Smithtown

Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a treatment involving the placement of radioactive seeds directly into tumors, for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard treatments. This prospective, multicenter, single-arm study aims to measure how well tumors respond to this therapy, the duration of response, progression-free survival, overall survival, local tumor control, and patient quality of life. The treatment involves inserting Alpha DaRT-224 seeds into the tumor using planned radiotherapy techniques. These radioactive seeds release alpha particles that target the tumor over a period of 14 to 21 days before being removed. Researchers use imaging to assess tumor response 2 to 3 weeks after placement. The study is open-label and does not include a comparison group. Participants will undergo regular assessments including imaging scans, blood tests, and quality of life questionnaires at specified intervals up to 12 months after treatment. Safety is closely monitored through reported adverse events related to the device. The main outcomes measured are tumor response and how long it lasts, with follow-up to document progression and survival. The total participation time varies with assessments scheduled from insertion through one year post-treatment.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 2/3, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone (TSH) levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults experiencing knee osteoarthritis (OA) pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating clofutriben, an 11-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, in patients with type 2 diabetes and elevated cortisol. This Phase 2, randomized, double-blind, placebo-controlled trial aims to understand how different doses of clofutriben affect blood sugar control and to identify doses suitable for further studies. The study includes patients with type 2 diabetes who have elevated cortisol levels and are already on stable diabetes treatments. The trial has two parts. Part 1 is a screening phase lasting about 5 to 9 weeks, which includes eligibility checks and a dexamethasone suppression test to confirm elevated cortisol. In Part 2, lasting 24 weeks, eligible participants are randomly assigned to take one of four doses of clofutriben or a placebo, all given as daily oral tablets. After completing the treatment, participants receive a follow-up phone call four weeks later. Participants will have their blood sugar control and cortisol levels monitored through blood tests, including glycated hemoglobin A1c and fasting plasma glucose, at the start and during the treatment period. The study also tracks the percentage of patients with specific cortisol and dexamethasone levels after testing. Safety and adherence will be checked throughout, with ongoing assessments to understand the drug's impact over the 24-week treatment and follow-up period.