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Wounds and Injuries clinical trials

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NCT ID: NCT04531592 Withdrawn - Acute Kidney Injury Clinical Trials

Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients

Start date: January 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out if a drug called valproic acid (VPA) will protect organs (like the kidneys) from harmful effects caused by the temporary drop and then rise of blood flow and oxygen (called ischemia reperfusion (I/R) injury that sometimes happens during liver transplant surgery. VPA is an approved drug for treating conditions such as seizures and migraines for many years. However, it is not approved for use at the higher dose that will be used in this study or for protecting organs from I/R injury. This study will enroll liver transplant patients and randomly assign them to receive either VPA diluted in salt water or salt water without VPA (placebo) and then follow the patients and compare their organ function and overall outcome. This study is masked meaning that the patients, doctors, and nurses will not know which patient received which treatment. The study treatment will be given in addition to the care that liver transplant patients normally receive. The researchers doing this study believe that VPA will lessen organ injury caused by I/R, meaning that patients who receive VPA will experience less kidney injury when compared to patients who receive the placebo.

NCT ID: NCT04531579 Withdrawn - Acute Kidney Injury Clinical Trials

Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Trauma Patients

Start date: January 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out if a drug called valproic acid (VPA) will protect organs (such as the kidneys) from damage when a person is injured and loses a large amount of blood. The organs may not get enough blood or oxygen when a patient loses a lot of blood. After the patient receives fluids such as blood, plasma, or saline and the bleeding is stopped, blood and oxygen return to the organs. This process called ischemia/reperfusion (I/R) is known to cause injury to organs such as the kidneys and heart. VPA is an approved drug for treating conditions like seizures and migraines for many years. However, it is not approved for use at the higher dose that will be used in this study or for protecting organs from I/R injury. This study will enroll trauma patients and randomly assign them to receive either VPA diluted in salt water or salt water without VPA (placebo) and then follow the patients and compare their organ function and overall outcome. This study is masked meaning that the patients, doctors, and nurses will not know which patient received which treatment. The study treatment will be given in addition to the care that trauma patients normally receive to treat their injuries. The researchers doing this study believe that VPA will lessen organ injury caused by I/R, meaning that patients who receive VPA will experience less kidney injury when compared to patients who receive the placebo.

NCT ID: NCT04527588 Withdrawn - Hand Osteoarthritis Clinical Trials

Italian Translation of the Michigan Hand Outcomes Questionnaire

Start date: December 1, 2021
Phase:
Study type: Observational

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian.

NCT ID: NCT04506099 Withdrawn - Neuropathic Pain Clinical Trials

Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

TINS
Start date: July 17, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.

NCT ID: NCT04405050 Withdrawn - Diabetic Wound Clinical Trials

RCT to Compare Restrata and NPWT to Heal Complex DFUs

Start date: June 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.

NCT ID: NCT04334499 Withdrawn - Glaucoma Clinical Trials

Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

Start date: February 21, 2020
Phase:
Study type: Observational

This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. This protocol examines the use of mtDNA populations as indicators of developing inflammation and resolution of injury. This may be used to provide proactive treatment or define appropriate treatment needs beyond the indications of an ophthalmological exam.

NCT ID: NCT04325165 Withdrawn - Clinical trials for Spinal Cord Injuries

DBS of PPN to Improve Walking in Chronic SCI Patients

Start date: June 30, 2015
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Recent groundbreaking research has demonstrated that deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR) greatly improves locomotion in a rat model with incomplete SCI. The pedunculopontine nucleus (PPN - a specific nucleus within the MLR) in humans has already been established as an auxillary DBS target in Parkinson Disease (PD), to improve motor control and locomotion. DBS of other targets has also been safely used in humans with SCI for chronic pain. These findings suggest that DBS of the PPN may have potential as a therapeutic intervention in the SCI population to improve locomotion. Our goal is to conduct a pioneering study in 5 select motor-incomplete chronic SCI patients that cannot functionally ambulate to examine if bilateral DBS of the PPN improves walking

NCT ID: NCT04270019 Withdrawn - Nerve Injury Clinical Trials

Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

Start date: June 26, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels. Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.

NCT ID: NCT04259684 Withdrawn - Acute Kidney Injury Clinical Trials

Nitric Oxide During Cardiopulmonary Bypass in Neonates to Reduce Risk of Acute Kidney Injury

Start date: October 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Based on preliminary data available in the literature, we hypothesize that nitric oxide (gNO), administered during cardiopulmonary bypass (CPB), may reduce the risk of acute kidney injury (AKI) via mechanisms of reduced inflammation and vasodilation. In this pilot study, 40 neonates undergoing cardiac surgery will be randomized to receive intraoperative administration of 20 ppm of nitric oxide to the oxygenator of the cardiopulmonary bypass circuit or standard CPB with no additional gas.

NCT ID: NCT04248413 Withdrawn - Clinical trials for Musculoskeletal Injury

Return to Baseball After BFR Therapy for Shoulder Injury

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

The literature is limited on whether BFR therapy provides improved return to function after acute rotator cuff or biceps rehabilitation in non-operative cases, and whether there is a clear mechanism of action in musculotendinous repair after BFR therapy. The purpose of the study is to 1) evaluate patient reported outcomes and return to play in baseball athletes undergoing rehabilitation with blood flow restriction (BFR) therapy for shoulder injury and 2) evaluate changes in blood biomarkers to assess the mechanism of action of BFR therapy in injured athletes. Investigators will perform a randomized blinded placebo-controlled trial of 2 separate study populations: 1) baseball players with biceps or rotator cuff tendinopathy undergoing non-operative treatment with BFR therapy incorporated into routine physical rehabilitation and 2) baseball players with biceps or rotator cuff tendinopathy undergoing non-operative treatment with routine physical rehabilitation alone. Primary outcomes will be functional outcomes and evaluation of return to sport. Functional outcomes will be evaluated using validated patient reported outcome surveys that are upper extremity-specific. Return to sport will be assessed by evaluating time to receiving clearance for returning to routine practices and reported level of physical performance and re-injury. Secondary outcomes will be measurement in muscle strength and blood biomarkers, as well as evaluation of 3D throwing motion. Strength will be measured using a biodex system at baseline prior to beginning physical rehabilitation, half-way through the rehabilitation protocol +/- BFR phase, and once cleared for return to play. Blood biomarkers GH, IGF-I, and IL-6 will be quantified at the same time points in order to investigate the mechanism of action of BFR on tissue repair. Patients will be followed longitudinally during this time for rates of reinjury.