Lower Back and Sciatica Pain
BSC Envision
Study Title
RELIEF Study – ENVISION Cohort
Purpose
The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems and may use observed relationships to make recommendations.
Basic Eligibility Criteria
- 18 years of age and older
- Planning to receive or has received a commercially approved Boston Scientific neurostimulation system for pain per local directions for use.
Study Site Locations
Springhill 2 and Ayers
Contact
Regina Knudsen, 352-273-6786, rknudsen@anest.ufl.edu
BSC RAPID RFA
Study Title
Radiofrequency (RF) Ablation Prospective Outcomes Study
Purpose
To compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain
Basic Eligibility Criteria
- 18 years of age or older
- Being treated with Boston Radio Frequency Ablation for pain
Study Site Location
Springhill 2 and Ayers
Contact
Amanda Slater, 352-273-8952, aslater@anest.ufl.edu
SI Stem Cell Injection
Study Title
A phase 1, open label dose-ranging study to assess the safety, tolerability, preliminary efficacy, and dose effect of CFL001 cord blood product in patients with symptomatic sacroiliac joint syndrome.
Purpose
The overall objective is to evaluate the safety and potential efficacy effect of specific type of umbilical cord blood product (CFL001).
Basic Eligibility Criteria
- 18 to 90 years old
- SI joint syndrome
- Have tried and failed other conservative pain therapies (i.e. Tylenol, NSAIDs, Tramadol, etc.)
Study Site Location(s)
Springhill 2 and Ayers
Contact
Amy Gunnett, RN, CCRC, 352-273-8911, agunnett@anest.ufl.edu
Cancer Pain
Sorrento
Study Title
A multicenter phase 2 study to assess the safety and efficacy of epidural resiniferatoxin for the treatment of intractable pain associated with advanced cancer.
Purpose
- To assess the safety of epidural RTX compared to the control groups
- Short-term treatment-emergent AEs (TEAEs) during the 6- and 24-hours post RTX administration
- Long-term TEAEs, particularly AEs of special interest (AESIs)
- Neurologic disorders in the area below the injection target
- Bladder incontinence
Basic Eligibility Criteria
- 18 years of age or older
- Have advanced or metastatic cancer
- Have pain that is “intractable” in that it has not responded to standard therapies
Study Site Location(s)
Springhill 2 and Florida Surgical Center
Contact
Amy Gunnett, RN, CCRC, 352-273-8911, agunnett@anest.ufl.edu
Knee Pain
SKOAP
Study Title
A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP)
Purpose
- To determine the extent to which duloxetine and the combined effects of painTrainer and duloxetine improve pain and function in participants with KOA and/or
- Among those interested in additional treatment, including those following conservative treatment and those inappropriate for conservative care, determine whether nonsurgical procedural interventions improve pain and function.
Basic Eligibility Criteria
- 18 years of age to 80 years of age
- Diagnosis of knee osteoarthritis
- Have insurance or willing to pay out of pocket
- Have access to reliable internet
Study Site Locations
Springhill 2 and Ayers
Contact
Amanda Slater, 352-273-8952, aslater@anest.ufl.edu
Study Website
Diabetic Neuropathy
EN21-01 Diabetic Peripheral Neuropathy
Study Title:
EN21-01, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg daily of NRD135S.E1 Versus Placebo in Adult and Elderly Participants with Painful Diabetic Peripheral Neuropathy (SERENDIPITY-1).
Purpose
To investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 12 weeks.
Basic Eligibility Criteria:
- 18 years of age and older
- Documented diagnosis of stable diabetes mellitus with painful diabetic peripheral neuropathy of at least 6 months’ duration
Basic Exclusion Criteria:
- BMI > 40
- History of heart attack, stroke, significant heart disease, or arrhythmia
- History of gastric bypass surgery
Study site location:
Springhill 2
Contact
Brandi Lattinville, 352-294-8346, blattinville@anest.ufl.edu
Anticoagulant Reversal
Takeda TAK330-3001
Study Title
A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure
Purpose
To compare the efficacy of TAK-330 to 4F-PCC used as a part of SOC for the reversal of direct oral Factor Xa inhibitor-induced anticoagulation in patients requiring urgent surgery/invasive procedure.
Basic Inclusion
- 18 years of age and older
- has taken an Anti-Xa medication (Eliquis (Apixaban), Xarelto (Rivaroxaban) or Savaysa (Edoxaban)) in the last 15 hours, or at any time beyond that if plasma anti-Fxa levels are elevated
- in need of urgent/emergent surgery (excluding cardiac catheterization, endoscopy, minor procedures)Study site location:
Study Site Locations
STH & HVN
Contact
Regina Knudsen, 352-273-6786, rknudsen@anest.ufl.edu
Octapharma
Study Title
Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor
Purpose
To show effectiveness of OCTAPLEX for emergency reversal of the anticoagulant effect of DOACs in patients with major bleeding associated with factor Xa inhibition
Basic Inclusion Criteria
- 18 years of age and older
- Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor (Eliquis (Apixaban), Xarelto (Rivaroxaban) or Savaysa (Edoxaban))
- Patients who have acute major bleeding
Study Site Location
STH & HVN
Contact
Regina Knudsen, 352-273-6786, rknudsen@anest.ufl.edu