Clinical Research Directory

A Novel Ultrasound Probe for Thyroid Imaging and Machine Learning

The objective of the THYMAL 01 pilot study is to evaluate the Sound Blade Imaging System in subjects with benign thyroid nodules undergoing standard-of-care ultrasound imaging.

The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules; 2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules

Thyroid Artery Embolization for the Treatment of Compressive Goiters.

Very few studies have investigated TAE as a treatment for goiter with compressive symptoms. What is the efficacy and safety of TAE for the treatment of compressive goiters in a population ineligible for or refusing standard therapy? This is a prospective interventional cohort study that will allow us to standardize imaging by improving quality data collection and fellow-up to assess the efficacy of TAE for compressive symptoms of nodular goiters. Not only to corroborate current emerging results but clearly define the expected results for this technique.

Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules

The goal of this clinical trial is to learn whether Xiaojin Pill or Neixiao Luoli Pill can safely treat thyroid nodules in adults aged 18 to 65 years with benign or low-risk thyroid nodules. The main questions it aims to answer are: * Does treatment with Xiaojin Pill or Neixiao Luoli Pill lower the size of thyroid nodules compared with lifestyle intervention alone? * Do Xiaojin Pill or Neixiao Luoli Pill improve thyroid nodule-related symptoms and ultrasound findings while remaining safe to use? Researchers will compare lifestyle intervention plus Xiaojin Pill, lifestyle intervention plus Neixiao Luoli Pill, and lifestyle intervention alone to see if adding Xiaojin Pill or Neixiao Luoli Pill works better than lifestyle intervention by itself. Participants will: * Be randomly assigned to one of the three study groups; * Receive lifestyle intervention guidance throughout the study; * Take Xiaojin Pill, Neixiao Luoli Pill, or no study medicine for 12 weeks, depending on their group; * Attend follow-up visits that include thyroid ultrasound exams, blood tests to check thyroid function and safety, and symptom assessments.

Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures

The purpose of this study is to evaluate the efficacy of lavender aromatherapy in adult patients undergoing awake otolaryngologic procedures in the outpatient clinic setting. The main questions it aims to answer are: * Does lavender aromatherapy help reduce anxiety and/or pain, and improve patient comfort during awake otolaryngologic procedures in the clinic? * Do patients subjectively find aromatherapy relaxing and/or beneficial during the procedure? Researchers will compare lavender aromatherapy to placebo (an odorless liquid) to see if lavender aromatherapy helps improve patient comfort during their awake procedure Participants will: * Have their scheduled procedure performed with lavender aromatherapy or placebo during the duration of the procedure * Take a short, less than 1 minute questionnaire both before and after the procedure, describing their levels of anxiety, pain and subjective impressions of the aromatherapy

Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules

To observe the outcomes of nsPFA therapy to treat benign thyroid nodules.

Comparing a New 3D Technology Used to Measure Thyroid Nodule Volume to Standard Ultrasound

After thyroid ablation procedure, the volume of the thyroid nodule (s) needs to be measured to see how well the procedure worked. Currently, these volumes are measured using traditional 2D ultrasound imaging. However, this approach comes with limitations because of the information 2D images cannot gather and because of differences in these measurements between different doctors. A new ultrasound technology called PIUR 3D imaging offers a novel alternative approach. The system uses advanced technology to create 3D images and can generate automated volume estimates. The PIUR imaging system, PIUR tUS Infinity, has been cleared by the Food and Drug Administration (FDA) to aid in treatment decisions when used alongside traditional 2D ultrasound imaging. The purpose of this study is to test how effective and consistent the PIUR imaging technology is compared to standard 2D ultrasound in measuring thyroid nodule volume.

Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry

Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.

Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules

There is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process. The EU-TIRADS classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (TA) (post-RF nodules). However, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by TA. The objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. Thus, an ultrasound and cytological atlas (Bethesda classification 2017) of nodules treated by thermal ablation will be constituted.

RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study

The purpose of this observational research is to evaluate and compare clinical outcomes after treatment for symptomatic benign multinodular goiter (MNG) patients. This is a data collection study in which we ask participants to give access to information generated before and after treatment of their condition.

18F-FDG PET/TC in TIR3A e TIR3B

The primary objective of this study is to evaluate the diagnostic performance of 18F-FDG PET/CT performed by normal care pathway in the identification of malignancy of undetermined resulting thyroid lesions at cytology (TIR3A and TIR3B) comparing the 18F-FDG PET/CT result with histological data. The secondary objective is to identify possible PET/ultrasound/genetic/radiomics variables that can more accurately define the potential malignancy of undetermined nodules and create a predictive model of malignity fed by standard parameters (derived from the normal care path). The identification of the prognostic value of 18F-FDG PET/CT in such patients setting could, in fact, make the PET useful in the future in the selection of patients for surgery/ follow-up.