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NCT ID: NCT05082571 Suspended - Clinical trials for Anemia of Chronic Kidney Disease

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease

CONVERSION
Start date: January 2025
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).

NCT ID: NCT05079568 Suspended - Gastroparesis Clinical Trials

A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.

NCT ID: NCT05074290 Suspended - Breast Cancer Clinical Trials

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Start date: March 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane in this patient population will also be determined in this study.

NCT ID: NCT05067257 Suspended - Pain Clinical Trials

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer

Start date: September 2025
Phase: Phase 2
Study type: Interventional

This Phase 2 study assesses the safety and efficacy of a single injection of Resiniferatoxin versus placebo for the treatment of intractable advanced cancer pain.

NCT ID: NCT05064111 Suspended - Prostate Cancer Clinical Trials

Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

Start date: September 1, 2024
Phase:
Study type: Observational

The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.

NCT ID: NCT05055050 Suspended - Bladder Cancer Clinical Trials

A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630

Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

he primary objective is to characterize the safety profile of UGN-201 in patients with urothelial carcinoma undergoing radical cystectomy. Corresponding primary endpoint: Toxicity of concern (TOX) will be monitored until 30 days after surgery or until the patient meets the surgery prevention or delay TOX definition below, whichever comes first. A patient will be considered to have a TOX if any of the following apply: - Any 30-day grade 3 or higher surgical complication at least possibly related to UGI-201 - Any toxicity at least possibly related to the treatment that prevents surgery or delays it more than 12 weeks from date of cystectomy decision with MDACC Urologist. Missing/delayed surgery due to progression or withdrawal not related to toxicity will not count as a TOX event. Rapid progression is not seen with UGN-201. For such a patient, TOX monitoring will follow for 30 days after the administered dose of UGN-201. - Death between the start of study and the 30-day post-surgical assessment will count if it is toxic death at least possibly related to the UGN-201 or surgery. Deaths clearly unrelated to treatment will not count as an event. Adverse events will be recorded using CTCAE v5 and surgical complications will be recorded using Clavien-Dindo classification. Exploratory objectives are: - To evaluate the efficacy of UGN-201 by pathologic T0 and ≤ pT1 rate (pathologic down-staging) after neoadjuvant treatment with UGN-201, in patients with NMBIC and MIBC undergoing radical cystectomy, respectively. - To assess the immunological/biomarker changes in tumor tissues, peripheral blood, and urine in response to UGN-201 treatment in patients with bladder cancer undergoing radical cystectomy and to explore any potential association between these biomarker measures and antitumor activity. Patients with MIBC will be defined as having a response if their pathologic stage is pT1 stage or less. Patients with NMIBC will be defined as having a response if their pathologic stage is pT0. Immunologic and other biomarker measures will be recorded by laboratory standards for each measure.

NCT ID: NCT05053737 Suspended - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC

Start date: November 2, 2021
Phase: Phase 1
Study type: Interventional

To determine the outcomes of patients with specific head and neck cancer after undergoing radiation therapy with atezolizumab followed by surgery then radiation with or without chemotherapy according to national guidelines.

NCT ID: NCT05051228 Suspended - Clinical trials for Acute Coronary Syndrome

Genetesis Accelerated Registry

GEAR
Start date: January 27, 2021
Phase:
Study type: Observational

Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.

NCT ID: NCT05046353 Suspended - Schizophrenia Clinical Trials

D-serine AudRem: R33 Phase

Start date: December 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Schizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. In addition, schizophrenia patients show reduced "plasticity", defined as reduced learning. D-serine is a naturally occurring activator of the N-methyl-d-aspartate-type glutamate receptors (NMDAR) in the brain, and this project will assess the D-serine treatment over 16 weeks of a program designed to measure auditory plasticity.

NCT ID: NCT05035420 Suspended - COVID-19 Clinical Trials

A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases

Start date: May 26, 2022
Phase: N/A
Study type: Interventional

Background: The COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19. Objective: To evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation. Eligibility: Healthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing. Design: Participants will have a physical exam. Their vital signs will be taken. Participants will sit in a chair. They will be monitored for 60 to 80 minutes while they do the following tasks: Rest for 10 minutes. They will repeat this after each task. Hold their breath for up to 2 minutes and then rest for 2 minutes. They will do this task 3 times. Pace-breathe with breathing rates of 10, 20, and 30 breaths per minute. They will do this task 2 times. Breathe air that has 5% of carbon dioxide for 5 minutes. During these tasks, data will be collected and recorded with a pulse oximeter, thermometer, respiratory belt, and spirometer. Participants will fill out questionnaires related to their daily activity (medication intake, exercise, smoking, and drinking). Participation will last for 2 to 3 hours.