Clinical Trials & Studies

Lower Back and Sciatica Pain

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


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


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

Learn more at skoapstudy.org


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