Rochester, NY Paid Clinical Trials

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Canada. Read Less

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Gaucher disease population. * To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected. Read Less

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values). Read Less

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%. Read Less

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research. Read Less

The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk. Read Less

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated. Read Less

The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule. The main questions it aims to answer are: * Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign? * Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer? Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups. Read Less

The purpose of this research is to better understand the impact of cortically-induced blindness (CB) and the compensatory strategies subjects with this condition may develop on naturalistic behaviors, specifically, driving. Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments. Through the combined use of computer vision, deep learning, and gaze-contingent manipulations of the visual field, this work will test the central hypothesis that changes to visually guided steering behaviors in CB are a consequence of changes to the visual sampling and processing of task-related motion information (i.e., optic flow). Read Less

This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected. Read Less

This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body. Read Less

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions. Read Less