Centro Histórico, Brazil
Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Phase
1/2Span
51 weeksSponsor
Regenerative Ocular Immunobiologics LLCPalm Harbor, Florida
Recruiting
Data Collection for CV-3E AI Software Development
Phase
N/ASpan
20 weeksSponsor
Capso Vision, Inc.Palm Harbor, Florida
Recruiting
Healthy Volunteers
Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
MHS-1031 is a specific proprietary digestion-resistant oligosaccharide carbohydrate that serves as a prebiotic. This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the effect of MHS-1031 adjunctive to PPI therapy on heartburn-free days in subjects with GERD-related heartburn symptoms who self-report improvement while on sustained daily PPI therapy. Heartburn-free days will be determined by subject report specific to any of the three questions ("burning feeling behind the breastbone" and/or "pain behind your breastbone" and/or "heartburn"; Questions 1, 2 & 3 of the RESQ-eD). For purposes of this trial, heartburn-free days are defined as subject report of 'Did Not Have', or 'Very Mild' on each of the three RESQ-eD questions listed above. All candidate subjects must self-report at least partial response to sustained daily PPI acid suppressive therapy (i.e. 'daily' defined as taking PPIs 5-7 days/week on average). Candidate subjects will be screened for medical history of chronic heartburn that may be associated with other medical conditions, and these subjects will be excluded. The entire study consists of three phases: Remote Screening Phase 2-Week Assessment (SP1), on-site Screening Phase Part 2 (SP2) and Treatment Phase (TP). Efficacy will be assessed using patient reported outcome (PRO) questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Remote Screening Phase 2-Week Assessment) to Treatment Phase Weeks 1-4 and Weeks 5-8. The primary analyses will be conducted to assess the efficacy of MHS-1031 adjunctive to PPI therapy, and separately as monotherapy subsequent to combined PPI and MHS-1031 therapy, in randomized subjects with GERD-related heartburn as determined by the RESQ-eD validated questionnaire, validated for use online.
Phase
2Span
126 weeksSponsor
Microbiome Health SciencesPalm Harbor, Florida
Recruiting
Palm Harbor, Florida
Recruiting
C-Brace Prospective Registry
The purpose of the C-Brace Prospective Registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace. Patients casted for C-Brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. All patients will be followed in accordance with the standard of care for a C-Brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the C-Brace.
Phase
N/ASpan
579 weeksSponsor
Otto Bock Healthcare Products GmbHPalm Harbor, Florida
Recruiting
A Study of Baricitinib in Participants With Rheumatoid Arthritis
Phase
4Span
324 weeksSponsor
Eli Lilly and CompanyPalm Harbor, Florida
Recruiting
Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
To determine whether a strategy of Vectra DA guided care (Arm A), compared with usual care (Arm B), achieves non-inferior clinical outcomes while reducing the cost of treatment in patients with active RA and an inadequate response to MTX monotherapy.
Phase
N/ASpan
326 weeksSponsor
Crescendo BiosciencePalm Harbor, Florida
Recruiting
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Phase
N/ASpan
432 weeksSponsor
Target PharmaSolutions, Inc.Palm Harbor, Florida
Recruiting
Palm Harbor, Florida
Recruiting
Palm Harbor, Florida
Recruiting