Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Hypercalcemia

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vasoconstrictor Agents

Vitamins

Vitamin D

Cholecalciferol

Calcitriol

Hormones

Calcium

Calcium, Dietary

Trace Elements

Vitamin D3

Calciferol

titrated to achieve 40-60% PTH suppression

1 mcg daily, adjusted to achieve 40-60% PTH suppression

Paricalcitol

0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Daniel W Coyne, MD

Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.

General Design

* Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
* Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
* Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism

Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.

Henry Ford Hospital

Northwestern University Feinberg School of Medicine

NorthShore University HealthSystem

Abbott

Washington University School of Medicine

Professor of Medicine

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Stage 3 and 4 CKD with SHPT, age \>18, a stable dose of phosphate binder (if receiving a binder), estimated glomerular filtration rate (eGFR) of 15-59 mL/min using the abbreviated MDRD equation, PTH \>120 pg/mL, albumin-corrected calcium \>8.5 mg/dL and \<10.0 mg/dL, phosphorus \<4.6 mg/dL.

Dr. Daniel W. Coyne

Confirmed Hypercalcemia

Overall Study

Musculoskeletal Diseases

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Muscle Weakness

Thyroid Neoplasms

Thyroid Diseases

Paralysis

Paresis

Thyroid Nodule

Hypoparathyroidism

Vocal Cord Paralysis

Goiter

Thyroid Cancer, Papillary

Hypocalcemia

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neurologic Manifestations

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Laryngeal Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Vagus Nerve Diseases

Cranial Nerve Diseases

Adenocarcinoma

Adenocarcinoma, Papillary

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Control (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched)

Experimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral)

Experimental (s/p TT, with only hypocalcemia-H, transient or permanent)

Experimental (s/p TT, with both vocal cord paralysis-VCP and hypocalcemia-H);

Subgroups:

4.1. VCP (Permanent) + H (Permanent) 4.2. VCP (Transient) + H (Transient) 4.3. VCP (Permanent) + H (Transient) 4.4. VCP (Transient) + H (Permanent)

Please answer:

* Improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?)
* Return of voice is parallel with the improvement in hypocalcemia? (any objective sign? Ca? PTH?

Patients with thyroid diseases either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) will be prepared for total thyroidectomy procedure and will be enrolled.

Total thyroidectomy

Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS

Kadir YILDIRAK, MD

Ethem UNAL, MD, PhD, USMLE & IFSO- Certified Board CSS

Kadir M YILDIRAK, MD

Sema YUKSEKDAG, MD

In the present study, the severity of recurrent laryngeal nerve injury (RLNI) and hypocalcemia (H) will be followed-up and the probable interrelation between them will be proposed considering the clinical situation of patients, e.g. improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?), return of voice is parallel with the improvement in hypocalcemia? Postoperative calcium (Ca), parathyroid hormone (PTH), regular vocal cord evaluations by ear-nose-throat (ENT) exams, deterioration-stability-improvement of clinical symptoms regarding both Ca metabolism and vocal cord function will be noted at regular intervals (postoperative day 1-3-first, weekly control/first month, monthly/first 6-month, 3-monthly/6-12 months) at outpatient controls. Serum Ca, PTH, ENT evaluation of vocal cords-noted.

Total thyroidectomy is currently the preferred surgical treatment modality for both thyroid carcinomas and benign disorders such as multinodular goitre, since it minimizes the risk of recurrence and eliminates the complication risks of repeat or completion surgery. Vocal cord paralysis due to injury to recurrent laryngeal nerve (RLN) is the most dreaded complication of total thyroidectomy. The reported incidence of temporary RLN injury (RLNI) varies between 0 and 12 %, while the incidence of permanent RLNI has been reported to be much lower (0-3.5 %). In case of bilateral RLNI, respiratory distress and aspiration can develop rapidly and may result in mortality. Therefore, all precautions including close monitoring and tracheostomy should be undertaken without any delay. The best known technique to avoid injury to RLN is meticulous dissection of the nerve throughout its anatomic pathway. However, functional impairment of RLN is not visible macroscopically and intraoperative nerve monitoring (IONM) has been developed to monitor the nerve to avoid unnecessary dissection. Meticulous hemostasis can be achieved with harmonic sealing instrument, since improper hemostasis is known to increase the risk of RLNI. Despite the lack of evidence to support an advantage of IONM over the standard anatomic dissection of RLN, surgeons have adopted it in increasing ratios. The second most feared compliation of thyroidectomy is iatrogenic hypocalcemia. Transient symptomatic hypocalcemia after total thyroidectomy occurs in approximately 7% to 25% of cases, but permanent hypocalcemia is less common (0.4% to 13.8%). Size and invasion of tumor, operative trauma and vascular compromise determines the severity of symptoms.

Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort

Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines

Study is open to high-volume INTERNATIONAL endocrine surgery centers, eager to join to present STROBE compatible observational study

Available upon email requests@drethemunal@gmail.com

Any improvement recorded? VCP? H? vice versa

Umraniye Education and Research Hospital

MD, PhD, USMLE & IFSO-Certified, BCSS, Associated Professor of General Surgery and Surgical Oncology

This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery.

When performing thyroid surgery for patients in the experimental group, the surgeon uses a head mounted magnifying glass for assistance

head mounted magnifying glass assistance

This study collected data on open thyroidectomy patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. This study investigated whether the application of head mounted magnifying glasses had an impact on preoperative and postoperative changes in PTH levels through inter group and self pre - and post control, in order to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery and provide reasonable suggestions for the selection of subsequent surgical treatment methods.

In thyroid surgery, changes in postoperative parathyroid hormone (PTH) levels have a significant impact on the patient\&#39;s recovery and long-term health status. Parathyroid hormone is responsible for regulating blood calcium levels, and its dysfunction can cause serious electrolyte imbalance and metabolic problems. In the process of thyroid surgery, especially in total thyroidectomy, protecting the function of the parathyroid gland is an important operation. The diameter of the parathyroid gland is small and similar to the morphology of lymph nodes, making it susceptible to damage during surgery. Although traditional magnification tools such as surgical microscopes have certain effects, their operation is complex and their adaptability to surgical scenes is limited.

In recent years, as an emerging magnifying tool, head mounted magnifying glasses have been increasingly used in thyroid surgery due to their portability, ease of operation, and providing a larger field of view. Wearing a head mounted magnifying glass can not only improve the clarity of vision during surgery, increase the recognition rate of parathyroid glands and nerves, but also reduce the risk of parathyroid injury by improving surgical accuracy, thereby more effectively maintaining the stability of postoperative PTH levels. In addition, the use of head mounted magnifying glasses can reduce surgical time, intraoperative uncertainty, and the risk of postoperative complications.

This study systematically evaluates the changes in PTH levels before and after surgery to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery, and further explores the effectiveness of parathyroid gland protection strategies, optimizing surgical techniques, and improving patient surgical safety and postoperative quality of life. In addition, the results of this study also have guiding significance for the innovation and improvement of surgical instruments, which may promote the development of related technologies and equipment, and thus promote their application in a wider range of surgical fields.

The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery

The data are not publicly available due to privacy and ethical restrictions.

To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery by examining changes in PTH levels before and after surgery.

Shandong University

Shandong Provincial Hospital

Principal Investigator

Parathyroid Hormone

By exploring the relationship between the number of lymph nodes in the central region of the thyroid gland and parathyroid function, evaluate the effectiveness of different surgical procedures and intraoperative protective measures on parathyroid function protection.

This study collected data from patients who underwent thyroidectomy in the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. The main calculation indicator was the changes in PTH before and after surgery. This study grouped patients based on the number of central lymph nodes under postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function, and to provide reference for surgical selection in thyroid cancer patients with multiple cervical lymph node metastases.

The central lymph nodes of the thyroid gland refer to the lymph nodes located around the thyroid and trachea. The central lymph nodes are the primary site of thyroid cancer metastasis, and therefore play an important role in thyroid surgery. In thyroid surgery, preventive central lymph node dissection is a routine procedure, but during this process, the parathyroid gland may be impaired due to surgical injury or insufficient blood supply.

Hypothyroidism, also known as parathyroidism, is a common complication of thyroid surgery. When the parathyroid gland is accidentally injured or its blood supply is disrupted, it can lead to insufficient production of parathyroid hormone. Parathyroid hormone is a key hormone that regulates blood calcium levels. Insufficient levels can lead to hypocalcemia, manifested as hand and foot spasms, muscle spasms, and even arrhythmia.

From a surgical perspective, the number of lymph nodes in the central region of the thyroid gland may affect the preservation and functional protection of the parathyroid gland. A large number of lymph nodes indicates that they may have a wider range of disease invasion, requiring more thorough lymph node dissection, thereby increasing the risk of damaging the parathyroid gland or its blood supply.

The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function

The IPD are not publicly available due to privacy and ethical restrictions.

This study grouped the central lymph nodes based on postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)	NCT00823303	Secondary Hyper... Chronic Kidney ...	Paricalcitol Calcitriol	18 Years -	Washington University School of Medicine
Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort	NCT04396912	Iatrogenic Hypo... Iatrogenic Hypo... Vocal Cord Para... Vocal Cord Pare... Vocal Cord; Inj... Thyroid Cancer,... Thyroid Cancer Multinodular Go... Thyroid Neoplas... Thyroid Nodule Calcium Deficie... PTH	Total thyroidec...	17 Years -	Umraniye Education and Research Hospital
The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery	NCT06432257	Thyroid Cancer	head mounted ma...	-	Shandong Provincial Hospital
The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function	NCT06432244	Thyroid Cancer		-	Shandong Provincial Hospital
The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function	NCT06432244	Thyroid Cancer		-	Shandong Provincial Hospital
The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery	NCT06432257	Thyroid Cancer	head mounted ma...	-	Shandong Provincial Hospital
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)	NCT00823303	Secondary Hyper... Chronic Kidney ...	Paricalcitol Calcitriol	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for pth

Every month we try and update this database with for pth cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pth

Every month we try and update this database with for pth cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pth cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.