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Thyroid Diseases clinical trials

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NCT ID: NCT06324578 Recruiting - Sjögren Clinical Trials

Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease

Start date: September 25, 2023
Phase:
Study type: Observational

The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine.

NCT ID: NCT06322160 Recruiting - Thyroid Cancer Clinical Trials

The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making

HANSOM
Start date: May 3, 2023
Phase:
Study type: Observational

Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway.

NCT ID: NCT06307990 Recruiting - Clinical trials for Resistance, Thyroid Hormone

Understanding, Diagnosis and Monitoring of Thyroid Hormone Action Defects

ADAM-THAD
Start date: January 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the neurological and cardiological phenotype of patients with resistance to thyroid hormone (RTH) syndromes beta and alpha (RTHß and RTHa) due to dominant negative variants in the genes encoding the thyroid hormone receptors alpha (THRA) and beta (THRB). The main question[s] it aims to answer are: - Define frequency and improve early diagnosis for RTH syndromes - Developing tools to accelerate diagnosis of RTH syndromes - Development and validation of monitoring tools Participants, recruited at neonatal screening or from cohorts of patients with unexplained specific neuro-cognitive or cardiovascular phenotypes will be submitted to biochemical and genetic investigations. In addition pluripotent stem cells will be generated from peripheral blood cells of RTHs patients and studied in vitro to understand the molecular mechanisms underlying neurological and cardiovascular consequences. In vitro and clinical data, will be correlated to identify biomarkers for monitoring treatment.

NCT ID: NCT06307626 Recruiting - Thyroid Eye Disease Clinical Trials

A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.

UplighTED
Start date: March 28, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks. An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307613)

NCT ID: NCT06307613 Recruiting - Thyroid Eye Disease Clinical Trials

A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease

UplighTED
Start date: March 27, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks. An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626)

NCT ID: NCT06296420 Recruiting - Goiter Clinical Trials

Dysphagia After Thyroidectomy

DYSPHATHYR
Start date: January 31, 2024
Phase:
Study type: Observational

The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery. Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy. The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy. In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy.

NCT ID: NCT06289309 Recruiting - Surgery Clinical Trials

NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury. The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique. A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy.

NCT ID: NCT06286631 Recruiting - Clinical trials for Papillary Thyroid Cancer

Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale

Start date: May 1, 2023
Phase:
Study type: Observational

The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients.

NCT ID: NCT06277180 Recruiting - Surgery Clinical Trials

68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

NCT ID: NCT06275373 Recruiting - Graves Disease Clinical Trials

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

Teprotumumab
Start date: May 12, 2021
Phase:
Study type: Observational

This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).