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 is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and pharmacokinetics of astegolimab in combination with standard of care (SOC) compared with placebo in combination with SOC in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

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 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 subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.

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.

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

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.

New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

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).

Evaluate the effect of 6 g/day of AB-2004 for 8 weeks in improving irritability symptoms in adolescent participants with autism spectrum disorder (ASD)

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes. Prospective subjects will be randomized to the PTB prevention strategy or to standard of care management (Control arm).  Subjects randomized to the preterm birth prevention strategy will receive either routine standard of care pregnancy management or a multimodal intervention protocol reserved for higher risk pregnancies based on the results of a commercially-available laboratory developed test, PreTRM^® (Sera Prognostics, Inc).  The intervention protocol utilizes well-established high-risk pregnancy interventions to improve maternal and neonatal health outcomes. 

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 multicenter prospective study is to collect urine samples to validate the NEPHROCLEARTM CCL14 Test in intensive care unit (ICU) patients with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (Stage 3 AKI lasting >72 hours) within 48 hours of patient assessment. The study is observational and will have no impact on the medical management of the subject.

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.

The purpose of this study is to see if establishing a reproductive health program will help to address the reproductive needs of women in the 15-55 age group who are diagnosed with cancer. This will be done through an intervention.

The purpose of this study is to compare any good and bad effects of using aspirin after someone has completed the usual chemotherapy, surgery and/or radiation therapy for breast cancer. Some studies have suggested that aspirin may lower the risk of breast cancer coming back, but others have not, so we do not know if aspirin will help decrease breast cancer recurrence. This study will evaluate whether patients taking aspirin once per day will have a lower rate of cancer recurrence than patients taking a placebo. A placebo is a tablet that looks like the study drug (aspirin), but contains no medication.

The main purpose is to determine whether screening for breast cancer with tomosynthesis mammography is superior to digital mammography. This study will also compare whether there is a difference in the number of additional tests recommended after tomosynthesis mammography and digital mammography.

The purpose of this study is to look at the effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, compared to the usual chemotherapy drugs given without carboplatin.  The addition to the usual chemotherapy could prevent your cancer from returning, but it could also cause side effects.  This study will allow the researchers to know whether giving carboplatin with the usual chemotherapy is better, the same, or worse than giving the usual chemotherapy. 

Researchers at LSU Health Shreveport are looking for volunteers to participate in a study to better understand Brain and Heart health, including Alzheimer's Research.