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NCT ID: NCT06461676 Not yet recruiting - Clinical trials for Hypoplastic Left Heart Syndrome

Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients With Hypoplastic Left Heart Syndrome (HLHS)

Start date: October 1, 2024
Phase: Phase 1
Study type: Interventional

The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS). The main questions it aims to answer are: - Whether VentriGel is safe in treating patients with HLHS - Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection

NCT ID: NCT06461559 Not yet recruiting - Stoma Ileostomy Clinical Trials

Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

Start date: August 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.

NCT ID: NCT06461455 Not yet recruiting - Presbyopia Clinical Trials

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

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

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

NCT ID: NCT06461221 Not yet recruiting - Reaction Time Clinical Trials

tFUS to Enhance Alertness and Performance

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

The investigators goal is to target FUS energy to the centromedian nucleus of the thalamus (CMT), the core of arousal, which is inaccessible by traditional non-invasive neuromodulation devices. The CMT is an ideal stimulation target for augmenting alertness, as it is intimately linked with the cortex through the well described thalamocortical circuit to entrain network oscillations.

NCT ID: NCT06460844 Not yet recruiting - Clinical trials for Retinitis Pigmentosa

Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa Patients

Start date: August 2024
Phase: Phase 1
Study type: Interventional

A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 9 eligible patients with retinitis pigmentosa will be enrolled sequentially in up to 3 dose cohorts of RTx-015. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 (Day 0) and be followed for a total of 12 months.

NCT ID: NCT06460350 Not yet recruiting - Clinical trials for Total Knee Arthroplasty

NEUROCUPLE™ in TKA Patients

Start date: June 24, 2024
Phase: N/A
Study type: Interventional

This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA. Results will establish NEUROCUPLE™ as an effective non-opioid postoperative pain management device for FDA approval. Importantly, we have a placebo device (device without the captor array layer) that looks exactly like the active device, allowing us to conduct a true placebo randomized study.

NCT ID: NCT06460298 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

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

This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer

NCT ID: NCT06460116 Not yet recruiting - Clinical trials for Educational Problems

Health Equity and Rural Education (HERE!) Clinical Trial

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

The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools. The main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health/mental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents/guardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents/guardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.

NCT ID: NCT06458998 Not yet recruiting - Cirrhosis Clinical Trials

Getting To Implementation: Improving Cancer Screening for Veterans

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

Gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the US. Testing could catch these cancers early, helping people live longer. The goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing. The main question it aims to answer is: how should healthcare systems go about choosing one or the other? Researchers will look at cancer testing rates over time at sites that are trying these different approaches. They will also survey and interview participants from these sites.

NCT ID: NCT06458907 Not yet recruiting - Clinical trials for Tricuspid Regurgitation

TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.

TRICAV-II
Start date: December 2024
Phase: N/A
Study type: Interventional

The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System). The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior and inferior vena cava. The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system. The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.