Miami, FL Paid Clinical Trials

A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint. Read Less

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS). Read Less

The main aims of the study are to see the side effects of Dexlansoprazole treatment effectiveness of Dexlansoprazole treatment in children having symptomatic nonerosive gastroesophageal reflux disease (GERD). Participants will take Dexlansoprazole by mouth once daily for 12 weeks Read Less

This is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P. aeruginosa infected cystic fibrosis (CF) subjects. Phase 1 of the study in HV subjects will consist of a single-ascending-dose (SAD) cohort, followed by the HV multiple-ascending-dose (MAD) cohort. Phase 2a of the study in CF subjects will consist of a MAD study design. The study will evaluate the safety and pharmacokinetic (PK) profile of single and repeat administrations of inhaled AR-501 solution in healthy adults, and the safety, PK and efficacy of repeat administrations of inhaled AR-501 solution in P. aeruginosa infected CF subjects. Read Less

This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality. Read Less

The goal of this clinical trial is to compare whether mental health therapists trained by a Family Therapy Training and Implementation Platform (FTTIP) or those trained in traditional face-to-face training differ on learning key family therapy domains, including competencies, agency readiness, and client outcomes. The main questions it aims to answer are: Will 75 FTTIP mental health therapists show improvement in all core family therapy competencies that are not inferior to 75 providers receiving traditional in person family therapy training? Will 150 families (child, parent, dyad) receiving CIFFTA family therapy show adequate retention in treatment therapeutic alliance and significant pre-post treatment improvements on family environment and presenting problems? Will 15 agency leaders receiving FTTIP agency readiness consultations show more pre and post change in agency readiness and knowledge than 15 leaders receiving agency engagement as usual? Participants will participate in: Complete pre and post surveys 20 hours of training in an evidenced based family therapy treatment 24 weeks of biweekly coaching to implement the treatment 24 weeks of implementation of the treatment with one family Agency leaders will complete 2 weeks of organizational readiness engagement Researchers will compare the Family Therapy Training and Implementation Platform (FTTIP) and traditional face-to-face training to see if FTTIP is not inferior to traditional training in key domains, including competencies, agency readiness, and client outcomes in mental health therapists. Read Less

The purpose of this study is to evaluate the feasibility and effectiveness of a non-contact Rock Steady Boxing class delivered to participants with Parkinson's Disease via an in-person community-based program. The study will also assess the overall feasibility of integrating an in-person community program within a neuromuscular course in a Doctor of Physical Therapy program. Specific Aim: To examine the effects of an in-person community-based Rock Steady Boxing class on the functional mobility, functional endurance, cardiovascular capacity, visual-motor reaction times, quality of life, mood/affect and overall physical activity completion and fear of falling on individuals with Parkinson's Disease. Read Less

The goal of this interventional study is to implement a Falls Prevention Program to impact the risk and injuries related to falls. The main question is to learn and examine the effects of a falls prevention program on the functional mobility of adults at risk for falls. Participants will: Complete functional mobility assessments Complete Falls prevention obstacle course training Complete Falls Strategies Training Complete walking and balance training Read Less

The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days. Read Less

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC. Read Less

The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Read Less

This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C) Read Less