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NCT ID: NCT05193929 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use.

NCT ID: NCT05193864 Recruiting - Clinical trials for Congestive Heart Failure

Office-based Validation of the JVPHome

Start date: November 29, 2021
Phase:
Study type: Observational

The JVPHome is a novel medical device that utilizes machine vision in order to facilitate assessment of jugular venous pressure (JVP) height relative to the sternal angle with the ultimate goal of enabling remote JVP monitoring. The current study aims to evaluate the ability of an enhanced version of the JVPHome to enable remote identification of JVP height relative to ultrasound among congestive heart failure (CHF) patients when the device is applied by the study team in the clinic.

NCT ID: NCT05193227 Recruiting - Postoperative Pain Clinical Trials

Sustained Release Lidocaine for the Treatment of Postoperative Pain

Start date: October 27, 2021
Phase: Phase 2
Study type: Interventional

In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic (circumcision, inguinal, scrotal), perineal (hemorrhoidectomy) or perianal (fistulotomy) incisions. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.

NCT ID: NCT05192863 Active, not recruiting - Crohn's Disease Clinical Trials

A Study of Vedolizumab in Adults With Crohn's Disease (CD)

SUNRISE
Start date: March 20, 2023
Phase:
Study type: Observational

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. Participants will be treated with vedolizumab according to their clinic's standard practice.

NCT ID: NCT05191745 Completed - Clinical trials for Coronary Artery Bypass Graft Surgery

Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

Start date: January 26, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.

NCT ID: NCT05191160 Active, not recruiting - Obesity Clinical Trials

The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.

NCT ID: NCT05190653 Recruiting - Multiple Myeloma Clinical Trials

Early Integration of Palliative and Supportive Care in Cellular Therapy

PALS_CT
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

Research has shown that early palliative care in cancer care is associated with improved symptom management, better prognostic understanding, improved quality of life for patients and family caregivers, and even improved survival. Yet, in spite of the proven benefits of integration of palliative care in oncology, it has been well established that patients with hematologic malignancies and those undergoing cellular therapy (hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor (CAR) T-cell therapy) do not routinely receive palliative care. Most of the published research on the early integration of palliative care in oncology describes studies that have involved patients with solid tumours. To date, only one randomized trial examining the impact of integrated palliative care among patients undergoing HSCT has been published and there have been no studies examining the impact of integrated palliative care for patients undergoing CAR T-cell therapy. The American Society of Clinical Oncology recommends early palliative care for patients with advanced cancers or for those with high symptom burden. Patients with blood cancers experience high symptom burden and in the last 30 days of life, compared to patients with solid tumours, patients with blood cancers are more likely to die in hospital, have more intensive care unit admissions, have prolonged hospitalizations (>14 days), and pass away in an acute care facility. There is an urgent need to proactively address suffering throughout cellular therapy trajectories, even before treatment starts, so that patients and caregivers are not inevitably waiting for symptoms to arise before they can be addressed and to optimize quality of life for patients undergoing transplant as well as their family caregivers. PALS_CT will compare early palliative care to standard care for patients and their family caregivers undergoing HSCT or CAR T-cell therapy for blood cancers.

NCT ID: NCT05190354 Completed - Amputation Clinical Trials

Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Start date: November 16, 2021
Phase: N/A
Study type: Interventional

Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.

NCT ID: NCT05190302 Terminated - Clinical trials for Peripheral Nerve Block

Determination of the Sensitivity, Specificity & Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During US Guided PNB

Start date: January 27, 2022
Phase:
Study type: Observational

Although the superiority of ultrasound guidance over neurostimulation (NS) has been demonstrated, it has its limits, namely when used for a deeper block (device limits) or if used by a less experienced operator (ability to recognize structures, to correctly position the needle). In addition, its use has failed to consistently prevent intra-neural injection. The question of the usefulness of NS in addition to ultrasound is therefore still relevant. A great geographical disparity exists in the habits of nerve localization. The reluctance to use NS stems mainly from doubts about its effectiveness. The threshold used to consider that the needle is sufficiently close to the nerve and the one used to exclude an intraneural injection have been disputed in several studies. Another weakness of studies concerning NS since the advent of ultrasound guidance is the impossibility of generalizing the results. All clinical studies were performed in an academic setting, and a large majority of them specify that the blocks were performed by - or supervised by - regional anesthesia experts. The only study that attempted to determine the sensitivity of NS used ultrasound as a gold standard. The choice of the ultrasound position as the gold standard is debatable, since it is dependent of the operator. The clinical success of nerve blocks would be a better standard. No study to date has made it possible to calculate the specificity and sensitivity of NS in addition to ultrasound guidance, and therefore, to obtain the positive and negative predictive values of the technique. Obtaining these values could allow each clinical setting or individual to determine the contribution of NS to their rate of success, as a modest increase in the success rate or a minimal decrease in the risk of neuropathy would be clinically significant. The hypothesis is that the sensitivity and specificity of NS justifies its use in combination with ultrasound guidance in most settings, but that the gain in efficiency varies depending on the context (for example depending on the local success rate). To determine the required sample size to test this hypothesis and plan for a definitive study on the question, the investigators need to know what is the local failure rate (incidence of studied event) and what could be the possible rate of patient enrollment. This preliminary, feasibility study will aim to confirm that the local failure rate is compatible with the 5% rate observed in the literature.

NCT ID: NCT05188820 Completed - Low Back Pain Clinical Trials

Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients With Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients with Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections: A Triple Blinded Randomized Controlled Trial.