Coralsprings, Florida
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
This is a Phase 2, 3-arm, multi-center, open-label, randomized, clinical study to evaluate the efficacy of SP-002 in combination with vismodegib in subjects with locally advanced Basal cell carcinoma. The study will be completed in 2 consecutive parts. Each part consists of a screening period, a treatment period, and a follow-up period. - Part A: 20 participants who meet study entry criteria will be randomized in a 1:1 ratio into 2 treatment arms (Arm 2 and Arm 3) and will provide preliminary safety and performance in a population with target Basal cell carcinoma lesions. - Part B: 60 participants who meet study entry criteria will be randomized in a 1:1:1 ratio into 3 treatment arms (Arm 1, Arm 2, and Arm 3) in a population with target Basal cell carcinoma lesions.
Phase
2Span
260 weeksSponsor
Stamford Pharmaceuticals, Inc.Coral Springs, Florida
Recruiting
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.
Phase
4Span
105 weeksSponsor
Primus PharmaceuticalsCoral Springs, Florida
Recruiting
Healthy Volunteers
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
Phase
3Span
1090 weeksSponsor
SWOG Cancer Research NetworkCoral Springs, Florida
Recruiting
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.
Phase
1/2Span
300 weeksSponsor
DualityBio Inc.Coral Springs, Florida
Recruiting
Coral Springs, Florida
Recruiting
LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.
Phase
N/ASpan
368 weeksSponsor
Foregut Research FoundationCoral Springs, Florida
Recruiting
Stem Cell Ophthalmology Treatment Study II
Eyes with loss of vision from retinal or optic nerve conditions generally considered irreversible will be treated with a combination of injections of autologous bone marrow derived stem cells isolated from the bone marrow using standard medical and surgical practices. Retinal conditions may include degenerative, ischemic or physical damage ( examples may include macular degeneration, hereditary retinal dystrophies such as retinitis pigmentosa, stargardt, non-perfusion retinopathies, post retinal detachment. Optic Nerve conditions may include degenerative, ischemic or physical damage ( examples may include optic nerve damage from glaucoma, compression, ischemic optic neuropathy, optic atrophy ). Injections may include retrobulbar, subtenon, intravitreal, intraocular, subretinal and intravenous. Patients will be followed for 12 months with serial comprehensive eye examinations including relevant imaging and diagnostic ophthalmic testing.
Phase
N/ASpan
605 weeksSponsor
MD Stem CellsCoral Springs, Florida
Recruiting
Neurologic Stem Cell Treatment Study
Various clinical studies have registered with the National Institutes of Health (NIH) to study neurologic diseases and damage. There have also been a number of journal reports of the benefits of treatment with BMSC for diseases and damage to nervous tissue. The investigators hope to add to the volume of literature regarding the use of BMSC in those neurologic diseases and conditions identified as likely to respond to this treatment. Intravenous administration of BMSC is a well-established approach to neurologic disease and injury with much support for its effectiveness in the pre-clinical and clinical literature. BMSC and the associated bone marrow fraction are posited to have a number of different mechanisms by which they may potentially improve neurologic function. In regards their ability to penetrate the blood-brain barrier for potential neuronal transdifferentiation and direct impact on the neurons and glial tissue within the brain, it should be remembered that within the diencephalon there are specific circumventricular organs which lie in the wall of the third ventricle. These are noteworthy for a significantly diminished blood-brain barrier and glial limitans which facilitates their function of coordinating homeostatic mechanisms of the endocrine and nervous systems. Therefore the investigators believe entry of BMSC may be facilitated in this area of the brain. The NEST Study provides a treatment Arm 1 which combines intravenous BMSC with topical application of BMSC to the lower 1/3 of the nasal passages as a means of introducing BMSC to the Central Nervous System (CNS). This is applied bilaterally to the inferior nasal conchas and meatuses. The Trigeminal Nerve or 5th Cranial Nerve is a paired, large sensory and motor nerve with multiple branches. It provides sensation to the surface and interior structures of the face including the nasal mucosa that lines the nose. The nerves of the Trigeminal Nerve providing sensation to this area converge and enter the brain at the level of the pons. There is documentation in the scientific literature that intranasal delivery of BMSC allows the BMSC to follow the pathways of the trigeminal nerve, facilitating entry into the parenchyma and cerebral spinal fluid (CSF) for effects on the CNS.
Phase
N/ASpan
583 weeksSponsor
MD Stem CellsCoral Springs, Florida
Recruiting
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness > 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.
Phase
N/ASpan
785 weeksSponsor
Melanoma and Skin Cancer Trials LimitedCoral Springs, Florida
Recruiting
Fabry Disease Registry & Pregnancy Sub-registry
Phase
N/ASpan
1696 weeksSponsor
Genzyme, a Sanofi CompanyCoral Springs, Florida
Recruiting