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NCT ID: NCT06444347 Not yet recruiting - Hiatal Hernia Clinical Trials

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Start date: June 2024
Phase: N/A
Study type: Interventional

The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.

NCT ID: NCT06444282 Not yet recruiting - Emergencies Clinical Trials

Emergency Care Action Plans for Infants With Medical Complexity

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

An Emergency Care Action Plan (ECAP) is a tool intended to be helpful to providers when treating a child with complex medical needs during an emergency. Once created, ECAPs are added to the Electronic Health Record (EHR), shared with the child's caregiver(s), and kept up by all of those involved in a child's care. The goal of this study is to measure important health outcomes (ex. inpatient days, emergency department visits) in terms of the use of the ECAP for infants discharged from the Neonatal Intensive Care Unit (NICU). This study will also measure other real-time potential challenges related to the use of the ECAP including, but not limited to, if it is being used, if providers and caregivers want to use it, and if they keep using it over a long period of time.

NCT ID: NCT06444269 Not yet recruiting - Breast Cancer Clinical Trials

Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial

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

1. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

NCT ID: NCT06444256 Not yet recruiting - Clinical trials for Stimulant Use Disorder

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

NCT ID: NCT06444165 Not yet recruiting - Atopic Dermatitis Clinical Trials

Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection. This study involves one study visit.

NCT ID: NCT06444048 Not yet recruiting - Clinical trials for Enterovirus Infection

Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults

Start date: June 11, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers. Three doses (3, 10 and 30 mg/kg) of EV68-228-N will be evaluated in three separate, sequential cohorts in this single dose escalation study. The cohorts will be randomized in a 5:1 randomization scheme. The first two participants in each cohort will serve as sentinels. Sentinel participants may be located at different sites. Sentinel safety data will be collected through Day 3 before submitting to the Safety Review Committee (SRC) for review. The SRC is comprised of the Principal Investigator (PI), the DMID Medical Monitor, and the DMID Medical Officer. Data to be reviewed will include clinical data collected from Visits 1, 2 and 3, the results of laboratory testing conducted at these visits, solicited adverse events (AEs) and the passive reporting of adverse events through Day 3. From the time of infusion of the sentinels to at least 48 hours after infusion, no new participants will be given study product or placebo, but screening may continue. If no safety signal is detected in the sentinel group, and after approval from the DMID Medical Monitor, the remaining 10 participants in the cohort will be dosed following the overall 5:1 randomization scheme. All participants will be actively monitored for AEs and safety laboratory data following dosing through Day 8. Data will be reviewed by the SRC and discussed with the Safety Monitoring Committee (SMC) for their concurrence before advancing to the next cohort. Electronic review of the safety data by the SMC is required prior to the cohort dose escalation when halting rules are met or there are any safety concerns. The primary objective is to evaluate the safety of a single IV infusion of either 3, 10, or 30 mg/kg of EV68-228-N when administered to healthy adults. The secondary objective is to: 1) characterize the PK of single ascending doses of EV68-228-N for approximately four months following the infusion and 2) measure the occurrence of anti-drug antibodies (ADAs) elicited following a single IV infusion of EV68-228-N in healthy adults.

NCT ID: NCT06443970 Not yet recruiting - Respiratory Failure Clinical Trials

Low and High Flow Suctioning in Intubated Infants

Start date: June 30, 2024
Phase: N/A
Study type: Interventional

Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.

NCT ID: NCT06443385 Not yet recruiting - Opioid Prescribing Clinical Trials

E-mail Nudges for Prescribing Risky Drugs

Start date: July 15, 2024
Phase: N/A
Study type: Interventional

This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.

NCT ID: NCT06443177 Not yet recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.

NCT ID: NCT06442956 Not yet recruiting - Heat Stress Clinical Trials

Effect of Rapid Heat Stress on Firefighters Musculoskeletal Injury Risk

Start date: July 2024
Phase: N/A
Study type: Interventional

This study will examine the effect of heat stress on factors that influence musculoskeletal injury risk in firefighters. Participants will attend 4 data collection sessions. 1: informed consent, screening, and familiarization. 2: pre-tests (strength, balance, and movement quality). 3: heat stress (rapid or gradual) followed by post-tests (strength, balance, and movement quality). 4: heat stress (rapid or gradual) followed by post-tests.