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NCT ID: NCT06112834 Not yet recruiting - Botulism Clinical Trials

Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection will be conducted to collect source plasma for potential use in the production of BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a 12-week period, with a follow-up safety assessment at 6 months.

NCT ID: NCT06112353 Not yet recruiting - Intestinal Disease Clinical Trials

Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Start date: April 2024
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery

NCT ID: NCT06111794 Not yet recruiting - Clinical trials for Traumatic Brain Injury

The REACH Intervention for Caregivers of Veterans and Service Members With TBI

REACH TBI
Start date: May 2024
Phase: N/A
Study type: Interventional

This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.

NCT ID: NCT06111521 Not yet recruiting - Healthy Clinical Trials

A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants

Start date: October 27, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein [P-gp] substrate), rosuvastatin (a breast cancer resistance protein [BCRP)] substrate), and midazolam (a substrate of Cytochrome P450 3A4 [CYP3A4]) in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982 with or without single doses of digoxin, rosuvastatin, and midazolam. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 23 and 11 days for part 1 and part 2, respectively, not including screening.

NCT ID: NCT06111313 Not yet recruiting - Prostate Cancer Clinical Trials

The University of Miami Adapt (UAdapt) Trial

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

The Miami UAdapt Trial is a risk-adapted parallel randomized study using single high-dose radiotherapy (SDRT) to treat favorable and unfavorable risk prostate cancer patients. The primary objective of the study is to determine the proportion of patients with Biochemical and/or Clinical Disease Failure 1 year after completion of radiotherapy (RT).

NCT ID: NCT06110598 Not yet recruiting - Pancreas Cancer Clinical Trials

CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

- This study is being done to find out if extending adjuvant chemotherapy for patients by giving additional chemotherapy can lengthen the amount of time before their cancer comes back. The additional chemotherapy is called capecitabine. - Capecitabine is an oral drug (taken by mouth). It is approved by the US Food and Drug Administration (FDA) for adjuvant treatment of adults with pancreatic cancer and also for the treatment of other types of cancer

NCT ID: NCT06110546 Not yet recruiting - Clinical trials for Effect of Methadone on the Duration on Mechanical Ventilation

Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids

IMPACTOR
Start date: November 15, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge

NCT ID: NCT06110364 Not yet recruiting - Clinical trials for Premature Ventricular Contraction

Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

Start date: October 2023
Phase: Phase 3
Study type: Interventional

Prospective randomized control pilot study

NCT ID: NCT06110065 Not yet recruiting - Clinical trials for Malignancy-induced Pelvic Pain

CT-guided Pudendal Nerve Cryoneurolysis for Palliation of Malignancy-induced Pelvic Pain

Start date: November 2023
Phase:
Study type: Observational

We want to study if a new treatment called "CT-guided bilateral pudendal nerve cryoneurolysis" can help people with severe and long-lasting pain in the pelvic area caused by cancer. We will closely follow and observe patients who undergo this treatment to see if it works well, what results it gives, and if there are any problems or side effects. "Percutaneous image-guided cryoneurolysis" involves using very cold temperatures to treat the nerves causing the pain. This method has been found to provide longer pain relief compared to injections or catheters, and it also has a lower risk of certain complications. We are conducting a study to assess the effectiveness of two different treatments for severe and persistent pelvic pain caused by cancer. The first treatment, known as "CT-guided bilateral pudendal nerve cryoneurolysis," involves using advanced imaging technology to precisely target and freeze the pudendal nerves, which are responsible for transmitting pain signals. By closely monitoring patients who receive this treatment, we aim to evaluate its efficacy, outcomes, and potential side effects. On the other hand, the second treatment approach, referred to as "Percutaneous image-guided cryoneurolysis," focuses on using extremely cold temperatures to alleviate pain originating from the pudendal nerves. This method has demonstrated extended pain relief compared to alternatives like injections or catheters. Additionally, it presents a lower risk of certain complications. Through our study, we seek to gain insights into the effectiveness and safety of both treatment methods, enhancing our understanding of how to address the challenging issue of cancer-related pelvic pain. The study will enroll patients who are dealing with severe and persistent pelvic pain from cancer. All patients will undergo the CT-guided bilateral pudendal nerve cryoneurolysis first type of treatment and if it is not effective in relieving the pain, they will be offered to undergo the second treatment called Percutaneous image-guided cryoneurolysis. Both of these treatments are done as standard of care. This research study will not alter standard of care. Subjects will only be enrolled into this study if they are already undergoing CT-guided bilateral pudendal nerve cryoneurolysis followed up with Percutaneous image-guided cryoneurolysis, as needed. This is a prospective study of these two treatments following patient outcomes.

NCT ID: NCT06107829 Not yet recruiting - Clinical trials for Intellectual Disability

Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities

TD-AIDD
Start date: August 2024
Phase: Phase 4
Study type: Interventional

The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are: - Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD? - Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD? - Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine? - Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD? - Does valbenazine treatment of TD in persons with IDD reduce caregiver burden? In this study, 25 participants with IDD and TD will undergo valbenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.