6 Clinical Trials for Various Conditions
The purpose of this research study is to measure the changes in energy metabolism (how the body burns energy), cardiovascular function (heart function), and lipid metabolism (cholesterol break down and building) before and after thyroidectomy (surgical removal of thyroid gland) in response to two approved therapies for hypothyroidism: levothyroxine (LT4) or Liothyronine/levothyroxine (LT3/LT4) combination therapy.
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.
This proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.
Forty-six (46) eligible, healthy subjects who provide written informed consent will be enrolled to participate in a 2 arm parallel group study to assess and compare the pharmacokinetics and safety profile of Thyrogen dosed at 0.1 mg versus a modified release formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0.1 mg. Ten (10) of these subjects will have the thyroid uptake of radioiodine (123I) measured at baseline and following their single dose of study medication. All doses will be administered via intramuscular (IM) injection. Following confirmation of study eligibility, subjects will be randomized in a 1:1 ratio to receive either a single administration of 0.1 mg of Thyrogen (THYR) or 0.1 mg of the modified release. Randomization will be stratified by whether or not patients will have the thyroid uptake of radioiodine (123I) measured following their single dose of study medication. Five (5) patients in each treatment arm will have uptake measured, while 18 in each arm will not. Each subject will have blood samples taken to determine the pharmacokinetics of serum TSH at -12 hours and just prior to dosing and at various hours up to 14 days following the administration of Thyrogen or the modified release formulation. In addition, for the evaluation of pharmacodynamics, each subject will have samples of blood taken to determine serum free T4, total T4, free T3, and total T3 at -12 hours and just prior to dosing and at various hours up to 14 days following the administration of study treatments. All subjects will undergo a 12-lead electrocardiogram (ECG) just prior to dose administration and 1, 2, 3, 4, 5, 7, 10 and 14 days following study treatment administration. In addition, subjects will undergo 24 hours of Holter monitoring at baseline and four (4) consecutive 24-hour Holter monitoring sessions post treatment to yield a total of 96 hours of continuous monitoring of cardiac function following treatment administration. All subjects will undergo ultrasound evaluations to determine thyroid volume at baseline and 48 hours following treatment administration. Twenty-four hours following the administration of Thyrogen or the modified release formulation, a subset of five (5) subjects in each treatment arm will receive a dose of 123I prepared to be 400µCi on the day of radioiodine administration based on the utilized nuclear pharmacy's calibration schedule. Thyroid gland uptake will be measured via a probe in these 10 subjects at 6, 24 and 48 hours following radioiodine administration. Blood chemistry, complete blood count (CBC), urinalysis and a physical exam will be conducted 14 days after treatment administration, or at the time of early termination, as a final safety assessment. Each subject's duration of study participation will be approximately 4 weeks.
We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.
Pleuropulmonary blastoma (PPB) is a rare malignant neoplasm of the lung presenting in early childhood. Type I PPB is a purely cystic lesion, Type II is a partially cystic, partially solid tumor, Type III is a completely solid tumor. Treatment of children with PPB is at the discretion of the treating institution. This study builds off of the 2009 study and will also seek to enroll individuals with DICER1-associated conditions, some of whom may present only with the DICER1 gene mutation, which will help the Registry understand how these tumors and conditions develop, their clinical course and the most effective treatments.