infants from birth to 6 months of age infected with IAV or IBV • To evaluate the PK of a single IV dose of peramivir in infants from birth to 6 months of age infected with IAV or IBV

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE)

The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.

The purpose of this study is to investigate acute changes in exercise capacity and exertional symptoms (i.e., dyspnea) post dosing of RT234, as assessed by a cardiopulmonary exercise test (CPET), and 6-minute walk test (6MWT). In addition, acute changes in severity of PAH symptoms before and after CPET and 6MWT will be assessed.

The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19). The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.

The primary objective is to assess whether the initiation of spironolactone or eplerenone plus standard of care compared to standard of care alone reduces the incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death in HFpEF, studied with the pragmatic Registry-based Randomized Clinical Trial (RRCT) methodology.