Thyroid Disorder

This research aims to study hyperthyroidism in children by collecting detailed information on diagnosis, treatment, and long-term follow-up. It focuses on understanding the clinical features, treatment effects, side effects, remission, and recurrence after stopping antithyroid drugs. The study also investigates risk factors linked to adverse reactions from antithyroid medications. Children in this study receive methimazole, starting at a dose of 0.2 to 0.8 mg per kilogram per day. The dose is gradually reduced by 25% to 50% and adjusted to keep thyroid hormone levels normal, based on regular blood tests. This is an observational study without additional interventions beyond usual care. Participants are followed over time to track remission, defined as normal thyroid function without methimazole for at least 12 months, and to monitor any side effects such as low white blood cells, liver problems, rash, or muscle pain. The study collects clinical data to analyze treatment outcomes and safety. Follow-up lasts up to 10 years for remission and 1 year for side effect monitoring.

Researchers are evaluating the safety and effectiveness of IBI311, also known as Teprotumumab N01 injection, in people with inactive thyroid eye disease (TED). This Phase III clinical study is randomized, double-masked, and placebo-controlled. The trial includes about 111 participants who will be assigned in a 2:1 ratio to receive either IBI311 or a placebo. The study is conducted across multiple centers and lasts up to approximately 64 weeks, divided into two parts. The first part of the study includes a screening period and a double-masked treatment phase lasting about 28 weeks. Participants receive either IBI311 or placebo during this time. The second part is a follow-up and open treatment phase lasting up to around 36 weeks. This design allows researchers to monitor the effects and safety of the treatment over an extended period. Participants will undergo various assessments, including measuring proptosis (eye bulging) response at 24 weeks as the primary outcome. Other evaluations include clinical activity scores, medical history reviews, and safety monitoring throughout the study. The study tracks participants for up to 64 weeks, with ongoing observation and follow-up to gather comprehensive data on treatment effects and safety.

Researchers are studying a new molecular imaging agent called 68Ga-labeled DOTA-TATE-RGD, designed to target both somatostatin receptor 2 (SSTR2) and integrin b1vb23, which are found in certain tumors and tumor blood vessels. This dual-targeting tracer is being evaluated for its ability to diagnose tumors that express these markers, including small cell lung cancer, pulmonary carcinoid, medullary thyroid cancer, and neuroendocrine tumors (NETs). The study builds on previous work with single-target tracers and aims to improve tumor detection and potentially guide future therapy. Participants will receive intravenous injections of two tracers: 68Ga-TATE-RGD at a dose of 1.8-2.2 MBq/kg for PET/CT imaging of dual-target positive tumors, and 18F-FDG at 1.8-2.2 MBq/kg for SPECT/CT imaging. The study follows an early phase 1 design and includes imaging procedures performed within one week to compare the tracers' effectiveness in detecting lesions. During the study, researchers will monitor tumor detection rates over an average of six months. Participants will undergo PET/CT and SPECT/CT scans using the tracers to assess tumor presence and characteristics. The study also involves obtaining written consent and observing for any adverse reactions to the tracers. This monitoring aims to evaluate the imaging agent's potential for diagnostic use in tumors positive for SSTR2 and integrin b1vb23.

Researchers are studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

Graves' disease is a common cause of overactive thyroid and is usually treated with anti-thyroid drugs, radioiodine therapy, or surgery. However, these treatments have limitations such as side effects or risks, and some patients experience relapse after drug treatment. This research is exploring a less invasive treatment option using microwave ablation (MWA) to treat patients with relapsed Graves' disease. MWA uses heat generated by microwaves to destroy thyroid tissue without surgery. The study uses a microwave ablation device guided by ultrasound to target and treat the entire thyroid gland, including both lobes and other parts of the thyroid. This procedure is performed percutaneously, meaning through the skin, and aims to avoid surgical scars and preserve organ function. MWA may have advantages over other thermal treatments by requiring less treatment time and avoiding some heat-related effects. Participants will be monitored to assess the remission of Graves' disease six months after the MWA treatment. The study will involve ultrasound guidance during the procedure and follow-up to evaluate treatment outcomes. Researchers will track disease status and any side effects to understand the safety and effectiveness of MWA as a treatment for relapsed Graves' disease.

Researchers are evaluating the safety and effectiveness of transoral endoscopic thyroidectomy vestibular approach (TOETVA) compared to the traditional open thyroidectomy for patients with benign or suspicious malignant thyroid nodules. This prospective case control study includes 40 patients divided into two groups: 20 undergoing TOETVA and 20 undergoing the traditional open procedure. The study aims to assess surgical outcomes like lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, and temporary or permanent hypoparathyroidism, along with patients' satisfaction and quality of life related to voice and swallowing. Participants will receive either the TOETVA, which is a remote access thyroid surgery, or the conventional open thyroidectomy via a trans-cervical approach. Assignment to either group is not randomized. The study uses the Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) to evaluate voice and swallowing outcomes. Both procedures are performed under general anesthesia. During the study, patients' satisfaction scores, voice quality of life, swallowing quality of life, post-operative pain, and complication rates will be measured at day 1, 2 weeks, and 6 months after surgery. Researchers will monitor complications such as nerve injury and hypoparathyroidism. The total participation duration includes these follow-up assessments to evaluate long-term results and safety of the surgical approaches.

After thyroid surgery, a small percentage of patients (0.6 to 4%) experience postoperative bleeding, with most bleeding events occurring within the first 48 hours. These complications often progress rapidly and require immediate medical attention, as they can lead to serious outcomes including death in up to 0.6% of cases. Research has shown that continuous pressure increases in the neck area, related to bleeding, can be detected early through invasive pressure measurements. Current routine care relies on patient symptoms and intermittent monitoring, which may delay detection of serious bleeding. This study is evaluating the use of the ISAR-M THYRO device, a diagnostic tool designed to detect haemorrhage early by continuously measuring pressure in the thyroid area after surgery. The device aims to identify increasing cervical pressure caused by hematoma growth before symptoms appear, allowing earlier intervention within 36 to 48 hours post-surgery. Early detection could help guide treatment decisions, such as timing of wound opening, to reduce complications and improve patient safety. Participants will be monitored using the device after thyroid surgery to assess its accuracy in detecting bleeding within 48 hours. The study measures sensitivity and specificity of the device in identifying haemorrhage during this critical postoperative period. By providing objective pressure readings, the study seeks to minimize risks of severe complications like brain damage and death. The trial involves routine clinical follow-up and aims to improve management and outcomes for patients undergoing thyroid surgery.

This research aims to compare same-day discharge with the usual overnight hospital stay for patients undergoing thyroid lobectomy. It focuses on patient-reported outcomes, safety, and economic impacts, evaluating symptom severity and other health measures after surgery. The study is a Phase 2 randomized controlled trial that seeks to determine if same-day discharge is as safe and effective as the standard care involving overnight observation. Participants are randomly assigned to either same-day discharge or usual care with an overnight stay after their thyroid lobectomy. They will complete surveys before surgery, about 1 day after surgery, and again 2 weeks post-procedure to report symptoms and recovery. The surveys are done electronically through the MyChart system and take 5-10 minutes. Monitoring continues for up to one month, including a standard post-operative visit around 2 weeks and a possible follow-up contact at 1 month. Throughout the study, researchers will assess symptom severity using the MD Anderson Symptom Inventory - Thyroid at 24 hours and 2 weeks after surgery. They will also monitor for adverse events such as post-operative hematoma, emergency care visits, readmission, pain levels, and mortality within 30 days. Medication use, specifically morphine milligram equivalents over 2 weeks, will be tracked. Safety outcomes are graded according to national criteria, and participants may be contacted by providers virtually or in person during the one-month follow-up period.

Hypothyroidism, marked by high thyrotropin (TSH) levels, is a common issue in patients with chronic kidney disease (CKD) who are on dialysis. Previous research has linked elevated TSH, even within the normal range, to poorer quality of life and increased cardiovascular problems in this group. This trial aims to determine if thyroid hormone replacement with levothyroxine improves quality of life, physical ability, strength, heart health, and metabolic function in dialysis patients with higher TSH levels. The study will randomly assign 336 hemodialysis patients with TSH levels between >3.0 and 10.0 mIU/L and normal free thyroxine (FT4) to receive either levothyroxine or a placebo for 24 weeks. Researchers will evaluate effects on quality of life using the Short Form 36 Physical Component Score and coronary artery calcification progression as the main measures. Secondary assessments include additional quality of life surveys, physical performance, endothelial function, vascular calcification markers, body fat percentage, muscle strength, heart systolic function, and resting energy use. Participants will undergo screening and monitoring throughout the six-month treatment period. Evaluations include laboratory tests for thyroid function and cardiovascular markers, physical assessments, and questionnaires. Safety and efficacy will be closely tracked, with primary outcomes measured at baseline, 12 weeks, and 24 weeks. The study will help clarify the benefits and risks of levothyroxine therapy in hemodialysis patients with mild thyroid dysfunction.

Researchers are evaluating AMG 732 in both healthy individuals and participants with moderate-to-severe active Thyroid Eye Disease (TED) in a Phase 1/2 clinical trial. The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of AMG 732 given by subcutaneous injection. Part A focuses on safety and tolerability after single doses in healthy participants, while Part B examines the efficacy of multiple doses in those with TED. Participants receive either AMG 732 or a placebo through subcutaneous injections. Part A involves single-dose administration to healthy adults aged 18 to 55 years, including a cohort of healthy Japanese participants. Part B enrolls adults aged 18 to 65 years with moderate-to-severe active TED, who receive multiple doses over approximately six months. The study design is randomized, double-masked, and placebo-controlled. During the trial, participants undergo various evaluations including safety monitoring for treatment-emergent adverse events up to 36 weeks, and measurement of proptosis (eye bulging) changes in the affected eye from baseline to the end of treatment. Assessments include clinical activity scores, laboratory tests, vital signs, ECGs, and physical exams. Researchers also track participants’ response to treatment and monitor for any side effects throughout the study duration.