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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.

The purpose of this study is to determine whether treatment with OP-1250 as a monotherapy will result in improvement of progression-free survival (PFS) and overall survival (OS) compared to SOC ET and assess the safety of treatment with OP-1250 in participants with ER+, HER2– advanced or MBC with and without estrogen receptor 1 gene (ESR1) activating mutation(-s) whose disease has relapsed or progressed on 1 or 2 prior lines of SOC ET, including a cyclin-dependent kinase (CDK) 4/6 inhibitor.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria.

Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous treatment options are available. The therapies vary in mechanism of action, mode of administration, side- effect (adverse event) profile, and cost. While consensus treatment guidelines are available, identifying an optimal treatment sequence is often based on clinician choice with treatment changes based on tolerability and short- term outcome. The N-of-1 trial will evaluate individual participant and aggregate data. Individual participants will be enrolled and randomized to a sequence of three U.S.

The primary goal of this study is to use the WHOOP fitness band as a way to measure heart rate variability (HRV) in patients with coronary artery disease (CAD) and to establish a change in HRV before coronary artery bypass graft (CABG) surgery and during post-operative stay. The secondary aim of this study would be to associate this change in HRV with the patient’s clinical course. The validation component will test WHOOP’s HRV capabilities compared to the gold-standard Holter monitor. 

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 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.

Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of programmed cell death 1 (PD-1) inhibitors in advanced lung cancer, such as pembrolizumab, there has been an improvement in  response rates and survival compared to chemotherapy.

However, there is still a need for improvement in response rates in first-line treatments for patients with stage 4 Non Small Cell Lung Cancer (NSCLC) without genetically targetable alterations, especially in those patients with PDL-1 <50%.

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.

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade E, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

The total duration of this study for each participant is approximately 165 weeks, which includes a screening period of 5 weeks, followed by a 16-week placebo-controlled period which will run concurrently with a 24-week active comparator-controlled period, followed by treatment with JNJ-77242113 200 mg once daily through Week 156 and a 4-week safety follow-up period.

Study DSP-5336-101 is a Phase 1/2, open-label, dose-escalation, dose-expansion study in which the safety, PK, pharmacodynamics, and clinical activity of orally administered DSP-5336 will be evaluated in adult patients with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage, as well as in adult patients with high-risk relapsed or refractory MDS or relapsed/refractory MM.

12-Week open label clinical trial looking at the effects of nicotinamide riboside on bioenergetic metabolism, oxidative stress, and cognition in Mild Cognitive Impairment and Mild Alzheimer's Disease.

Observational study to evaluate new imaging methods and software of the Topcon prototype OCT instrument for ocular blood flow imaging of patients with different retinal diseases and healthy volunteers.

This is a single center prospective cohort study. The cohort (interventional) patients will receive the study intervention (ABCLO). The control group retrospective patients that were previously managed at the same center, regardless of the technique or the device used to close the OA.

Breast cancer (BC) is the leading cause of cancer and the second most common cause of cancer related mortality in the United States. Although the prognosis of patients with BC has greatly improved over the past few years, there are still many unanswered questions. There is growing interest in identifying markers for treatment de-escalation or intensification in early and advanced breast cancer as well as in ductal carcinoma in situ (DCIS). Additionally, there are well known differences in disease biology and outcomes in groups from diverse genetic ancestry.

This is a prospective, multi-center, multi-arm, double-blind, randomized, controlled platform trial evaluating antiviral and other therapeutics for use in the treatment of Post-Acute Sequelae of COVID-19 (PASC). The hypothesis is that persistent viral infection and/or overactive/chronic immune response are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.

This is a Phase 2/3 study designed to evaluate the efficacy and safety of BIIB059 for the treatment of participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice.

Patients receiving commercial CAR-T therapy for their clinical care are invited to provide 5 blood draws at the time blood is drawn for their clinical care. The samples will be used to help develop a new technology for detecting CAR-T cells in the blood.